Appendix A - Limited Use Benefits and Criteria

08:00 ANTI-INFECTIVE AGENTS

08:12.02 AMINOGLYCOSIDES

AMIKACIN SULFATE

Limited use benefit (prior approval required).

Table: AMIKACIN SULFATE
Drug strength and dosage form DIN Brand name Manufacturer code
250MG Liquid 02242971 AMIKACIN SULFATE SDZ

TOBRAMYCIN

Limited use benefit (prior approval required).

Table: TOBRAMYCIN
Drug strength and dosage form DIN Brand name Manufacturer code
28MG Capsule 02365154 TOBI PODHALER BGP
1.2G Powder For Solution 00533688 TOBRAMYCIN FKD
1.2G Powder For Solution 02285150 TOBRAMYCIN RAX
10MG/ML Solution 02230639 TOBRAMYCIN FKD
10MG/ML Solution 02241209 TOBRAMYCIN SDZ
40MG/ML Solution 02420287 JAMP-TOBRAMYCIN JMP
40MG/ML Solution 02230640 TOBRAMYCIN FKD
40MG/ML Solution 02241210 TOBRAMYCIN SDZ
40MG/ML Solution 02382814 TOBRAMYCIN MYL
40MG/ML Solution 99005069 TOBRAMYCINE UNK
60MG Solution 02389622 TEVA-TOBRAMYCIN TEV
300MG Solution 02443368 TOBRAMYCIN INHALATION SDZ

08:12.07 MISCELLANEOUS B-LACTAM ANTIBIOTICS

AZTREONAM

Limited use benefit (prior approval required).

For the management of cystic fibrosis (CF) in patients if the following criteria are met:

  • Patient has CF with chronic pulmonary Pseudomonas aeruginosa infections; AND
  • Prescribed by a clinician with experience in the diagnosis and treatment of CF.
Table: AZTREONAM
Drug strength and dosage form DIN Brand name Manufacturer code
75MG Powder For Solution 02329840 CAYSTON GIL

ERTAPENEM

Limited use benefit (prior approval required).

Table: ERTAPENEM
Drug strength and dosage form DIN Brand name Manufacturer code
1G Powder For Solution 02247437 INVANZ FRS

MEROPENEM

Limited use benefit (prior approval required).

Table: MEROPENEM
Drug strength and dosage form DIN Brand name Manufacturer code
500MG Powder For Solution 02378787 MEROPENEM SDZ
1G Powder For Solution 02378795 MEROPENEM SDZ
1G Powder For Solution 02436507 MEROPENEM RAX

08:12.12 MACROLIDES

FIDAXOMICIN

Limited use benefit (prior approval required).

For the treatment of confirmed severea Clostridium Difficile Infection (CDI); AND

Fidaxomicin has been prescribed or recommended by an infectious disease specialist or gastroenterologist; AND

There is a documented allergy (immune-mediated reaction) or severe intolerance to oral vancomycin resulting in discontinuation of vancomycin.

OR

  • After an unsuccessful but adequateb trial of oral vancomycin; AND

- Retreatment with vancomycin is not an optionc; AND

- The patient is at a high risk of hospitalization due to severe complications; AND

- Fidaxomicin is being used as monotherapy.

Notes:

a. Severe infection is defined as having any of the following symptoms: white blood cell count > 15,000 mm3 and fever; acute kidney injury with rising serum creatinine ≥ 1.5 times premorbid level or ≥ 175 micromoles/L; pseudomembranous colitis, hypotension, shock or megacolon.

b. An adequate trial of oral vancomycin is considered to be at least 10 days of therapy with a dose of at least 125mg four times daily.

c. Retreatment with fidaxomicin in recurrent CDI will be considered in symptomatic patients who require treatment of a previously resolved CDI episode. This is defined as a subsequent CDI episode occurring within 2 to 8 weeks of a previous episode from the date of diagnosis.

Table: FIDAXOMICIN
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Tablet 02387174 DIFICID FRS

08:12.16 PENICILLINS

PIPERACILLIN, TAZOBACTAM

Limited use benefit (prior approval required).

Table: PIPERACILLIN, TAZOBACTAM
Drug strength and dosage form DIN Brand name Manufacturer code
2G & 0.25G Powder For Solution 02299623 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM SDZ
2G & 0.25G Powder For Solution 02370158 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM TEV
3G & 0.375G Powder For Solution 02299631 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM SDZ
3G & 0.375G Powder For Solution 02308452 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM APX
3G & 0.375G Powder For Solution 02362627 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM RAX
3G & 0.375G Powder For Solution 02370166 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM TEV
4G & 0.5G Powder For Solution 02299658 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM SDZ
4G & 0.5G Powder For Solution 02308460 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM APX
4G & 0.5G Powder For Solution 02362635 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM RAX
4G & 0.5G Powder For Solution 02370174 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM TEV
12G & 1.5G Powder For Solution 02330547 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM SDZ
12G & 1.5G Powder For Solution 02377748 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM RAX
36G & 4.5G Powder For Solution 02439131 PIPERACILLIN SODIUM/TAZOBACTAM SODIUM RAX

08:12.18 QUINOLONES

LEVOFLOXACIN HEMIHYDRATE

Limited use benefit (prior approval not required).

Coverage will be limited to 14 tablets every 14 days, followed by a 14 day lockout.

Table: LEVOFLOXACIN HEMIHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
240MG Solution 02442302 QUINSAIR UNK
250MG Tablet 02315424 ACT LEVOFLOXACIN TEV
250MG Tablet 02284707 APO-LEVOFLOXACIN APX
250MG Tablet 02284677 PMS-LEVOFLOXACIN PMS
250MG Tablet 02298635 SANDOZ LEVOFLOXACIN SDZ
500MG Tablet 02315432 ACT LEVOFLOXACIN TEV
500MG Tablet 02284715 APO-LEVOFLOXACIN APX
500MG Tablet 02415879 LEVOFLOXACIN PDL
500MG Tablet 02284685 PMS-LEVOFLOXACIN PMS
500MG Tablet 02298643 SANDOZ LEVOFLOXACIN SDZ
750MG Tablet 02315440 ACT LEVOFLOXACIN TEV
750MG Tablet 02325942 APO-LEVOFLOXACIN APX
750MG Tablet 02305585 PMS-LEVOFLOXACIN PMS
750MG Tablet 02298651 SANDOZ LEVOFLOXACIN SDZ

MOXIFLOXACIN HYDROCHLORIDE

Limited use benefit (prior approval not required).

Coverage will be limited to 14 tablets every 14 days, followed by a 14 day lockout.

Table: MOXIFLOXACIN HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
400MG Tablet 02478137 AG-MOXIFLOXACIN ANG
400MG Tablet 02404923 APO-MOXIFLOXACIN APX
400MG Tablet 02432242 AURO-MOXIFLOXACIN AUR
400MG Tablet 02447266 BIO-MOXIFLOXACIN BMI
400MG Tablet 02443929 JAMP-MOXIFLOXACIN JMP
400MG Tablet 02447061 JAMP-MOXIFLOXACIN JMP
400MG Tablet 02447053 MAR-MOXIFLOXACIN MAR
400MG Tablet 02457814 MED-MOXIFLOXACIN GMP
400MG Tablet 02472791 M-MOXIFLOXACIN MAN
400MG Tablet 02462974 MOXIFLOXACIN PDL
400MG Tablet 02450976 RIVA-MOXIFLOXACIN RIV
400MG Tablet 02383381 SANDOZ MOXIFLOXACIN SDZ
400MG Tablet 02375702 TEVA-MOXIFLOXACIN TEV

08:12.28 MISCELLANEOUS ANTIBIOTICS

COLISTIN

Limited use benefit (prior approval required).

For the management of cystic fibrosis (CF) in patients if the following criteria are met:

  • Patient has CF with chronic pulmonary Pseudomonas aeruginosa infections; AND
  • Prescribed by a clinician with experience in the diagnosis and treatment of CF.
Table: COLISTIN
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Powder For Solution 02244849 COLISTIMETHATE FOR U.S.P RAX
150MG Powder For Solution 00476420 COLY-MYCIN M PARENTERAL ERF

LINEZOLID

Limited use benefit (prior approval required).

Tablets:

For treatment of proven vancomycin-resistant enterococci (VRE) infections.

For the treatment of proven methicillin-resistant staphylococcus aureus (MRSA) infections in patients who cannot tolerate vancomycin.

I.V. Solution:

When linezolid cannot be administered orally in the above mentioned situations.

Oral Liquid:

When linezolid cannot be administered orally in the above mentioned situations;

Plus at least one of the following:

  • For treatment of proven vancomycin-resistant enterococci (VRE) infections
  • For the treatment of proven methicillin-resistant staphylococcus aureus (MRSA) infections in patients who cannot tolerate vancomycin.
Table: LINEZOLID
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Powder For Suspension 02243686 ZYVOXAM PFI
2MG/ML Solution 02243685 ZYVOXAM PFI
600MG Tablet 02426552 APO-LINEZOLID APX
600MG Tablet 02422689 SANDOZ LINEZOLID SDZ
600MG Tablet 02243684 ZYVOXAM PFI

RIFAXIMIN

Limited use benefit (prior approval required).

For reducing the risk of overt hepatic encephalopathy (HE) recurrence in patients:

  • Who are unable to achieve adequate control of HE recurrence with a maximal tolerated dose of lactulose alone; AND
  • When used in combination with a maximal tolerated dose of lactulose.
Table: RIFAXIMIN
Drug strength and dosage form DIN Brand name Manufacturer code
ST550MG Tablet 02410702 ZAXINE SLX

VANCOMYCIN HYDROCHLORIDE (INJECTION)

Limited use benefit (prior approval required).

Table: VANCOMYCIN HYDROCHLORIDE (INJECTION)
Drug strength and dosage form DIN Brand name Manufacturer code
Powder 99100176 VANCOMYCIN MDS
500MG Powder For Solution 02420295 JAMP-VANCOMYCIN JMP
500MG Powder For Solution 02406535 MYLAN-VANCOMYCIN MYL
500MG Powder For Solution 02139375 VANCOMYCIN FKD
500MG Powder For Solution 02230191 VANCOMYCIN PFI
500MG Powder For Solution 02394626 VANCOMYCIN SDZ
500MG Powder For Solution 02411032 VANCOMYCIN RAX
500MG Powder For Solution 02435713 VANCOMYCIN GMP
500MG Powder For Solution 02342855 VANCOMYCIN HYDROCHLORIDE RAX
1,000MG Powder For Solution 02230192 VANCOMYCIN PFI
1,000MG Powder For Solution 02396386 VANCOMYCIN RAX
1,000MG Powder For Solution 02435721 VANCOMYCIN GMP
1G Powder For Solution 02420309 JAMP-VANCOMYCIN JMP
1G Powder For Solution 02406543 MYLAN-VANCOMYCIN MYL
1G Powder For Solution 02241821 PMS-VANCOMYCIN 1 G PMS
1G Powder For Solution 02139383 VANCOMYCIN FKD
1G Powder For Solution 02394634 VANCOMYCIN SDZ
1G Powder For Solution 02342863 VANCOMYCIN HYDROCHLORIDE RAX
5G Powder For Solution 02420317 JAMP-VANCOMYCIN JMP
5G Powder For Solution 02406551 MYLAN-VANCOMYCIN MYL
5G Powder For Solution 02139243 VANCOMYCIN FKD
5G Powder For Solution 02378337 VANCOMYCIN PFI
5G Powder For Solution 02394642 VANCOMYCIN SDZ
10G Powder For Solution 02420325 JAMP-VANCOMYCIN JMP
10G Powder For Solution 02406578 MYLAN-VANCOMYCIN MYL
10G Powder For Solution 02241807 VANCOMYCIN FKD
10G Powder For Solution 02378345 VANCOMYCIN PFI
10G Powder For Solution 02394650 VANCOMYCIN SDZ
10G Powder For Solution 02411040 VANCOMYCIN RAX
10G Powder For Solution 02405830 VANCOMYCIN HYDROCHLORIDE RAX

08:14.08 AZOLES

VORICONAZOLE

Limited use benefit (prior approval required).

For the treatment of patients with invasive aspergillosis; OR

For the treatment of culture proven invasive candidiasis with documented resistance to fluconazole.

Table: VORICONAZOLE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Tablet 02409674 APO-VORICONAZOLE APX
50MG Tablet 02399245 SANDOZ VORICONAZOLE SDZ
50MG Tablet 02396866 TEVA-VORICONAZOLE TEV
50MG Tablet 02256460 VFEND PFI
200MG Tablet 02409682 APO-VORICONAZOLE APX
200MG Tablet 02399253 SANDOZ VORICONAZOLE SDZ
200MG Tablet 02396874 TEVA-VORICONAZOLE TEV
200MG Tablet 02256479 VFEND PFI

08:18.08 ANTIRETROVIRALS

TENOFOVIR DISOPROXIL FUMARATE

Limited use benefit (prior approval required).

For the treatment of patients with HIV-1 infection who have failed or have experienced adverse events to an alternative agent.

For the treatment of patients with chronic hepatitis B infection who have cirrhosis documented on radiologic or histologic grounds and a HBV concentration above 2,000 IU/mL.

Table: TENOFOVIR DISOPROXIL FUMARATE
Drug strength and dosage form DIN Brand name Manufacturer code
245MG Tablet 02247128 VIREAD GIL
300MG Tablet 02451980 APO-TENOFOVIR APX
300MG Tablet 02460173 AURO-TENOFOVIR AUR
300MG Tablet 02479087 JAMP-TENOFOVIR JMP
300MG Tablet 02452634 MYLAN-TENOFOVIR DISOPROXIL MYL
300MG Tablet 02472511 NAT-TENOFOVIR NPH
300MG Tablet 02453940 PMS-TENOFOVIR PMS
300MG Tablet 02403889 TEVA-TENOFOVIR TEV

08:18.20 INTERFERONS

PEGINTERFERON ALFA-2A

Limited use benefit (prior approval required).

For the treatment of patients with chronic hepatitis B infection who have a HBV DNA concentration above 2,000 IU/mL without decompensated cirrhosis, upon the written request of a hepatologist or other specialist in this area.

Table: PEGINTERFERON ALFA-2A
Drug strength and dosage form DIN Brand name Manufacturer code
180MCG/0.5ML Solution 02248077 PEGASYS HLR

PEGINTERFERON ALFA-2B, RIBAVIRIN

Limited use benefit (prior approval required).

For the treatment of chronic hepatitis C in patients who are treatment naïve, upon the written request of a hepatologist or other specialist in this area.

  • For genotypes 1, 4, 5 and 6, an initial 24 week supply will be approved. A further 24 week supply may be approved if patient has a viral reduction of at least 2 logs or HCV is undetectable at 12 weeks (48 weeks total).
  • For genotypes 2 or 3, initial coverage for a maximum of 24 weeks will be approved. Renewals will not be covered.
Table: PEGINTERFERON ALFA-2B, RIBAVIRIN
Drug strength and dosage form DIN Brand name Manufacturer code
50MCG/0.5ML & 200MG Kit 02254573 PEGETRON KIT FRS

PEGINTERFERON BETA-1A

Limited use benefit (prior approval required).

  • As a first-line therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist experienced in the management of RRMS.

AND for patients who meet ALL of the following criteria:

  • Patient has had a clinical relapse and/or new MRI activity in the last two years; AND
  • Patient is fully ambulatory for 100 meters without aids; AND
  • Patient is 18 years of age or older.
Table: PEGINTERFERON BETA-1A
Drug strength and dosage form DIN Brand name Manufacturer code
94MCG Injection 02444402 PLEGRIDY UNK
125MCG Liquid 02444399 PLEGRIDY UNK

08:18.32 NUCLEOSIDES AND NUCLEOTIDES

ADEFOVIR DIPIVOXIL

Limited use benefit (prior approval required).

For the treatment of chronic hepatitis B infection when used in combination with lamivudine in patients who have developed failure to lamivudine, as defined by an increase in HBV DNA of ≥ 1 log10 IU/mL above the nadir, measured on two separate occasions within an interval of at least one month, after the first three months of lamivudine therapy, and when failure to lamivudine is not due to poor adherence to therapy.

Table: ADEFOVIR DIPIVOXIL
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Tablet 02420333 APO-ADEFOVIR APX
10MG Tablet 02247823 HEPSERA GIL

ENTECAVIR MONOHYDRATE

Limited use benefit (prior approval required).

For the treatment of chronic hepatitis B infection in patients with cirrhosis documented on radiologic or histologic grounds and a HBV DNA concentration above 2000IU/mL.

Table: ENTECAVIR MONOHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
0.5MG Tablet 02396955 APO-ENTECAVIR APX
0.5MG Tablet 02448777 AURO-ENTECAVIR AUR
0.5MG Tablet 02282224 BARACLUDE BMS
0.5MG Tablet 02467232 JAMP ENTECAVIR JMP
0.5MG Tablet 02430576 PMS-ENTECAVIR PMS

08:18.40 HCV ANTIVIRALS

DACLATASVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria:

Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); AND

Laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

Table: DACLATASVIR
Drug strength and dosage form DIN Brand name Manufacturer code
60MG Tablet 02444755 DAKLINZA BMS

ELBASVIR, GRAZOPREVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria:

Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); AND

Laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

Table: ELBASVIR, GRAZOPREVIR
Drug strength and dosage form DIN Brand name Manufacturer code
50MG & 100MG Tablet 02451131 ZEPATIER FRS

GLECAPREVIR, PIBRENTASVIR

Limited use benefit (prior approval required).

For treatment-naïve or treatment-experienced adult patients with genotypes 1, 2, 3, 4, 5, 6 with; OR

For the treatment of direct acting antivirals (DAA)-experienced2 adult patients with genotype 1 with:

  • Chronic hepatitis C at any fibrosis stage (F0-F4); AND
  • Detectable levels of HCV RNA in the last 12 months;

For genotypes 1, 2, 3, 4, 5 or 6, treatment-experienced is defined as a patient who has been previously treated with interferon, peginterferon (P), ribavirin (R) and/or sofosbuvir (SOF) (PR, SOF + PR, SOF + RBV), but no prior treatment experience with an NS3/4A protease inhibitor or NS5A inhibitor.

For genotype 1, DAA treatment-experienced is defined as a patient who has been previously treated with DAA regimens containing NS5A inhibitor [daclatasvir (DCV) + SOF or DCV + PR or ledipasvir/sofosbuvir, but no prior treatment experience with NS3/4A protease inhibitors] or containing NS3/4A protease inhibitors [simeprevir+SOF or simeprevir+PR or boceprevir+PR or telaprevir+PR, but no prior treatment experience with an NS5Ainhibitor].

Table: GLECAPREVIR, PIBRENTASVIR
Drug strength and dosage form DIN Brand name Manufacturer code
100MG & 40MG Tablet 02467550 MAVIRET ABV

RIBAVIRIN

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria:

Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); AND

Laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

Table: RIBAVIRIN
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Tablet 02439212 IBAVYR PED
400MG Tablet 02425890 IBAVYR PED
600MG Tablet 02425904 IBAVYR PED

SOFOSBUVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria:

Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); AND

Laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

Table: SOFOSBUVIR
Drug strength and dosage form DIN Brand name Manufacturer code
400MG Tablet 02418355 SOVALDI GIL

SOFOSBUVIR, LEDIPASVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria:

Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); AND

Laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

Table: SOFOSBUVIR, LEDIPASVIR
Drug strength and dosage form DIN Brand name Manufacturer code
400MG & 90MG Tablet 02432226 HARVONI GIL

SOFOSBUVIR, VELPATASVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria:

Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); AND

Laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

Table: SOFOSBUVIR, VELPATASVIR
Drug strength and dosage form DIN Brand name Manufacturer code
400MG & 100MG Tablet 02456370 EPCLUSA GIL

SOFOSBUVIR, VELPATASVIR, VOXILAPREVIR

Limited use benefit (prior approval required).

For treatment-experienced adult patients with:

  • Chronic hepatitis C at any fibrosis stage (F0-F4); AND
  • Detectable levels of HCV RNA in the last 12 months;

AND

Treatment-experienced having failed a prior therapy with an HCV regimen containing:

  • NS5A inhibitor: daclatasvir (Daklinza), elbasvir (part of Zepatier), ledipasvir (part of Harvoni), ombitasvir (part of Holkira Pak ), velpatasvir (part of Epclusa ) for genotype 1, 2, 3, 4, 5 or 6; OR
  • sofosbuvir (Sovaldi ) without an NS5A inhibitor for genotype 1, 2, 3 or 4.
Table: SOFOSBUVIR, VELPATASVIR, VOXILAPREVIR
Drug strength and dosage form DIN Brand name Manufacturer code
400MG & 100MG & 100MG Tablet 02467542 VOSEVI GIL

08:36.00 URINARY ANTI-INFECTIVES

FOSFOMYCIN TROMETHAMINE

Limited use benefit (prior approval required).

For the treatment of women (>12 years old) with:

  • Urinary tract infections with organisms resistant to first line therapy; OR
  • Urinary tract infections in pregnancy when first-line agents are contraindicated.
Table: FOSFOMYCIN TROMETHAMINE
Drug strength and dosage form DIN Brand name Manufacturer code
3G/PK Powder For Solution 02240335 MONUROL PAL
3G Powder For Solution 02473801 JAMP-FOSFOMYCIN JMP

10:00 ANTINEOPLASTIC AGENTS

10:00.00 ANTINEOPLASTIC AGENTS

ABIRATERONE ACETATE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of metastatic castration resistant prostate cancer patients (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) and who have not received prior chemotherapy if they meet the following criteria:

  • Used in combination with prednisone; AND
  • Patient has an ECOG performance status of 0 or 1.

For the treatment of metastatic castration resistant prostate cancer patients (mCRPC) who progressed on docetaxel-based chemotherapy if they meet the following criteria:

  • Used in combination with prednisone; AND
  • Patient has an ECOG performance status ≤ 2; AND
  • Abiraterone is not used as an add-on therapy to enzalutamide (Xtandi); AND
  • Abiraterone has not been used in the pre-docetaxel setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression

Table: ABIRATERONE ACETATE
Drug strength and dosage form DIN Brand name Manufacturer code
250MG Tablet 02371065 ZYTIGA JSO
500MG Tablet 02457113 ZYTIGA JSO

AFATINIB DIMALEATE

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC) who meet ALL of the following criteria:

  • First line treatment of patients; AND
  • EGFR mutation positive; AND
  • Advanced or metastatic adenocarcinoma of the lung; AND
  • An ECOG performance status of 0 or 1.

Criteria for renewal every 6 months:

  • There is no objective evidence of disease progression.

Use of afatinib precludes the use of any other EGFR inhibitor as a subsequent line of therapy.

Table: AFATINIB DIMALEATE
Drug strength and dosage form DIN Brand name Manufacturer code
20MG Tablet 02415666 GIOTRIF BOE
30MG Tablet 02415674 GIOTRIF BOE
40MG Tablet 02415682 GIOTRIF BOE

ALECTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC); OR

Second-line treatment of patients with locally advanced not amenable to curative therapy or metastatic NSCLC who have disease progression on or intolerance to crizotinib.

AND

To be used as monotherapy; AND

Disease is anaplastic lymphoma kinase (ALK)-positive; AND

Patient has a good performance status.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: ALECTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Capsule 02458136 ALECENSARO HLR

AXITINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the second-line treatment of patients with advanced or metastatic clear cell renal carcinoma after failure of prior therapy with a first-line agent.

Patients are only eligible for either everolimus or axitinib in the second-line setting, but not sequential use of both agents except in cases of intolerance.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: AXITINIB
Drug strength and dosage form DIN Brand name Manufacturer code
1MG Tablet 02389630 INLYTA PFI
5MG Tablet 02389649 INLYTA PFI

BOSUTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Patients has Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML); AND

Patient has an ECOG performance status of 0 to 2;

AND

  • Documented resistance/disease progression to at least one prior oral tyrosine kinase inhibitor [TKI] (imatinib, dasatinib or nilotinib); OR
  • Documented intolerance to one prior oral TKI (imatinib, dasatinib or nilotinib) where subsequent treatment with an alternative oral TKI is not clinically appropriate.

Criteria for renewal every 12 months:

Confirmation from the clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so AND has not developed unacceptable toxicities.

Table: BOSUTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02419149 BOSULIF PFI
500MG Tablet 02419157 BOSULIF PFI

CERITINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

  • Second-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have disease progression on or intolerance to crizotinib; AND
  • To be used as monotherapy; AND
  • Disease is anaplastic lymphoma kinase (ALK)-positive; AND
  • Patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

  • There is no objective evidence of disease progression.
Table: CERITINIB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Capsule 02436779 ZYKADIA NVR

COBIMETINIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with vemurafenib (Zelboraf).

AND for patients who meet the following criteria:

  • Patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; AND
  • Patient does not have brain metastases or brain metastases are asymptomatic or stable; AND
  • Patient has an ECOG performance status of 0 to 1.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: COBIMETINIB
Drug strength and dosage form DIN Brand name Manufacturer code
20MG Tablet 02452340 COTELLIC HLR

CRIZOTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

First-line treatment of patients with advanced non-small cell lung cancer (NSCLC); OR

Second-line treatment of patients with advanced NSCLC who have received one prior chemotherapy regimen.*

AND

  • Patient is anaplastic lymphoma kinase (ALK)-positive; AND
  • Patient has an ECOG performance status of 0 to 2.

*Patients who have progressed during or following first-line therapy with crizotinib are not eligible to receive crizotinib as a second-line therapy.

Criteria for renewal every 12 months:

The patient has experienced a hematologic and/or cytogenic response to crizotinib and is expected to continue to do so.

Table: CRIZOTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Capsule 02384256 XALKORI PFI

DABRAFENIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

  • For the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; OR
  • For the first-line treatment of patients with metastatic or unresectable melanoma in combination with trametinib (Mekinist)

AND for patients who meet the following criteria:

  • Patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; AND
  • Patient does not have brain metastases or brain metastases are asymptomatic or stable; AND
  • Patient has an ECOG performance status of 0 to 1;

AND

  • Patient is previously untreated.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: DABRAFENIB
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Capsule 02409607 TAFINLAR NVR
75MG Capsule 02409615 TAFINLAR NVR

ENZALUTAMIDE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are/have:

  • Asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) who have not received prior chemotherapy; AND
  • Have an ECOG performance status of 0 or 1 with no risk factors for seizures; OR
  • Progressed on docetaxel-based chemotherapy with an ECOG performance status ≤2 and no risk factors for seizures; AND
  • Would be an alternative to abiraterone for patients in the post-docetaxel setting but would not be an add-on therapy to abiraterone treatment.

Patients previously treated with abiraterone would not be eligible for enzalutamide unless unable to tolerate abiraterone.

Use of enzalutamide in the post-docetaxel setting is not permitted if previously used in the pre-chemotherapy setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression

Table: ENZALUTAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Capsule 02407329 XTANDI AST

ERLOTINIB HYDROCHLORIDE

Limited use benefit (prior approval required).

Treatment of non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown.

Table: ERLOTINIB HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Tablet 02461862 APO-ERLOTINIB APX
25MG Tablet 02483912 NAT-ERLOTINIB NPH
25MG Tablet 02269007 TARCEVA HLR
25MG Tablet 02377691 TEVA-ERLOTINIB TEV
100MG Tablet 02461870 APO-ERLOTINIB APX
100MG Tablet 02454386 PMS-ERLOTINIB PMS
100MG Tablet 02269015 TARCEVA HLR
100MG Tablet 02377705 TEVA-ERLOTINIB TEV
150MG Tablet 02461889 APO-ERLOTINIB APX
150MG Tablet 02454394 PMS-ERLOTINIB PMS
150MG Tablet 02269023 TARCEVA HLR
150MG Tablet 02377713 TEVA-ERLOTINIB TEV

EVEROLIMUS

Limited use benefit (prior approval required).

1. Advanced Breast Cancer

Criteria for initial 12-month coverage:

For documented hormone receptor positive, HER2 negative advanced breast cancer; AND

  • Used in combination with exemestane; AND
  • Patient has an ECOG performance status of 0 to 2; AND
  • Patient's condition recurred or progressed on a non-steroidal aromatase inhibitor.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

2. Advanced or Metastatic Renal Cell Carcinoma (mRCC)

Criteria for initial 12-month coverage:

For documented advanced or metastatic clear cell renal carcinoma; AND

For use as second- or third-line treatment of mRCC.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

3. Pancreatic Neuroendocrine Tumors (pNET)

Criteria for initial 12-month coverage:

For documented, progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors; AND

  • Patient has an ECOG performance status of 0 to 2; AND
  • For patients previously treated with other agents,

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

4. Non-functional Neuroendocrine Tumors (NETs) of Gastrointestinal or Lung Origin (GIL)

Criteria for initial 12-month coverage:

For documented unresectable, locally advanced or metastatic, progressive, well-differentiated non-functional NET-GIL in adults ≥18 years of age; AND

  • Patient has documented radiological disease progression within the previous six months; AND
  • Patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: EVEROLIMUS
Drug strength and dosage form DIN Brand name Manufacturer code
2.5MG Tablet 02369257 AFINITOR NVR
5MG Tablet 02339501 AFINITOR NVR
10MG Tablet 02339528 AFINITOR NVR
2MG Tablet For Suspension 02425645 AFINITOR DISPERZ NVR
3MG Tablet For Suspension 02425653 AFINITOR DISPERZ NVR
5MG Tablet For Suspension 02425661 AFINITOR DISPERZ NVR

GEFITINIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who meet ALL of the following criteria:

  • First-line treatment; AND
  • EGFR mutation positive; AND
  • Patient has an ECOG* performance status of 0 to 2.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: GEFITINIB
Drug strength and dosage form DIN Brand name Manufacturer code
250MG Tablet 02468050 APO-GEFITINIB APX
250MG Tablet 02248676 IRESSA AZC

IBRUTINIB

Limited use benefit (prior approval required).

1. For the treatment of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (first-line)

Criteria for initial 12-month coverage:

As a first-line treatment option for newly diagnosed treatment naive chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); AND

  • Patient's prescriber has deemed that it would be inappropriate for the patient to receive treatment with a fludarabine-based regimen; AND
  • Patient has high risk CLL, such that ibrutinib is preferred over anti-CD20 therapy, with one of the following cytogenic markers:

- Chromosome 17p deletion [del(17p)]

- TP 53 mutation

- Unmutated immunoglobulin heavy chain variable region (IgHV)

  • Other reason.

Note: Anti-CD20 therapy is not funded as a sequential treatment option after ibrutinib. Choice of ibrutinib as first-line therapy must take this into account.

Ibrutinib is not funded as a sequential treatment option for patients who have progressed on idelalisib treatment in the relapsed setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

2. For the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (second-line)

Criteria for initial 12-month coverage:

Demonstrated diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); AND

  • Patient has received at least one prior therapy to treat CLL/SLL; AND
  • Patient's prescriber has deemed that it would be inappropriate for the patient to receive treatment or retreatment with a fludarabine-based regimen.

Note: Ibrutinib is not funded as a sequential treatment option for patients who have progressed on idelalisib treatment in the relapsed setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

3. For the treatment of relapsed/refractory mantle cell lymphoma (MCL)

Criteria for initial 12-month coverage:

Demonstrated diagnosis of relapsed/refractory mantle cell lymphoma (MCL); AND

  • Patient has received at least one prior therapy to treat MCL.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: IBRUTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
140MG Capsule 02434407 IMBRUVICA JSO

IDELALISIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

  • For the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab. Treatment should continue until unacceptable toxicity or disease progression.

Criteria for renewal every 6 months:

  • There is no objective evidence of disease progression.
Table: IDELALISIB
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02438798 ZYDELIG GIL
150MG Tablet 02438801 ZYDELIG GIL

IMATINIB MESYLATE

Limited use benefit (prior approval required).

  • For the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase.
  • For the treatment of patients with gastrointestinal stromal tumour.
  • For newly diagnosed adult patients with Philadelphia chromosome-positive (CML).
  • For the treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia

(Ph+ ALL).

Table: IMATINIB MESYLATE
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02355337 APO-IMATINIB APX
100MG Tablet 02253275 GLEEVEC NVR
100MG Tablet 02397285 NAT-IMATINIB NPH
100MG Tablet 02431114 PMS-IMATINIB PMS
100MG Tablet 02399806 TEVA-IMATINIB TEV
400MG Tablet 02355345 APO-IMATINIB APX
400MG Tablet 02253283 GLEEVEC NVR
400MG Tablet 02397293 NAT-IMATINIB NPH
400MG Tablet 02431122 PMS-IMATINIB PMS
400MG Tablet 02399814 TEVA-IMATINIB TEV

LENALIDOMIDE

Limited use benefit (prior approval required).

1. For the treatment of Myelodysplastic syndrome (MDS)

Criteria for initial 6-month coverage:

  • Demonstrated diagnosis of Myelodysplastic syndrome (MDS) on bone marrow aspiration; AND
  • Documented presence of del(5q) abnormality by standard cytogenetic or fluorescence in situ hybridization; AND
  • International prognostic scoring system (IPSS) risk category low or intermediate-1; AND
  • Transfusion-dependent symptomatic anemia.

Criteria for renewal every 12 months:

  • Patient has demonstrated a reduction in transfusion requirements of at least 50%.

2. For the treatment of Refractory/relapsed Multiple Myeloma after one prior therapy (MM-AOPT)

Criteria for initial 12-month coverage:

  • Progressive Multiple Myeloma; AND
  • For use in combination with dexamethasone; AND
  • Patient is refractory to initial or subsequent treatments or has relapsed after the conclusion of prior treatments and is suitable for further chemotherapy; OR
  • Patient has completed at least one full treatment regimen as initial therapy and has demonstrated an intolerance to their current chemotherapy.

Criteria for renewal every 12 months:

  • There is no objective evidence of disease progression or development of unacceptable toxicity to lenalidomide requiring discontinuation of therapy.

3. For the treatment of Newly diagnosed Multiple Myeloma for patients who are not eligible for autologous stem cell transplant - (MM-TNE)

Criteria for initial 12-month coverage:

  • As a first-line treatment option for newly diagnosed patients with multiple myeloma who are not candidates for autologous stem-cell transplant; AND
  • For use in combination with dexamethasone; AND
  • Who have an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

  • There is no objective evidence of disease progression or development of unacceptable toxicity to lenalidomide requiring discontinuation of therapy.

4. For the maintenance treatment for newly diagnosed Multiple Myeloma post-autologous stem cell transplant

Criteria for initial 12-month coverage:

  • Newly diagnosed Multiple Myeloma; AND
  • The disease is stable or improved, with no evidence of progression after autologous stem-cell transplant.

Coverage is provided for lenalidomide at an initial dose of 10 mg daily. Doses adjustments of up to 15 mg daily may be required based on individual patient characteristics/response.

Criteria for renewal every 12 months:

  • There is no objective evidence of disease progression or development of unacceptable toxicity to lenalidomide requiring discontinuation of therapy.
Table: LENALIDOMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
2.5MG Capsule 02459418 REVLIMID UNK
5MG Capsule 02304899 REVLIMID UNK
10MG Capsule 02304902 REVLIMID UNK
15MG Capsule 02317699 REVLIMID UNK
20MG Capsule 02440601 REVLIMID UNK
25MG Capsule 02317710 REVLIMID UNK

LENVATINIB

Limited use benefit (prior approval required).

Criteria for initial 4-month coverage:

  • Used as monotherapy for treatment of patients with locally recurrent or metastatic, progressive differentiated thyroid cancer (DTC); AND
  • DTC is refractory to radioactive iodine treatment; AND
  • Have an ECOG performance status of ≤ 2;

AND

Patient meets the eligibility criteria of the SELECT trial as follows:

  • Pathologically confirmed differentiated thyroid cancer (patients with anaplastic or medullary thyroid cancer are not eligible)
  • Evidence of iodine-131 refractory disease according to at least one of the following criteria:

- At least one measurable lesion without iodine uptake on any iodine-131 scan

- At least one measurable lesion that had progressed according to RECIST criteria within 12 months after iodine-131 therapy despite iodine-131 avidity at the time of treatment

- Total lifetime radioactive iodine dose greater than 600 mCi (millicurie)

  • Radiologic evidence of progression within the previous 13 months
  • No prior therapy with a tyrosine kinase inhibitor or have received one prior treatment regimen with a tyrosine kinase inhibitor

Criteria for renewal every 4 months:

There is no objective evidence of disease progression.

Table: LENVATINIB
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Capsule 02450321 LENVIMA EIS
14MG Capsule 02450313 LENVIMA EIS
20MG Capsule 02450305 LENVIMA EIS
24MG Capsule 02450291 LENVIMA EIS

MIDOSTAURIN

Limited use benefit (prior approval required).

Criteria for 12-month coverage:

  • Patient has newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML); AND
  • Patient's FLT3-mutation status has been confirmed; AND
  • Midostaurin is being used in combination with standard cytarabine and daunorubicin (or idarubicin) induction and cytarabine consolidation chemotherapy; AND
  • Patient has an ECOG performance status of 0 to 2.
Table: MIDOSTAURIN
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Capsule 02466236 RYDAPT NVR

NILOTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Patients has newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase; OR

Patient has chronic phase or accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia;

AND

  • Patient has disease progression/resistance to imatinib; OR
  • Documented intolerance to a prior oral TKI (imatinib, dasatinib or bosutinib).

Criteria for renewal every 12 months:

  • Confirmation from the clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so AND has not developed unacceptable toxicities.
Table: NILOTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Capsule 02368250 TASIGNA NVR
200MG Capsule 02315874 TASIGNA NVR

OLAPARIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

  • Maintenance treatment of adult patients with high grade serous epithelial ovarian fallopian tube cancer; OR
  • Primary peritoneal cancer;

AND

  • Platinum-sensitive disease; AND
  • Relapsed BRCA-mutated disease (germline or somatic as detected by approved testing)
  • Have completed at least two previous lines of platinum-based chemotherapy; AND
  • Radiologic response (complete or partial response) to their most recent platinum-based chemotherapy regimen as per the SOLO-2 trial; AND
  • Patient has an ECOG performance status of 0 to 2;

AND

  • Olaparib is used as monotherapy

Criteria for renewal every 12 months:

  • There is no objective evidence of disease progression.
Table: OLAPARIB
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Capsule 02454408 LYNPARZA AZC
100MG Tablet 02475200 LYNPARZA AZC
150MG Tablet 02475219 LYNPARZA AZC

OSIMERTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Patient with locally advanced or metastatic non-small cell lung cancer (NSCLC) who has progressed on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor therapy;

AND

Patient is EGFR T790M mutation- positive; AND

Patient has an ECOG* performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: OSIMERTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Tablet 02456214 TAGRISSO AZC
80MG Tablet 02456222 TAGRISSO AZC

PALBOCICLIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of post-menopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer; AND

  • The patient has not received any prior treatment for metastatic disease (first-line treatment); AND
  • Palbociclib will be used in combination with an aromatase inhibitor; AND
  • Patient has an ECOG performance status of 0 to 2; AND
  • Patient is not resistant to prior (neo)adjuvant aromatase inhibitor therapy; AND
  • Patient does not have active or uncontrolled metastases to the central nervous system.

Criteria for renewal every 12 months:

  • There is no objective evidence of disease progression.
Table: PALBOCICLIB
Drug strength and dosage form DIN Brand name Manufacturer code
75MG Capsule 02453150 IBRANCE PFI
100MG Capsule 02453169 IBRANCE PFI
125MG Capsule 02453177 IBRANCE PFI

PAZOPANIB

Limited use benefit (prior approval required).

Initial coverage criteria (12 months)

For the first-line treatment of patients with advanced or metastatic clear cell renal carcinoma; AND

Patient has an ECOG performance status of 0 to 2.

Renewal coverage criteria (12 months)

There is no objective evidence of disease progression.

Table: PAZOPANIB
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Tablet 02352303 VOTRIENT NVR

POMALIDOMIDE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of relapsed or refractory multiple myeloma who meet all of the following criteria:

  • Used in combination with dexamethasone; AND
  • Patient has relapsed or is refractory to at least two treatment regimens, including both bortezomib and lenalidomide; AND
  • Patient has demonstrated disease progression on the last regimen.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or development of unacceptable toxicity to pomalidomide requiring discontinuation of therapy.

Table: POMALIDOMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
1MG Capsule 02419580 POMALYST UNK
2MG Capsule 02419599 POMALYST UNK
3MG Capsule 02419602 POMALYST UNK
4MG Capsule 02419610 POMALYST UNK

PONATINIB HYDROCHLORIDE

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

  • For the treatment of patients who have confirmed T315i mutation positive disease, independent of previous TKI therapy; OR
  • Treatment of last resort for patients with intolerances or contraindications to imatinib and all other second generation TKI's (dasatinib, nilotinib, bosutinib); OR
  • For the treatment of patients with chronic phase chronic myeloid leukemia (CML) who have resistance/disease progression after at least two prior lines of TKI therapy where Iclusig would be available as third-line TKI option; OR
  • For the treatment of patients with accelerated phase or blast phase CML or Ph+ ALL who have resistance or disease progression after at least one second generation TKI therapy;

AND

  • An ECOG performance status of 0 to 2.

Note: Second generation TKI's (dasatinib, nilotinib, bosutinib) are not covered as options after ponatinib.

Criteria for renewal every 6 months:

  • There is no objective evidence of disease progression.
Table: PONATINIB HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
15MG Tablet 02437333 ICLUSIG ARI
45MG Tablet 02437341 ICLUSIG ARI

REGORAFENIB

Limited use benefit (prior approval required).

1. For the treatment of Gastrointestinal Stromal Tumors (GIST)

Criteria for initial six-month coverage:

  • For patients with gastrointestinal stromal tumors (GIST) who have failed or are unable to tolerate imatinib and sunitinib therapy; AND
  • Patient has an ECOG performance status of 0 or 1;

Note: Regorafenib will not be funded concomitantly with imatinib or sunitinib.

Criteria for assessment every 12 months:

  • There is no objective evidence of disease progression.

2. For the treatment of Hepatocellular Carcinoma (HCC)

Criteria for initial six-month coverage:

  • Patient diagnosed with unresectable HCC; AND
  • Patient has been previously treated with sorafenib; AND
  • Patient was able to tolerate sorafenib as defined in the RESORCE trial criteria (≥400mg/day for ≥20 days of the last 28 days of treatment); AND
  • Patient has a Child-Pugh class status of A; AND
  • Patient has an ECOG* performance status of 0 to 1

Criteria for assessment every 12 months:

  • There is no objective evidence of disease progression.
Table: REGORAFENIB
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Tablet 02403390 STIVARGA BAY

RIBOCICLIB (RIBOCICLIB SUCCINATE)

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer:

  • The patient has not received any prior treatment for metastatic disease (first-line treatment); AND
  • Ribociclib will be used in combination with letrozole; AND
  • Patient has an ECOG* performance status of 0 to 2.
  • Patient is not resistant* to prior (neo)adjuvant nonsteroidal aromatase inhibitor therapy (NSAI); AND
  • Patient does not have active or uncontrolled metastases to the central nervous system.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

*Resistance is defined as disease progression occurring during or within 12 months following aromatase inhibitor therapy.

Table: RIBOCICLIB (RIBOCICLIB SUCCINATE)
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Tablet 02473569 KISQALI NVR

RITUXIMAB

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Initial coverage is provided for 24 weeks at a dose of 1000 mg x 2 doses at 0 & 2 weeks.

  • Prescribed by a rheumatologist

For the treatment of adult patients with severely active rheumatoid arthritis who have failed to respond to a trial of an anti-TNF agent. Treatment should be combined with methotrexate. Rituximab should not be used in combination with anti-TNF agents.

For continued coverage for rituximab beyond twenty-four weeks, patient must meet all the following criteria:

  • Initially prescribed by a rheumatologist;

AND

Patient has been assessed after the twentieth to twenty-fourth week of rituximab therapy and meets the response criteria of:

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of GRANULOMATOSIS POLYANGIITIS OR MICROSCOPIC POLYANGIITIS

Coverage is provided at a dose of 375 mg/m2body surface area, administered as an IV infusion once weekly for 4 weeks.

For the induction of remission in patients with severely active granulomatosis with polyangiitis or microscopic polyangiitis; AND

  • Who have failed an adequate trial of cyclophosphamide; OR
  • Who have a contraindication to cyclophosphamide.
Table: RITUXIMAB
Drug strength and dosage form DIN Brand name Manufacturer code
10MG/ML Solution 02241927 RITUXAN HLR

RUXOLITINIB

Limited use benefit (prior approval required).

1. For the treatment of Myelofibrosis:

Criteria for initial 6-month coverage:

  • Intermediate to high risk symptomatic myelofibrosis as assessed using the Dynamic International Prognostic Scoring System (DIPSS) Plus; OR
  • Patient has symptomatic splenomegaly;

AND

  • Patient has an ECOG performance status of 0 to 3; AND
  • Patient previously untreated OR refractory to other treatment.

Criteria for renewal every 12 months:

  • Reduction in spleen size; OR
  • Improvement in disease symptoms.

2. For the treatment of patients with polycythemia vera:

Criteria for initial 6-month coverage:

Disease is resistant to hydroxyurea (HU) according to the modified European LeukemiaNet Criteria defined as below:

After 3 months of at least 2g/day of HU or at the maximally tolerated HU dose, patient showed:

  • Need for phlebotomy to keep hematocrit < 45%; OR
  • Uncontrolled myeloproliferation (platelet > 400x109/L and WBC > 10x109/L); OR
  • Failure to reduce massive splenomegaly > 50% as measured by palpation.

OR

Patient is intolerant to HU according to the modified European LeukemiaNet Criteria defined below:

After any dose of HU, patient showed:

  • Absolute neutrophil count < 1.0 x 109/L , or platelet < 100x109/L or hemoglobin < 100 g/L at the lowest dose of HU required to achieve a response (response defined as hematocrit < 45% without phlebotomy, and/or all of the following : platelet ≤ 400x109/L , WBC ≤ 10 x 109/L , and non-palpable spleen); OR
  • Presence of leg ulcers or other unacceptable HU-related non-hematological toxicities (such as mucocutaneous manifestations, gastrointestinal symptoms, pneumonitis or fever, defined as Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade 3 or 4, or more than one week of CTCAE version 3.0 grade 2, or permanent discontinuation of HU, or interruption of HU until toxicity resolved, or hospitalization due to HU toxicity).

AND

  • Patient has an ECOG performance status of 0 to 3.

Criteria for renewal every 12 months:

  • Reduction in spleen size; OR
  • Improvement in disease symptoms.
Table: RUXOLITINIB
Drug strength and dosage form DIN Brand name Manufacturer code
5MG Tablet 02388006 JAKAVI NVR
10MG Tablet 02434814 JAKAVI NVR
15MG Tablet 02388014 JAKAVI NVR
20MG Tablet 02388022 JAKAVI NVR

SUNITINIB MALATE

Limited use benefit (Prior approval required).

Criteria for initial 6-month coverage:

  • For patients with histologically proven unresectable or recurrent/metastatic GIST who have failed or are unable to tolerate imatinib therapy.

Sunitinib will not be funded concomitantly with imatinib.

OR

Criteria for initial 12-month coverage:

  • Documented, progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors; AND
  • Patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

  • There is no objective evidence of disease progression.
Table: SUNITINIB MALATE
Drug strength and dosage form DIN Brand name Manufacturer code
12.5MG Capsule 02280795 SUTENT PFI
25MG Capsule 02280809 SUTENT PFI
50MG Capsule 02280817 SUTENT PFI

TRAMETINIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; OR

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with dabrafenib(Tafinlar)

AND for patients who meet the following criteria:

  • Patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; AND
  • Patient does not have brain metastases or brain metastases are asymptomatic or stable; AND
  • Patient has an ECOG performance status of 0 to 1;

AND

  • Patient is previously untreated.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: TRAMETINIB
Drug strength and dosage form DIN Brand name Manufacturer code
0.5MG Tablet 02409623 MEKINIST NVR
2MG Tablet 02409658 MEKINIST NVR

VANDETANIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For patients with symptomatic and/or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease; AND

An ECOG* performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: VANDETANIB
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02378582 CAPRELSA SAC
300MG Tablet 02378590 CAPRELSA SAC

VEMURAFENIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; OR

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with cobimetinib (Cotellic).

AND for patients who meet the following criteria:

  • Patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; AND
  • Patient does not have brain metastases or brain metastases are asymptomatic or stable; AND
  • Patient has an ECOG performance status of 0 to 1.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: VEMURAFENIB
Drug strength and dosage form DIN Brand name Manufacturer code
ST240MG Tablet 02380242 ZELBORAF HLR

VENETOCLAX

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of chronic lymphocytic leukemia (CLL) who meet all of the following criteria:

  • Venclexta will be used as monotherapy; AND
  • Patient has received at least one prior therapy; AND
  • Patient has failed a B-cell receptor inhibitor (BCRi) or is intolerant to prior ibrutinib therapy; AND
  • Patient has an ECOG* performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

Coverage is for a maximum duration of two years.

Table: VENETOCLAX
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Tablet 02458039 VENCLEXTA ABV
50MG Tablet 02458047 VENCLEXTA ABV
100MG Tablet 02458055 VENCLEXTA ABV
100MG Tablet 02458063 VENCLEXTA ABV

12:00 AUTONOMIC DRUGS

12:04.00 PARASYMPATHOMIMETIC AGENTS

DONEPEZIL HYDROCHLORIDE

Limited use benefit (prior approval required).

Initial 12 month coverage for cholinesterase inhibitors:

  • Diagnosis of mild to moderate Alzheimer's disease; AND
  • Mini Mental State Exam (MMSE) score of 10-26, established within the last 60 days; OR
  • Montreal Cognitive Assessment (MoCA) score of 10-26, established within the last 60 days; OR
  • Global Deterioration Scale (GDS) score between 4 to 6, established within the last 60 days.

Continued coverage beyond 12 months will be based on improvement or stabilization of cognition, function or behaviour.

Criteria for coverage at every 12 month interval:

  • Clinically meaningful response as determined by stabilization or improvement while on therapy; AND
  • Alzheimer's Disease has not progressed to GDS stage 7 or MMSE or MoCA less than 10.
Table: DONEPEZIL HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02419866 ACCEL-DONEPEZIL ACP
ST5MG Tablet 02362260 APO-DONEPEZIL APX
ST5MG Tablet 02232043 ARICEPT PFI
ST5MG Tablet 02400561 AURO-DONEPEZIL AUR
ST5MG Tablet 02412853 BIO-DONEPEZIL BMI
ST5MG Tablet 02402645 DONEPEZIL ACC
ST5MG Tablet 02416417 DONEPEZIL PDL
ST5MG Tablet 02420597 DONEPEZIL SIV
ST5MG Tablet 02426846 DONEPEZIL SAN
5MG Tablet 02475278 DONEPEZIL RIV
ST5MG Tablet 02416948 JAMP-DONEPEZIL JMP
ST5MG Tablet 02402092 MAR-DONEPEZIL MAR
5MG Tablet 02467453 M-DONEPEZIL MAN
ST5MG Tablet 02439557 NAT-DONEPEZIL NPH
ST5MG Tablet 02322331 PMS-DONEPEZIL PMS
ST5MG Tablet 02381508 RAN-DONEPEZIL RBY
ST5MG Tablet 02412918 RIVA-DONEPEZIL RIV
ST5MG Tablet 02328666 SANDOZ DONEPEZIL SDZ
ST5MG Tablet 02428482 SEPTA DONEPEZIL SPT
ST5MG Tablet 02340607 TEVA-DONEPEZIL TEV
ST10MG Tablet 02419874 ACCEL-DONEPEZIL ACP
ST10MG Tablet 02362279 APO-DONEPEZIL APX
ST10MG Tablet 02232044 ARICEPT PFI
ST10MG Tablet 02400588 AURO-DONEPEZIL AUR
ST10MG Tablet 02412861 BIO-DONEPEZIL BMI
ST10MG Tablet 02402653 DONEPEZIL ACC
ST10MG Tablet 02416425 DONEPEZIL PDL
ST10MG Tablet 02420600 DONEPEZIL SIV
ST10MG Tablet 02426854 DONEPEZIL SAN
ST10MG Tablet 02416956 JAMP-DONEPEZIL JMP
ST10MG Tablet 02402106 MAR-DONEPEZIL MAR
10MG Tablet 02467461 M-DONEPEZIL MAN
ST10MG Tablet 02439565 NAT-DONEPEZIL NPH
ST10MG Tablet 02322358 PMS-DONEPEZIL PMS
ST10MG Tablet 02381516 RAN-DONEPEZIL RBY
ST10MG Tablet 02412934 RIVA-DONEPEZIL RIV
ST10MG Tablet 02328682 SANDOZ DONEPEZIL SDZ
ST10MG Tablet 02428490 SEPTA DONEPEZIL SPT
ST10MG Tablet 02340615 TEVA-DONEPEZIL TEV

GALANTAMINE HYDROBROMIDE

Limited use benefit (prior approval required).

Initial 12 month coverage for cholinesterase inhibitors:

  • Diagnosis of mild to moderate Alzheimer's disease; AND
  • Mini Mental State Exam (MMSE) score of 10-26, established within the last 60 days; OR
  • Montreal Cognitive Assessment (MoCA) score of 10-26, established within the last 60 days; OR
  • Global Deterioration Scale (GDS) score between 4 to 6, established within the last 60 days.

Continued coverage beyond 12 months will be based on improvement or stabilization of cognition, function or behaviour.

Criteria for coverage at every 12 month interval:

  • Clinically meaningful response as determined by stabilization or improvement while on therapy; AND
  • Alzheimer's Disease has not progressed to GDS stage 7 or MMSE or MoCA less than 10.
Table: GALANTAMINE HYDROBROMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST8MG Capsule (Extended Release) 02425157 AURO-GALANTAMINE ER AUR
ST8MG Capsule (Extended Release) 02443015 GALANTAMINE SAN
ST8MG Capsule (Extended Release) 02416573 GALANTAMINE ER PDL
ST8MG Capsule (Extended Release) 02420821 MAR-GALANTAMINE ER MAR
ST8MG Capsule (Extended Release) 02339439 MYLAN-GALANTAMINE ER MYL
ST8MG Capsule (Extended Release) 02316943 PAT-GALANTAMINE ER JSO
ST8MG Capsule (Extended Release) 02398370 PMS-GALANTAMINE ER PMS
ST16MG Capsule (Extended Release) 02425165 AURO-GALANTAMINE ER AUR
ST16MG Capsule (Extended Release) 02443023 GALANTAMINE SAN
ST16MG Capsule (Extended Release) 02416581 GALANTAMINE ER PDL
ST16MG Capsule (Extended Release) 02420848 MAR-GALANTAMINE ER MAR
ST16MG Capsule (Extended Release) 02339447 MYLAN-GALANTAMINE ER MYL
ST16MG Capsule (Extended Release) 02316951 PAT-GALANTAMINE ER JSO
ST16MG Capsule (Extended Release) 02398389 PMS-GALANTAMINE ER PMS
ST24MG Capsule (Extended Release) 02425173 AURO-GALANTAMINE ER AUR
ST24MG Capsule (Extended Release) 02443031 GALANTAMINE SAN
ST24MG Capsule (Extended Release) 02416603 GALANTAMINE ER PDL
ST24MG Capsule (Extended Release) 02420856 MAR-GALANTAMINE ER MAR
ST24MG Capsule (Extended Release) 02339455 MYLAN-GALANTAMINE ER MYL
ST24MG Capsule (Extended Release) 02316978 PAT-GALANTAMINE ER JSO
ST24MG Capsule (Extended Release) 02398397 PMS-GALANTAMINE ER PMS

RIVASTIGMINE HYDROGEN TARTRATE

Limited use benefit (prior approval required).

Initial 12 month coverage for cholinesterase inhibitors:

  • Diagnosis of mild to moderate Alzheimer's disease; AND
  • Mini Mental State Exam (MMSE) score of 10-26, established within the last 60 days; OR
  • Montreal Cognitive Assessment (MoCA) score of 10-26, established within the last 60 days; OR
  • Global Deterioration Scale (GDS) score between 4 to 6, established within the last 60 days.

Continued coverage beyond 12 months will be based on improvement or stabilization of cognition, function or behaviour.

Criteria for coverage at every 12 month interval:

  • Clinically meaningful response as determined by stabilization or improvement while on therapy; AND
  • Alzheimer's Disease has not progressed to GDS stage 7 or MMSE or MoCA less than 10.
Table: RIVASTIGMINE HYDROGEN TARTRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST1.5MG Capsule 02336715 APO-RIVASTIGMINE APX
ST1.5MG Capsule 02242115 EXELON NVR
ST1.5MG Capsule 02401614 MED-RIVASTIGMINE GMP
ST1.5MG Capsule 02306034 PMS-RIVASTIGMINE PMS
ST1.5MG Capsule 02416999 RIVASTIGMINE PDL
ST1.5MG Capsule 02324563 SANDOZ RIVASTIGMINE SDZ
ST3MG Capsule 02336723 APO-RIVASTIGMINE APX
ST3MG Capsule 02242116 EXELON NVR
ST3MG Capsule 02401622 MED-RIVASTIGMINE GMP
ST3MG Capsule 02306042 PMS-RIVASTIGMINE PMS
ST3MG Capsule 02417006 RIVASTIGMINE PDL
ST3MG Capsule 02324571 SANDOZ RIVASTIGMINE SDZ
ST4.5MG Capsule 02336731 APO-RIVASTIGMINE APX
ST4.5MG Capsule 02242117 EXELON NVR
ST4.5MG Capsule 02401630 MED-RIVASTIGMINE GMP
ST4.5MG Capsule 02306050 PMS-RIVASTIGMINE PMS
ST4.5MG Capsule 02417014 RIVASTIGMINE PDL
ST4.5MG Capsule 02324598 SANDOZ RIVASTIGMINE SDZ
ST6MG Capsule 02336758 APO-RIVASTIGMINE APX
ST6MG Capsule 02242118 EXELON NVR
ST6MG Capsule 02401649 MED-RIVASTIGMINE GMP
ST6MG Capsule 02306069 PMS-RIVASTIGMINE PMS
ST6MG Capsule 02417022 RIVASTIGMINE PDL
ST6MG Capsule 02324601 SANDOZ RIVASTIGMINE SDZ
ST2MG/ML Solution 02245240 EXELON NVR

12:08.08 ANTIMUSCARINICS / ANTISPASMODICS

TRIMEBUTINE MALEATE

Limited use benefit (prior approval required).

For the treatment and relief of symptoms associated with functional bowel disorders including Irritable Bowel Syndrome (IBS), spastic colon, spastic colitis and mucous colitis; OR

In postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.

Table: TRIMEBUTINE MALEATE
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02349027 AA-TRIMEBUTINE AAP
100MG Tablet 02245663 TRIMEBUTINE AAP
200MG Tablet 02349035 AA-TRIMEBUTINE AAP
200MG Tablet 02245664 TRIMEBUTINE AAP

12:12.08 BETA ADRENERGIC AGONISTS

FLUTICASONE FUROATE, VILANTEROL TRIFENATATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are not adequately controlled on medium doses of inhaled corticosteroids (e.g. fluticasone 251-500mcg daily, or the equivalent) as the sole agent and require addition of a long-acting beta agonist. Patients using this combination product must also have access to a short-acting bronchodilator for symptomatic relief.

OR

For the treatment of chronic obstructive pulmonary disease (COPD) in patients who have:

  • moderate to severe COPD, as defined by spirometry; OR
  • inadequate response to a long-acting beta-2 agonist (LABA) or a long-acting muscarinic antagonist (LAMA).
Table: FLUTICASONE FUROATE, VILANTEROL TRIFENATATE
Drug strength and dosage form DIN Brand name Manufacturer code
100MCG & 25MCG Powder 02408872 BREO ELLIPTA GSK

FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (ASTHMA)

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are not adequately controlled on medium doses of inhaled corticosteroids (e.g. fluticasone 251-500mcg daily, or the equivalent) as the sole agent and require addition of a long-acting beta agonist. Patients using this combination product must also have access to a short-acting bronchodilator for symptomatic relief.

Table: FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (ASTHMA)
Drug strength and dosage form DIN Brand name Manufacturer code
200MCG & 25MCG Powder 02444186 BREO ELLIPTA GSK

FORMOTEROL FUMARATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are using optimal corticosteroid therapy and experiencing breakthrough symptoms requiring regular use of a rapid-onset, short-duration bronchodilator.

OR

For the treatment of Chronic Obstructive Pulmonary Disease (COPD) in patients not adequately controlled with either ipratropium, tiotropium or a short acting beta-agonist.

Table: FORMOTEROL FUMARATE
Drug strength and dosage form DIN Brand name Manufacturer code
12MCG/CAPSULE Capsule 02230898 FORADIL NVR

FORMOTEROL FUMARATE DIHYDRATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are using optimal corticosteroid therapy and experiencing breakthrough symptoms requiring regular use of rapid onset, short duration bronchodilator.

Table: FORMOTEROL FUMARATE DIHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
6MCG/DOSE Powder 02237225 OXEZE TURBUHALER AZC
12MCG/DOSE Powder 02237224 OXEZE TURBUHALER AZC

FORMOTEROL FUMARATE DIHYDRATE, BUDESONIDE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are not adequately controlled on medium doses of inhaled corticosteroids (e.g. fluticasone 251-500mcg daily, or the equivalent) as the sole agent and require addition of a long-acting beta agonist. Patients using this combination product must also have access to a short-acting bronchodilator for symptomatic relief.

OR

For the treatment of chronic obstructive pulmonary disease (COPD) in patients who have:

  • moderate to severe COPD, as defined by spirometry; OR
  • inadequate response to a long-acting beta-2 agonist (LABA) or a long-acting muscarinic antagonist (LAMA).
Table: FORMOTEROL FUMARATE DIHYDRATE, BUDESONIDE
Drug strength and dosage form DIN Brand name Manufacturer code
6MCG & 100MCG/INHALATION Powder 02245385 SYMBICORT 100 TURBUHALER AZC
6MCG & 200MCG/INHALATION Powder 02245386 SYMBICORT 200 TURBUHALER AZC

FORMOTEROL FUMARATE DIHYDRATE, MOMETASONE FUROATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are using optimal corticosteroid therapy and experiencing breakthrough symptoms requiring regular use of rapid onset, short duration bronchodilator.

Table: FORMOTEROL FUMARATE DIHYDRATE, MOMETASONE FUROATE
Drug strength and dosage form DIN Brand name Manufacturer code
5MCG & 100MCG/INHALATION Aerosol 02361752 ZENHALE FRS
5MCG & 200MCG/INHALATION Aerosol 02361760 ZENHALE FRS
5MCG & 50MCG/INHALATION Aerosol 02361744 ZENHALE FRS

INDACATEROL MALEATE

Limited use benefit (prior approval required).

For the treatment of chronic obstructive pulmonary disease (COPD) in patients who:

  • are not adequately controlled with either ipratropium, tiotropium or a short acting beta-agonist; OR
  • have moderate to severe COPD, as defined by spirometry.
Table: INDACATEROL MALEATE
Drug strength and dosage form DIN Brand name Manufacturer code
75MCG Capsule 02376938 ONBREZ BREEZHALER NVR

SALMETEROL XINAFOATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are using optimal corticosteroid therapy and experiencing breakthrough symptoms requiring regular use of a rapid-onset, short-duration bronchodilator.

OR

For the treatment of Chronic Obstructive Pulmonary Disease (COPD) in patients not adequately controlled with either ipratropium, tiotropium or a short acting beta-agonist.

Table: SALMETEROL XINAFOATE
Drug strength and dosage form DIN Brand name Manufacturer code
50MCG/INHALATION Powder 02231129 SEREVENT DISKUS GSK

SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are not adequately controlled on medium doses of inhaled corticosteroids (e.g. fluticasone 251-500mcg daily, or the equivalent) as the sole agent and require addition of a long-acting beta agonist. Patients using this combination product must also have access to a short-acting bronchodilator for symptomatic relief.

OR

For the treatment of chronic obstructive pulmonary disease (COPD) in patients who have:

  • moderate to severe COPD, as defined by spirometry; OR
  • inadequate response to a long-acting beta-2 agonist (LABA) or a long-acting muscarinic antagonist (LAMA).
Table: SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE
Drug strength and dosage form DIN Brand name Manufacturer code
25MCG & 125MCG Aerosol 02245126 ADVAIR 125 GSK
25MCG & 250MCG Aerosol 02245127 ADVAIR 250 GSK
50MCG & 100MCG Powder 02240835 ADVAIR 100 DISKUS GSK
50MCG & 250MCG Powder 02240836 ADVAIR 250 DISKUS GSK
50MCG & 500MCG Powder 02240837 ADVAIR 500 DISKUS GSK

12:20.04 CENTRALL ACTING SKELETAL MUSCLE RELAXANTS

CYCLOBENZAPRINE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

For relief of muscle spasm associated with acute, painful musculoskeletal conditions. Coverage is limited to 60mg per day for three (3) weeks renewable every two (2) months.

Table: CYCLOBENZAPRINE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Tablet 02177145 APO-CYCLOBENZAPRINE APX
ST10MG Tablet 02348853 AURO-CYCLOBENZAPRINE AUR
ST10MG Tablet 02220644 CYCLOBENZAPRINE PDL
ST10MG Tablet 02287064 CYCLOBENZAPRINE SAN
ST10MG Tablet 02424584 CYCLOBENZAPRINE SIV
ST10MG Tablet 02238633 DOM-CYCLOBENZAPRINE DPC
ST10MG Tablet 02357127 JAMP-CYCLOBENZAPRINE JMP
ST10MG Tablet 02212048 PMS-CYCLOBENZAPRINE PMS
ST10MG Tablet 02242079 RIVA-CYCLOBENZAPRINE RIV
ST10MG Tablet 02080052 TEVA-CYCLOBENZAPRINE TEV

TIZANIDINE HYDROCHLORIDE

Limited use benefit (prior approval required).

For treatment of spasticity in patients with multiple sclerosis, who have failed therapy with or are intolerant to baclofen.

Table: TIZANIDINE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
4MG Tablet 02259893 TIZANIDINE AAP

12:92.00 MISCELLANEOUS AUTONOMIC DRUGS

NICOTINE (GUM)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 945 pieces during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for nicotine gum or lozenges when one year has elapsed from the day the initial prescription was filled.

Table: NICOTINE (GUM)
Drug strength and dosage form DIN Brand name Manufacturer code
ST2MG Gum 02091933 NICORETTE GUM KIM
ST2MG Gum 80015240 RUGBY NICOTINE POLACRILEX GUM ACG
2MG Gum 80000396 THRIVE NICOTINELL GUM GSK
ST4MG Gum 02091941 NICORETTE GUM KIM
ST4MG Gum 80000118 NICOTINE GUM PER
4MG Gum 80000402 THRIVE NICOTINELL GUM NVC

NICOTINE (INHALER)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 945 doses during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for nicotine gum or lozenges when one year has elapsed from the day the initial prescription was filled.

Table: NICOTINE (INHALER)
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Spray 02241742 NICORETTE INHALER KIM

NICOTINE (LOZENGE)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 945 pieces during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for nicotine gum or lozenges when one year has elapsed from the day the initial prescription was filled.

Table: NICOTINE (LOZENGE)
Drug strength and dosage form DIN Brand name Manufacturer code
ST1MG Lozenge 80007461 THRIVE NICOTINE LOZENGES NVC
ST2MG Lozenge 02247347 NICORETTE LOZENGE KIM
ST2MG Lozenge 80007464 THRIVE NICOTINE LOZENGES NVC
ST4MG Lozenge 02247348 NICORETTE LOZENGE KIM

NICOTINE (PATCH)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage will be provided for up to the allowable number of patches for one of the following products, during a one-year period. The year starts on the date the first prescription is filled.

NIHB clients are eligible to receive:

- up to 252 nicotine patches of any listed brand in a 12-month period; AND

- ONE course of an as-needed nicotine replacement therapy (NRT) product (i.e. gum, lozenge or inhaler) in a 12-month period; AND

- up to 180 tablets of Zyban in a 12-month period; AND

- up to 165 tablets of Champix in a 12-month period.

Once this quantity has been reached, the client is eligible again for coverage for nicotine patches when one year has elapsed from the day the initial prescription was filled.

Table: NICOTINE (PATCH)
Drug strength and dosage form DIN Brand name Manufacturer code
ST2MG Gum 80025660 CHU NICOTINE ANTI SMOKING AID UNK
2MG Gum 94799974 THRIVE GUM (NS) NVC
ST1MG Lozenge 80061161 NICHIT EUR
ST2MG Lozenge 80059877 NICHIT EUR
ST7MG Patch 01943057 HABITROL NVC
ST7MG Patch 80051602 NICOTINE TRANSDERMAL APX
ST7MG Patch 80044393 TRANSDERMAL NICOTINE ACG
ST14MG Patch 01943065 HABITROL NVC
ST14MG Patch 80013549 NICOTINE TRANSDERMAL SYSTEM ADD
ST14MG Patch 80044392 TRANSDERMAL NICOTINE ACG
ST18MG Patch 02241227 TRANSDERMAL NICOTINE PATCHDAY NVC
ST21MG Patch 01943073 HABITROL NVC
ST21MG Patch 80051603 NICOTINE TRANSDERMAL APX
ST21MG Patch 80014250 NICOTINE TRANSDERMAL SYSTEM ADD
ST21MG Patch 80044389 TRANSDERMAL NICOTINE ACG
ST36MG Patch 02093111 NICODERM KIM
ST53MG Patch 02241228 TRANSDERMAL NICOTINE PATCHDAY NVC
ST78MG Patch 02093138 NICODERM KIM
ST114MG Patch 02093146 NICODERM KIM

NICOTINE (SPRAY)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 3450 sprays during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for nicotine spray when one year has elapsed from the day the initial prescription was filled.

Table: NICOTINE (SPRAY)
Drug strength and dosage form DIN Brand name Manufacturer code
1MG Oral Spray 80038858 NICORETTE QUICKMIST KIM

VARENICLINE TARTRATE

Limited use benefit with quantity and frequency limits (prior approval is not required).

Coverage will be limited to 165 tablets during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for varenicline (Champix(r)) when one year has elapsed from the day the initial prescription was filled.

Table: VARENICLINE TARTRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST0.5MG & 1MG Tablet 02435675 APO-VARENICLINE APX
ST0.5MG & 1MG Tablet 02298309 CHAMPIX STARTER PACK PFI
ST0.5MG Tablet 02419882 APO-VARENICLINE APX
ST0.5MG Tablet 02291177 CHAMPIX PFI
0.5MG Tablet 02426226 TEVA-VARENICLINE TEV
ST1MG Tablet 02419890 APO-VARENICLINE APX
ST1MG Tablet 02291185 CHAMPIX PFI
1MG Tablet 02426234 TEVA-VARENICLINE TEV
1MG Tablet 02426781 TEVA-VARENICLINE TEV

20:00 BLOOD FORMATION COAGULATION AND THROMBOSIS

20:04.04 IRON PREPARATIONS

POLYSACCHARIDE IRON COMPLEX

Limited use benefit (prior approval not required).

For children 12 years of age or under.

Table: POLYSACCHARIDE IRON COMPLEX
Drug strength and dosage form DIN Brand name Manufacturer code
15MG Powder 80033717 FERAMAX POWDER WATER SOLUBLE POLYSACCHARIDE IRON COMPLEX BSY

20:12.04 ANTICOAGULANTS

APIXABAN

Limited use benefit (prior approval required).

For at-risk patients (CHADS2 score ≥1) with non-valvular atrial fibrillation who require apixaban for the prevention of stroke and systemic embolism AND in whom:

  • Anticoagulation is inadequate (outside the desired INR range for at least 35% of the tests) with a two-month trial of warfarin; OR
  • Anticoagulation with warfarin is contraindicated; OR
  • Anticoagulation with warfarin is not possible due to inability to regularly monitor via INR testing (i.e., no access to INR testing services at a laboratory, clinic, pharmacy and at home).

OR

For the treatment of venous thromboembolism: Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)

Table: APIXABAN
Drug strength and dosage form DIN Brand name Manufacturer code
ST2.5MG Tablet 02377233 ELIQUIS BMS
ST5MG Tablet 02397714 ELIQUIS BMS

DABIGATRAN ETEXILATE MESILATE

Limited use benefit (prior approval required).

For at-risk patients (CHADS2 score ≥1) with non-valvular atrial fibrillation who require dabigatran etexilate for the prevention of stroke and systemic embolism AND in whom:

  • Anticoagulation is inadequate (outside the desired INR range for at least 35% of the tests) with a two-month trial of warfarin; OR
  • Anticoagulation with warfarin is contraindicated; OR
  • Anticoagulation with warfarin is not possible due to inability to regularly monitor via INR testing (i.e., no access to INR testing services at a laboratory, clinic, pharmacy and at home).
Table: DABIGATRAN ETEXILATE MESILATE
Drug strength and dosage form DIN Brand name Manufacturer code
110MG Capsule 02468905 APO-DABIGATRAN APX
ST110MG Capsule 02312441 PRADAXA BOE
150MG Capsule 02468913 APO-DABIGATRAN APX
ST150MG Capsule 02358808 PRADAXA BOE

EDOXABAN (EDOXABAN TOSYLATE MONOHYDRATE)

Limited use benefit (prior approval required).

For at-risk patients (CHADS2 score ≥1) with non-valvular atrial fibrillation who require edoxaban for the prevention of stroke and systemic embolism AND in whom:

  • Anticoagulation is inadequate (outside the desired INR range for at least 35% of the tests) with a two-month trial of warfarin; OR
  • Anticoagulation with warfarin is contraindicated; OR
  • Anticoagulation with warfarin is not possible due to inability to regularly monitor via INR testing (i.e., no access to INR testing services at a laboratory, clinic, pharmacy and at home).

OR

For the treatment of venous thromboembolism: Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)

Table: EDOXABAN (EDOXABAN TOSYLATE MONOHYDRATE)
Drug strength and dosage form DIN Brand name Manufacturer code
15MG Tablet 02458640 LIXIANA SEV
30MG Tablet 02458659 LIXIANA SEV
60MG Tablet 02458667 LIXIANA SEV

RIVAROXABAN

Limited use benefit (prior approval required).

Criteria for rivaroxaban 15 mg, 20mg tablets (Xarelto) for Stroke Prevention in Atrial Fibrillation (SPAF)

For at-risk patients (CHADS2 score ≥1) with non-valvular atrial fibrillation who require rivaroxaban for the prevention of stroke and systemic embolism AND in whom:

  • Anticoagulation is inadequate (outside the desired INR range for at least 35% of the tests) with a two-month trial of warfarin; OR
  • Anticoagulation with warfarin is contraindicated; OR
  • Anticoagulation is not possible due to inability to regularly monitor via International Normalized Ratio (INR) testing (i.e., no access to INR testing service at a laboratory, clinic, pharmacy, and at home)

Criteria for rivaroxaban 15 mg, 20mg tablets (Xarelto)

For the treatment of venous thromboembolism: Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE).

Table: RIVAROXABAN
Drug strength and dosage form DIN Brand name Manufacturer code
ST15MG Tablet 02378604 XARELTO BAY
ST20MG Tablet 02378612 XARELTO BAY

RIVAROXABAN (10)

Limited use benefit (prior approval not required).

For the prevention of venous thromboembolism following total knee replacement or total hip replacement surgery, for up to 35 days.

Table: RIVAROXABAN (10)
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Tablet 02316986 XARELTO BAY

20:16.00 HEMATOPOIETIC AGENTS

PEGFILGRASTIM

Limited use benefit (prior approval required).

CHEMOTHERAPY SUPPORT

Primary Prophylaxis

For use in previously untreated patients receiving a moderate to severely myelosuppressive chemotherapy regimen (i.e. ≥40% incidence of febrile neutropenia). Febrile neutropenia is defined as a temperature ≥38.5°C or >38.0°C three times in a 24 hour period and neutropenia with an absolute neutrophil count (ANC) <0.5 x 109/L.

Secondary Prophylaxis

For use in patients receiving myelosuppressive chemotherapy who have experienced an episode of febrile neutropenic sepsis or profound neutropenia in a previous cycle of chemotherapy; OR

For use in patients who have experienced a dose reduction or treatment delay longer than one week, due to neutropenia.

The recommended dosage of pegfilgrastim is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy. Pegfilgrastim should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy.

Table: PEGFILGRASTIM
Drug strength and dosage form DIN Brand name Manufacturer code
10MG/ML Solution 02249790 NEULASTA AMG

PLERIXAFOR

Limited use benefit (prior approval required).

For use in combination with filgrastim to mobilize hematopoietic stem cells for subsequent autologous transplantation in patients with:

  • Non-Hodgkin's lymphoma (NHL); OR
  • Multiple myeloma (MM);

AND

  • Prescribed by an oncologist or hematologist.

AND if one of the following are met

  • A PBCD34+ count of < 10 cells/uL after 4 days of filgrastim; OR
  • Less than 50% of the target CD34 yield is achieved on the 1st day of apheresis (after being mobilized with filgrastim alone or following chemotherapy); OR
  • If a patient has failed a previous stem cell mobilization with filgrastim alone or following chemotherapy.

Reimbursement is limited to a maximum of 4 doses (0.24mg/kg given daily) for a single mobilization attempt.

The dose of Mozobil is limited to a maximum of 40mg per day

Table: PLERIXAFOR
Drug strength and dosage form DIN Brand name Manufacturer code
20MG Solution 02377225 MOZOBIL SAC

24:00 CARDIOVASCULAR DRUGS

24:04.92 MISCELLANEOUS CARDIAC DRUGS

IVABRADINE (IVABRADINE HYDROCHLORIDE)

Limited use benefit (prior approval required).

For the treatment of stable chronic heart failure with New York Heart Association (NYHA) class II or III symptoms in adult patients if the following criteria are met:

  • Left ventricular ejection fraction ≤ 35%; AND
  • Resting heart rate must be documented as ≥ 77 bpm on average using either an ECG on at least three separate visits or by continuous monitoring; AND
  • Patient has had at least one hospitalization due to heart failure in the last year; AND
  • NYHA class II to III symptoms despite at least four weeks of treatment with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB) in combination with a beta blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA).
Table: IVABRADINE (IVABRADINE HYDROCHLORIDE)
Drug strength and dosage form DIN Brand name Manufacturer code
5MG Tablet 02459973 LANCORA SEV
7.5MG Tablet 02459981 LANCORA SEV

24:06.24 

ALIROCUMAB

Limited use benefit (prior approval required).

Initial Coverage (12 weeks):

For adult patients with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) if the following clinical criteria are met:

  • Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing;

AND

  • Patient is unable to reach an LDL-C target of < 2.0 mmol/L for secondary CVD prevention, or at least a 50% reduction in LDL-C from untreated baseline for primary prevention despite:

- Confirmed adherence to a high-dose statin (e.g., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for a total of at least 3 months of continuous treatment;

OR

- Patient is unable to tolerate at least two statins, with at least one statin initiated at the lowest daily starting dose; AND

- For each statin (two statins in total), dose reduction was attempted to resolve intolerable myopathy or creatine kinase > 5 times the upper limit of normal rather than statin discontinuation; AND

- For each statin (two statins in total), intolerable myopathy or creatine kinase > 5 times the upper limit of normal was reversed upon statin discontinuation, but reoccurred with statin rechallenge where clinically appropriate; AND

- Confirmed adherence to ezetimibe for a total of at least 3 months continuous treatment; AND

- Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out;

OR

- Patient developed confirmed and documented rhabdomyolysis;

OR

- Patient has a contraindication to statins; AND

- Confirmed adherence to ezetimibe for a total of at least 3 months continuous treatment.

Continued coverage (6 months):

  • Patient is adherent to therapy;

AND

  • Patient has achieved a reduction in LDL-C of at least 40% from baseline.

Note: Annual coverage is limited to 26 prefilled syringes or prefilled pens per year.

Table: ALIROCUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
75MG Solution 02453754 PRALUENT SAC
75MG Solution 02453819 PRALUENT SAC
150MG Solution 02453762 PRALUENT SAC
150MG Solution 02453835 PRALUENT SAC

EVOLOCUMAB

Limited use benefit (prior approval required).

Initial coverage criteria (Initial approval for 12 weeks):

For adult patients with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) if the following clinical criteria are met:

  • Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; AND
  • Patient is unable to reach an LDL-C target of < 2.0 mmol/L for secondary CVD prevention, or at least a 50% reduction in LDL-C from untreated baseline for primary prevention despite:

- Confirmed adherence to a high-dose statin (e.g., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for a total of at least 3 months of continuous treatment;

OR

- Patient is unable to tolerate at least two statins, with at least one statin initiated at the lowest daily starting dose; AND

- For each statin (two statins in total), dose reduction was attempted to resolve intolerable myopathy or creatine kinase > 5 times the upper limit of normal rather than statin discontinuation; AND

- For each statin (two statins in total), intolerable myopathy or creatine kinase > 5 times the upper limit of normal was reversed upon statin discontinuation, but reoccurred with statin rechallenge where clinically appropriate; AND

- Confirmed adherence to ezetimibe for a total of at least 3 months continuous treatment; AND

- Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out;

OR

- Patient developed confirmed and documented rhabdomyolysis;

OR

- Patient has a contraindication to statins; AND

- Confirmed adherence to ezetimibe for a total of at least 3 months continuous treatment.

Note: Annual coverage is limited to 26 prefilled autoinjectors (140 mg every 2 weeks) or 12 automated Mini-Dosers with prefilled cartridges (420 mg once a month).

Renewal coverage criteria (Renewal for 6 months):

  • Patient is adherent to therapy;

AND

  • Patient has achieved a reduction in LDL-C of at least 40% from baseline.

Note: Annual coverage is limited to 26 prefilled Autoinjectors (140 mg every 2 weeks) or 12 automated Mini-Dosers with prefilled cartridges (420 mg once a month).

Table: EVOLOCUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
120MG Solution 02459779 REPATHA AMG
140MG Solution 02446057 REPATHA AMG

24:12.12 PHOSPHODIESTERASE INHIBITORS

SILDENAFIL CITRATE

Limited use benefit (prior approval required).

Must be initiated by a Pulmonary Hypertension specialist

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization.

Table: SILDENAFIL CITRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST20MG Tablet 02418118 APO-SILDENAFIL R APX
ST20MG Tablet 02412179 PMS-SILDENAFIL R PMS
ST20MG Tablet 02279401 REVATIO PFI
ST20MG Tablet 02319500 TEVA-SILDENAFIL R TEV

TADALAFIL

Limited use benefit (prior approval required).

Must be initiated by a Pulmonary Hypertension specialist

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization.

Table: TADALAFIL
Drug strength and dosage form DIN Brand name Manufacturer code
ST20MG Tablet 02338327 ADCIRCA LIL
ST20MG Tablet 02421933 APO-TADALAFIL PAH APX

24:12.92 MISCELLANEOUS VASODILATING AGENTS

AMBRISENTAN

Limited use benefit (prior approval required).

Maximum dose covered is 10 mg once daily.

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization; AND

  • who have failed to respond to sildenafil OR tadalafil; OR
  • who have contraindications to sildenafil OR tadalafil.
Table: AMBRISENTAN
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02307065 VOLIBRIS GSK
ST10MG Tablet 02307073 VOLIBRIS GSK

BOSENTAN MONOHYDRATE

Limited use benefit (prior approval required).

Maximum dose covered is 125 mg twice daily

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization; AND

  • who have failed to respond to sildenafil OR tadalafil; OR
  • who have contraindications to sildenafil OR tadalafil.
Table: BOSENTAN MONOHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST62.5MG Tablet 02399202 APO-BOSENTAN APX
ST62.5MG Tablet 02383012 PMS-BOSENTAN PMS
ST62.5MG Tablet 02386275 SANDOZ BOSENTAN SDZ
ST62.5MG Tablet 02398400 TEVA-BOSENTAN TEV
ST62.5MG Tablet 02244981 TRACLEER JSO
ST125MG Tablet 02383020 PMS-BOSENTAN PMS
ST125MG Tablet 02386283 SANDOZ BOSENTAN SDZ
ST125MG Tablet 02244982 TRACLEER JSO

24:24.00 BETA ADRENERGIC BLOCKING AGENTS

PROPRANOLOL (HEMANGIOL)

Limited use benefit (prior approval required).

For the treatment of proliferating infantile hemangioma requiring systemic therapy and at least one of the following:

  • Life or function-threatening hemangioma, OR
  • Ulcerated hemangioma with pain and/or lack of response to simple wound care measures, OR
  • Hemangioma with a risk of permanent scarring or disfigurement.
Table: PROPRANOLOL (HEMANGIOL)
Drug strength and dosage form DIN Brand name Manufacturer code
3.75MG Solution 02457857 HEMANGIOL PFD

24:32.20 MINERALOCORTICOIDE (ALDOSTERONE) RECEPTOR ANTAGONISTS

EPLERENONE

Limited use benefit (prior approval required).

For the treatment of patients with New York Heart Association (NYHA) class II chronic heart failure with left ventricular systolic dysfunction (with ejection fraction ≤ 35%), as an adjunct to standard therapy.

Note: Patients must be on optimal therapy with an angiotensin-converting-enzyme (ACE) inhibitor or an angiotensin-receptor blocker (ARB), and a beta-blocker (unless contraindicated) at the recommended dose or maximal tolerated dose.

Table: EPLERENONE
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Tablet 02323052 INSPRA PFI
25MG Tablet 02471442 MINT-EPLERENONE MIN
50MG Tablet 02323060 INSPRA PFI
50MG Tablet 02471450 MINT-EPLERENONE MIN

24:32.92 

VALSARTAN, SACUBITRIL

Limited use benefit (prior approval required).

For the treatment of New York Heart Association (NYHA) class II or III heart failure if the following criteria are met:

  • Must be initiated by a physician experienced in the treatment of heart failure; AND
  • Left ventricular ejection fraction < 40%; AND
  • NYHA class II to III symptoms despite at least four weeks of treatment with an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB); OR If your patient has a contraindication or intolerance to ACEI or ARBs;

AND

  • Must be used in combination with a beta blocker and an aldosterone antagonist (if tolerated); OR If your patient has a contraindication or intolerance to beta blockers or aldosterone antagonists.
Table: VALSARTAN, SACUBITRIL
Drug strength and dosage form DIN Brand name Manufacturer code
26MG & 24MG Tablet 02446928 ENTRESTO NVR
51MG & 49MG Tablet 02446936 ENTRESTO NVR
103MG & 97MG Tablet 02446944 ENTRESTO NVR

28:00 CENTRAL NERVOUS SYSTEM AGENTS

28:08.04 NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

ACETYLSALICYLIC ACID

Limited use benefit (prior approval is not required).

ASA 80 mg tablets are a benefit to clients age 21 years and under to allow access for use in pediatric conditions (e.g. Kawasaki Syndrome).

Table: ACETYLSALICYLIC ACID
Drug strength and dosage form DIN Brand name Manufacturer code
ST80MG Tablet 02269139 ACETYLSALICYLIC ACID JMP
ST80MG Tablet 02295563 LOWPRIN EUR
ST80MG Tablet 02202360 RIVASA RIV
ST80MG Tablet (Chewable) 02009013 ASAPHEN PMS
ST80MG Tablet (Chewable) 02280167 ASATAB ODN
ST80MG Tablet (Chewable) 02250675 EURO-ASA EUR
ST80MG Tablet (Chewable) 02296004 LOWPRIN SDZ
ST80MG Tablet (Chewable) 02429950 M-ASA MAN
ST80MG Tablet (Chewable) 02311518 PRO-AAS PDL
ST80MG Tablet (Chewable) 02202352 RIVASA RIV
ST80MG Tablet (Delayed Release) 02427176 ASA EC SAN
ST80MG Tablet (Delayed Release) 02238545 ASAPHEN PMS
ST80MG Tablet (Delayed Release) 02283905 JAMP-ASA JMP
ST80MG Tablet (Delayed Release) 02311496 PRO-AAS PDL
ST80MG Tablet (Delayed Release) 02485222 RIVASA EC RIV

DICLOFENAC SODIUM (TOPICAL)

Limited use benefit (prior approval required).

For the treatment of osteoarthritis when:

  • pain is inadequately controlled with acetaminophen AND a non-steroidal anti-inflammatory (NSAID); OR
  • there is contraindication to acetaminophen and NSAID; OR
  • there is intolerance to acetaminophen and NSAID.
Table: DICLOFENAC SODIUM (TOPICAL)
Drug strength and dosage form DIN Brand name Manufacturer code
ST1.5% Solution 02354403 APO-DICLOFENAC APX
ST1.5% Solution 02476134 DICLOFENAC SODIUM TEL
ST1.5% Solution 02434571 DICLOFENAC TOPICAL RAX
ST1.5% Solution 02472309 JAMP DICLOFENAC TOPICAL JMP
ST1.5% Solution 02356783 PMS-DICLOFENAC PMS
ST1.5% Solution 02420988 TARO-DICLOFENAC TAR

28:08.08 OPIATE AGONISTS

ACETAMINOPHEN, CAFFEINE CITRATE, CODEINE PHOSPHATE

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on acetaminophen. The limit accumulates against the amount of acetaminophen claimed to the program from plain acetaminophen and/or acetaminophen in combination with opioids such as codeine (i.e. Tylenol(r) #3) or oxycodone (i.e. Percocet(r)). A total of 360 grams of acetaminophen is permitted in a 100-day period, for a total daily dose of 3600mg/day.

Table: ACETAMINOPHEN, CAFFEINE CITRATE, CODEINE PHOSPHATE
Drug strength and dosage form DIN Brand name Manufacturer code
300MG & 15MG & 15MG Tablet 00653241 RATIO-LENOLTEC NO 2 TEV
300MG & 15MG & 15MG Tablet 02163934 TYLENOL WITH CODEINE NO.2 JSO
300MG & 15MG & 30MG Tablet 00653276 RATIO-LENOLTEC NO 3 TEV
300MG & 15MG & 30MG Tablet 02163926 TYLENOL WITH CODEINE NO.3 JSO
325MG & 30MG & 15MG Tablet 00293504 ATASOL 15 CHU

ACETAMINOPHEN, CODEINE PHOSPHATE

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on acetaminophen. The limit accumulates against the amount of acetaminophen claimed to the program from plain acetaminophen and/or acetaminophen in combination with opioids such as codeine (i.e. Tylenol(r) #3) or oxycodone (i.e. Percocet(r)). A total of 360 grams of acetaminophen is permitted in a 100-day period, for a total daily dose of 3600mg/day.

Table: ACETAMINOPHEN, CODEINE PHOSPHATE
Drug strength and dosage form DIN Brand name Manufacturer code
32MG & 1.6MG/ML Elixir 00816027 PMS-ACETAMINOPHEN PMS
300MG & 30MG Tablet 02232658 PROCET-30 PDL
300MG & 30MG Tablet 00608882 TEVA-EMTEC-30 TEV
300MG & 30MG Tablet 00789828 TRIATEC-30 RIV

ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on acetaminophen. The limit accumulates against the amount of acetaminophen claimed to the program from plain acetaminophen and/or acetaminophen in combination with opioids such as codeine (i.e. Tylenol(r) #3) or oxycodone (i.e. Percocet(r)). A total of 360 grams of acetaminophen is permitted in a 100-day period, for a total daily dose of 3600mg/day.

Table: ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
325MG & 5MG Tablet 02324628 APO-OXYCODONE/ACET APX
325MG & 5MG Tablet 02361361 OXYCODONE/ACET SAN
325MG & 5MG Tablet 02327171 OXYCODONE-ACET PDL
325MG & 5MG Tablet 02242468 RIVACOCET RIV
325MG & 5MG Tablet 02307898 SANDOZ OXYCODONE/ACETAMINOPHEN SDZ
325MG & 5MG Tablet 00608165 TEVA-OXYCOCET TEV

ACETYLSALICYLIC ACID, OXYCODONE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: ACETYLSALICYLIC ACID, OXYCODONE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
325MG & 5MG Tablet 00608157 TEVA-OXYCODAN TEV

CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE

Limited use benefit (prior approval required).

For treatment of:

  • chronic pain and palliative care patients as an alternative to products containing codeine in combination with acetaminophen or ASA with or without caffeine; OR
  • chronic pain and palliative care patients as an alternative to regular release codeine tablets when large doses are required.

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Tablet (Extended Release) 02230302 CODEINE CONTIN CR PFR
100MG Tablet (Extended Release) 02163748 CODEINE CONTIN CR PFR
150MG Tablet (Extended Release) 02163780 CODEINE CONTIN CR PFR
200MG Tablet (Extended Release) 02163799 CODEINE CONTIN CR PFR

CODEINE PHOSPHATE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: CODEINE PHOSPHATE
Drug strength and dosage form DIN Brand name Manufacturer code
5MG/ML Liquid 00050024 CODEINE PHOSPHATE ATL
2MG/ML Solution 00380571 LINCTUS CODEINE ATL
15MG Tablet 02009889 CODEINE RIV
15MG Tablet 00593435 TEVA-CODEINE TEV
30MG Tablet 02009757 CODEINE RIV
30MG Tablet 00593451 TEVA-CODEINE TEV

FENTANYL

Limited use benefit (prior approval required).

For the management of chronic pain in patients who are unresponsive or intolerant to at least one long-acting oral sustained released product, such as morphine, hydromorphone and oxycodone, despite appropriate dose titration and adjunctive therapy including laxatives and antiemetics.

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: FENTANYL
Drug strength and dosage form DIN Brand name Manufacturer code
12MCG/HR Patch 02395657 FENTANYL PDL
12MCG/HR Patch 02341379 PMS-FENTANYL MTX PMS
12MCG/HR Patch 02330105 RAN-FENTANYL MATRIX RBY
12MCG/HR Patch 02327112 SANDOZ FENTANYL SDZ
12MCG/HR Patch 02311925 TEVA-FENTANYL TEV
25MCG/HR Patch 02395665 FENTANYL PDL
25MCG/HR Patch 02341387 PMS-FENTANYL MTX PMS
25MCG/HR Patch 02330113 RAN-FENTANYL MATRIX RBY
25MCG/HR Patch 02327120 SANDOZ FENTANYL SDZ
25MCG/HR Patch 02282941 TEVA-FENTANYL TEV
50MCG/HR Patch 02395673 FENTANYL PDL
50MCG/HR Patch 02341395 PMS-FENTANYL MTX PMS
50MCG/HR Patch 02330121 RAN-FENTANYL MATRIX RBY
50MCG/HR Patch 02327147 SANDOZ FENTANYL SDZ
50MCG/HR Patch 02282968 TEVA-FENTANYL TEV
75MCG/HR Patch 02395681 FENTANYL PDL
75MCG/HR Patch 02341409 PMS-FENTANYL MTX PMS
75MCG/HR Patch 02330148 RAN-FENTANYL MATRIX RBY
75MCG/HR Patch 02327155 SANDOZ FENTANYL SDZ
75MCG/HR Patch 02282976 TEVA-FENTANYL TEV
100MCG/HR Patch 02395703 FENTANYL PDL
100MCG/HR Patch 02341417 PMS-FENTANYL MTX PMS
100MCG/HR Patch 02330156 RAN-FENTANYL MATRIX RBY
100MCG/HR Patch 02327163 SANDOZ FENTANYL SDZ
100MCG/HR Patch 02282984 TEVA-FENTANYL TEV

HYDROMORPHONE HYDROCHLORIDE

Limited use benefit.

Prior approval required for controlled release capsules only. Regular release dosage forms are full benefits and do not require prior approval.

For treatment of moderate to severe chronic pain when other opioids such as morphine have been ineffective in controlling pain or in patients experiencing intolerable side effects.

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: HYDROMORPHONE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
3MG Capsule (Extended Release) 02476614 APO-HYDROMORPHONE APX
4.5MG Capsule (Extended Release) 02476622 APO-HYDROMORPHONE APX
6MG Capsule (Extended Release) 02476630 APO-HYDROMORPHONE APX
9MG Capsule (Extended Release) 02476649 APO-HYDROMORPHONE APX
12MG Capsule (Extended Release) 02476657 APO-HYDROMORPHONE APX
18MG Capsule (Extended Release) 02476665 APO-HYDROMORPHONE APX
24MG Capsule (Extended Release) 02476673 APO-HYDROMORPHONE APX
30MG Capsule (Extended Release) 02476681 APO-HYDROMORPHONE APX
3MG Capsule (Sustained Release) 02125323 HYDROMORPH CONTIN PFR
4.5MG Capsule (Sustained Release) 02359502 HYDROMORPH CONTIN PFR
6MG Capsule (Sustained Release) 02125331 HYDROMORPH CONTIN PFR
9MG Capsule (Sustained Release) 02359510 HYDROMORPH CONTIN PFR
12MG Capsule (Sustained Release) 02125366 HYDROMORPH CONTIN PFR
18MG Capsule (Sustained Release) 02243562 HYDROMORPH CONTIN PFR
24MG Capsule (Sustained Release) 02125382 HYDROMORPH CONTIN PFR
30MG Capsule (Sustained Release) 02125390 HYDROMORPH CONTIN PFR
1MG/ML Liquid 01916386 PMS HYDROMORPHONE PMS
3MG Suppository 01916394 PMS HYDROMORPHONE PMS
1MG Tablet 02364115 APO-HYDROMORPHONE APX
1MG Tablet 00705438 DILAUDID PFR
1MG Tablet 00885444 PMS-HYDROMORPHONE PMS
1MG Tablet 02319403 TEVA-HYDROMORPHONE TEV
2MG Tablet 02364123 APO-HYDROMORPHONE APX
2MG Tablet 00125083 DILAUDID PFR
2MG Tablet 00885436 PMS-HYDROMORPHONE PMS
2MG Tablet 02319411 TEVA-HYDROMORPHONE TEV
4MG Tablet 02364131 APO-HYDROMORPHONE APX
4MG Tablet 00125121 DILAUDID PFR
4MG Tablet 00885401 PMS-HYDROMORPHONE PMS
4MG Tablet 02319438 TEVA-HYDROMORPHONE TEV
8MG Tablet 02364158 APO-HYDROMORPHONE APX
8MG Tablet 00786543 DILAUDID PFR
8MG Tablet 00885428 PMS-HYDROMORPHONE PMS
8MG Tablet 02319446 TEVA-HYDROMORPHONE TEV

METHADONE HYDROCHLORIDE (METADOL)

Limited use benefit (prior approval required) with the following criteria:

Prescriber is registered with Health Canada and is eligible to prescribe methadone for the management of pain; AND

For the management of moderate to severe cancer pain or chronic non-cancer pain, as an alternative to other opioids; OR

For the management of pain for palliative care patients. Pharmacists may only dispense a maximum supply of 30 days at one time.

Table: METHADONE HYDROCHLORIDE (METADOL)
Drug strength and dosage form DIN Brand name Manufacturer code
1MG/ML Solution 02247694 METADOL PAL
10MG/ML Solution 02241377 METADOL PAL
1MG Tablet 02247698 METADOL PAL
5MG Tablet 02247699 METADOL PAL
10MG Tablet 02247700 METADOL PAL
25MG Tablet 02247701 METADOL PAL

MORPHINE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: MORPHINE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
1MG/ML Syrup 00614491 DOLORAL 1 ATL
5MG/ML Syrup 00614505 DOLORAL 5 ATL

MORPHINE SULFATE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: MORPHINE SULFATE
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Capsule (Extended Release) 02019930 M-ESLON ETH
15MG Capsule (Extended Release) 02177749 M-ESLON ETH
30MG Capsule (Extended Release) 02019949 M-ESLON ETH
60MG Capsule (Extended Release) 02019957 M-ESLON ETH
100MG Capsule (Extended Release) 02019965 M-ESLON ETH
200MG Capsule (Extended Release) 02177757 M-ESLON ETH
5MG Suppository 00632228 STATEX PAL
10MG Suppository 00632201 STATEX PAL
20MG Suppository 00596965 STATEX PAL
5MG Tablet 00594652 STATEX PAL
10MG Tablet 00594644 STATEX PAL
25MG Tablet 00594636 STATEX PAL
50MG Tablet 00675962 STATEX PAL
15MG Tablet (Extended Release) 02350815 MORPHINE SR SAN
15MG Tablet (Extended Release) 02015439 MS CONTIN SR PFR
15MG Tablet (Extended Release) 02244790 SANDOZ MORPHINE SR SDZ
15MG Tablet (Extended Release) 02302764 TEVA-MORPHINE SR TEV
30MG Tablet (Extended Release) 02350890 MORPHINE SR SAN
30MG Tablet (Extended Release) 02014297 MS CONTIN SR PFR
30MG Tablet (Extended Release) 02244791 SANDOZ MORPHINE SR SDZ
30MG Tablet (Extended Release) 02302772 TEVA-MORPHINE SR TEV
60MG Tablet (Extended Release) 02350912 MORPHINE SR SAN
60MG Tablet (Extended Release) 02014300 MS CONTIN SR PFR
60MG Tablet (Extended Release) 02244792 SANDOZ MORPHINE SR SDZ
60MG Tablet (Extended Release) 02302780 TEVA-MORPHINE SR TEV
100MG Tablet (Extended Release) 02014319 MS CONTIN SR PFR
100MG Tablet (Extended Release) 02302799 TEVA-MORPHINE SR TEV
200MG Tablet (Extended Release) 02014327 MS CONTIN SR PFR
200MG Tablet (Extended Release) 02302802 TEVA-MORPHINE SR TEV
5MG Tablet (Immediate Release) 02014203 MS IR PFR
10MG Tablet (Immediate Release) 02014211 MS IR PFR
20MG Tablet (Immediate Release) 02014238 MS IR PFR
30MG Tablet (Immediate Release) 02014254 MS IR PFR

MORPHINE SULFATE (KADIAN)

Limited use benefit (prior approval required).

  • For the treatment of opioid dependence where methadone and Suboxone are not available or not appropriate; OR
  • For the treatment of chronic pain.

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: MORPHINE SULFATE (KADIAN)
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Capsule (Sustained Release) 02242163 KADIAN BGP
10MG Capsule (Sustained Release) 09991310 KADIAN MAY
20MG Capsule (Sustained Release) 02184435 KADIAN BGP
20MG Capsule (Sustained Release) 09991311 KADIAN MAY
50MG Capsule (Sustained Release) 02184443 KADIAN BGP
50MG Capsule (Sustained Release) 09991312 KADIAN MAY
100MG Capsule (Sustained Release) 02184451 KADIAN BGP
100MG Capsule (Sustained Release) 09991313 KADIAN MAY

OXYCODONE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for non-cancer, non-palliative pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

Table: OXYCODONE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Suppository 00392480 SUPEUDOL SDZ
20MG Suppository 00392472 SUPEUDOL SDZ
5MG Tablet 02325950 OXYCODONE PDL
5MG Tablet 02231934 OXY-IR PFR
5MG Tablet 02319977 PMS-OXYCODONE PMS
5MG Tablet 00789739 SUPEUDOL SDZ
10MG Tablet 02325969 OXYCODONE PDL
10MG Tablet 02240131 OXY-IR PFR
10MG Tablet 02319985 PMS-OXYCODONE PMS
10MG Tablet 00443948 SUPEUDOL SDZ
20MG Tablet 02325977 OXYCODONE PDL
20MG Tablet 02319993 PMS-OXYCODONE PMS
20MG Tablet 02262983 SUPEUDOL SDZ
20MG Tablet (Immediate Release) 02240132 OXY-IR PFR

28:08.12 OPIATE PARTIAL AGONISTS

BUPRENORPHINE HYDROCHLORIDE

Limited use benefit (prior approval required).

For the management of patients with opioid use disorder, in combination with psychosocial support:

  • In combination with psychosocial support; AND
  • Patient is stabilized on a dose of no more than 8 mg per day of sublingual buprenorphine/naloxone for the preceding 90 days; AND
  • Patient is under the care of a health care provider with experience in the diagnosis and management of opioid use disorder; AND
  • The prescriber has been trained to implant the buprenorphine subdermal implant.

Approval is for a maximum of FOUR lifetime doses. One package of 4 implants is approved at every 6 months (e.g. four times X package of 4 implants)

Table: BUPRENORPHINE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
80MG Implant 02474921 PROBUPHINE UNK

BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of opioid dependence when:

  • The client must be 16 years or older.
  • In cases where the client lives in a remote or isolated location, confirmation is required that the community has the ability to support buprenorphine/naloxone administration. These supports include the safe daily witnessing, storage and handling of the buprenorphine/naloxone doses. After this confirmation, NIHB will approve the buprenorphine/naloxone for the client.
Table: BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
2MG & 0.5MG Tablet 02453908 ACT BUPRENORPHINE/NALOXONE ACG
2MG & 0.5MG Tablet 02408090 MYLAN-BUPRENORPHINE/NALOXONE MYL
2MG & 0.5MG Tablet 02424851 PMS-BUPRENORPHINE-NALOXONE PMS
2MG & 0.5MG Tablet 02295695 SUBOXONE IND
8MG & 2MG Tablet 02453916 ACT BUPRENORPHINE/NALOXONE ACG
8MG & 2MG Tablet 02408104 MYLAN-BUPRENORPHINE/NALOXONE MYL
8MG & 2MG Tablet 02424878 PMS-BUPRENORPHINE-NALOXONE PMS
8MG & 2MG Tablet 02295709 SUBOXONE IND
12MG & 3MG Tablet 02468085 SUBOXONE IND
16MG & 4MG Tablet 02468093 SUBOXONE IND

28:08.92 MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

ACETAMINOPHEN

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on acetaminophen. The limit accumulates against the amount of acetaminophen claimed to the program from plain acetaminophen and/or acetaminophen in combination with opioids such as codeine (i.e. Tylenol(r) #3) or oxycodone (i.e. Percocet(r)). A total of 360 grams of acetaminophen is permitted in a 100-day period, for a total daily dose of 3600mg/day.

Table: ACETAMINOPHEN
Drug strength and dosage form DIN Brand name Manufacturer code
ST80MG/ML Drop 01904140 ACETAMINOPHEN TAN
ST80MG/ML Drop 01905864 ACETAMINOPHEN TLI
ST80MG/ML Drop 02263793 PEDIAPHEN EUR
ST80MG/ML Drop 02027801 PEDIATRIX TEV
ST80MG/ML Drop 00875988 TEMPRA INFANT PAL
80MG/ML Drop 02046059 TYLENOL MCL
ST16MG/ML Liquid 01905848 ACETAMINOPHEN TLI
ST16MG/ML Liquid 00792713 PDP-ACETAMINOPHEN PED
ST16MG/ML Liquid 02263807 PEDIAPHEN EUR
ST16MG/ML Liquid 00884553 TEMPRA CHILDREN'S PAL
ST32MG/ML Liquid 01901389 ACETAMINOPHEN JMP
ST32MG/ML Liquid 01958836 ACETAMINOPHEN TLI
ST32MG/ML Liquid 00792691 PDP-ACETAMINOPHEN PED
ST32MG/ML Liquid 02263831 PEDIAPHEN EUR
32MG/ML Liquid 02027798 PEDIATRIX TEV
ST32MG/ML Liquid 00875996 TEMPRA CHILDREN'S DOUBLE STRENGTH PAL
32MG/ML Liquid 02046040 TYLENOL MCL
325MG Suppository 01919393 ABENOL PED
325MG Suppository 02230436 ACET 325 PED
325MG Suppository 02046687 PMS-ACETAMINOPHEN PMS
650MG Suppository 02230437 ACET 650 PED
650MG Suppository 02046695 PMS-ACETAMINOPHEN PMS
ST80MG Tablet 02015676 ACETAMINOPHEN TAN
ST80MG Tablet 02263815 PEDIAPHEN EUR
ST160MG Tablet 02230934 ACETAMINOPHEN TAN
ST325MG Tablet 00605751 ACETAMINOPHEN VTH
ST325MG Tablet 00743542 ACETAMINOPHEN PMT
ST325MG Tablet 00789801 ACETAMINOPHEN TLI
ST325MG Tablet 01938088 ACETAMINOPHEN JMP
ST325MG Tablet 02022214 ACÉTAMINOPHÈNE RIV
ST325MG Tablet 02362198 ACÉTAMINOPHÈNE RIV
ST325MG Tablet 00544981 APO ACETAMINOPHEN APX
ST325MG Tablet 02229873 APO-ACETAMINOPHEN APX
ST325MG Tablet 00389218 NOVO-GESIC TEV
ST325MG Tablet 00559393 TYLENOL MCL
ST325MG Tablet 00723894 TYLENOL MCL
ST500MG Tablet 00549703 ACETAMINOPHEN PMT
ST500MG Tablet 00605778 ACETAMINOPHEN VTH
ST500MG Tablet 00789798 ACETAMINOPHEN TLI
ST500MG Tablet 01939122 ACETAMINOPHEN JMP
ST500MG Tablet 01962353 ACETAMINOPHEN TAN
ST500MG Tablet 02252813 ACETAMINOPHEN PMT
ST500MG Tablet 02255251 ACETAMINOPHEN PMT
ST500MG Tablet 02022222 ACÉTAMINOPHÈNE RIV
ST500MG Tablet 02362228 ACÉTAMINOPHÈNE RIV
ST500MG Tablet 02362201 ACÉTAMINOPHÈNE BLASON SHIELD RIV
ST500MG Tablet 00545007 APO ACETAMINOPHEN APX
ST500MG Tablet 02229977 APO-ACETAMINOPHEN APX
ST500MG Tablet 02355299 JAMP ACETAMINOPHEN BLAZON JMP
ST500MG Tablet 00482323 NOVO-GESIC FORTE TEV
ST500MG Tablet 00892505 PMS-ACETAMINOPHEN PMS
ST500MG Tablet 00723908 TYLENOL MCL
ST500MG Tablet 00559407 TYLENOL EXTRA STRENGTH MCL
ST80MG Tablet (Chewable) 01905856 ACETAMINOPHEN TLI
ST80MG Tablet (Chewable) 02017458 ACETAMINOPHEN RIV
ST80MG Tablet (Chewable) 02129957 ACETAMINOPHEN VTH
ST160MG Tablet (Chewable) 02017431 ACETAMINOPHEN RIV
ST160MG Tablet (Chewable) 02142805 ACETAMINOPHEN VTH
ST160MG Tablet (Chewable) 02263823 PEDIAPHEN EUR
ST160MG Tablet (Chewable) 02347792 TYLENOL JR STRENGTH FASTMELTS MCL
ST160MG Tablet (Chewable) 02241361 TYLENOL JUNIOR STRENGTH MCL

28:12.08 ANTICONVULSANTS - BENZODIAZEPINES

CLONAZEPAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: CLONAZEPAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST0.25MG Tablet 02179660 PMS-CLONAZEPAM PMS
ST0.5MG Tablet 02177889 APO-CLONAZEPAM APX
ST0.5MG Tablet 02230366 CLONAPAM VAE
ST0.5MG Tablet 02048701 PMS-CLONAZEPAM PMS
ST0.5MG Tablet 02207818 PMS-CLONAZEPAM-R PMS
ST0.5MG Tablet 02311593 PRO-CLONAZEPAM PDL
ST0.5MG Tablet 02242077 RIVA-CLONAZEPAM RIV
ST0.5MG Tablet 00382825 RIVOTRIL HLR
ST0.5MG Tablet 02239024 TEVA-CLONAZEPAM TEV
ST1MG Tablet 02230368 CLONAPAM VAE
ST1MG Tablet 02048728 PMS-CLONAZEPAM PMS
ST1MG Tablet 02311607 PRO-CLONAZEPAM PDL
ST2MG Tablet 02177897 APO-CLONAZEPAM APX
ST2MG Tablet 02230369 CLONAPAM VAE
ST2MG Tablet 02048736 PMS-CLONAZEPAM PMS
ST2MG Tablet 02311615 PRO-CLONAZEPAM PDL
ST2MG Tablet 02242078 RIVA-CLONAZEPAM RIV
ST2MG Tablet 00382841 RIVOTRIL HLR
ST2MG Tablet 02239025 TEVA-CLONAZEPAM TEV

28:12.92 MISCELLANEOUS ANTICONVULSANTS

BRIVARACETAM

Limited use benefit (prior approval required).

For adjunctive therapy in adult patients with refractory partial-onset seizures who meet all of the following criteria:

  • Are under the care of a physician experienced in the treatment of epilepsy; AND
  • Are currently receiving two or more antiepileptic medications; AND
  • Have failed or demonstrated intolerance to at least two other antiepileptic medications; AND
  • Are not receiving concurrent therapy with levetiracetam.
Table: BRIVARACETAM
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Tablet 02452936 BRIVLERA UCB
25MG Tablet 02452944 BRIVLERA UCB
50MG Tablet 02452952 BRIVLERA UCB
75MG Tablet 02452960 BRIVLERA UCB
100MG Tablet 02452979 BRIVLERA UCB

ESLICARBAZEPINE ACETATE

Limited use benefit (prior approval required).

For adjunctive therapy in adult patients with refractory partial-onset seizures who meet all of the following criteria:

  • Are under the care of a physician experienced in the treatment of epilepsy; AND
  • Are currently receiving two or more antiepileptic medications; AND
  • Have failed or demonstrated intolerance to at least two other antiepileptic medications.
Table: ESLICARBAZEPINE ACETATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST200MG Tablet 02426862 APTIOM SPC
ST400MG Tablet 02426870 APTIOM SPC
ST600MG Tablet 02426889 APTIOM SPC
ST800MG Tablet 02426897 APTIOM SPC

GABAPENTIN

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on gabapentin. The limit accumulates against the amount of gabapentin claimed to the program. A total of 400 grams of gabapentin is permitted in a 30-day period, for a total daily dose of 4000 mg/day.

The gabapentin dose limit will be further reduced to 3600 mg per day. The new limit will be implemented region-by-region.

Table: GABAPENTIN
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Capsule 02477912 AG-GABAPENTIN ANG
ST100MG Capsule 02244304 APO-GABAPENTIN APX
ST100MG Capsule 02321203 AURO-GABAPENTIN AUR
ST100MG Capsule 02243743 DOM-GABAPENTIN DPC
ST100MG Capsule 02246314 GABAPENTIN SIV
ST100MG Capsule 02353245 GABAPENTIN SAN
ST100MG Capsule 02416840 GABAPENTIN ACC
ST100MG Capsule 02285819 GD-GABAPENTIN PFI
ST100MG Capsule 02361469 JAMP-GABAPENTIN JMP
ST100MG Capsule 02391473 MAR-GABAPENTIN MAR
ST100MG Capsule 02084260 NEURONTIN PFI
ST100MG Capsule 02243446 PMS-GABAPENTIN PMS
ST100MG Capsule 02310449 PRO-GABAPENTIN PDL
ST100MG Capsule 02319055 RAN-GABAPENTIN RBY
ST100MG Capsule 02251167 RIVA-GABAPENTIN RIV
ST100MG Capsule 02244513 TEVA-GABAPENTIN TEV
300MG Capsule 02477920 AG-GABAPENTIN ANG
ST300MG Capsule 02244305 APO-GABAPENTIN APX
ST300MG Capsule 02321211 AURO-GABAPENTIN AUR
ST300MG Capsule 02243744 DOM-GABAPENTIN DPC
ST300MG Capsule 02246315 GABAPENTIN SIV
ST300MG Capsule 02353253 GABAPENTIN SAN
ST300MG Capsule 02416859 GABAPENTIN ACC
ST300MG Capsule 02285827 GD-GABAPENTIN PFI
ST300MG Capsule 02361485 JAMP-GABAPENTIN JMP
ST300MG Capsule 02391481 MAR-GABAPENTIN MAR
ST300MG Capsule 02084279 NEURONTIN PFI
ST300MG Capsule 02243447 PMS-GABAPENTIN PMS
ST300MG Capsule 02310457 PRO-GABAPENTIN PDL
ST300MG Capsule 02319063 RAN-GABAPENTIN RBY
ST300MG Capsule 02251175 RIVA-GABAPENTIN RIV
ST300MG Capsule 02244514 TEVA-GABAPENTIN TEV
400MG Capsule 02477939 AG-GABAPENTIN ANG
ST400MG Capsule 02244306 APO-GABAPENTIN APX
ST400MG Capsule 02321238 AURO-GABAPENTIN AUR
ST400MG Capsule 02243745 DOM-GABAPENTIN DPC
ST400MG Capsule 02246316 GABAPENTIN SIV
ST400MG Capsule 02353261 GABAPENTIN SAN
ST400MG Capsule 02416867 GABAPENTIN ACC
ST400MG Capsule 02361493 JAMP-GABAPENTIN JMP
ST400MG Capsule 02391503 MAR-GABAPENTIN MAR
ST400MG Capsule 02084287 NEURONTIN PFI
ST400MG Capsule 02243448 PMS-GABAPENTIN PMS
ST400MG Capsule 02310465 PRO-GABAPENTIN PDL
ST400MG Capsule 02319071 RAN-GABAPENTIN RBY
ST400MG Capsule 02251183 RIVA-GABAPENTIN RIV
ST400MG Capsule 02244515 TEVA-GABAPENTIN TEV
ST600MG Tablet 02293358 APO-GABAPENTIN APX
ST600MG Tablet 02388200 GABAPENTIN SIV
ST600MG Tablet 02392526 GABAPENTIN ACC
ST600MG Tablet 02431289 GABAPENTIN SAN
ST600MG Tablet 02285843 GD-GABAPENTIN PFI
ST600MG Tablet 02402289 JAMP-GABAPENTIN JMP
ST600MG Tablet 02239717 NEURONTIN PFI
ST600MG Tablet 02255898 PMS-GABAPENTIN PMS
ST600MG Tablet 02310473 PRO-GABAPENTIN PDL
ST600MG Tablet 02259796 RIVA-GABAPENTIN RIV
ST600MG Tablet 02248457 TEVA-GABAPENTIN TEV
ST800MG Tablet 02293366 APO-GABAPENTIN APX
ST800MG Tablet 02388219 GABAPENTIN SIV
ST800MG Tablet 02392534 GABAPENTIN ACC
ST800MG Tablet 02431297 GABAPENTIN SAN
ST800MG Tablet 02402297 JAMP-GABAPENTIN JMP
ST800MG Tablet 02239718 NEURONTIN PFI
ST800MG Tablet 02255901 PMS-GABAPENTIN PMS
ST800MG Tablet 02310481 PRO-GABAPENTIN PDL
ST800MG Tablet 02259818 RIVA-GABAPENTIN RIV
ST800MG Tablet 02247346 TEVA-GABAPENTIN TEV
ST600MG Tablet (Immediate Release) 02410990 GLN-GABAPENTIN GLK
ST800MG Tablet (Immediate Release) 02411008 GLN-GABAPENTIN GLK

LACOSAMIDE

Limited use benefit (prior approval required).

For adjunctive therapy in adult patients with refractory partial-onset seizures who meet all of the following criteria:

  • Are under the care of a physician experienced in the treatment of epilepsy; AND
  • Are currently receiving two or more antiepileptic medications; AND
  • Have failed or demonstrated intolerance to at least two other antiepileptic medications.
Table: LACOSAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST50MG Tablet 02475332 AURO-LACOSAMIDE AUR
ST50MG Tablet 02478196 PHARMA-LACOSAMIDE PMS
ST50MG Tablet 02474670 SANDOZ LACOSAMIDE SDZ
50MG Tablet 02472902 TEVA-LACOSAMIDE TEV
ST50MG Tablet 02357615 VIMPAT UCB
ST100MG Tablet 02475340 AURO-LACOSAMIDE AUR
ST100MG Tablet 02478218 PHARMA-LACOSAMIDE PMS
ST100MG Tablet 02474689 SANDOZ LACOSAMIDE SDZ
100MG Tablet 02472910 TEVA-LACOSAMIDE TEV
ST100MG Tablet 02357623 VIMPAT UCB
ST150MG Tablet 02475359 AURO-LACOSAMIDE AUR
ST150MG Tablet 02478226 PHARMA-LACOSAMIDE PMS
ST150MG Tablet 02474697 SANDOZ LACOSAMIDE SDZ
150MG Tablet 02472929 TEVA-LACOSAMIDE TEV
ST150MG Tablet 02357631 VIMPAT UCB
ST200MG Tablet 02475367 AURO-LACOSAMIDE AUR
ST200MG Tablet 02478234 PHARMA-LACOSAMIDE PMS
ST200MG Tablet 02474700 SANDOZ LACOSAMIDE SDZ
200MG Tablet 02472937 TEVA-LACOSAMIDE TEV
ST200MG Tablet 02357658 VIMPAT UCB

OXCARBAZEPINE (SUSPENSION)

Limited use benefit (prior approval is not required).

For patients 19 years of age or over who are unable to swallow the tablet formulation due to:

- Tube feeding; OR

- Severe dysphagia

Note:

Trileptal (oxcarbazepine) suspension is an open benefit for patients 18 years of age and under and does not require prior approval for these patients.

Oxcarbazepine tablets are an open benefit for patients of all ages and do not require prior approval.

Table: OXCARBAZEPINE (SUSPENSION)
Drug strength and dosage form DIN Brand name Manufacturer code
60MG Suspension 02244673 TRILEPTAL NVR

PREGABALIN

Limited use benefit (prior approval required).

For the treatment of neuropathic pain in patients who have failed to effectively treat their pain with a tricyclic antidepressant (TCA);

OR

For the treatment of neuropathic pain in patients who have a contraindication or intolerance to a tricyclic antidepressant (TCA).

Coverage is limited to a maximum of 600mg per day.

Table: PREGABALIN
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Capsule 02480727 AG-PREGABALIN ANG
ST25MG Capsule 02394235 APO-PREGABALIN APX
ST25MG Capsule 02433869 AURO-PREGABALIN AUR
ST25MG Capsule 02402556 DOM-PREGABALIN DPC
ST25MG Capsule 02435977 JAMP-PREGABALIN JMP
ST25MG Capsule 02268418 LYRICA PFI
ST25MG Capsule 02417529 MAR-PREGABALIN MAR
ST25MG Capsule 02423804 MINT-PREGABALIN MIN
25MG Capsule 02467291 M-PREGABALIN MAN
25MG Capsule 02479117 NRA-PREGABALIN UNK
ST25MG Capsule 02359596 PMS-PREGABALIN PMS
25MG Capsule 02396483 PREGABALIN PDL
ST25MG Capsule 02403692 PREGABALIN SIV
ST25MG Capsule 02405539 PREGABALIN SAN
25MG Capsule 02476304 PREGABALIN RIV
ST25MG Capsule 02392801 RAN-PREGABALIN RBY
ST25MG Capsule 02377039 RIVA-PREGABALIN RIV
ST25MG Capsule 02390817 SANDOZ PREGABALIN SDZ
ST25MG Capsule 02361159 TEVA-PREGABALIN TEV
50MG Capsule 02480735 AG-PREGABALIN ANG
ST50MG Capsule 02394243 APO-PREGABALIN APX
ST50MG Capsule 02433877 AURO-PREGABALIN AUR
ST50MG Capsule 02402564 DOM-PREGABALIN DPC
ST50MG Capsule 02435985 JAMP-PREGABALIN JMP
ST50MG Capsule 02268426 LYRICA PFI
ST50MG Capsule 02417537 MAR-PREGABALIN MAR
ST50MG Capsule 02423812 MINT-PREGABALIN MIN
50MG Capsule 02467305 M-PREGABALIN MAN
50MG Capsule 02479125 NRA-PREGABALIN UNK
ST50MG Capsule 02359618 PMS-PREGABALIN PMS
50MG Capsule 02396505 PREGABALIN PDL
ST50MG Capsule 02403706 PREGABALIN SIV
ST50MG Capsule 02405547 PREGABALIN SAN
50MG Capsule 02476312 PREGABALIN RIV
ST50MG Capsule 02392828 RAN-PREGABALIN RBY
ST50MG Capsule 02377047 RIVA-PREGABALIN RIV
ST50MG Capsule 02390825 SANDOZ PREGABALIN SDZ
ST50MG Capsule 02361175 TEVA-PREGABALIN TEV
75MG Capsule 02480743 AG-PREGABALIN ANG
ST75MG Capsule 02394251 APO-PREGABALIN APX
ST75MG Capsule 02433885 AURO-PREGABALIN AUR
ST75MG Capsule 02402572 DOM-PREGABALIN DPC
ST75MG Capsule 02435993 JAMP-PREGABALIN JMP
ST75MG Capsule 02268434 LYRICA PFI
ST75MG Capsule 02417545 MAR-PREGABALIN MAR
ST75MG Capsule 02424185 MINT-PREGABALIN MIN
75MG Capsule 02467313 M-PREGABALIN MAN
75MG Capsule 02479133 NRA-PREGABALIN UNK
ST75MG Capsule 02359626 PMS-PREGABALIN PMS
75MG Capsule 02396513 PREGABALIN PDL
ST75MG Capsule 02403714 PREGABALIN SIV
ST75MG Capsule 02405555 PREGABALIN SAN
75MG Capsule 02476320 PREGABALIN RIV
ST75MG Capsule 02392836 RAN-PREGABALIN RBY
ST75MG Capsule 02377055 RIVA-PREGABALIN RIV
ST75MG Capsule 02390833 SANDOZ PREGABALIN SDZ
ST75MG Capsule 02361183 TEVA-PREGABALIN TEV
150MG Capsule 02480751 AG-PREGABALIN ANG
ST150MG Capsule 02394278 APO-PREGABALIN APX
ST150MG Capsule 02433907 AURO-PREGABALIN AUR
ST150MG Capsule 02402580 DOM-PREGABALIN DPC
ST150MG Capsule 02436000 JAMP-PREGABALIN JMP
ST150MG Capsule 02268450 LYRICA PFI
ST150MG Capsule 02417561 MAR-PREGABALIN MAR
ST150MG Capsule 02424207 MINT-PREGABALIN MIN
150MG Capsule 02467321 M-PREGABALIN MAN
150MG Capsule 02479168 NRA-PREGABALIN UNK
ST150MG Capsule 02359634 PMS-PREGABALIN PMS
150MG Capsule 02396521 PREGABALIN PDL
ST150MG Capsule 02403722 PREGABALIN SIV
ST150MG Capsule 02405563 PREGABALIN SAN
150MG Capsule 02476347 PREGABALIN RIV
ST150MG Capsule 02392844 RAN-PREGABALIN RBY
ST150MG Capsule 02377063 RIVA-PREGABALIN RIV
ST150MG Capsule 02390841 SANDOZ PREGABALIN SDZ
ST150MG Capsule 02361205 TEVA-PREGABALIN TEV
ST300MG Capsule 02394294 APO-PREGABALIN APX
ST300MG Capsule 02436019 JAMP-PREGABALIN JMP
ST300MG Capsule 02268485 LYRICA PFI
ST300MG Capsule 02359642 PMS-PREGABALIN PMS
300MG Capsule 02396548 PREGABALIN PDL
ST300MG Capsule 02403730 PREGABALIN SIV
ST300MG Capsule 02405598 PREGABALIN SAN
300MG Capsule 02476371 PREGABALIN RIV
ST300MG Capsule 02392860 RAN-PREGABALIN RBY
ST300MG Capsule 02377071 RIVA-PREGABALIN RIV
ST300MG Capsule 02390868 SANDOZ PREGABALIN SDZ
ST300MG Capsule 02361248 TEVA-PREGABALIN TEV

RUFINAMIDE

Limited use benefit (prior approval required).

  • For the adjunctive treatment of seizures associated with Lennox-Gastaux syndrome in adults and children 4 years and older when prescribed by a neurologist or experienced specialist.
  • Patient has failed or is intolerant to or has contraindications to at least two adjunctive antiepileptic drugs.
Table: RUFINAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST100MG Tablet 02369613 BANZEL EIS
ST200MG Tablet 02369621 BANZEL EIS
ST400MG Tablet 02369648 BANZEL EIS

28:16.04 ANTIDEPRESSANTS

BUPROPION HYDROCHLORIDE (ZYBAN)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 180 tablets during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached the client is eligible again for coverage for bupropion hydrochloride when one year has elapsed from the day the initial prescription was filled.

Table: BUPROPION HYDROCHLORIDE (ZYBAN)
Drug strength and dosage form DIN Brand name Manufacturer code
ST150MG Tablet (Extended Release) 02238441 ZYBAN VAE

28:16.08 ANTIPSYCHOTIC AGENTS

ASENAPINE MALEATE

Limited use benefit (prior approval required).

For the acute treatment of manic or mixed episodes associated with bipolar I disorder as either:

  • Monotherapy, after a trial of lithium or divalproex sodium has failed or is contraindicated, and trials of two atypical antipsychotic agents have failed due to intolerance or lack of response; OR
  • Co-therapy with lithium or divalproex sodium, after trials of two atypical antipsychotic agents have failed due to intolerance or lack of response.
Table: ASENAPINE MALEATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02374803 SAPHRIS FRS
ST10MG Tablet 02374811 SAPHRIS FRS

LURASIDONE HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of schizophrenia and schizoaffective disorders in patients:

  • who have intolerance or lack of response to an adequate trial of another antipsychotic agent; OR
  • a contraindication to another antipsychotic agent.
Table: LURASIDONE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST20MG Tablet 02422050 LATUDA SPC
ST40MG Tablet 02387751 LATUDA SPC
ST60MG Tablet 02413361 LATUDA SPC
ST80MG Tablet 02387778 LATUDA SPC
ST120MG Tablet 02387786 LATUDA SPC

28:20.04 AMPHETAMINES

AMPHETAMINE, DEXTROAMPHETAMINE

Limited use benefit (prior approval is not required).

The NIHB Program introduced a dose coverage limit for stimulants on February 25, 2015 as part of a strategy to deal with the potential misuse and abuse of these medications. The stimulant dose coverage limit is set at 100 mg of methylphenidate equivalents* per day for adults and children. This limit is calculated based on the total dose of all stimulants that patients are receiving from NIHB. The Program will continue to monitor the utilization of stimulants and adjust the eligible dose limit as required.

* To convert to methylphenidate equivalents, 1 mg of METHYLPHENIDATE, or LISDEXAMFETAMINE is equal to 0.5 mg DEXTROAMPHETAMINE

Table: AMPHETAMINE, DEXTROAMPHETAMINE
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Capsule (Extended Release) 02439239 ACT AMPHETAMINE XR TEV
5MG Capsule (Extended Release) 02248808 ADDERALL XR UNK
ST5MG Capsule (Extended Release) 02445492 APO-AMPHETAMINE XR APX
ST5MG Capsule (Extended Release) 02440369 PMS-AMPHETAMINES XR PMS
ST5MG Capsule (Extended Release) 02457288 SANDOZ AMPHETAMINE XR SDZ
ST10MG Capsule (Extended Release) 02439247 ACT AMPHETAMINE XR TEV
10MG Capsule (Extended Release) 02248809 ADDERALL XR UNK
ST10MG Capsule (Extended Release) 02445506 APO-AMPHETAMINE XR APX
ST10MG Capsule (Extended Release) 02440377 PMS-AMPHETAMINES XR PMS
ST10MG Capsule (Extended Release) 02457296 SANDOZ AMPHETAMINE XR SDZ
ST15MG Capsule (Extended Release) 02439255 ACT AMPHETAMINE XR TEV
15MG Capsule (Extended Release) 02248810 ADDERALL XR UNK
ST15MG Capsule (Extended Release) 02445514 APO-AMPHETAMINE XR APX
ST15MG Capsule (Extended Release) 02440385 PMS-AMPHETAMINES XR PMS
ST15MG Capsule (Extended Release) 02457318 SANDOZ AMPHETAMINE XR SDZ
ST20MG Capsule (Extended Release) 02439263 ACT AMPHETAMINE XR TEV
20MG Capsule (Extended Release) 02248811 ADDERALL XR UNK
ST20MG Capsule (Extended Release) 02445522 APO-AMPHETAMINE XR APX
ST20MG Capsule (Extended Release) 02440393 PMS-AMPHETAMINES XR PMS
ST20MG Capsule (Extended Release) 02457326 SANDOZ AMPHETAMINE XR SDZ
ST25MG Capsule (Extended Release) 02439271 ACT AMPHETAMINE XR TEV
25MG Capsule (Extended Release) 02248812 ADDERALL XR UNK
ST25MG Capsule (Extended Release) 02445530 APO-AMPHETAMINE XR APX
ST25MG Capsule (Extended Release) 02440407 PMS-AMPHETAMINES XR PMS
ST25MG Capsule (Extended Release) 02457334 SANDOZ AMPHETAMINE XR SDZ
ST30MG Capsule (Extended Release) 02439298 ACT AMPHETAMINE XR TEV
30MG Capsule (Extended Release) 02248813 ADDERALL XR UNK
ST30MG Capsule (Extended Release) 02445549 APO-AMPHETAMINE XR APX
ST30MG Capsule (Extended Release) 02440415 PMS-AMPHETAMINES XR PMS
ST30MG Capsule (Extended Release) 02457342 SANDOZ AMPHETAMINE XR SDZ

DEXTROAMPHETAMINE SULFATE

Limited use benefit (prior approval is not required).

The NIHB Program introduced a dose coverage limit for stimulants on February 25, 2015 as part of a strategy to deal with the potential misuse and abuse of these medications. The stimulant dose coverage limit is set at 100 mg of methylphenidate equivalents* per day for adults and children. This limit is calculated based on the total dose of all stimulants that patients are receiving from NIHB. The Program will continue to monitor the utilization of stimulants and adjust the eligible dose limit as required.

* To convert to methylphenidate equivalents, 1 mg of METHYLPHENIDATE, or LISDEXAMFETAMINE is equal to 0.5 mg DEXTROAMPHETAMINE

Table: DEXTROAMPHETAMINE SULFATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Capsule (Sustained Release) 02448319 ACT DEXTROAMPHETAMINE SR ACG
ST10MG Capsule (Sustained Release) 01924559 DEXEDRINE SPANSULE PAL
ST15MG Capsule (Sustained Release) 02448327 ACT DEXTROAMPHETAMINE SR ACG
ST15MG Capsule (Sustained Release) 01924567 DEXEDRINE SPANSULE PAL
ST5MG Tablet 01924516 DEXEDRINE PAL
ST5MG Tablet 02443236 DEXTROAMPHETAMINE AAP

LISDEXAMFETAMINE DIMESYLATE

Limited use benefit (prior approval is not required).

The NIHB Program introduced a dose coverage limit for stimulants on February 25, 2015 as part of a strategy to deal with the potential misuse and abuse of these medications. The stimulant dose coverage limit is set at 100 mg of methylphenidate equivalents* per day for adults and children. This limit is calculated based on the total dose of all stimulants that patients are receiving from NIHB. The Program will continue to monitor the utilization of stimulants and adjust the eligible dose limit as required.

* To convert to methylphenidate equivalents, 1 mg of METHYLPHENIDATE, or LISDEXAMFETAMINE is equal to 0.5 mg DEXTROAMPHETAMINE

Table: LISDEXAMFETAMINE DIMESYLATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Capsule 02439603 VYVANSE SHI
ST20MG Capsule 02347156 VYVANSE SHI
ST30MG Capsule 02322951 VYVANSE SHI
ST40MG Capsule 02347164 VYVANSE SHI
ST50MG Capsule 02322978 VYVANSE SHI
ST60MG Capsule 02347172 VYVANSE SHI

28:20.32 CNS STIMULANTS

METHYLPHENIDATE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

The NIHB Program introduced a dose coverage limit for stimulants on February 25, 2015 as part of a strategy to deal with the potential misuse and abuse of these medications. The stimulant dose coverage limit is set at 100 mg of methylphenidate equivalents* per day for adults and children. This limit is calculated based on the total dose of all stimulants that patients are receiving from NIHB. The Program will continue to monitor the utilization of stimulants and adjust the eligible dose limit as required.

* To convert to methylphenidate equivalents, 1 mg of METHYLPHENIDATE, or LISDEXAMFETAMINE is equal to 0.5 mg DEXTROAMPHETAMINE

Table: METHYLPHENIDATE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02273950 APO-METHYLPHENIDATE APX
ST5MG Tablet 02234749 PMS-METHYLPHENIDATE PMS
ST10MG Tablet 02249324 APO-METHYLPHENIDATE APX
ST10MG Tablet 00584991 PMS-METHYLPHENIDATE PMS
ST20MG Tablet 02249332 APO-METHYLPHENIDATE APX
ST20MG Tablet 00585009 PMS-METHYLPHENIDATE PMS
ST18MG Tablet (Extended Release) 02441934 ACT METHYLPHENIDATE ER ACG
ST18MG Tablet (Extended Release) 02452731 APO-METHYLPHENIDATE ER APX
ST18MG Tablet (Extended Release) 02247732 CONCERTA JSO
ST18MG Tablet (Extended Release) 02413728 PMS-METHYLPHENIDATE ER PMS
ST18MG Tablet (Extended Release) 02315068 TEVA-METHYLPHENIDATE TEV
ST20MG Tablet (Extended Release) 02266687 APO-METHYLPHENIDATE SR APX
ST20MG Tablet (Extended Release) 02320312 SANDOZ METHYLPHENIDATE SR SDZ
ST27MG Tablet (Extended Release) 02441942 ACT METHYLPHENIDATE ER ACG
ST27MG Tablet (Extended Release) 02452758 APO-METHYLPHENIDATE ER APX
ST27MG Tablet (Extended Release) 02250241 CONCERTA JSO
ST27MG Tablet (Extended Release) 02413736 PMS-METHYLPHENIDATE ER PMS
ST27MG Tablet (Extended Release) 02315076 TEVA-METHYLPHENIDATE TEV
ST36MG Tablet (Extended Release) 02441950 ACT METHYLPHENIDATE ER ACG
ST36MG Tablet (Extended Release) 02452766 APO-METHYLPHENIDATE ER APX
ST36MG Tablet (Extended Release) 02247733 CONCERTA JSO
ST36MG Tablet (Extended Release) 02413744 PMS-METHYLPHENIDATE ER PMS
ST36MG Tablet (Extended Release) 02315084 TEVA-METHYLPHENIDATE TEV
ST54MG Tablet (Extended Release) 02441969 ACT METHYLPHENIDATE ER ACG
ST54MG Tablet (Extended Release) 02330377 APO-METHYLPHENIDATE ER APX
ST54MG Tablet (Extended Release) 02247734 CONCERTA JSO
ST54MG Tablet (Extended Release) 02413752 PMS-METHYLPHENIDATE ER PMS
ST54MG Tablet (Extended Release) 02315092 TEVA-METHYLPHENIDATE TEV

28:20.92 MISC ANOREXIGENIC AGENTS & RESPIRATORY & CEREBRAL STIMULANT

CAFFEINE CITRATE

Limited use benefit (prior approval not required).

For children up to 1 year of age

Table: CAFFEINE CITRATE
Drug strength and dosage form DIN Brand name Manufacturer code
Powder 00972037 CAFFEINE CITRATE MDS

28:24.08 ANXIOLYTICS, SEDATIVES AND HYPNOTICS - BENZODIAZEPINES

ALPRAZOLAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: ALPRAZOLAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST0.25MG Tablet 01908189 ALPRAZOLAM PDL
ST0.25MG Tablet 02349191 ALPRAZOLAM SAN
ST0.25MG Tablet 00865397 APO-ALPRAZ APX
ST0.25MG Tablet 02400111 JAMP-ALPRAZOLAM JMP
ST0.25MG Tablet 01913484 TEVA-ALPRAZOLAM TEV
ST0.25MG Tablet 00548359 XANAX PFI
ST0.5MG Tablet 01908170 ALPRAZOLAM PDL
ST0.5MG Tablet 02349205 ALPRAZOLAM SAN
ST0.5MG Tablet 00865400 APO-ALPRAZ APX
ST0.5MG Tablet 02400138 JAMP-ALPRAZOLAM JMP
ST0.5MG Tablet 01913492 TEVA-ALPRAZOLAM TEV
ST0.5MG Tablet 00548367 XANAX PFI
ST1MG Tablet 02248706 ALPRAZOLAM PDL
ST1MG Tablet 02243611 APO-ALPRAZ APX
ST1MG Tablet 02400146 JAMP-ALPRAZOLAM JMP
ST1MG Tablet 00723770 XANAX PFI
ST2MG Tablet 02243612 APO-ALPRAZ APX
ST2MG Tablet 02400154 JAMP-ALPRAZOLAM JMP
ST2MG Tablet 00813958 XANAX TS PFI

BROMAZEPAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: BROMAZEPAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST1.5MG Tablet 02177153 APO-BROMAZEPAM APX
ST3MG Tablet 02177161 APO-BROMAZEPAM APX
ST3MG Tablet 02230584 TEVA-BROMAZEPAM TEV
ST6MG Tablet 02177188 APO-BROMAZEPAM APX
ST6MG Tablet 02230585 TEVA-BROMAZEPAM TEV

DIAZEPAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: DIAZEPAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST1MG/ML Solution 00891797 PMS-DIAZEPAM PMS
ST2MG Tablet 00405329 DIAZEPAM AAP
ST2MG Tablet 02247490 PMS-DIAZEPAM PMS
ST5MG Tablet 00313580 DIAZEPAM PDL
ST5MG Tablet 00362158 DIAZEPAM AAP
ST5MG Tablet 02247491 PMS-DIAZEPAM PMS
ST5MG Tablet 00013285 VALIUM HLR
ST10MG Tablet 00405337 DIAZEPAM AAP
ST10MG Tablet 02247492 PMS-DIAZEPAM PMS

DIAZEPAM (DIASTAT)

Limited use benefit (prior approval not required).

For children 12 years of age or under.

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4,000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: DIAZEPAM (DIASTAT)
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG/ML Gel 02238162 DIASTAT VAE
ST5MG/ML Gel 09853340 DIASTAT 2X10MG RECTAL PACK ELN
ST5MG/ML Gel 09853430 DIASTAT 2X15MG RECTAL PACK ELN

LORAZEPAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: LORAZEPAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST0.5MG Tablet 00655740 APO-LORAZEPAM APX
ST0.5MG Tablet 02041413 ATIVAN PFI
ST0.5MG Tablet 02041456 ATIVAN SUBLINGUAL PFI
ST0.5MG Tablet 02351072 LORAZEPAM SAN
ST0.5MG Tablet 02410745 LORAZEPAM SUBLINGUAL AAP
ST0.5MG Tablet 00728187 PMS-LORAZEPAM PMS
ST0.5MG Tablet 00655643 PRO-LORAZEPAM PDL
ST0.5MG Tablet 00711101 TEVA-LORAZEPAM TEV
ST1MG Tablet 00655759 APO-LORAZEPAM APX
ST1MG Tablet 02041421 ATIVAN PFI
ST1MG Tablet 02041464 ATIVAN SUBLINGUAL PFI
ST1MG Tablet 02351080 LORAZEPAM SAN
ST1MG Tablet 02410753 LORAZEPAM SUBLINGUAL AAP
ST1MG Tablet 00728195 PMS-LORAZEPAM PMS
ST1MG Tablet 00655651 PRO-LORAZEPAM PDL
ST1MG Tablet 00637742 TEVA-LORAZEPAM TEV
ST2MG Tablet 00655767 APO-LORAZEPAM APX
ST2MG Tablet 02041448 ATIVAN PFI
ST2MG Tablet 02041472 ATIVAN SUBLINGUAL PFI
ST2MG Tablet 02351099 LORAZEPAM SAN
ST2MG Tablet 02410761 LORAZEPAM SUBLINGUAL AAP
ST2MG Tablet 00728209 PMS-LORAZEPAM PMS
ST2MG Tablet 00655678 PRO-LORAZEPAM PDL
ST2MG Tablet 00637750 TEVA-LORAZEPAM TEV

NITRAZEPAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: NITRAZEPAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 00511528 MOGADON AAP
ST10MG Tablet 00511536 MOGADON AAP

OXAZEPAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: OXAZEPAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Tablet 00402680 APO OXAZEPAM APX
ST10MG Tablet 00497754 OXAZEPAM PDL
ST10MG Tablet 00414247 OXPAM BMI
ST10MG Tablet 00568392 RIVA OXAZEPAM RIV
ST15MG Tablet 00402745 APO OXAZEPAM APX
ST15MG Tablet 00497762 OXAZEPAM PDL
ST15MG Tablet 00568406 RIVA OXAZEPAM RIV
ST30MG Tablet 00402737 APO OXAZEPAM APX
ST30MG Tablet 00497770 OXAZEPAM PDL
ST30MG Tablet 00414263 OXPAM BMI
ST30MG Tablet 00568414 RIVA OXAZEPAM RIV

TEMAZEPAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: TEMAZEPAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST15MG Capsule 00604453 RESTORIL AAP
ST15MG Capsule 02225964 TEMAZEPAM APX
ST15MG Capsule 02229760 TEMAZEPAM PDL
ST15MG Capsule 02230095 TEVA-TEMAZEPAM TEV
ST30MG Capsule 00604461 RESTORIL AAP
ST30MG Capsule 02225972 TEMAZEPAM APX
ST30MG Capsule 02229761 TEMAZEPAM PDL
ST30MG Capsule 02230102 TEVA-TEMAZEPAM TEV

TRIAZOLAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 40 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 4 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 40 mg per day.

The benzodiazepine dose limit will be further reduced to 30 mg DEQ per day. The new limit will be implemented region-by-region.

Table: TRIAZOLAM
Drug strength and dosage form DIN Brand name Manufacturer code
ST0.25MG Tablet 00808571 TRIAZOLAM AAP

28:32.28 SELECTIVE SEROTONIN AGONISTS

ALMOTRIPTAN MALATE

Limited use benefit (prior approval is not required).

A total of 12 tablets are permitted in a 30-day period.

Table: ALMOTRIPTAN MALATE
Drug strength and dosage form DIN Brand name Manufacturer code
6.25MG Tablet 02405792 APO-ALMOTRIPTAN APX
6.25MG Tablet 02248128 AXERT MCL
6.25MG Tablet 02398435 MYLAN-ALMOTRIPTAN MYL
12.5MG Tablet 02424029 ALMOTRIPTAN PDL
12.5MG Tablet 02466821 ALMOTRIPTAN SAN
12.5MG Tablet 02405806 APO-ALMOTRIPTAN APX
12.5MG Tablet 02248129 AXERT MCL
12.5MG Tablet 02398443 MYLAN-ALMOTRIPTAN MYL
12.5MG Tablet 02405334 SANDOZ ALMOTRIPTAN SDZ
12.5MG Tablet 02434849 TEVA-ALMOTRIPTAN TEV

NARATRIPTAN HYDROCHLORIDE

Limited use benefit (prior approval is not required).

A total of 12 tablets are permitted in a 30-day period.

Table: NARATRIPTAN HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
1MG Tablet 02237820 AMERGE GSK
1MG Tablet 02314290 TEVA-NARATRIPTAN TEV
2.5MG Tablet 02237821 AMERGE GSK
2.5MG Tablet 02322323 SANDOZ NARATRIPTAN SDZ
2.5MG Tablet 02314304 TEVA-NARATRIPTAN TEV

RIZATRIPTAN BENZOATE

Limited use benefit (prior approval is not required).

A total of 12 tablets are permitted in a 30-day period.

Table: RIZATRIPTAN BENZOATE
Drug strength and dosage form DIN Brand name Manufacturer code
5MG Tablet 02393468 APO-RIZATRIPTAN APX
5MG Tablet 02380455 JAMP-RIZATRIPTAN JMP
5MG Tablet 02429233 JAMP-RIZATRIPTAN IR JMP
5MG Tablet 02379651 MAR-RIZATRIPTAN MAR
10MG Tablet 02381702 ACT RIZATRIPTAN ACG
10MG Tablet 02393476 APO-RIZATRIPTAN APX
10MG Tablet 02441144 AURO-RIZATRIPTAN AUR
10MG Tablet 02380463 JAMP-RIZATRIPTAN JMP
10MG Tablet 02429241 JAMP-RIZATRIPTAN IR JMP
10MG Tablet 02379678 MAR-RIZATRIPTAN MAR
10MG Tablet 02240521 MAXALT FRS
5MG Tablet (Orally Disintegrating) 02393484 APO-RIZATRIPTAN RPD APX
ST5MG Tablet (Orally Disintegrating) 02465086 JAMP-RIZATRIPTAN ODT JMP
5MG Tablet (Orally Disintegrating) 02462788 MAR-RIZATRIPTAN ODT MAR
5MG Tablet (Orally Disintegrating) 02240518 MAXALT RPD FRS
5MG Tablet (Orally Disintegrating) 02379198 MYLAN-RIZATRIPTAN ODT MYL
5MG Tablet (Orally Disintegrating) 02436604 NAT-RIZATRIPTAN ODT NPH
5MG Tablet (Orally Disintegrating) 02393360 PMS-RIZATRIPTAN RDT PMS
5MG Tablet (Orally Disintegrating) 02442906 RIZATRIPTAN ODT SAN
5MG Tablet (Orally Disintegrating) 02446111 RIZATRIPTAN ODT SIV
5MG Tablet (Orally Disintegrating) 02415798 RIZATRIPTAN RDT PDL
5MG Tablet (Orally Disintegrating) 02351870 SANDOZ RIZATRIPTAN ODT SDZ
5MG Tablet (Orally Disintegrating) 02396661 TEVA-RIZATRIPTAN ODT TEV
10MG Tablet (Orally Disintegrating) 02393492 APO-RIZATRIPTAN RPD APX
10MG Tablet (Orally Disintegrating) 02396203 DOM-RIZATRIPTAN RDT DPC
10MG Tablet (Orally Disintegrating) 02465094 JAMP-RIZATRIPTAN ODT JMP
10MG Tablet (Orally Disintegrating) 02462796 MAR-RIZATRIPTAN ODT MAR
10MG Tablet (Orally Disintegrating) 02240519 MAXALT RPD FRS
10MG Tablet (Orally Disintegrating) 02379201 MYLAN-RIZATRIPTAN ODT MYL
10MG Tablet (Orally Disintegrating) 02436612 NAT-RIZATRIPTAN ODT NPH
10MG Tablet (Orally Disintegrating) 02393379 PMS-RIZATRIPTAN RDT PMS
10MG Tablet (Orally Disintegrating) 02442914 RIZATRIPTAN ODT SAN
10MG Tablet (Orally Disintegrating) 02446138 RIZATRIPTAN ODT SIV
10MG Tablet (Orally Disintegrating) 02415801 RIZATRIPTAN RDT PDL
10MG Tablet (Orally Disintegrating) 02351889 SANDOZ RIZATRIPTAN ODT SDZ
10MG Tablet (Orally Disintegrating) 02396688 TEVA-RIZATRIPTAN ODT TEV

SUMATRIPTAN SUCCINATE

Limited use benefit (prior approval is not required).

A total of 12 tablets (or injections) are permitted in a 30-day period.

Table: SUMATRIPTAN SUCCINATE
Drug strength and dosage form DIN Brand name Manufacturer code
6MG/0.5ML Injection 99000598 IMITREX STAT DOSE KIT GSK
12MG/ML Solution 02212188 IMITREX GSK
12MG/ML Solution 02361698 TARO-SUMATRIPTAN TAR
25MG Tablet 02270749 DOM-SUMATRIPTAN DPC
25MG Tablet 02268906 MYLAN-SUMATRIPTAN MYL
25MG Tablet 02256428 PMS-SUMATRIPTAN PMS
25MG Tablet 02286815 TEVA-SUMATRIPTAN DF TEV
50MG Tablet 02268388 APO-SUMATRIPTAN APX
50MG Tablet 02270757 DOM-SUMATRIPTAN DPC
50MG Tablet 02212153 IMITREX DF GSK
50MG Tablet 02268914 MYLAN-SUMATRIPTAN MYL
50MG Tablet 02256436 PMS-SUMATRIPTAN PMS
50MG Tablet 02263025 SANDOZ SUMATRIPTAN SDZ
50MG Tablet 02286521 SUMATRIPTAN SAN
50MG Tablet 02324652 SUMATRIPTAN PDL
ST50MG Tablet 02385570 SUMATRIPTAN DF SIV
50MG Tablet 02286823 TEVA-SUMATRIPTAN DF TEV
100MG Tablet 02257904 ACT SUMATRIPTAN ACG
100MG Tablet 02268396 APO-SUMATRIPTAN APX
100MG Tablet 02270765 DOM-SUMATRIPTAN DPC
100MG Tablet 02212161 IMITREX DF GSK
100MG Tablet 02268922 MYLAN-SUMATRIPTAN MYL
100MG Tablet 02256444 PMS-SUMATRIPTAN PMS
100MG Tablet 02263033 SANDOZ SUMATRIPTAN SDZ
100MG Tablet 02286548 SUMATRIPTAN SAN
100MG Tablet 02324660 SUMATRIPTAN PDL
100MG Tablet 02385589 SUMATRIPTAN DF SIV
100MG Tablet 02239367 TEVA-SUMATRIPTAN TEV
100MG Tablet 02286831 TEVA-SUMATRIPTAN DF TEV

ZOLMITRIPTAN

Limited use benefit (prior approval is not required).

A total of 12 tablets are permitted in a 30-day period.

Table: ZOLMITRIPTAN
Drug strength and dosage form DIN Brand name Manufacturer code
2.5MG Tablet 02380951 APO-ZOLMITRIPTAN APX
2.5MG Tablet 02389525 DOM-ZOLMITRIPTAN DPC
2.5MG Tablet 02421623 JAMP-ZOLMITRIPTAN JMP
2.5MG Tablet 02399458 MAR-ZOLMITRIPTAN MAR
2.5MG Tablet 02419521 MINT-ZOLMITRIPTAN MIN
2.5MG Tablet 02421534 NAT-ZOLMITRIPTAN NPH
2.5MG Tablet 02324229 PMS-ZOLMITRIPTAN PMS
2.5MG Tablet 02362988 SANDOZ ZOLMITRIPTAN SDZ
2.5MG Tablet 02313960 TEVA-ZOLMITRIPTAN TEV
2.5MG Tablet 02379929 ZOLMITRIPTAN PDL
2.5MG Tablet 02238660 ZOMIG AZC
2.5MG Tablet (Orally Disintegrating) 02438453 AG-ZOLMITRIPTAN ODT ANG
2.5MG Tablet (Orally Disintegrating) 02381575 APO-ZOLMITRIPTAN RAPID APX
2.5MG Tablet (Orally Disintegrating) 02428237 JAMP-ZOLMITRIPTAN ODT JMP
2.5MG Tablet (Orally Disintegrating) 02324768 PMS-ZOLMITRIPTAN ODT PMS
2.5MG Tablet (Orally Disintegrating) 02362996 SANDOZ ZOLMITRIPTAN ODT SDZ
2.5MG Tablet (Orally Disintegrating) 02428474 SEPTA-ZOLMITRIPTAN-ODT SPT
2.5MG Tablet (Orally Disintegrating) 02342545 TEVA-ZOLMITRIPTAN OD TEV
2.5MG Tablet (Orally Disintegrating) 02379988 ZOLMITRIPTAN ODT PDL
2.5MG Tablet (Orally Disintegrating) 02243045 ZOMIG RAPIMELT AZC

28:36.16 ANTIPARKINSONIAN AGENTS - DOPAMINE PRECURSORS

LEVODOPA, CARBIDOPA (CARBIDOPA MONOHYDRATE)

Limited use benefit (prior approval required).

Initial coverage criteria (12 months):

For the treatment of patients with advanced levodopa-responsive Parkinson's disease; AND

  • Patient has severe disability associated with at least 25% of the waking day in the off state*;AND/OR
  • Patient has ongoing, bothersome levodopa-induced dyskinesias, despite having tried frequent dosing of levodopa (at least five doses per day); AND
  • Patient has failed an adequate trial of adjunctive medications if not contraindicated or contrary to judgement of prescriber; AND
  • Patient is able to administer the medication and care for the administration port and infusion pump. Or alternatively, trained personnel or a care partner must be available to perform these tasks reliably; AND
  • Patient does not have a contraindication to the insertion of a percutaneous endoscopic gastrostomy-jejunostomy (PEG-J tube); AND
  • Patient does not have severe psychosis or dementia.

* Time in the off state, frequency of motor fluctuations, and severity of associated disability should be assessed by a movement disorder subspecialist and be based on an adequate and reliable account from longitudinal specialist care, clinical interview of a patient and/or care partner, or motor symptom diary.

Criteria for renewal or for initial NIHB coverage in patients currently maintained on Duodopa (12 months):

  • Patient continues to demonstrate a significant reduction in the time spent in the off state; AND/OR
  • Patient has had a decrease in bothersome levodopa-induced dyskinesias.
Table: LEVODOPA, CARBIDOPA (CARBIDOPA MONOHYDRATE)
Drug strength and dosage form DIN Brand name Manufacturer code
20MG & 5MG Gel 02292165 DUODOPA ABV

28:36.20 ANTIPARKINSONIAN AGENTS - DOPAMINE RECEPTOR AGONISTS

APOMORPHINE HYDROCHLORIDE

Limited use benefit (prior approval required).

For the acute, intermittent treatment of hypomobility "off " episodes ("end-of-dose wearing off " and unpredictable "on/off " episodes) in patients with advanced Parkinson's disease (PD);

AND

Patient is under the care of a physician with experience in the diagnosis and management of PD;

AND

Apomorphine (Movapo) is being used as adjunctive therapy in patients who are receiving optimized PD therapy (levodopa and derivatives and dopaminergic agonists) and still experiencing "off " episodes.

Table: APOMORPHINE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Solution 02459132 MOVAPO PAL

CABERGOLINE

Limited use benefit (prior approval required).

For treatment of hyperprolactinemia in patients who have failed therapy with or are intolerant to bromocriptine.

Table: CABERGOLINE
Drug strength and dosage form DIN Brand name Manufacturer code
0.5MG Tablet 02455897 APO-CABERGOLINE APX
0.5MG Tablet 02242471 DOSTINEX PFI

ROTIGOTINE

Limited use benefit (prior approval required).

As an adjunct to levodopa for the treatment of patients with advanced stage Parkinson's disease; AND

Patient is currently receiving treatment with levodopa.

Table: ROTIGOTINE
Drug strength and dosage form DIN Brand name Manufacturer code
2MG Patch 02403900 NEUPRO UCB
4MG Patch 02403927 NEUPRO UCB
6MG Patch 02403935 NEUPRO UCB
8MG Patch 02403943 NEUPRO UCB

28:92.00 MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

ACAMPROSATE CALCIUM

Limited use benefit (prior approval required).

For patients who have been abstinent from alcohol for at least four days and where available, are currently enrolled in an alcohol addiction treatment program.

Table: ACAMPROSATE CALCIUM
Drug strength and dosage form DIN Brand name Manufacturer code
333MG Tablet (Delayed Release) 02293269 CAMPRAL MYL

ATOMOXETINE HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of patients with Attention Deficit Hyperactivity Disorder (ADHD) who meet one of the following criteria:

  • Failure or intolerance to methylphenidate or amphetamine; OR
  • Contraindication to stimulant medication; OR
  • Potential risk of stimulant misuse or diversion; OR
  • Prescribed or recommended by a pediatrician or a psychiatrist.
Table: ATOMOXETINE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Capsule 02318024 APO-ATOMOXETINE APX
10MG Capsule 02358190 ATOMOXETINE AAP
10MG Capsule 02396904 ATOMOXETINE PDL
10MG Capsule 02445883 ATOMOXETINE SIV
10MG Capsule 02467747 ATOMOXETINE SAN
10MG Capsule 02471485 AURO-ATOMOXETINE AUR
10MG Capsule 02390469 DOM-ATOMOXETINE DPC
10MG Capsule 02381028 PMS-ATOMOXETINE PMS
10MG Capsule 02405962 RIVA-ATOMOXETINE RIV
10MG Capsule 02386410 SANDOZ ATOMOXETINE SDZ
10MG Capsule 02262800 STRATTERA LIL
10MG Capsule 02314541 TEVA-ATOMOXETINE TEV
18MG Capsule 02318032 APO-ATOMOXETINE APX
18MG Capsule 02358204 ATOMOXETINE AAP
18MG Capsule 02396912 ATOMOXETINE PDL
18MG Capsule 02445905 ATOMOXETINE SIV
18MG Capsule 02467755 ATOMOXETINE SAN
18MG Capsule 02471493 AURO-ATOMOXETINE AUR
18MG Capsule 02390477 DOM-ATOMOXETINE DPC
18MG Capsule 02381036 PMS-ATOMOXETINE PMS
18MG Capsule 02405970 RIVA-ATOMOXETINE RIV
18MG Capsule 02386429 SANDOZ ATOMOXETINE SDZ
18MG Capsule 02262819 STRATTERA LIL
18MG Capsule 02314568 TEVA-ATOMOXETINE TEV
25MG Capsule 02318040 APO-ATOMOXETINE APX
25MG Capsule 02358212 ATOMOXETINE AAP
25MG Capsule 02396920 ATOMOXETINE PDL
25MG Capsule 02445913 ATOMOXETINE SIV
25MG Capsule 02467763 ATOMOXETINE SAN
25MG Capsule 02471507 AURO-ATOMOXETINE AUR
25MG Capsule 02390485 DOM-ATOMOXETINE DPC
25MG Capsule 02381044 PMS-ATOMOXETINE PMS
25MG Capsule 02405989 RIVA-ATOMOXETINE RIV
25MG Capsule 02386437 SANDOZ ATOMOXETINE SDZ
25MG Capsule 02262827 STRATTERA LIL
25MG Capsule 02314576 TEVA-ATOMOXETINE TEV
40MG Capsule 02318059 APO-ATOMOXETINE APX
40MG Capsule 02358220 ATOMOXETINE AAP
40MG Capsule 02396939 ATOMOXETINE PDL
40MG Capsule 02445948 ATOMOXETINE SIV
40MG Capsule 02467771 ATOMOXETINE SAN
40MG Capsule 02471515 AURO-ATOMOXETINE AUR
40MG Capsule 02390493 DOM-ATOMOXETINE DPC
40MG Capsule 02381052 PMS-ATOMOXETINE PMS
40MG Capsule 02405997 RIVA-ATOMOXETINE RIV
40MG Capsule 02386445 SANDOZ ATOMOXETINE SDZ
40MG Capsule 02262835 STRATTERA LIL
40MG Capsule 02314584 TEVA-ATOMOXETINE TEV
60MG Capsule 02318067 APO-ATOMOXETINE APX
60MG Capsule 02358239 ATOMOXETINE AAP
60MG Capsule 02396947 ATOMOXETINE PDL
60MG Capsule 02445956 ATOMOXETINE SIV
60MG Capsule 02467798 ATOMOXETINE SAN
60MG Capsule 02471523 AURO-ATOMOXETINE AUR
60MG Capsule 02390515 DOM-ATOMOXETINE DPC
60MG Capsule 02381060 PMS-ATOMOXETINE PMS
60MG Capsule 02406004 RIVA-ATOMOXETINE RIV
60MG Capsule 02386453 SANDOZ ATOMOXETINE SDZ
60MG Capsule 02262843 STRATTERA LIL
60MG Capsule 02314592 TEVA-ATOMOXETINE TEV
80MG Capsule 02318075 APO-ATOMOXETINE APX
80MG Capsule 02358247 ATOMOXETINE AAP
80MG Capsule 02467801 ATOMOXETINE SAN
80MG Capsule 02471531 AURO-ATOMOXETINE AUR
80MG Capsule 02404664 PMS-ATOMOXETINE PMS
80MG Capsule 02422824 RIVA-ATOMOXETINE RIV
80MG Capsule 02386461 SANDOZ ATOMOXETINE SDZ
80MG Capsule 02279347 STRATTERA LIL
80MG Capsule 02362511 TEVA-ATOMOXETINE TEV
100MG Capsule 02318083 APO-ATOMOXETINE APX
100MG Capsule 02358255 ATOMOXETINE AAP
100MG Capsule 02467828 ATOMOXETINE SAN
100MG Capsule 02404672 PMS-ATOMOXETINE PMS
100MG Capsule 02422832 RIVA-ATOMOXETINE RIV
100MG Capsule 02386488 SANDOZ ATOMOXETINE SDZ
100MG Capsule 02279355 STRATTERA LIL
100MG Capsule 02362538 TEVA-ATOMOXETINE TEV

DIMETHYL FUMARATE

Limited use benefit (prior approval required).

  • As a first-line therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist experienced in the management of RRMS.

AND for patients who meet ALL of the following criteria:

  • Patient has had a clinical relapse and/or new MRI activity in the last two years; AND
  • Patient is fully ambulatory for 100 meters without aids; AND
  • Patient is 18 years of age or older.
Table: DIMETHYL FUMARATE
Drug strength and dosage form DIN Brand name Manufacturer code
120MG Capsule (Delayed Release) 02404508 TECFIDERA UNK
240MG Capsule (Delayed Release) 02420201 TECFIDERA UNK

32:00 CONTRACEPTIVES (NON-ORAL)

32:00.00 CONTRACEPTIVES (NON-ORAL)

INTRAUTERINE DEVICE

Limited use benefit with quantity and frequency limits (prior approval is not required).

Coverage is granted for 1 device every 12 months.

Table: INTRAUTERINE DEVICE
Drug strength and dosage form DIN Brand name Manufacturer code
Device 00970328 FLEXI-T +300 IUD TSN
Device 00970336 FLEXI-T +380 IUD TSN
Device 98099999 FLEXI-TD TSN
Device 99401085 LIBERTE UT380 SHORT IUD MSF
Device 99401086 LIBERTE UT380 STANDARD IUD MSF
Device 99400482 NOVA-T BEX

36:00 DIAGNOSTIC AGENTS (DX)

36:26.00 DX - DIABETES MELLITUS

GLUCOSE OXIDASE, PEROXIDASE

Limited use benefit (prior approval not required).

The number of test strips that will be covered by the NIHB Program will depend on the client's medical treatment:

  • Clients managing diabetes with insulin will be allowed 800 test strips per 100 days. A client can test up to five times per day.
  • Clients managing diabetes with diabetes medication with a high risk of causing low blood sugar will be allowed 400 test strips per 365 days. A client can test once daily.
  • Clients managing diabetes with diabetes medication with a low risk of causing low blood sugar will be allowed 200 test strips per 365 days. A client can test three to four times per week.
  • Clients managing diabetes with diet/lifestyle therapy only (no insulin or diabetes medications) will be allowed 200 test strips per 365 days. A client can test three to four times per week.
  • Non-diabetic clients with rare conditions leading to symptomatic hypo or hyperglycemia will be allowed 800 test strips per 100 days.
Table: GLUCOSE OXIDASE, PEROXIDASE
Drug strength and dosage form DIN Brand name Manufacturer code
ACCU-CHEK ADVANTAGE Strip 09853626 ACCU-CHEK ADVANTAGE ROD
ACCU-CHEK ADVANTAGE Strip 97799824 ACCU-CHEK ADVANTAGE ROD
ACCU-CHEK AVIVA Strip 09857178 ACCU-CHEK AVIVA ROD
ACCU-CHEK AVIVA Strip 97799814 ACCU-CHEK AVIVA ROD
ACCU-CHEK COMPACT Strip 09854282 ACCU-CHEK COMPACT ROD
ACCU-CHEK COMPACT Strip 97799962 ACCU-CHEK COMPACT ROD
ACCU-CHEK MOBILE Strip 09857452 ACCU-CHEK MOBILE BG ROD
ACCU-CHEK MOBILE Strip 97799497 ACCU-CHEK MOBILE CASSETT ROD
ACCUTREND Strip 09853162 ACCUTREND ROD
ACCUTREND Strip 97799959 ACCUTREND ROD
ASCENSIA BREEZE 2 Strip 97799748 ASCENSIA BREEZE 2 BAY
ASCENSIA BREEZE 2 Strip 09857293 BREEZE 2 BG (ON) BAY
ASCENSIA CONTOUR Strip 97799702 ASCENCIA CONTOUR BAY
ASCENSIA CONTOUR Strip 09857127 CONTOUR BG (ON) BAY
BG STAR Strip 97799465 BG STAR SAC
BG STAR Strip 09857422 BG STAR (ON) SAC
CONTOUR NEXT Strip 97799459 CONTOUR NEXT BAY
CONTOUR NEXT Strip 09857453 CONTOUR NEXT (ON) BAY
EZ HEALTH Strip 09857357 EZ HEALTH ORACLE TRE
EZ HEALTH Strip 97799564 EZ HEALTH ORACLE TRE
FREESTYLE LITE Strip 97799597 FREESTYLE LITE ABB
FREESTYLE LITE Strip 09857297 FREESTYLE LITE (ON) ABB
FREESTYLE PRECISION Strip 97799346 FREESTYLE PRECISION ABB
FREESTYLE PRECISION Strip 09857502 FREESTYLE PRECISION (ON) ABB
FREESTYLE Strip 97799829 FREESTYLE ABB
FREESTYLE Strip 09857141 FREESTYLE (ON) ABB
GE200 Strip 97799373 GE200 AUC
GE200 Strip 09857525 GE200 (ON) AUC
ITEST Strip 09857348 ITEST AUC
ITEST Strip 97799692 ITEST AUC
MEDI+SURE Strip 97799403 MEDI+SURE MEC
MEDI+SURE Strip 09857432 MEDI+SURE (ON) MEC
NOVA MAX Strip 09857313 NOVA MAX NCA
ONE TOUCH ULTRA Strip 09854290 ONE TOUCH ULTRA JAJ
ONE TOUCH ULTRA Strip 97799985 ONE TOUCH ULTRA JAJ
ONE TOUCH VERIO Strip 97799475 ONETOUCH VERIO JAJ
ONE TOUCH VERIO Strip 09857392 ONETOUCH VERIO (ON) JAJ
PRECISION XTRA Strip 09854070 PRECISION XTRA ABB
PRECISION XTRA Strip 97799840 PRECISION XTRA AUC
SIDEKICK Strip 97799601 SIDEKICK HOD
SPIRIT Strip 97799291 FIRST CANHEALTH SPIRIT ARA
SPIRIT Strip 09857547 SPIRIT TEST STRIP (ON) ARA
Strip 09857563 ACCU-CHEK GUIDE (ON) ROD
Strip 97799177 ACCU-CHEK GUIDE (SK) ROD
SURE STEP Strip 97799355 SURE STEP SKY
SURETEST Strip 09857522 SURETEST (ON) SKY
TRUETEST Strip 97799532 TRUETEST HOD
TRUETRACK Strip 09857283 TRUE TRACK AUC
TRUETRACK Strip 97799602 TRUE TRACK HOD

40:00 ELECTROLYTIC, CALORIC, AND WATER BALANCE

40:10.20 

BENRALIZUMAB

Limited use benefit (prior approval required).

Initial coverage criteria (12 months):

For the adjunctive treatment of severe eosinophilic asthma in adults who are inadequately controlled with high-dose inhaled corticosteroids* plus one or more additional asthma controller(s) (e.g. long-acting beta-agonist);

AND

  • Patient has had a blood eosinophil count of ≥0.15x109/L before initiation of benralizumab; AND
  • Patient is receiving maintenance treatment with oral corticosteroids (at a dose equivalent to ≥5mg prednisone per day) prior to starting benralizumab;

OR

  • Patient has had a blood eosinophil count of ≥0.3x109/L within the 12-month period prior to starting benralizumab; AND
  • Patient has experienced two or more clinically significant asthma exacerbations** within the 12-month period prior to starting benralizumab;

AND

  • A baseline assessment of asthma symptom control using a validated asthma control questionnaire has been completed prior to the initiation of benralizumab; AND
  • Patient is managed by a physician with expertise in the treatment of asthma.

Coverage for benralizumab is provided for a maximum dose of 30 mg administered subcutaneously once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter.

Fasenra will not be funded as a dual therapy with another biologic for the treatment of asthma.

Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period). Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.

Criteria for renewal or for initial NIHB coverage in patients currently maintained on Fasenra (12 months):

  • Patient has not experienced an increase in clinically significant asthma exacerbations** with benralizumab treatment; AND
  • For patients receiving maintenance oral corticosteroids, patient's oral corticosteroid maintenance dose has decreased from the pre-treatment dose. After the first 12 months, subsequent oral corticosteroid dose should be maintained; AND
  • The 12-month asthma control questionnaire score has improved from baseline, where baseline represents the initiation of treatment. After the first 12 months, subsequent scores should be maintained.

* High-dose inhaled corticosteroid is defined as ≥ 500mcg of fluticasone propionate or equivalent daily.

** A clinically significant asthma exacerbation is defined as worsening of asthma such that the treating physician elected to administer systemic glucocorticoids for at least three days or the patient visited an emergency department or was hospitalized.

Table: BENRALIZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
30MG Solution 02473232 FASENRA AZC

40:18.19 PHOSPHATE - REMOVING AGENTS

LANTHANUM CARBONATE HYDRATE

Limited use benefit (prior approval required).

For patients with elevated phosphate levels OR elevated phosphate X calcium product despite dietary restriction of phosphate and use of calcium-based phosphate binders (short term elevations should be managed with aluminium based binders).

For patients with elevated calcium levels despite discontinuation of calcium binder, and Vitamin D analogue and/or modification of dialysate calcium.

For patients with adynamic bone disease and low PTH levels (<100 pg/ml or <0.9 pmol/L) with normal or elevated calcium levels.

Table: LANTHANUM CARBONATE HYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
250MG Tablet (Chewable) 02287145 FOSRENOL UNK
500MG Tablet (Chewable) 02287153 FOSRENOL UNK
750MG Tablet (Chewable) 02287161 FOSRENOL UNK
1000MG Tablet (Chewable) 02287188 FOSRENOL UNK

SEVELAMER CARBONATE

Limited use benefit (prior approval required).

For patients with elevated phosphate levels OR elevated phosphate X calcium product despite dietary restriction of phosphate and use of calcium-based phosphate binders (short term elevations should be managed with aluminium based binders).

For patients with elevated calcium levels despite discontinuation of calcium binder, and Vitamin D analogue and/or modification of dialysate calcium.

For patients with adynamic bone disease and low PTH levels (<100 pg/ml or <0.9 pmol/L) with normal or elevated calcium levels.

Table: SEVELAMER CARBONATE
Drug strength and dosage form DIN Brand name Manufacturer code
800MG Tablet 02461501 ACCEL-SEVELAMER ACP
800MG Tablet 02354586 RENVELA SAC

SEVELAMER HYDROCHLORIDE

Limited use benefit (prior approval required).

For patients with elevated phosphate levels OR elevated phosphate X calcium product despite dietary restriction of phosphate and use of calcium-based phosphate binders (short term elevations should be managed with aluminium based binders).

For patients with elevated calcium levels despite discontinuation of calcium binder, and Vitamin D analogue and/or modification of dialysate calcium.

For patients with adynamic bone disease and low PTH levels (<100 pg/ml or <0.9 pmol/L) with normal or elevated calcium levels.

Table: SEVELAMER HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
800MG Tablet 02244310 RENAGEL SAC

40:20.00 CALORIC AGENTS

LEVOCARNITINE

Limited use benefit (prior approval required).

For treatment of carnitine deficiency.

Table: LEVOCARNITINE
Drug strength and dosage form DIN Brand name Manufacturer code
100MG/ML Solution 02144336 CARNITOR UNK
200MG/ML Solution 02144344 CARNITOR UNK
330MG Tablet 02144328 CARNITOR UNK

48:00 RESPIRATORY TRACT AGENTS

48:02.00 ANTIFIBROTIC AGENTS

NINTEDANIB ESILATE

Limited use benefit (prior approval required).

Initial Request - Coverage is provided for a period of 7 months (6 months plus a 4 week allowance for repeat pulmonary function tests):

For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF) who meet the following criteria:

  • Diagnosis confirmed by a respirologist and a high-resolution CT scan within the previous 24 months; AND
  • All other causes of restrictive lung disease (e.g. collagen vascular disorder or hypersensitivity pneumonitis) should be excluded; AND
  • Mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted; AND
  • Patient is under the care of a physician with experience in IPF.

Renewal at 6 months - Coverage is provided for a period of 6 months:

  • Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% from initiation of therapy until renewal (initial 6 month treatment period). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Subsequent Renewals at 12 months and thereafter - Coverage is provided for a period of 12 months:

  • Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% within any 12 month period. If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Combination use of Ofev (nintedanib) and Esbriet (pirfenidone) will not be provided.

Table: NINTEDANIB ESILATE
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Capsule 02443066 OFEV BOE
150MG Capsule 02443074 OFEV BOE

PIRFENIDONE

Limited use benefit (prior approval required).

Initial Request - Coverage is provided for a period of 7 months (6 months plus a 4 weeks allowance for repeat pulmonary function tests):

For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF) who meet the following criteria:

  • Diagnosis confirmed by a respirologist and a high-resolution CT scan within the previous 24 months; AND
  • All other causes of restrictive lung disease (e.g. collagen vascular disorder or hypersensitivity pneumonitis) should be excluded; AND
  • Mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted; AND
  • Patient is under the care of a physician with experience in IPF.

Renewal at 6 months - Coverage is provided for a period of 6 months:

  • Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% from initiation of therapy until renewal (initial 6 month treatment period). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Subsequent Renewals at 12 months and thereafter - Coverage is provided for a period of 12 months:

  • Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% within any 12 month period. If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Combination use of Ofev (nintedanib) and Esbriet (pirfenidone) will not be provided.

Table: PIRFENIDONE
Drug strength and dosage form DIN Brand name Manufacturer code
267MG Capsule 02393751 ESBRIET HLR
267MG Tablet 02464489 ESBRIET HLR
801MG Tablet 02464500 ESBRIET HLR

48:10.24 LEUKOTRIENE MODIFIERS

MONTELUKAST SODIUM

Table: MONTELUKAST SODIUM
Drug strength and dosage form DIN Brand name Manufacturer code
ST4MG Granules 02358611 SANDOZ MONTELUKAST SDZ
ST4MG Granules 02247997 SINGULAIR FRS
ST10MG Tablet 02374609 APO-MONTELUKAST APX
ST10MG Tablet 02401274 AURO-MONTELUKAST AUR
10MG Tablet 02445735 BIO-MONTELUKAST UNK
ST10MG Tablet 02376695 DOM-MONTELUKAST DPC
ST10MG Tablet 02391422 JAMP-MONTELUKAST JMP
ST10MG Tablet 02399997 MAR-MONTELUKAST MAR
ST10MG Tablet 02408643 MINT-MONTELUKAST MIN
ST10MG Tablet 02379333 MONTELUKAST SAN
ST10MG Tablet 02379856 MONTELUKAST PDL
ST10MG Tablet 02382474 MONTELUKAST SIV
ST10MG Tablet 02379236 MONTELUKAST SODIUM ACC
ST10MG Tablet 02373947 PMS-MONTELUKAST PMS
ST10MG Tablet 02389517 RAN-MONTELUKAST RBY
ST10MG Tablet 02398826 RIVA-MONTELUKAST RIV
ST10MG Tablet 02328593 SANDOZ MONTELUKAST SDZ
ST10MG Tablet 02238217 SINGULAIR FRS
ST10MG Tablet 02355523 TEVA-MONTELUKAST TEV
4MG Tablet (Chewable) 02377608 APO-MONTELUKAST APX
ST4MG Tablet (Chewable) 02422867 AURO-MONTELUKAST AUR
ST4MG Tablet (Chewable) 02442353 JAMP-MONTELUKAST JMP
ST4MG Tablet (Chewable) 02399865 MAR-MONTELUKAST MAR
ST4MG Tablet (Chewable) 02408627 MINT-MONTELUKAST MIN
ST4MG Tablet (Chewable) 02379317 MONTELUKAST SAN
ST4MG Tablet (Chewable) 02379821 MONTELUKAST PDL
ST4MG Tablet (Chewable) 02382458 MONTELUKAST SIV
ST4MG Tablet (Chewable) 02354977 PMS-MONTELUKAST PMS
ST4MG Tablet (Chewable) 02402793 RAN-MONTELUKAST RBY
ST4MG Tablet (Chewable) 02330385 SANDOZ MONTELUKAST SDZ
ST4MG Tablet (Chewable) 02243602 SINGULAIR FRS
ST4MG Tablet (Chewable) 02355507 TEVA-MONTELUKAST TEV
ST5MG Tablet (Chewable) 02377616 APO-MONTELUKAST APX
ST5MG Tablet (Chewable) 02422875 AURO-MONTELUKAST AUR
ST5MG Tablet (Chewable) 02442361 JAMP-MONTELUKAST JMP
ST5MG Tablet (Chewable) 02399873 MAR-MONTELUKAST MAR
ST5MG Tablet (Chewable) 02408635 MINT-MONTELUKAST MIN
ST5MG Tablet (Chewable) 02379325 MONTELUKAST SAN
ST5MG Tablet (Chewable) 02379848 MONTELUKAST PDL
ST5MG Tablet (Chewable) 02382466 MONTELUKAST SIV
ST5MG Tablet (Chewable) 02354985 PMS-MONTELUKAST PMS
ST5MG Tablet (Chewable) 02402807 RAN-MONTELUKAST RBY
ST5MG Tablet (Chewable) 02330393 SANDOZ MONTELUKAST SDZ
ST5MG Tablet (Chewable) 02238216 SINGULAIR FRS
ST5MG Tablet (Chewable) 02355515 TEVA-MONTELUKAST TEV

48:48.00 VASODILATING AGENTS

AMBRISENTAN

Limited use benefit (prior approval required).

Maximum dose covered is 10 mg once daily.

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization; AND

  • who have failed to respond to sildenafil OR tadalafil; OR
  • who have contraindications to sildenafil OR tadalafil.
Table: AMBRISENTAN
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02475375 APO-AMBRISENTAN APX
ST10MG Tablet 02475383 APO-AMBRISENTAN APX

BOSENTAN MONOHYDRATE

Limited use benefit (prior approval required).

Maximum dose covered is 125 mg twice daily

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization; AND

  • who have failed to respond to sildenafil OR tadalafil; OR
  • who have contraindications to sildenafil OR tadalafil.
Table: BOSENTAN MONOHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST125MG Tablet 02399210 APO-BOSENTAN APX

RIOCIGUAT

Limited use benefit (prior approval required).

For the treatment of patients 18 years of age or older with chronic thromboembolic pulmonary hypertension (CTEPH) with World Health Organization (WHO) Functional Class 2 or 3 pulmonary hypertension with:

  • Inoperable CTEPH, World Health Organization (WHO) Group 4;

OR

  • Persistent or recurrent CTEPH after surgical treatment; AND
  • Prescriber experienced in the diagnosis and treatment of CTEPH.
Table: RIOCIGUAT
Drug strength and dosage form DIN Brand name Manufacturer code
0.5MG Tablet 02412764 ADEMPAS BAY
1MG Tablet 02412772 ADEMPAS BAY
1.5MG Tablet 02412799 ADEMPAS BAY
2MG Tablet 02412802 ADEMPAS BAY
2.5MG Tablet 02412810 ADEMPAS BAY

SELEXIPAG

Limited use benefit (prior approval required).

For the treatment of adult patients with World Health Organization (WHO) functional class (FC) II to III pulmonary arterial hypertension (PAH), including idiopathic PAH, heritable PAH, PAH associated with connective tissue disorders or PAH associated with congenital heart disease:

  • Patient is under the care of a physician with experience in the diagnosis and treatment of PAH; AND
  • Patient has failed to respond to first- and second-line PAH therapies; OR
  • Patient has contraindications/intolerance to first- and second-line PAH therapies.
Table: SELEXIPAG
Drug strength and dosage form DIN Brand name Manufacturer code
200MCG Tablet 02451158 UPTRAVI JSO
400MCG Tablet 02451166 UPTRAVI JSO
600MCG Tablet 02451174 UPTRAVI JSO
800MCG Tablet 02451182 UPTRAVI JSO
1000MCG Tablet 02451190 UPTRAVI JSO
1200MCG Tablet 02451204 UPTRAVI JSO
1400MCG Tablet 02451212 UPTRAVI JSO
1600MCG Tablet 02451220 UPTRAVI JSO

48:92.00 MISCELLANEOUS RESPIRATORY TRACT AGENTS

OMALIZUMAB

Limited use benefit (prior approval required).

Coverage is provided for an initial period of 24 weeks at a maximum dose of 300 mg every 4 weeks (6 injections over a 24 week period).

1. For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic urticaria (CIU) who remain symptomatic (presence of hives and/or associated itching) despite optimum management with H1 antihistamines; AND

Prescriber is experienced in the treatment of CIU (Allergist, Dermatologist, Immunologist, OR other authorized prescriber experienced in the treatment of CIU).

Treatment cessation could be considered for patients who experience complete symptom control (UAS-7 = 0) for at least 12 consecutive weeks at the end of a 24-week treatment period.

Renewal coverage is provided for 24 weeks at a maximum dose of 300 mg every 4 weeks (6 injections/24 weeks).

2. For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic urticaria (CIU);

AND

Patient stopped omalizumab after achieving complete symptom control (UAS-7 = 0) for at least 12 weeks while on treatment, but has experienced symptom relapse; OR

Patient achieved complete symptom control, but for a period of less than 12 consecutive weeks; OR

Patient achieved a partial response to treatment, defined as a ≥ 9.5-point reduction in baseline urticaria activity score over 7 days (UAS-7).

In patients where treatment is discontinued due to temporary symptom control, treatment re-initiation may be considered should CIU symptoms reappear.

Table: OMALIZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Powder For Solution 02260565 XOLAIR NVR

52:00 EYE, EAR, NOSE AND THROAT (EENT) PREPARATIONS

52:28.00 EENT - MOUTHWASHES AND GARGLES

BENZYDAMINE HYDROCHLORIDE

Limited use benefit (prior approval required).

  • For the treatment of radiation mucositis and oral ulcerative complications of chemotherapy.
  • For use in immunocompromised patients who are at risk of mucosal breakdown.
Table: BENZYDAMINE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
0.15% Mouthwash 02239044 APO-BENZYDAMINE APX
0.15% Mouthwash 02229777 PHARIXIA PED
0.15% Mouthwash 02239537 PMS-BENZYDAMINE PMS

52:92.00 MISCELLANEOUS EENT DRUGS

AFLIBERCEPT

Limited use benefit (prior approval required).

For the treatment of:

Diabetic Macular Edema (DME)

Wet Age-Related Macular Degeneration (w-AMD)

Retinal Vein Occlusion (RVO)

Criteria for coverage of aflibercept (Eylea) for DME, RVO and w-AMD:

  • Administered by a qualified ophthalmologist experienced in intravitreal injections
  • Interval between doses not shorter than 1 month

Note: Coverage will be limited to a maximum of 1 vial of Eylea per eye treated every 30 days

1. For the treatment of diabetic macular edema (DME) for patients who meet the following:

  • Clinically significant diabetic macular edema for whom laser photocoagulation is also indicated; AND
  • Have a hemoglobin A1c of less than 12%

2. Initial Coverage for the treatment of neovascular wet age-related macular degeneration (wAMD) where all of the following apply to the eye to be treated:

  • Best Corrected Visual Acuity (BCVA) is between 6/12 and 6/96
  • The lesion size is less than or equal to 12 disc areas in greatest linear dimension
  • There is evidence of recent (< 3 months) presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or optical coherence tomography (OCT))

Note: Coverage will not be approved for patients:

  • With permanent retinal damage as defined by the Royal College of Ophthalmology guidelines.
  • Receiving concurrent treatment with verteporfin

Continued Coverage:

Treatment with Eylea for wAMD should be continued only in people who maintain adequate response to therapy

Treatment with Eylea should be permanently discontinued if any one of the following occurs:

  • Reduction in BCVA in the treated eye to less than 15 letters (absolute) on two (2) consecutive visits in the treated eye, attributed to AMD in the absence of other pathology
  • Reductions in BCVA of 30 letters or more compared to either baseline and/or best recorded level since baseline as this may indicate either poor treatment effect, adverse events or both.
  • There is evidence of deterioration of the lesion morphology despite optimum treatment over three (3) consecutive visits.

3. For the treatment of RVO for patients who meet one of the following:

  • Clinically significant macular edema secondary to branch retinal vein occlusion (BRVO); OR
  • Central retinal vein occlusion (CRVO).
  • It is recommended that Eylea be administered once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess (every 1 to 2 months) the need for continued therapy.
  • Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy.
Table: AFLIBERCEPT
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Solution 02415992 EYLEA BAY

RANIBIZUMAB

Limited use benefit (prior approval required).

For the treatment of:

Diabetic Macular Edema (DME)

Wet Age-Related Macular Degeneration (w-AMD)

Retinal Vein Occlusion (RVO)

Choroidal Neovascularization secondary to pathologic myopia (mCNV)

Criteria for coverage of ranibizumab (Lucentis) for DME, RVO, mCNV and w-AMD:

  • Administered by a qualified ophthalmologist experienced in intravitreal injections
  • Interval between doses not shorter than 1 month

Note: Coverage will be limited to a maximum of 1 vial of Lucentis per eye treated every 30 days

1. For the treatment of diabetic macular edema (DME) for patients who meet the following:

  • Clinically significant diabetic macular edema for whom laser photocoagulation is also indicated; AND
  • Have a hemoglobin A1c of less than 11%

2. Initial Coverage for the treatment of neovascular wet age-related macular degeneration (wAMD) where all of the following apply to the eye to be treated:

  • Best Corrected Visual Acuity (BCVA) is between 6/12 and 6/96
  • The lesion size is less than or equal to 12 disc areas in greatest linear dimension
  • There is evidence of recent (< 3 months) presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or optical coherence tomography (OCT))

Note: Coverage will not be approved for patients:

  • With permanent retinal damage as defined by the Royal College of Ophthalmology guidelines.
  • Receiving concurrent treatment with verteporfin

Continued Coverage:

Treatment with Lucentis for wAMD should be continued only in people who maintain adequate response to therapy

Treatment with Lucentis should be permanently discontinued if any one of the following occurs:

  • Reduction in BCVA in the treated eye to less than 15 letters (absolute) on two (2) consecutive visits in the treated eye, attributed to AMD in the absence of other pathology
  • Reductions in BCVA of 30 letters or more compared to either baseline and/or best recorded level since baseline as this may indicate either poor treatment effect, adverse events or both.
  • There is evidence of deterioration of the lesion morphology despite optimum treatment over three (3) consecutive visits.

3. For the treatment of RVO for patients who meet one of the following:

  • Clinically significant macular edema secondary to branch retinal vein occlusion (BRVO); OR
  • Central retinal vein occlusion (CRVO).
  • Treatment to be given monthly and continued until maximum visual acuity is achieved, confirmed by stable visual acuity for three consecutive monthly assessments performed while on ranibizumab treatment. Thereafter patients should be monitored monthly for visual acuity.
  • Treatment is resumed with monthly injections when monitoring indicates a loss of visual acuity due to macular edema secondary to retinal vein occlusion and continued until stable visual acuity is reached again for three consecutive monthly assessments.
  • Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy.

4. For the treatment of mCNV for patients who meet the following:

  • Visual impairment due to choroidal neovascularization secondary to pathologic myopia (mCNV).

Treatment is initiated with a single intravitreal injection. Monitoring is recommended monthly for the first two months and at least every three months thereafter during the first year. If monitoring reveals signs of disease activity (e.g. reduced visual acuity and/or signs of lesion activity), further treatment is recommended at a frequency of 1 injection per month until no disease activity is seen.

Table: RANIBIZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
10MG/ML Solution 02296810 LUCENTIS NVR
10MG/ML Solution 02425629 LUCENTIS PFS NVR

VERTEPORFIN

Limited use benefit (prior approval required).

For treatment of age related macular degeneration for patients with this diagnosis who are being treated by a certified ophthalmologist.

Table: VERTEPORFIN
Drug strength and dosage form DIN Brand name Manufacturer code
15MG/VIAL Powder For Solution 02242367 VISUDYNE VAE

56:00 GASTROINTESTINAL DRUGS

56:04.00 ANTACIDS AND ADSORBENTS

BISMUTH SUBSALICYLATE

Limited use benefit (prior approval not required).

Coverage will be limited to 8 tablets a day every 14 days, followed by a 28 day lockout;

OR

Coverage will be limited to 120mL a day every 14 days, followed by a 28 day lockout.

Table: BISMUTH SUBSALICYLATE
Drug strength and dosage form DIN Brand name Manufacturer code
262MG Caplet 00245730 BISMUTH JMP
17.6MG/ML Suspension 02097079 PEPTO-BISMOL PGI
262MG Tablet 02326582 BISMUTH SUBSALICYLATE UNK
262MG Tablet 02177994 PEPTO BISMOL PGI

56:22.00 ANTIEMETICS

NETUPITANT, PALONOSETRON (PALONOSETRON HYDROCHLORIDE)

Limited use benefit (prior approval required).

When used in combination with dexamethasone for the prevention of acute and delayed nausea and vomiting due to highly emetogenic cancer chemotherapy (eg. cisplatin > 70mg/m2).

Table: NETUPITANT, PALONOSETRON (PALONOSETRON HYDROCHLORIDE)
Drug strength and dosage form DIN Brand name Manufacturer code
ST300MG & 0.5MG Capsule 02468735 AKYNZEO PFR

56:22.08 ANTIHISTAMINES

DIMENHYDRINATE

Limited use benefit (prior approval not required).

The NIHB Program implemented a dose coverage limit for DIMENHYDRINATE in June 2017 as part of a strategy to address safety concerns and potential misuse.

The dimenhydrinate dose limit is currently 400 mg per day for a total of 12,000 mg of dimenhydrinate in a 30-day period.

This limit applies only to the 15 mg and 50 mg tablets. Dimenhydrinate in liquid, suppository and injectable forms are not included in this limit.

Table: DIMENHYDRINATE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Tablet 02241532 ANTI-NAUSEANT VTH
ST50MG Tablet 00363766 APO DIMENHYDRINATE APX
ST50MG Tablet 00013803 GRAVOL CHU
ST50MG Tablet 02245416 JAMP-DIMENHYDRINATE JMP
ST50MG Tablet 02377179 MOTION SICKNESS APX
ST50MG Tablet 00586331 PMS-DIMENHYDRINATE PMS
ST50MG Tablet 00605786 TRAVEL VTH
ST50MG Tablet 00021423 TRAVEL ON NOP

56:22.32 MISCELLANEOUS ANTIEMETICS

APREPITANT

Limited use benefit (prior approval required).

When used in combination with a 5-HT3 antagonist and dexamethasone for the prevention of acute and delayed nausea and vomiting due to highly emetogenic cancer chemotherapy (e.g. Cisplatin > 70mg/m2).

Table: APREPITANT
Drug strength and dosage form DIN Brand name Manufacturer code
ST80MG Capsule 02298791 EMEND FRS
ST125MG & 80MG Capsule 02298813 EMEND TRI-PACK FRS
ST125MG Capsule 02298805 EMEND FRS

56:22.92 MISCELLANEOUS ANTIEMETICS

NABILONE

Limited use benefit (prior approval required).

For patients who are experiencing nausea and vomiting due to cancer chemotherapy or radiation;

OR

Patient is palliative (diagnosed with a terminal illness or disease which is expected to be the primary cause of death within six months or less).

Table: NABILONE
Drug strength and dosage form DIN Brand name Manufacturer code
0.25MG Capsule 02312263 CESAMET UNK
0.25MG Capsule 02358077 RAN-NABILONE RBY
0.25MG Capsule 02392925 TEVA-NABILONE TEV
0.5MG Capsule 02393581 ACT NABILONE ACG
0.5MG Capsule 02256193 CESAMET UNK
0.5MG Capsule 02380900 PMS-NABILONE PMS
0.5MG Capsule 02358085 RAN-NABILONE RBY
0.5MG Capsule 02384884 TEVA-NABILONE TEV
1MG Capsule 02393603 ACT NABILONE ACG
1MG Capsule 00548375 CESAMET UNK
1MG Capsule 02380919 PMS-NABILONE PMS
1MG Capsule 02358093 RAN-NABILONE RBY
1MG Capsule 02384892 TEVA-NABILONE TEV

56:28.36 PROTON-PUMP INHIBITORS

LANSOPRAZOLE

Limited use benefit (prior approval not required).

Coverage will be limited to 400 tablets/capsules every 180 days.

The following PPI status change is primarily based on the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) report on optimal PPI therapy. The report concluded that:

  • All PPIs are equally efficacious
  • Double dose PPI is not necessary for initial therapy
  • Double dose PPI is effective in H. Pylori eradication; however, treatment is not needed beyond 14 days.

PPI use has been associated with increased risk of hip fracture, community-acquired pneumonia and Clostridium difficile associated diarrhea. Although further study is needed to establish clinical significance, it is prudent to use the lowest dose and shortest duration of therapy required to control symptoms.

All proton pump inhibitors (open benefit and limited use (LU) PPIs) have a maximum quantity limit of 400 tablets/capsules per 180 day period. This quantity limit will be in effect for the entire class of PPIs.

  • For example, if a patient fills 30 tablets of rabeprazole, then switch to 30 tablets of omeprazole, then switch to 30 capsules of lansoprazole, this will count as 90 PPI tablets/capsules towards the quantity limit.
  • Patients taking two rabeprazole 10mg tablets a day can be switched to one rabeprazole 20mg tablet a day to avoid reaching the quantity limit
  • Patients taking two omeprazole 10mg tablets/capsules a day can be switched to one omeprazole 20mg tablet/capsule a day to avoid reaching the quantity limit

Patients with Zollinger Ellison Syndrome, Barrett's esophagus, erosive esophagitis and those who remain symptomatic on a single dose PPI will be eligible for additional doses above 400 tablets/capsules per 180 days through the prior approval process.

Table: LANSOPRAZOLE
Drug strength and dosage form DIN Brand name Manufacturer code
ST15MG Capsule (Delayed Release) 02293811 APO-LANSOPRAZOLE APX
ST15MG Capsule (Delayed Release) 02357682 LANSOPRAZOLE SAN
ST15MG Capsule (Delayed Release) 02385767 LANSOPRAZOLE SIV
ST15MG Capsule (Delayed Release) 02433001 LANSOPRAZOLE PMS
ST15MG Capsule (Delayed Release) 02353830 MYLAN-LANSOPRAZOLE MYL
ST15MG Capsule (Delayed Release) 02395258 PMS-LANSOPRAZOLE PMS
ST15MG Capsule (Delayed Release) 02165503 PREVACID TAK
ST15MG Capsule (Delayed Release) 02402610 RAN-LANSOPRAZOLE RBY
ST15MG Capsule (Delayed Release) 02422808 RIVA-LANSOPRAZOLE RIV
ST15MG Capsule (Delayed Release) 02385643 SANDOZ LANSOPRAZOLE SDZ
ST15MG Capsule (Delayed Release) 02280515 TEVA-LANSOPRAZOLE TEV
ST30MG Capsule (Delayed Release) 02293838 APO-LANSOPRAZOLE APX
ST30MG Capsule (Delayed Release) 02414775 DOM-LANSOPRAZOLE DPC
ST30MG Capsule (Delayed Release) 02357690 LANSOPRAZOLE SAN
ST30MG Capsule (Delayed Release) 02366282 LANSOPRAZOLE PDL
ST30MG Capsule (Delayed Release) 02410389 LANSOPRAZOLE SIV
ST30MG Capsule (Delayed Release) 02433028 LANSOPRAZOLE PMS
ST30MG Capsule (Delayed Release) 02353849 MYLAN-LANSOPRAZOLE MYL
ST30MG Capsule (Delayed Release) 02395266 PMS-LANSOPRAZOLE PMS
ST30MG Capsule (Delayed Release) 02165511 PREVACID TAK
ST30MG Capsule (Delayed Release) 02402629 RAN-LANSOPRAZOLE RBY
ST30MG Capsule (Delayed Release) 02422816 RIVA-LANSOPRAZOLE RIV
ST30MG Capsule (Delayed Release) 02280523 TEVA-LANSOPRAZOLE TEV
ST30MG Tablet (Delayed Release) 02385651 SANDOZ LANSOPRAZOLE SDZ

LANSOPRAZOLE ODT

Limited use benefit (prior approval not required).

Coverage will be limited to 400 tablets/capsules every 180 days.

For children 12 years of age or under who are unable to swallow the capsule formulation; OR

For patients with dysphagia or a feeding tube when the use of the capsule formulation is not possible.

The following PPI status change is primarily based on the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) report on optimal PPI therapy. The report concluded that:

  • All PPIs are equally efficacious
  • Double dose PPI is not necessary for initial therapy
  • Double dose PPI is effective in H. Pylori eradication; however, treatment is not needed beyond 14 days.

PPI use has been associated with increased risk of hip fracture, community-acquired pneumonia and Clostridium difficile associated diarrhea. Although further study is needed to establish clinical significance, it is prudent to use the lowest dose and shortest duration of therapy required to control symptoms.

All proton pump inhibitors (open benefit and limited use (LU) PPIs) have a maximum quantity limit of 400 tablets/capsules per 180 day period. This quantity limit will be in effect for the entire class of PPIs.

  • For example, if a patient fills 30 tablets of rabeprazole, then switch to 30 tablets of omeprazole, then switch to 30 capsules of lansoprazole, this will count as 90 PPI tablets/capsules towards the quantity limit.
  • Patients taking two rabeprazole 10mg tablets a day can be switched to one rabeprazole 20mg tablet a day to avoid reaching the quantity limit
  • Patients taking two omeprazole 10mg tablets/capsules a day can be switched to one omeprazole 20mg tablet/capsule a day to avoid reaching the quantity limit

Patients with Zollinger Ellison Syndrome, Barrett's esophagus, erosive esophagitis and those who remain symptomatic on a single dose PPI will be eligible for additional doses above 400 tablets/capsules per 180 days through the prior approval process.

Table: LANSOPRAZOLE ODT
Drug strength and dosage form DIN Brand name Manufacturer code
ST15MG Tablet (Delayed Release) 02249464 PREVACID FASTAB TAK
ST30MG Tablet (Delayed Release) 02249472 PREVACID FASTAB TAK

OMEPRAZOLE MAGNESIUM

Limited use benefit (prior approval not required).

Coverage will be limited to 400 tablets/capsules every 180 days.

The following PPI status change is primarily based on the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) report on optimal PPI therapy. The report concluded that:

  • All PPIs are equally efficacious
  • Double dose PPI is not necessary for initial therapy
  • Double dose PPI is effective in H. Pylori eradication; however, treatment is not needed beyond 14 days.

PPI use has been associated with increased risk of hip fracture, community-acquired pneumonia and Clostridium difficile associated diarrhea. Although further study is needed to establish clinical significance, it is prudent to use the lowest dose and shortest duration of therapy required to control symptoms.

All proton pump inhibitors (open benefit and limited use (LU) PPIs) have a maximum quantity limit of 400 tablets/capsules per 180 day period. This quantity limit will be in effect for the entire class of PPIs.

  • For example, if a patient fills 30 tablets of rabeprazole, then switch to 30 tablets of omeprazole, then switch to 30 capsules of lansoprazole, this will count as 90 PPI tablets/capsules towards the quantity limit.
  • Patients taking two rabeprazole 10mg tablets a day can be switched to one rabeprazole 20mg tablet a day to avoid reaching the quantity limit
  • Patients taking two omeprazole 10mg tablets/capsules a day can be switched to one omeprazole 20mg tablet/capsule a day to avoid reaching the quantity limit

Patients with Zollinger Ellison Syndrome, Barrett's esophagus, erosive esophagitis and those who remain symptomatic on a single dose PPI will be eligible for additional doses above 400 tablets/capsules per 180 days through the prior approval process.

Table: OMEPRAZOLE MAGNESIUM
Drug strength and dosage form DIN Brand name Manufacturer code
ST20MG Capsule (Delayed Release) 02245058 APO-OMEPRAZOLE APX
ST20MG Capsule (Delayed Release) 00846503 LOSEC AZC
ST20MG Capsule (Delayed Release) 02339927 OMEPRAZOLE PDL
ST20MG Capsule (Delayed Release) 02348691 OMEPRAZOLE SAN
ST20MG Capsule (Delayed Release) 02411857 OMEPRAZOLE-20 SIV
ST20MG Capsule (Delayed Release) 02320851 PMS-OMEPRAZOLE PMS
ST20MG Capsule (Delayed Release) 02403617 RAN-OMEPRAZOLE RBY
ST20MG Capsule (Delayed Release) 02296446 SANDOZ OMEPRAZOLE SDZ
20MG Tablet (Delayed Release) 02449927 BIO-OMEPRAZOLE BMI
ST20MG Tablet (Delayed Release) 02420198 JAMP-OMEPRAZOLE DR JMP
ST20MG Tablet (Delayed Release) 02190915 LOSEC AZC
ST20MG Tablet (Delayed Release) 02439549 NAT-OMEPRAZOLE DR NPH
ST20MG Tablet (Delayed Release) 02416549 OMEPRAZOLE ACC
ST20MG Tablet (Delayed Release) 02374870 RAN-OMEPRAZOLE RBY
ST20MG Tablet (Delayed Release) 02402416 RIVA-OMEPRAZOLE DR RIV
ST20MG Tablet (Delayed Release) 02295415 TEVA-OMEPRAZOLE TEV

PANTOPRAZOLE MAGNESIUM

Limited use benefit (prior approval not required).

Coverage will be limited to 400 tablets/capsules every 180 days.

The following PPI status change is primarily based on the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) report on optimal PPI therapy. The report concluded that:

  • All PPIs are equally efficacious
  • Double dose PPI is not necessary for initial therapy
  • Double dose PPI is effective in H. Pylori eradication; however, treatment is not needed beyond 14 days.

PPI use has been associated with increased risk of hip fracture, community-acquired pneumonia and Clostridium difficile associated diarrhea. Although further study is needed to establish clinical significance, it is prudent to use the lowest dose and shortest duration of therapy required to control symptoms.

All proton pump inhibitors (open benefit and limited use (LU) PPIs) have a maximum quantity limit of 400 tablets/capsules per 180 day period. This quantity limit will be in effect for the entire class of PPIs.

  • For example, if a patient fills 30 tablets of rabeprazole, then switch to 30 tablets of omeprazole, then switch to 30 capsules of lansoprazole, this will count as 90 PPI tablets/capsules towards the quantity limit.
  • Patients taking two rabeprazole 10mg tablets a day can be switched to one rabeprazole 20mg tablet a day to avoid reaching the quantity limit
  • Patients taking two omeprazole 10mg tablets/capsules a day can be switched to one omeprazole 20mg tablet/capsule a day to avoid reaching the quantity limit

Patients with Zollinger Ellison Syndrome, Barrett's esophagus, erosive esophagitis and those who remain symptomatic on a single dose PPI will be eligible for additional doses above 400 tablets/capsules per 180 days through the prior approval process.

Table: PANTOPRAZOLE MAGNESIUM
Drug strength and dosage form DIN Brand name Manufacturer code
ST40MG Tablet (Delayed Release) 02466147 PANTOPRAZOLE T SAN
ST40MG Tablet (Enteric Coated) 02408570 MYLAN-PANTOPRAZOLE T MYL
ST40MG Tablet (Enteric Coated) 02441853 PANTOPRAZOLE MAGNESIUM UNK
ST40MG Tablet (Enteric Coated) 02267233 TECTA TAK
ST40MG Tablet (Enteric Coated) 02440628 TEVA-PANTOPRAZOLE MAGNESIUM TEV

PANTOPRAZOLE SODIUM

Limited use benefit (prior approval not required).

Coverage will be limited to 400 tablets/capsules every 180 days.

The following PPI status change is primarily based on the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) report on optimal PPI therapy. The report concluded that:

  • All PPIs are equally efficacious
  • Double dose PPI is not necessary for initial therapy
  • Double dose PPI is effective in H. Pylori eradication; however, treatment is not needed beyond 14 days.

PPI use has been associated with increased risk of hip fracture, community-acquired pneumonia and Clostridium difficile associated diarrhea. Although further study is needed to establish clinical significance, it is prudent to use the lowest dose and shortest duration of therapy required to control symptoms.

All proton pump inhibitors (open benefit and limited use (LU) PPIs) have a maximum quantity limit of 400 tablets/capsules per 180 day period. This quantity limit will be in effect for the entire class of PPIs.

  • For example, if a patient fills 30 tablets of rabeprazole, then switch to 30 tablets of omeprazole, then switch to 30 capsules of lansoprazole, this will count as 90 PPI tablets/capsules towards the quantity limit.
  • Patients taking two rabeprazole 10mg tablets a day can be switched to one rabeprazole 20mg tablet a day to avoid reaching the quantity limit
  • Patients taking two omeprazole 10mg tablets/capsules a day can be switched to one omeprazole 20mg tablet/capsule a day to avoid reaching the quantity limit

Patients with Zollinger Ellison Syndrome, Barrett's esophagus, erosive esophagitis and those who remain symptomatic on a single dose PPI will be eligible for additional doses above 400 tablets/capsules per 180 days through the prior approval process.

Table: PANTOPRAZOLE SODIUM
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Tablet (Delayed Release) 02478781 AG-PANTOPRAZOLE ANG
ST40MG Tablet (Delayed Release) 02292920 APO-PANTOPRAZOLE APX
ST40MG Tablet (Delayed Release) 02415208 AURO-PANTOPRAZOLE AUR
40MG Tablet (Delayed Release) 02445867 BIO-PANTOPRAZOLE BMI
ST40MG Tablet (Delayed Release) 02357054 JAMP-PANTOPRAZOLE JMP
ST40MG Tablet (Delayed Release) 02416565 MAR-PANTOPRAZOLE MAR
ST40MG Tablet (Delayed Release) 02417448 MINT-PANTOPRAZOLE MIN
40MG Tablet (Delayed Release) 02467372 M-PANTOPRAZOLE MAN
ST40MG Tablet (Delayed Release) 02229453 PANTOLOC TAK
ST40MG Tablet (Delayed Release) 02318695 PANTOPRAZOLE PDL
ST40MG Tablet (Delayed Release) 02370808 PANTOPRAZOLE SAN
ST40MG Tablet (Delayed Release) 02431327 PANTOPRAZOLE RIV
ST40MG Tablet (Delayed Release) 02437945 PANTOPRAZOLE PMS
ST40MG Tablet (Delayed Release) 02439107 PANTOPRAZOLE DPC
ST40MG Tablet (Delayed Release) 02428180 PANTOPRAZOLE-40 SIV
ST40MG Tablet (Delayed Release) 02307871 PMS-PANTOPRAZOLE PMS
ST40MG Tablet (Delayed Release) 02425378 PRIVA-PANTOPRAZOLE PHA
ST40MG Tablet (Delayed Release) 02305046 RAN-PANTOPRAZOLE RBY
ST40MG Tablet (Delayed Release) 02316463 RIVA-PANTOPRAZOLE RIV
ST40MG Tablet (Delayed Release) 02301083 SANDOZ PANTOPRAZOLE SDZ
ST40MG Tablet (Delayed Release) 02285487 TEVA-PANTOPRAZOLE TEV

RABEPRAZOLE SODIUM

Limited use benefit (prior approval not required).

Coverage will be limited to 400 tablets/capsules every 180 days.

The following PPI status change is primarily based on the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) report on optimal PPI therapy. The report concluded that:

  • All PPIs are equally efficacious
  • Double dose PPI is not necessary for initial therapy
  • Double dose PPI is effective in H. Pylori eradication; however, treatment is not needed beyond 14 days.

PPI use has been associated with increased risk of hip fracture, community-acquired pneumonia and Clostridium difficile associated diarrhea. Although further study is needed to establish clinical significance, it is prudent to use the lowest dose and shortest duration of therapy required to control symptoms.

All proton pump inhibitors (open benefit and limited use (LU) PPIs) have a maximum quantity limit of 400 tablets/capsules per 180 day period. This quantity limit will be in effect for the entire class of PPIs.

  • For example, if a patient fills 30 tablets of rabeprazole, then switch to 30 tablets of omeprazole, then switch to 30 capsules of lansoprazole, this will count as 90 PPI tablets/capsules towards the quantity limit.
  • Patients taking two rabeprazole 10mg tablets a day can be switched to one rabeprazole 20mg tablet a day to avoid reaching the quantity limit
  • Patients taking two omeprazole 10mg tablets/capsules a day can be switched to one omeprazole 20mg tablet/capsule a day to avoid reaching the quantity limit

Patients with Zollinger Ellison Syndrome, Barrett's esophagus, erosive esophagitis and those who remain symptomatic on a single dose PPI will be eligible for additional doses above 400 tablets/capsules per 180 days through the prior approval process.

Table: RABEPRAZOLE SODIUM
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Tablet (Enteric Coated) 02345579 APO-RABEPRAZOLE APX
ST10MG Tablet (Enteric Coated) 02243796 PARIET JSO
ST10MG Tablet (Enteric Coated) 02310805 PMS-RABEPRAZOLE PMS
ST10MG Tablet (Enteric Coated) 02315181 PRO-RABEPRAZOLE PDL
ST10MG Tablet (Enteric Coated) 02385449 RABEPRAZOLE SIV
ST10MG Tablet (Enteric Coated) 02356511 RABEPRAZOLE EC SAN
ST10MG Tablet (Enteric Coated) 02298074 RAN-RABEPRAZOLE RBY
ST10MG Tablet (Enteric Coated) 02330083 RIVA-RABEPRAZOLE EC RIV
ST10MG Tablet (Enteric Coated) 02314177 SANDOZ RABEPRAZOLE SDZ
ST10MG Tablet (Enteric Coated) 02296632 TEVA-RABEPRAZOLE TEV
ST20MG Tablet (Enteric Coated) 02345587 APO-RABEPRAZOLE APX
ST20MG Tablet (Enteric Coated) 02320460 DOM-RABEPRAZOLE EC DPC
ST20MG Tablet (Enteric Coated) 02243797 PARIET JSO
ST20MG Tablet (Enteric Coated) 02310813 PMS-RABEPRAZOLE PMS
ST20MG Tablet (Enteric Coated) 02315203 PRO-RABEPRAZOLE PDL
ST20MG Tablet (Enteric Coated) 02385457 RABEPRAZOLE SIV
ST20MG Tablet (Enteric Coated) 02356538 RABEPRAZOLE EC SAN
ST20MG Tablet (Enteric Coated) 02298082 RAN-RABEPRAZOLE RBY
ST20MG Tablet (Enteric Coated) 02330091 RIVA-RABEPRAZOLE RIV
ST20MG Tablet (Enteric Coated) 02314185 SANDOZ RABEPRAZOLE SDZ
ST20MG Tablet (Enteric Coated) 02296640 TEVA-RABEPRAZOLE TEV

56:92.00 MISCELLANEOUS GI DRUGS

OBETICHOLIC ACID

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

The patient has a confirmed diagnosis of primary biliary cholangitis (PBC), defined as:

  • Positive antimitochondrial antibodies (AMA); OR
  • Liver biopsy results consistent with PBC.

AND

The patient is under the care of a gastroenterologist, hepatologist or internal medicine specialist with experience in the treatment of PBC.

AND

The patient has received ursodeoxycholic acid (UDCA) for a minimum of 12 months and has experienced an inadequate response to UDCA and can benefit from the addition of obeticholic acid. An inadequate response is defined as:

  • Alkaline phosphatase (ALP) ≥ 1.67 x upper limit of normal (ULN); AND/OR
  • Bilirubin > ULN and < 2 x ULN; AND/OR
  • Evidence of compensated cirrhosis by fibroscan or biopsy.

OR

The patient has experienced documented and unmanageable intolerance to UDCA.

Criteria for renewal every 12 months:

The patient continues to benefit from treatment with obeticholic acid as evidenced by:

  • A reduction in the ALP level to less than 1.67 x ULN; OR
  • A 15% reduction in the ALP level compared with values before beginning treatment with obeticholic acid.
Table: OBETICHOLIC ACID
Drug strength and dosage form DIN Brand name Manufacturer code
5MG Tablet 02463121 OCALIVA UNK
10MG Tablet 02463148 OCALIVA UNK

PINAVERIUM BROMIDE

Limited use benefit (prior approval required).

For the treatment and relief of symptoms associated with functional bowel disorders including Irritable Bowel Syndrome (IBS), spastic colon, spastic colitis and mucous colitis; OR

In postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.

Table: PINAVERIUM BROMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Capsule 00465240 DICETEL SPH
50MG Tablet 01950592 DICETEL BGP
100MG Tablet 02230684 DICETEL BGP

68:00 HORMONES AND SYNTHETIC SUBSTITUTES

68:08.00 ANDROGENS

TESTOSTERONE (TOPICAL)

Limited use benefit (prior approval required).

The NIHB Program covers topical testosterone for the treatment of the following in adult males above 18 years old.

- Orchiectomy, undescended testes, Klinefelter's; OR

- Pituitary tumour or post-pituitary surgery with low testosterone; OR

- AIDS-wasting syndrome with low testosterone; OR

- Gender affirming hormone therapy.

Note: Older males with non-specific symptoms such as, but not limited to, fatigue, malaise, or depression who have a low random testosterone level do not meet coverage criteria.

Table: TESTOSTERONE (TOPICAL)
Drug strength and dosage form DIN Brand name Manufacturer code
1% Gel 02245345 ANDROGEL BGP
1% Gel 02245346 ANDROGEL BGP
1% Gel 02463792 TARO-TESTOSTERONE TAR
1% Gel 02463806 TARO-TESTOSTERONE TAR
1% Gel 02280248 TESTIM PAL
12.5MG Gel 02249499 ANDROGEL BGP
2.5MG Patch 02239653 ANDRODERM ALL
5MG Patch 02245972 ANDRODERM ALL

68:12.00 CONTRACEPTIVES

LEVONORGESTREL INTRAUTERINE INSERT

Limited use benefit with quantity and frequency limits (prior approval is not required).

Coverage is granted for 1 device every 2 years.

Table: LEVONORGESTREL INTRAUTERINE INSERT
Drug strength and dosage form DIN Brand name Manufacturer code
52MG Insert (Extended-Release) 02243005 MIRENA BAY

ULIPRISTAL ACETATE

Limited use benefit (prior approval not required).

For the preoperative treatment of moderate-to-severe signs and symptoms of uterine fibroids in adult women of reproductive age; and for the intermittent treatment of moderate-to-severe signs and symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery, with the duration of each treatment course being three months, if the following conditions are met:

  • The patient is under the care of an obstetrician/gynecologist.
  • Patients receiving ulipristal acetate should have their liver function tests monitored before, during, and after treatment.

Coverage will be limited to a maximum of four courses of therapy for women aged 18 to 60 years.

Table: ULIPRISTAL ACETATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02408163 FIBRISTAL ALL

68:16.12 ESTROGEN AGONISTS-ANTAGONISTS

RALOXIFENE HYDROCHLORIDE

Limited use benefit (prior approval required).

For secondary prevention of osteoporosis in women who experience failure on bisphosphonates.

For secondary prevention of osteoporosis in women who have a personal history or a first degree relative with a history of breast cancer.

Table: RALOXIFENE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
60MG Tablet 02358840 ACT RALOXIFENE ACG
60MG Tablet 02279215 APO-RALOXIFENE APX
60MG Tablet 02239028 EVISTA LIL
60MG Tablet 02358921 PMS-RALOXIFENE PMS

68:20.05 DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

LINAGLIPTIN

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who did not achieve glycemic control and who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: LINAGLIPTIN
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02370921 TRAJENTA BOE

LINAGLIPTIN, METFORMIN HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who did not achieve glycemic control and who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: LINAGLIPTIN, METFORMIN HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST2.5MG & 1000MG Tablet 02403277 JENTADUETO BOE
ST2.5MG & 500MG Tablet 02403250 JENTADUETO BOE
ST2.5MG & 850MG Tablet 02403269 JENTADUETO BOE

SAXAGLIPTIN HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who: did not achieve glycemic control or who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: SAXAGLIPTIN HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST2.5MG Tablet 02375842 ONGLYZA AZC
ST5MG Tablet 02333554 ONGLYZA AZC

SAXAGLIPTIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who did not achieve glycemic control and who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: SAXAGLIPTIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST2.5MG & 1000MG Tablet 02389185 KOMBOGLYZE AZC
ST2.5MG & 500MG Tablet 02389169 KOMBOGLYZE AZC
ST2.5MG & 850MG Tablet 02389177 KOMBOGLYZE AZC

SITAGLIPTIN PHOSPHATE MONOHYDRATE

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who did not achieve glycemic control and who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: SITAGLIPTIN PHOSPHATE MONOHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST25MG Tablet 02388839 JANUVIA FRS
ST50MG Tablet 02388847 JANUVIA FRS
ST100MG Tablet 02303922 JANUVIA FRS

SITAGLIPTIN PHOSPHATE MONOHYDRATE, METFORMIN HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who did not achieve glycemic control and who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: SITAGLIPTIN PHOSPHATE MONOHYDRATE, METFORMIN HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST50MG & 1000MG Tablet 02333872 JANUMET FRS
ST50MG & 500MG Tablet 02333856 JANUMET FRS
ST50MG & 850MG Tablet 02333864 JANUMET FRS
ST50MG & 1000MG Tablet (Extended Release) 02416794 JANUMET XR FRS
ST50MG & 500MG Tablet (Extended Release) 02416786 JANUMET XR FRS
ST100MG & 1000MG Tablet (Extended Release) 02416808 JANUMET XR FRS

68:20.06 INCRETIN MIMETICS

SEMAGLUTIDE

Open benefit.

For the treatment of type 2 diabetes in combination with metformin alone, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control.

Table: SEMAGLUTIDE
Drug strength and dosage form DIN Brand name Manufacturer code
1MG Solution 02471469 OZEMPIC NOO
1.34MG Solution 02471477 OZEMPIC NOO

68:20.18 SODIUM-GLUCOSE CONTRANSPORTER 2 (SGLT2) INHIBITORS

CANAGLIFLOZIN

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who did not achieve glycemic control and who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: CANAGLIFLOZIN
Drug strength and dosage form DIN Brand name Manufacturer code
ST100MG Tablet 02425483 INVOKANA JSO
ST300MG Tablet 02425491 INVOKANA JSO

DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who did not achieve glycemic control and who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02435462 FORXIGA AZC
ST10MG Tablet 02435470 FORXIGA AZC

EMPAGLIFLOZIN

Open benefit.

For the treatment of type 2 diabetes mellitus:

- in patients who did not achieve glycemic control with an adequate trial of metformin AND a sulfonylurea

OR

- to reduce the incidence of cardiovascular death in patients with established cardiovascular disease who did not achieve adequate glycemic control despite an appropriate trial of metformin

Established cardiovascular disease is defined as one of the following:

  • history of myocardial infarction
  • multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status)
  • single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina
  • unstable angina with confirmed evidence of coronary multi-vessel or single-vessel disease
  • history of ischemic or hemorrhagic stroke
  • occlusive peripheral artery disease.
Table: EMPAGLIFLOZIN
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Tablet 02443937 JARDIANCE BOE
ST25MG Tablet 02443945 JARDIANCE BOE

METFORMIN HYDROCHLORIDE, DAPAGLIFLOZIN

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who did not achieve glycemic control and who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Table: METFORMIN HYDROCHLORIDE, DAPAGLIFLOZIN
Drug strength and dosage form DIN Brand name Manufacturer code
ST850MG & 5MG Tablet 02449935 XIGDUO AZC
ST1000MG & 5MG Tablet 02449943 XIGDUO AZC

METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN

Open benefit.

For the treatment of patients with type 2 diabetes mellitus in patients who are eligible to receive metformin and empagliflozin, to replace the individual components.

Table: METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN
Drug strength and dosage form DIN Brand name Manufacturer code
500MG & 12.5MG Tablet 02456605 SYNJARDY BOE
500MG & 5MG Tablet 02456575 SYNJARDY BOE
850MG & 12.5MG Tablet 02456613 SYNJARDY BOE
850MG & 5MG Tablet 02456583 SYNJARDY BOE
1000MG & 12.5MG Tablet 02456621 SYNJARDY BOE
1000MG & 5MG Tablet 02456591 SYNJARDY BOE

68:32.00 PROGESTINS

DIENOGEST

Limited use benefit (prior approval required).

For the management of pelvic pain associated with endometriosis.

Table: DIENOGEST
Drug strength and dosage form DIN Brand name Manufacturer code
ST2MG Tablet 02374900 VISANNE BAY

PROGESTERONE

Limited use benefit (prior approval required).

For the treatment of women:

  • With postmenopausal symptoms who are intolerant to medroxyprogesterone acetate (MPA); OR
  • Who are at risk of preterm birth; OR
  • Who are using the medication to prevent miscarriage.

In adults:

  • For use as Gender Affirming Hormone Therapy.
Table: PROGESTERONE
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Capsule 02476576 PMS-PROGESTERONE PMS
ST100MG Capsule 02166704 PROMETRIUM FRS
ST100MG Capsule 02463113 REDDY-PROGESTERONE REC
ST100MG Capsule 02439913 TEVA-PROGESTERONE TEV

84:00 SKIN AND MUCOUS MEMBRANE AGENTS (SMMA)

84:08.00 SMMA - ANTIPRURITICS AND LOCAL ANESTHETICS

LIDOCAINE

Limited use benefit (prior approval not required).

Coverage will be limited to 35 grams every 30 days.

Table: LIDOCAINE
Drug strength and dosage form DIN Brand name Manufacturer code
5% Ointment 02386836 JAMPOCAINE JMP
5% Ointment 01963988 LIDODAN ODN
5% Ointment 02083795 LIDODAN ODN
5% Ointment 00001961 XYLOCAINE UNK

84:92.00 MISCELLANEOUS SKIN AND MUCOUS MEMBRANE AGENTS

BRODALUMAB

Limited use benefit (prior approval required).

For PSORIASIS, coverage is provided for an initial period of 12 weeks at a dose of 210 mg at week 0, 1, and 2, followed by 210 mg every 2 weeks.

  • Prescribed by a dermatologist

For the treatment of patients with moderate to severe PSORIASIS who meet all of the following criteria:

  • Body surface area (BSA) involvement greater than 10% and/or significant involvement of the face, hands, feet or genital region; AND
  • Intolerance or lack of response to phototherapy; OR
  • Inability to access phototherapy; AND
  • Intolerance or lack of response to methotrexate (MTX) weekly oral or parenteral at 20 mg or greater (15 mg or greater if patient is > 65 years of age) for more than 8 weeks; AND
  • Intolerance or lack of response to cyclosporine; OR
  • A contraindication to methotrexate or cyclosporine.

Coverage beyond 12 to16 weeks will be based on a significant reduction in the Body Surface Area (BSA) involved and improvements in the Psoriasis Area Severity Index (PASI) score and the Dermatology Life Quality Index (DLQI).

  • A 75% reduction in Psoriasis Area Severity Index (PASI) score; OR
  • A ≥ 50% reduction in the Psoriasis Area Severity Index (PASI) score with a ≥ 5-point improvement in the Dermatology Life Quality Index (DLQI); OR
  • A significant reduction in Body Surface Area (BSA) involved, with consideration of important areas such as the face, hands, feet or genital regions.
Table: BRODALUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
210MG Solution 02473623 SILIQ VAE

IMIQUIMOD

Limited use benefit (prior approval required).

For the treatment of condylomata acuminate (genital warts) in patients who have failed:

  • self-applied podophyllotoxin (podofilox 0.5% solution); OR
  • provider-applied podophyllum resin (10%-25%).
Table: IMIQUIMOD
Drug strength and dosage form DIN Brand name Manufacturer code
5% Cream 02239505 ALDARA P BSH
5% Cream 02407825 APO-IMIQUIMOD APX
5% Cream 02482983 TARO-IMIQUIMOD PUMP TAR

IXEKIZUMAB

Limited use benefit (prior approval required).

1. For the treatment of moderate to severe PSORIATIC ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 160 mg at Week 0, followed by 80 mg every 4weeks. For psoriatic arthritis patients with coexistent moderate-to-severe psoriasis, coverage is provided for psoriasis dosing: 160 mg at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks. For psoriatic arthritis patients with coexistent mild plaque psoriasis, coverage is provided for psoriatic arthritis dosing: 160 mg at Week 0, followed by 80 mg every 4 weeks.

  • Prescribed by a rheumatologist

Client who meet at least 2 of the following criteria:

  • 5 or more swollen joints
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle
  • more than one joint with erosion on imaging study
  • dactylitis of two or more digits
  • tenosynovitis refractory to oral NSAIDs and steroid injections
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon)
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4
  • daily use of corticosteroids
  • use of opioids > 12 hours per day for pain resulting from inflammation

AND patient is refractory to:

  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks;

PLUS a minimum of any two of the following:

  • methotrexate weekly (weekly oral or parenteral)at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR
  • leflunomide: 20mg daily for 10 weeks; OR
  • sulfasalazine at least 2g daily for 3 months; OR
  • cyclosporine

OR Axial disease with both of the following:

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks.

Coverage beyond one year will be based on improvement in at least 2 of 4 Psoriatic Arthritis Response Criteria (PsARC).

  • Improvement in at least two of the four PsARC criteria, one of which has to be joint tenderness or swelling score, with no worsening in any of the four criteria. A response in joint count is determined by a reduction of ≥ 30%. A response in the Physician or Patient Global Assessment scale is determined by a reduction of 1 point.

2. For PSORIASIS ONLY, coverage is provided for an initial period of 12 weeks at a dose of 160mg at week 0, followed by 80mg at weeks 2, 4, 6, 8, 10, and 12, then 80mg every 4 weeks.

  • Prescribed by a dermatologist

For the treatment of patients with moderate to severe PSORIASIS who meet all of the following criteria:

  • Body surface area (BSA) involvement greater than 10% and/or significant involvement of the face, hands, feet or genital region; AND
  • Intolerance or lack of response to phototherapy; OR
  • Inability to access phototherapy; AND
  • Intolerance or lack of response to methotrexate (MTX) weekly oral or parenteral at 20 mg or greater (15 mg or greater if patient is > 65 years of age) for more than 8 weeks; AND
  • Intolerance or lack of response to cyclosporine; OR
  • A contraindication to methotrexate or cyclosporine.

Coverage beyond 12 weeks will be based on a significant reduction in the Body Surface Area (BSA) involved and improvements in the Psoriasis Area Severity Index (PASI) score and the Dermatology Life Quality Index (DLQI):

  • A 75% reduction in Psoriasis Area Severity Index (PASI) score; OR
  • A ≥ 50% reduction in the Psoriasis Area Severity Index (PASI) score with a ≥ 5-point improvement in the Dermatology Life Quality Index (DLQI); OR
  • A significant reduction in Body Surface Area (BSA) involved, with consideration of important areas such as the face, hands, feet or genital regions.
Table: IXEKIZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
80MG Solution 02455102 TALTZ LIL
80MG Solution 02455110 TALTZ LIL

PIMECROLIMUS

Limited use benefit (prior approval required).

For patients who have failed topical corticosteroid therapy or have experienced side effects from such treatment.

Note: Contraindicated in children less than 2 years of age.

Table: PIMECROLIMUS
Drug strength and dosage form DIN Brand name Manufacturer code
1% Cream 02247238 ELIDEL VAE

SECUKINUMAB

Limited use benefit (prior approval required).

1. For the treatment of moderate to severe PSORIASIS

Coverage is provided for an initial period of 12 weeks at a dose of 300mg at Weeks 0, 1, 2 and 3, followed by 300mg per month starting at Week 4.

  • Prescribed by a dermatologist

For the treatment of patients with moderate to severe PSORIASIS who meet all of the following criteria:

  • Body surface area (BSA) involvement greater than 10% and/or significant involvement of the face, hands, feet or genital region; AND
  • Intolerance or lack of response to phototherapy; OR
  • Inability to access phototherapy; AND
  • Intolerance or lack of response to methotrexate (MTX) weekly oral or parenteral at 20 mg or greater (15 mg or greater if patient is > 65 years of age) for more than 8 weeks; AND
  • Intolerance or lack of response to cyclosporine; OR
  • A contraindication to methotrexate or cyclosporine.

Coverage beyond 12 weeks will be based on a significant reduction in the Body Surface Area (BSA) involved and improvements in the Psoriasis Area Severity Index (PASI) score and the Dermatology Life Quality Index (DLQI):

  • A 75% reduction in Psoriasis Area Severity Index (PASI) score; OR
  • A ≥ 50% reduction in the Psoriasis Area Severity Index (PASI) score with a ≥ 5-point improvement in the Dermatology Life Quality Index (DLQI); OR
  • A significant reduction in Body Surface Area (BSA) involved, with consideration of important areas such as the face, hands, feet or genital regions.

2. For the treatment of moderate to severe PSORIATIC ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 150 mg at weeks 0, 1, 2 and 3, followed by 150 mg per month starting at week 4. If patient is an anti-TNF inadequate responder and continues to have active psoriatic arthritis or has co-existent severe plaque psoriasis, 300 mg per month will be considered.

  • Prescribed by a rheumatologist

Client who meet at least 2 of the following criteria:

  • 5 or more swollen joints
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle
  • more than one joint with erosion on imaging study
  • dactylitis of two or more digits
  • tenosynovitis refractory to oral NSAIDs and steroid injections
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon)
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4
  • daily use of corticosteroids
  • use of opioids > 12 hours per day for pain resulting from inflammation

AND patient is refractory to:

  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks;

PLUS a minimum of any two of the following:

  • methotrexate weekly (weekly oral or parenteral)at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR
  • leflunomide: 20mg daily for 10 weeks; OR
  • sulfasalazine at least 2g daily for 3 months; OR
  • cyclosporine

OR Axial disease with both of the following:

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks.

Coverage beyond one year will be based on improvement according to the Psoriatic Arthritis Response Criteria (PsARC).

  • Improvement in at least two of the four PsARC criteria, one of which has to be joint tenderness or swelling score, with no worsening in any of the four criteria. A response in joint count is determined by a reduction of ≥ 30%. A response in the Physician or Patient Global Assessment scale is determined by a reduction of 1 point.

3. For the treatment of ANKYLOSING SPONDYLITIS

Coverage is provided for an initial period of one year at a dose of 150 mg at weeks 0, 1, 2 and 3, followed by 150 mg per month starting at week 4.

  • Prescribed by a rheumatologist
  • BASDAI > 4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks;

AND for peripheral joint involvement, patient is refractory:

  • Methotrexate (MTX) (weekly oral or parenteral) weekly at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND
  • Sulfasalazine 2 g/day for at least 3 months.

NOTE: For axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

Coverage beyond one year will be based on improvement in the BASDAI score.

  • Improvement of at least 50% or 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score.
Table: SECUKINUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG/ML Injection 99101215 COSENTYX (STYLO) NVC
150MG/ML Injection 09857548 COSENTYX PEN (ON) NVC
150MG Solution 02438070 COSENTYX NVR

TACROLIMUS (PROTOPIC)

Limited use benefit (prior approval required).

For patients who have failed topical corticosteroid therapy or have experienced side effects from such treatment.

Note: Contraindicated in children less than 2 years of age.

Table: TACROLIMUS (PROTOPIC)
Drug strength and dosage form DIN Brand name Manufacturer code
0.03% Ointment 02244149 PROTOPIC LEO
0.1% Ointment 02244148 PROTOPIC LEO

86:00 SMOOTH MUSCLE RELAXANTS

86:12.04 ANTIMUSCARINICS

DARIFENACIN HYDROBROMIDE

Limited use benefit (prior approval required).

For the symptomatic relief of overactive bladder in patients:

  • with symptoms of urinary frequency, urgency or urge incontinence; AND
  • who have failed on or are intolerant to therapy with immediate-release oxybutynin OR solifenacin OR tolterodine ER.
Table: DARIFENACIN HYDROBROMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
7.5MG Tablet (Extended Release) 02273217 ENABLEX UNK
15MG Tablet (Extended Release) 02273225 ENABLEX UNK

FESOTERODINE FUMARATE

Limited use benefit (prior approval required).

For the symptomatic relief of overactive bladder in patients:

  • with symptoms of urinary frequency, urgency or urge incontinence; AND
  • who have failed on or are intolerant to therapy with immediate-release oxybutynin OR solifenacin OR tolterodine ER.
Table: FESOTERODINE FUMARATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST4MG Tablet (Extended Release) 02380021 TOVIAZ PFI
ST8MG Tablet (Extended Release) 02380048 TOVIAZ PFI

TROSPIUM CHLORIDE

Limited use benefit (prior approval required).

For the symptomatic relief of overactive bladder in patients:

  • with symptoms of urinary frequency, urgency or urge incontinence; AND
  • who have failed on or are intolerant to therapy with immediate-release oxybutynin OR solifenacin OR tolterodine ER.
Table: TROSPIUM CHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
ST20MG Tablet 02488353 MAR-TROSPIUM MAR
ST20MG Tablet 02275066 TROSEC SPC

86:12.08 BETA-ADRENERGIC AGONISTS

MIRABEGRON

Limited use benefit (prior approval required).

For the symptomatic relief of overactive bladder in patients:

  • with symptoms of urinary frequency, urgency or urge incontinence; AND
  • who have failed on or are intolerant to therapy with immediate-release oxybutynin OR solifenacin OR tolterodine ER.
Table: MIRABEGRON
Drug strength and dosage form DIN Brand name Manufacturer code
ST25MG Tablet (Extended Release) 02402874 MYRBETRIQ AST
ST50MG Tablet (Extended Release) 02402882 MYRBETRIQ AST

88:00 VITAMINS

88:20.00 VITAMIN E

VITAMIN E

Limited use benefit (prior approval required).

For use in malabsorption

Table: VITAMIN E
Drug strength and dosage form DIN Brand name Manufacturer code
ST100IU Capsule (Softgel) 00122823 VITAMIN E JAM
ST200IU Capsule (Softgel) 00122831 VITAMIN E JAM
ST400IU Capsule (Softgel) 00122858 VITAMIN E JAM
ST800IU Capsule (Softgel) 00330191 VITAMIN E JAM
ST20U/ML Liquid 09991656 AQUA-E/ML UNK
ST75U/ML Liquid 09991652 AQUA-E UNK
ST50IU Oral Liquid 00480215 AQUASOL E NVC
ST50IU/ML Oral Liquid 02162075 AQUASOL E VITAMIN E CLC

88:28.00 MULTIVITAMIN PREPARATIONS

MULTIVITAMINS (CHILDREN AND YOUTH)

Limited use benefit (prior approval is not required).

Multivitamins are benefits for children up to 19 years of age.

Table: MULTIVITAMINS (CHILDREN AND YOUTH)
Drug strength and dosage form DIN Brand name Manufacturer code
ST Drop 00762946 ENFAMIL POLYVISOL MJO
ST450MG & 10MG & 30MG Liquid 80008471 JAMP VITAMIN A, D AND C JMP
ST2,500IU & 666.67IU & 50MG/ML Liquid 00762903 ENFAMIL TRIVISOL MJO
ST2,500IU & 666.67IU & 50MG/ML Liquid 02229790 PEDIAVIT EUR
0MG Tablet 02246362 CENTRUM PFI
0MG Tablet 80021452 CENTRUM PFI
0MG Tablet 80024482 CENTRUM FOR WOMEN PFI
2MG Tablet 80045908 ONE A DAY WOMEN BAY
10MG Tablet 80039441 STRESSTABS FOR WOMEN PFI
ST Tablet (Chewable) 80011134 CENTRUM JUNIOR COMPLETE PFI
ST Tablet (Chewable) 80020794 CENTRUM JUNIOR COMPLETE PFI
ST Tablet (Chewable) 02247995 FLINTSTONES MULTIPLE VITAMINS PLUS IRON BAY
ST Tablet (Chewable) 02247975 FLINTSTONES MULTIPLE VITAMINS WITH EXTRA C BAY

MULTIVITAMINS (PRENATAL)

Limited use benefit (prior approval is not required.).

Prenatal and postnatal vitamins are benefits only for women of childbearing age (12 to 50 years).

Table: MULTIVITAMINS (PRENATAL)
Drug strength and dosage form DIN Brand name Manufacturer code
ST Capsule 80042704 CENTRUM DHA PFI
ST Tablet 80045822 CENTRUM PRENATAL PFI
ST Tablet 80080882 MATERNA NES
ST Tablet 80082297 MATERNA NES
ST Tablet 80001842 NESTL MATERNA NES
ST Tablet 02241235 PRENATAL AND POSTPARTUM VITAMINS AND MINERALS VTH
ST Tablet 80005770 PRENATAL AND POSTPARTUM VITAMINS AND MINERALS PMT
ST Tablet 02229535 WAMPOLE COMPLETE MULT-PRE AND POST NATAL WITH FOLIC ACID WAM
2MG Tablet 80004919 NATURES BOUNTY PRENATAL VITAMINS VTH

92:00 UNCLASSIFIED THERAPEUTIC AGENTS

92:00.00 UNCLASSIFIED THERAPEUTIC AGENTS

EXTEMPORANEOUS MIXTURE (GENDER AFFIRMING)

Limited use benefit (prior approval required).

For gender affirming hormone therapy.

Table: EXTEMPORANEOUS MIXTURE (GENDER AFFIRMING)
Drug strength and dosage form DIN Brand name Manufacturer code
Injection 00915312 GENDER AFFIRMING HORMONES UNK
Liquid 00915311 GENDER AFFIRMING TOPICAL HORMONES UNK

EXTEMPORANEOUS MIXTURE (LU)

Limited use benefit (prior approval required).

Table: EXTEMPORANEOUS MIXTURE (LU)
Drug strength and dosage form DIN Brand name Manufacturer code
Injection 99506021 MISCELLANEOUS COMPOUNDED INJECTION/INFUSION UNK
Miscellaneous 99504001 MISC LIMITED USE EXTERNAL COMPOUND MIXTURE UNK
Ophthalmic And Otic Solution 99507000 MISCELLANEOUS COMPOUNDED EYE/EAR DROP UNK
Oral Liquid 99503033 MISC LIMITED USE COMPOUND INTERNAL UNK
Oral Liquid 99503032 OPIOID COMPOUNDED UNK
Powder 99504000 MISCELLANEOUS COMPOUNDED EXTERNAL POWDER UNK
Suppository 99508000 MISCELLANEOUS COMPOUNDED SUPPOSITORY UNK

USTEKINUMAB

Limited use benefit (prior approval required).

Coverage is provided for an initial period of 16 weeks. For patients ≤ 100 kg, the initial dose is 45 mg at week 0, followed by 45 mg at weeks 4 and 16. Alternatively, ustekinumab 90 mg may be used in patients weighing more than 100 kg. Response must be assessed prior to a fourth dose and further doses will be provided only for responders.

  • Prescribed by a dermatologist

For the treatment of patients with moderate to severe PSORIASIS who meet all of the following criteria:

  • Body surface area (BSA) involvement greater than 10% and/or significant involvement of the face, hands, feet or genital region; AND
  • Intolerance or lack of response to phototherapy; OR
  • Inability to access phototherapy; AND
  • Intolerance or lack of response to methotrexate (MTX) weekly oral or parenteral at 20 mg or greater (15 mg or greater if patient is > 65 years of age) for more than 8 weeks; AND
  • Intolerance or lack of response to cyclosporine; OR
  • A contraindication to methotrexate or cyclosporine.

Coverage beyond 16 weeks will be based on a significant reduction in the Body Surface Area (BSA) involved and improvements in the Psoriasis Area Severity Index (PASI) score and the Dermatology Life Quality Index (DLQI):

  • A 75% reduction in Psoriasis Area Severity Index (PASI) score; OR
  • A ≥ 50% reduction in the Psoriasis Area Severity Index (PASI) score with a ≥ 5-point improvement in the Dermatology Life Quality Index (DLQI); OR
  • A significant reduction in Body Surface Area (BSA) involved, with consideration of important areas such as the face, hands, feet or genital regions.
Table: USTEKINUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
45MG/0.5ML Solution 02320673 STELARA JSO
90MG/ML Solution 02320681 STELARA JSO

92:16.00 ANTIGOUT AGENTS

FEBUXOSTAT

Limited use benefit (prior approval required).

For patients with symptomatic gout who have documented hypersensitivity to allopurinol.

Table: FEBUXOSTAT
Drug strength and dosage form DIN Brand name Manufacturer code
ST80MG Tablet 02473607 MAR-FEBUXOSTAT MAR
ST80MG Tablet 02357380 ULORIC TAK

92:20.00 IMMUNOMODULAROTY AGENTS

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Limited use benefit (prior approval required).

Initial Coverage (one year):

For the treatment of patients with Relapsing Remitting Multiple Sclerosis (RRMS) who meet ALL of the following criteria:

  • Failure to respond to full and adequate courses of at least ONE initial disease-modifying therapy (an interferon, glatiramer acetate, dimethyl fumarate or teriflunomide) OR documented intolerance to at least 2 therapies; AND
  • One or more clinically disabling relapses in the previous year; AND
  • Significant increase in T2 lesion load compared with that from a previous MRI scan or at least one gadolinium-enhancing lesion; AND
  • Requested and followed by a neurologist experienced in the management of RRMS; AND
  • Recent Expanded Disability Status Scale (EDSS) score.

Renewal Coverage (two years):

  • EDSS scores must be provided (exam must have occurred within that last 90 days).
  • Patients must be stable or have experienced no more than 1 disabling attack/relapse in the past year.
Table: FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
Drug strength and dosage form DIN Brand name Manufacturer code
0.5MG Capsule 02365480 GILENYA NVR

GLATIRAMER ACETATE

Limited use benefit (prior approval required).

  • As a first-line therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist experienced in the management of RRMS.

AND for patients who meet ALL of the following criteria:

  • Patient has had a clinical relapse and/or new MRI activity in the last two years; AND
  • Patient is fully ambulatory for 100 meters without aids; AND
  • Patient is 18 years of age or older.
Table: GLATIRAMER ACETATE
Drug strength and dosage form DIN Brand name Manufacturer code
20MG Solution 02245619 COPAXONE TEV
20MG Solution 02460661 GLATECT PMS

INTERFERON BETA-1A

Limited use benefit (prior approval required).

  • As a first-line therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist experienced in the management of RRMS.

AND for patients who meet ALL of the following criteria:

  • Patient has had a clinical relapse and/or new MRI activity in the last two years; AND
  • Patient is fully ambulatory for 100 meters without aids; AND
  • Patient is 18 years of age or older.
Table: INTERFERON BETA-1A
Drug strength and dosage form DIN Brand name Manufacturer code
30MCG Injection 09857395 AVONEX PEN UNK
30MCG Injection 99100763 AVONEX PEN UNK
60MCG Powder For Solution 02267594 AVONEX UNK
22MCG Solution 02237319 REBIF SRO
30MCG Solution 02269201 AVONEX UNK
44MCG Solution 02237318 REBIF SRO
44MCG Solution 02237320 REBIF SRO
66MCG Solution 02318253 REBIF SRO
132MCG Solution 02318261 REBIF SRO
132MCG Solution 02318288 REBIF SRO

INTERFERON BETA-1B

Limited use benefit (prior approval required).

  • As a first-line therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist experienced in the management of RRMS.

AND for patients who meet ALL of the following criteria:

  • Patient has had a clinical relapse and/or new MRI activity in the last two years; AND
  • Patient is fully ambulatory for 100 meters without aids; AND
  • Patient is 18 years of age or older.
Table: INTERFERON BETA-1B
Drug strength and dosage form DIN Brand name Manufacturer code
0.3MG Injection 99100555 BETASERON INITIATION KIT BAY
0.3MG Powder For Solution 02169649 BETASERON BAY
0.3MG Powder For Solution 02337819 EXTAVIA NVR

OCRELIZUMAB

Limited use benefit (prior approval required).

1. For the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence who meet all of the following criteria:

  • Prescribed by a neurologist experienced in the management of RRMS; AND
  • Patient has had a clinical relapsea and/or new MRI activityb in the last two years; AND
  • Patient is fully ambulatory for 100 meters without aids. Expanded Disability Status Scale score (EDSS) of 5.5 or less.
  • Patient is 18 years of age or older.

a. A clinical relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 24 hours in the absence of fever, preceded by stability for at least one month.

b. MRI activity is defined as any new multiple sclerosis lesion/s, expanding lesion/s, and/or enhancing lesion/s.

OR

2. For the treatment of primary progressive multiple sclerosis (PPMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence who meet all of the following criteria:

Initial Coverage (one year)

  • Prescribed by a neurologist experienced in the management of PPMS; AND
  • Expanded Disability Status Scale (EDSS) between 3.0 and 6.5; AND
  • Score of at least 2.0 on the Functional Systems scale (FSS) for the pyramidal system due to lower extremity findings; AND
  • Disease duration of less than 15 years for those with an EDSS greater than 5.0 or less than 10 years for those with an EDSS of 5.0 of less; AND
  • Patient is 18 years of age or older.

Renewal Coverage for PPMS (one year):

  • EDSS of less than 7.0.
Table: OCRELIZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
30MG Solution 02467224 OCREVUS HLR

TERIFLUNOMIDE

Limited use benefit (prior approval required).

  • As a first-line therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist experienced in the management of RRMS.

AND for patients who meet ALL of the following criteria:

  • Patient has had a clinical relapse and/or new MRI activity in the last two years; AND
  • Patient is fully ambulatory for 100 meters without aids; AND
  • Patient is 18 years of age or older.
Table: TERIFLUNOMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
14MG Tablet 02416328 AUBAGIO GEE

92:24.00 BONE RESORPTION INHIBITORS

DENOSUMAB (PROLIA)

Limited use benefit (prior approval required).

For the treatment of osteoporosis in patients who have a significant fracture risk defined as either:

- moderate 10-year fracture risk (10% to 20%) with a prior fragility fracture; OR

- high 10-year fracture risk (≥ 20%);

AND

- Have a contraindication to oral bisphosphonates (e.g. hypersensitivity, esophageal abnormality, renal impairment); OR

- Have failed or have an intolerance to oral bisphosphonates (e.g. hypersensitivity, esophageal abnormality, renal impairment).

Table: DENOSUMAB (PROLIA)
Drug strength and dosage form DIN Brand name Manufacturer code
60MG/ML Solution 02343541 PROLIA AMG

DENOSUMAB (XGEVA)

Limited use benefit (prior approval required).

For the prevention of skeletal-related events (SREs) in patients with castrate-resistant prostate cancer (CRPC) with:

  • one or more documented bone metastases; AND
  • good performance status (ECOG performance status score of 0, 1, or 2).
Table: DENOSUMAB (XGEVA)
Drug strength and dosage form DIN Brand name Manufacturer code
120MG/1.7ML Solution 02368153 XGEVA AMG

ZOLEDRONIC ACID MONOHYDRATE

Limited use benefit (prior approval required).

Maximum dose covered is 5mg per 12-month period

For the treatment of Paget's disease;

OR

For the treatment of osteoporosis in patients who have a significant fracture risk defined as either:

  • moderate 10-year fracture risk (10% to 20%) with a prior fragility fracture; OR
  • high 10-year fracture risk (≥ 20%)

AND

  • Have a contraindication to oral bisphosphonates (e.g. hypersensitivity, esophageal abnormality, renal impairment);OR
  • Have failed or have an intolerance to oral bisphosphonates (e.g. hypersensitivity, esophageal abnormality, renal impairment).
Table: ZOLEDRONIC ACID MONOHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
5MG/100ML Solution 02269198 ACLASTA NVR
5MG/100ML Solution 02415100 TARO-ZOLEDRONIC ACID TAR
5MG/100ML Solution 02422433 ZOLEDRONIC ACID REC

92:36.00 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

ABATACEPT

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 500mg IV for patients weighting <60kg; 750mg IV for patients weighting 60kg to 100kg; and 1000mg IV for patients weighing >100kg. Initial IV doses are given at 0, 2, and 4 weeks, then every 4 weeks. Alternatively, a single weight-based IV loading dose is covered (if required), followed by 125mg SC weekly.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX; AND
  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

AND (FOR IV FORMULATION ONLY):

  • etanercept (sc) OR adalimumab (sc) OR golimumab (sc) OR certolizumab (sc) OR abatacept (sc) OR tocilizumab OR tofacitinib (po) OR Inflectra (iv) OR Renflexis (iv): for a minimum trial of 12 weeks.

Coverage beyond one year will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of severely active polyarticular JUVENILE IDIOPATHIC ARTHRITIS

Coverage is provided for an initial period of 16 weeks at a dose of 10mg/kg for children weighing < 75kg; Pediatric patients weighing 75kg or more should be dosed according to the adult regimen, not to exceed a maximum dose of 1000mg. Doses are given at 0, 2, and 4 weeks, then every 4 weeks.

  • Prescribed by a rheumatologist

In patients six to seventeen years of age who meet the following criteria:

  • ≥ 5 swollen joints; AND
  • ≥ 3 joints with limited range of motion and/or pain/tenderness; AND
  • Condition is refractory to an adequate trial of a therapeutic dose of methotrexate.

Coverage beyond 16 weeks is based on a >30% improvement in 3 of 6 baseline clinical parameters

Patient has experienced 3 of 6 of the following variables:

  • >30% reduction in the number of active joints
  • >30% reduction in the number of joints with loss of range of motion
  • >30% improvement in the Physician Global Assessment scale
  • >30% improvement in the Patient or Parent Global Assessment scale
  • >30% improvement in the Child Health Assessment Questionnaire (CHAQ)
  • >30% reduction in ESR; AND
  • No more than one of these variables has worsened by greater than 30%
Table: ABATACEPT
Drug strength and dosage form DIN Brand name Manufacturer code
250MG Powder For Solution 02282097 ORENCIA BMS
125MG Solution 02402475 ORENCIA BMS

ADALIMUMAB

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 40 mg every two weeks.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX; AND
  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond one year will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of moderate to severe PSORIATIC ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 40 mg every two weeks.

  • Prescribed by a rheumatologist

Client who meet at least 2 of the following criteria:

  • 5 or more swollen joints
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle
  • more than one joint with erosion on imaging study
  • dactylitis of two or more digits
  • tenosynovitis refractory to oral NSAIDs and steroid injections
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon)
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4
  • daily use of corticosteroids
  • use of opioids > 12 hours per day for pain resulting from inflammation

AND patient is refractory to:

  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks;

PLUS a minimum of any two of the following:

  • methotrexate weekly (weekly oral or parenteral)at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR
  • leflunomide: 20mg daily for 10 weeks; OR
  • sulfasalazine at least 2g daily for 3 months; OR
  • cyclosporine

OR Axial disease with both of the following:

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks.

Coverage beyond one year will be based on improvement according to the Psoriatic Arthritis Response Criteria (PsARC).

  • Improvement in at least two of the four PsARC criteria, one of which has to be joint tenderness or swelling score, with no worsening in any of the four criteria. A response in joint count is determined by a reduction of ≥ 30%. A response in the Physician or Patient Global Assessment scale is determined by a reduction of 1 point.

3. For the treatment of ANKYLOSING SPONDYLITIS

Coverage is provided for an initial period of one year at a dose of 40 mg every two weeks.

  • Prescribed by a rheumatologist
  • BASDAI > 4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks;

AND for peripheral joint involvement, patient is refractory:

  • Methotrexate (MTX) (weekly oral or parenteral) weekly at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND
  • Sulfasalazine 2 g/day for at least 3 months.

NOTE: For axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

Coverage beyond one year will be based on improvement in the BASDAI score.

  • Improvement of at least 50% or 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score.

4. For the treatment of patients with moderate to severe PSORIASIS who meet all of the following criteria:

Coverage is provided for an initial period of 16 weeks at a dose of 80 mg as an initial dose, followed by 40 mg every 2 weeks, starting one week after the initial dose.

  • Prescribed by a dermatologist
  • Body surface area (BSA) involvement greater than 10% and/or significant involvement of the face, hands, feet or genital region; AND
  • Intolerance or lack of response to phototherapy; OR
  • Inability to access phototherapy; AND
  • Intolerance or lack of response to methotrexate (MTX) (weekly oral or parenteral)at 20 mg or greater (15 mg or greater if patient is > 65 years of age) for more than 8 weeks; AND
  • Intolerance or lack of response to cyclosporine; OR
  • A contraindication to methotrexate or cyclosporine.

Coverage beyond 16 weeks will be based on a significant reduction in the Body Surface Area (BSA) involved and improvements in the Psoriasis Area Severity Index (PASI) score and the Dermatology Life Quality Index (DLQI):

  • A 75% reduction in Psoriasis Area Severity Index (PASI) score; OR
  • A ≥ 50% reduction in the Psoriasis Area Severity Index (PASI) score with a ≥ 5-point improvement in the Dermatology Life Quality Index (DLQI); OR
  • A significant reduction in Body Surface Area (BSA) involved, with consideration of important areas such as the face, hands, feet or genital regions.

5. For the treatment of moderately to severely active CROHN`S DISEASE

Coverage is provided for an initial period of 12 weeks at an induction dose of 160 mg, followed by 80 mg two weeks later. Maintenance therapy is provided at a dose not exceeding 40 mg every two weeks.

  • Prescribed by a gastroenterology specialist

Patient meets the following criteria:

  • Glucocorticoids equivalent to prednisone 40 mg/day for a minimum of 2 weeks OR treatment discontinued due to intolerance or contraindication;

PLUS

  • Azathioprine 2 mg/kg/day for a minimum of 12 weeks; OR
  • 6-mercaptopurine 1 mg/day for a minimum of 12 weeks; OR
  • MTX (oral or parenteral) 15 mg per week for a minimum of 12 weeks..

Coverage beyond the initial twelve-week period will be based on improvement in the CDAI or HBI scores.

  • At least a 100-point reduction in the Crohn's Disease Activity Index (CDAI) OR at least a 3-point reduction in the Harvey Bradshaw Index (HBI).

6. For the treatment of severely active polyarticular JUVENILE IDIOPATHIC ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 24 mg/m2 body surface area up to a maximum single dose of 40 mg every other week.

  • Prescribed by a rheumatologist

In patients two years of age and older who meet the following criteria:

  • ≥ 5 swollen joints; AND
  • ≥ 3 joints with limited range of motion and/or pain/tenderness; AND
  • Condition is refractory to an adequate trial of a therapeutic dose of methotrexate.

Coverage beyond the initial one-year period will be based on a 30% improvement in 3 of 6 clinical parameters

Patient has experienced 3 of 6 of the following variables:

  • >30% reduction in the number of active joints
  • >30% reduction in the number of joints with loss of range of motion
  • >30% improvement in the Physician Global Assessment scale
  • >30% improvement in the Patient or Parent Global Assessment scale
  • >30% improvement in the Child Health Assessment Questionnaire (CHAQ)
  • >30% reduction in ESR; AND
  • No more than one of these variables has worsened by greater than 30%

7. For the treatment of adult patients with moderately to severely active ULCERATIVE COLITIS who meet the following:

Coverage is provided for an initial period of 12 weeks at a dose of 160 mg at week 0, followed by 80 mg two weeks later and then 40 mg every two weeks thereafter.

  • Prescribed by expert in gastroenterology
  • Partial Mayo score > 4
  • Inadequate response to conventional therapies:

- 5-ASA 4grams/day for 6 weeks; PLUS

- Glucocorticoids equivalent to prednisone 40 mg/day for a minimum of 2 weeks OR treatment discontinued due to intolerance or contraindication.

Coverage beyond the initial 12 week period will be based on improvement in the partial Mayo score of ≥ 2 points.

8. For the treatment of adult patients with active moderate to severe HIDRADENITIS SUPPURATIVA

Coverage is provided for an initial period of 12 weeks at a dose of 160 mg at week 0, followed by 80 mg two weeks later, and then 40 mg every week beginning 4 weeks after the initial dose.

  • Prescribed by a dermatologist

For the treatment of adult patients with active moderate to severe HIDRADENITIS SUPPURATIVA who meet all of the following criteria:

  • Total inflammatory lesion (abscess and nodule) count of 3 or greater; AND
  • Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III*; AND
  • Inadequate response to a 90-day trial of oral antibiotics.

* Hurley Stage II and III defined as:

Stage II :One or more widely separated recurrent abscesses with tract formation and scars

Stage III: Multiple interconnected tracts and abscesses throughout an entire area

Coverage beyond the initial 12-week period will be based on decreases in inflammatory nodule and abscess counts:

  • At least a 50% reduction in abscesses and inflammatory nodule count from baseline; AND
  • No increase in abscess count; AND
  • No increase in draining fistula count.
Table: ADALIMUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
40MG/VIAL Solution 02258595 HUMIRA ABV

CERTOLIZUMAB PEGOL

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 400mg at weeks 0, 2, and 4, followed by 200mg every other week or 400mg every 4 weeks.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX; AND
  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond the initial three doses will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of moderate to severe PSORIATIC ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 400mg at weeks 0, 2, and 4, followed by 200mg every other week or 400mg every 4 weeks.

  • Prescribed by a rheumatologist

Client who meet at least 2 of the following criteria:

  • 5 or more swollen joints
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle
  • more than one joint with erosion on imaging study
  • dactylitis of two or more digits
  • tenosynovitis refractory to oral NSAIDs and steroid injections
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon)
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4
  • daily use of corticosteroids
  • use of opioids > 12 hours per day for pain resulting from inflammation

AND patient is refractory to:

  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks;

PLUS a minimum of any two of the following:

  • methotrexate weekly parenteral (SC or IM) at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR
  • leflunomide: 20mg daily for 10 weeks; OR
  • sulfasalazine at least 2g daily for 3 months; OR
  • cyclosporine

OR Axial disease with both of the following:

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks.

Coverage beyond one year will be based on improvement according to the Psoriatic Arthritis Response Criteria (PsARC).

  • Improvement in at least two of the four PsARC criteria, one of which has to be joint tenderness or swelling score, with no worsening in any of the four criteria. A response in joint count is determined by a reduction of ≥ 30%. A response in the Physician or Patient Global Assessment scale is determined by a reduction of 1 point.

3. For the treatment of ANKYLOSING SPONDYLITIS

Coverage is provided for an initial period of one year at a dose of 400mg at weeks 0, 2, and 4, followed by 200mg every other week or 400mg every 4 weeks.

  • Prescribed by a rheumatologist
  • BASDAI > 4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks;

AND for peripheral joint involvement, patient is refractory:

  • Methotrexate (MTX) weekly at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND
  • Sulfasalazine 2 g/day for at least 3 months.

NOTE: For axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

Coverage beyond the initial three doses will be based on improvement in the BASDAI score.

  • Improvement of at least 50% or 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score.
Table: CERTOLIZUMAB PEGOL
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Solution 02465574 CIMZIA UCB
200MG/ML Solution 02331675 CIMZIA UCB

ETANERCEPT

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 50 mg weekly.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX; AND
  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond the initial three doses will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of moderate to severe PSORIATIC ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 50 mg weekly.

  • Prescribed by a rheumatologist

Client who meet at least 2 of the following criteria:

  • 5 or more swollen joints
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle
  • more than one joint with erosion on imaging study
  • dactylitis of two or more digits
  • tenosynovitis refractory to oral NSAIDs and steroid injections
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon)
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4
  • daily use of corticosteroids
  • use of opioids > 12 hours per day for pain resulting from inflammation

AND patient is refractory to:

  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks;

PLUS a minimum of any two of the following:

  • methotrexate (oral or parenteral) at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR
  • leflunomide: 20mg daily for 10 weeks; OR
  • sulfasalazine at least 2g daily for 3 months; OR
  • cyclosporine

OR Axial disease with both of the following:

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks.

Coverage beyond one year will be based on improvement according to the Psoriatic Arthritis Response Criteria (PsARC).

  • Improvement in at least two of the four PsARC criteria, one of which has to be joint tenderness or swelling score, with no worsening in any of the four criteria. A response in joint count is determined by a reduction of ≥ 30%. A response in the Physician or Patient Global Assessment scale is determined by a reduction of 1 point.

3. For the treatment of ANKYLOSING SPONDYLITIS

Coverage is provided for an initial period of one year at a dose of 50 mg weekly.

  • Prescribed by a rheumatologist
  • BASDAI > 4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks;

AND for peripheral joint involvement, patient is refractory:

  • Methotrexate (MTX) weekly (oral or parenteral) at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND
  • Sulfasalazine 2 g/day for at least 3 months.

NOTE: For axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

Coverage beyond one year will be based on improvement in the BASDAI score.

  • Improvement of at least 50% or 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score.

4. For the treatment of severely active polyarticular JUVENILE IDIOPATHIC ARTHRITIS

Coverage is provided for children age 4 to 17, for an initial period of one year at a dose of 0.8 mg/kg/week body surface area up to a maximum single dose of 50 mg/week.

  • Prescribed by a rheumatologist

In patients four to seventeen years of age and older who meet the following criteria:

  • ≥ 5 swollen joints; AND
  • ≥ 3 joints with limited range of motion and/or pain/tenderness; AND
  • Condition is refractory to an adequate trial of a therapeutic dose of methotrexate.

Coverage beyond the initial one-year period will be based on a 30% improvement in 3 of 6 clinical parameters.

Patient has experienced 3 of 6 of the following variables:

  • >30% reduction in the number of active joints
  • >30% reduction in the number of joints with loss of range of motion
  • >30% improvement in the Physician Global Assessment scale
  • >30% improvement in the Patient or Parent Global Assessment scale
  • >30% improvement in the Child Health Assessment Questionnaire (CHAQ)
  • >30% reduction in ESR

AND

  • No more than one of these variables has worsened by greater than 30%
Table: ETANERCEPT
Drug strength and dosage form DIN Brand name Manufacturer code
25MG/VIAL Injection 02242903 ENBREL PED
50MG/ML Injection 02274728 ENBREL PED
50MG/ML Injection 99100373 ENBREL SURECLICK AMG

ETANERCEPT (BRENZYS)

Limited use benefit (prior approval required).

Coverage for BRENZYS will be approved indefinitely.

1. For the treatment of severely active RHEUMATOID ARTHRITIS

  • Prescribed by a rheumatologist.

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX; AND
  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

2. For the treatment of ANKYLOSING SPONDYLITIS

  • Prescribed by a rheumatologist
  • BASDAI > 4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks;

AND for peripheral joint involvement, patient is refractory:

  • Methotrexate (MTX) weekly (oral or parenteral) at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND
  • Sulfasalazine 2 g/day for at least 3 months.

NOTE: For axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

Table: ETANERCEPT (BRENZYS)
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Solution 02455323 BRENZYS UNK
50MG Solution 02455331 BRENZYS UNK

ETANERCEPT (ERELZI)

Limited use benefit (prior approval required).

Coverage for ERELZI will be approved indefinitely.

1. For the treatment of severely active RHEUMATOID ARTHRITIS

  • Prescribed by a rheumatologist.

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX; AND
  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

2. For the treatment of moderate to severe PSORIATIC ARTHRITIS

  • Prescribed by a rheumatologist

Client who meet at least 2 of the following criteria:

  • 5 or more swollen joints
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle
  • more than one joint with erosion on imaging study
  • dactylitis of two or more digits
  • tenosynovitis refractory to oral NSAIDs and steroid injections
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon)
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4
  • daily use of corticosteroids
  • use of opioids > 12 hours per day for pain resulting from inflammation

AND patient is refractory to:

  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks;

PLUS a minimum of any two of the following:

  • methotrexate (oral or parenteral) at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR
  • leflunomide: 20mg daily for 10 weeks; OR
  • sulfasalazine at least 2g daily for 3 months; OR
  • cyclosporine

OR Axial disease with both of the following:

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks.

Coverage beyond one year will be based on improvement according to the Psoriatic Arthritis Response Criteria (PsARC).

  • Improvement in at least two of the four PsARC criteria, one of which has to be joint tenderness or swelling score, with no worsening in any of the four criteria. A response in joint count is determined by a reduction of ≥ 30%. A response in the Physician or Patient Global Assessment scale is determined by a reduction of 1 point.

3. For the treatment of ANKYLOSING SPONDYLITIS

  • Prescribed by a rheumatologist
  • BASDAI > 4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks;

AND for peripheral joint involvement, patient is refractory:

  • Methotrexate (MTX) weekly (oral or parenteral) at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND
  • Sulfasalazine 2 g/day for at least 3 months.

NOTE: For axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

4. For the treatment of severely active polyarticular JUVENILE IDIOPATHIC ARTHRITIS

  • Prescribed by a rheumatologist

In children 4 years or older who meet the following criteria:

  • ≥ 5 swollen joints; AND
  • ≥ 3 joints with limited range of motion and/or pain/tenderness; AND
  • Condition is refractory to an adequate trial of a therapeutic dose of methotrexate.
Table: ETANERCEPT (ERELZI)
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Solution 02462877 ERELZI SDZ
50MG Solution 02462850 ERELZI SDZ
50MG Solution 02462869 ERELZI SDZ

GOLIMUMAB

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 50 mg every month.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX;

AND

  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond one year will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of moderate to severe PSORIATIC ARTHRITIS

Coverage is provided for an initial period of one year at a dose of 50 mg every month.

  • Prescribed by a rheumatologist

Client who meet at least 2 of the following criteria:

  • 5 or more swollen joints
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle
  • more than one joint with erosion on imaging study
  • dactylitis of two or more digits
  • tenosynovitis refractory to oral NSAIDs and steroid injections
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon)
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4
  • daily use of corticosteroids
  • use of opioids > 12 hours per day for pain resulting from inflammation

AND patient is refractory to:

  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks;

PLUS a minimum of any two of the following:

  • methotrexate weekly parenteral at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR
  • leflunomide: 20mg daily for 10 weeks; OR
  • sulfasalazine at least 2g daily for 3 months; OR
  • cyclosporine

OR Axial disease with both of the following:

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks.

Coverage beyond one year will be based on improvement according to the Psoriatic Arthritis Response Criteria (PsARC).

  • Improvement in at least two of the four PsARC criteria, one of which has to be joint tenderness or swelling score, with no worsening in any of the four criteria. A response in joint count is determined by a reduction of ≥ 30%. A response in the Physician or Patient Global Assessment scale is determined by a reduction of 1 point.

3. For the treatment of ANKYLOSING SPONDYLITIS

Coverage is provided for an initial period of one year at a dose of 50 mg every month.

  • Prescribed by a rheumatologist
  • BASDAI > 4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks;

AND for peripheral joint involvement, patient is refractory:

  • Methotrexate (MTX) (oral or parenteral) weekly at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND
  • Sulfasalazine 2 g/day for at least 3 months.

NOTE: For axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

Coverage beyond one year will be based on improvement in the BASDAI score.

  • Improvement of at least 50% or 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score.

4. For the treatment of adult patients with moderately to severely active ULCERATIVE COLITIS who meet the following:

Coverage is provided for an initial period of three months at a dose of 200 mg at week 0, followed by 100 mg at week 2 and then 50 mg every four weeks thereafter.

  • Prescribed by expert in gastroenterology
  • Partial Mayo score > 4
  • Inadequate response to conventional therapies:

- 5-ASA 4grams/day for 6 weeks; PLUS

- Glucocorticoids equivalent to prednisone 40 mg/day for a minimum of 2 weeks OR treatment discontinued due to intolerance or contraindication.

The treating physician may utilize 100 mg every four weeks as a maintenance dose if necessary.

Coverage beyond one year will be based on a decrease in the partial Mayo score of ≥ 2 points and patients should be off corticosteroids.

Table: GOLIMUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
50MG/0.5ML Solution 02324776 SIMPONI JSO
50MG/0.5ML Solution 02324784 SIMPONI JSO
100MG/ML Solution 02413175 SIMPONI JSO
100MG/ML Solution 02413183 SIMPONI JSO

INFLIXIMAB (INFLECTRA)

Limited use benefit (prior approval required).

Coverage for INFLECTRA will be approved indefinitely.

1. For the treatment of severely active RHEUMATOID ARTHRITIS

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX;

AND

  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

2. For the treatment of moderate to severe PSORIATIC ARTHRITIS

  • Prescribed by a rheumatologist

Client who meet at least 2 of the following criteria:

  • 5 or more swollen joints
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle
  • more than one joint with erosion on imaging study
  • dactylitis of two or more digits
  • tenosynovitis refractory to oral NSAIDs and steroid injections
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon)
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4
  • daily use of corticosteroids
  • use of opioids > 12 hours per day for pain resulting from inflammation

AND patient is refractory to:

  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks;

PLUS a minimum of any two of the following:

  • methotrexate weekly parenteral (SC or IM) at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR
  • leflunomide: 20mg daily for 10 weeks; OR
  • sulfasalazine at least 2g daily for 3 months; OR
  • cyclosporine

OR Axial disease with both of the following:

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks.

3. For the treatment of ANKYLOSING SPONDYLITIS

  • Prescribed by a rheumatologist
  • BASDAI > 4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks;

AND for peripheral joint involvement, patient is refractory:

  • Methotrexate (MTX) weekly at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND
  • Sulfasalazine 2 g/day for at least 3 months.

NOTE: For axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

4. For the treatment of patients with moderate to severe PSORIASIS who meet all of the following criteria:

  • Prescribed by a dermatologist
  • Body surface area (BSA) involvement greater than 10% and/or significant involvement of the face, hands, feet or genital region;

AND

  • Intolerance or lack of response to phototherapy; OR
  • Inability to access phototherapy;

AND

  • Intolerance or lack of response to methotrexate (MTX) weekly oral or parenteral (SC or IM) at 20 mg or greater (15 mg or greater if patient is > 65 years of age) for more than 8 weeks;

AND

  • Intolerance or lack of response to cyclosporine; OR
  • A contraindication to methotrexate or cyclosporine.

5. For the treatment of moderately to severely active CROHN`S DISEASE

  • Prescribed by a gastroenterology specialist

Patient meets the following criteria:

  • Glucocorticoids equivalent to prednisone 40 mg/day for a minimum of 2 weeks OR treatment discontinued due to intolerance or contraindication;

PLUS

  • Azathioprine 2 mg/kg/day for a minimum of 12 weeks; OR
  • 6-mercaptopurine 1 mg/day for a minimum of 12 weeks; OR
  • MTX (oral or parenteral) 15 mg per week for a minimum of 12 weeks.

6. For the treatment of FISTULIZING CROHN?S DISEASE

  • Prescribed by a gastroenterology specialist

Patient meets all the following criteria:

  • Patients with actively draining perianal or enterocutaneous fistulae that are refractory to a course of appropriate antibiotic therapy (e.g. ciprofloxacin with or without metronidazole for a minimum of 3 weeks);

PLUS

Patient has failed a trial of one (1) immunosuppressive agent:

  • Azathioprine 2 to 2.5 mg/kg/day for a minimum of 3 months or treatment discontinued at < 3 months due to severe adverse: reactions.

OR

  • 6-mercaptopurine 50-70 mg/day for a minimum of 3 months or treatment discontinued at <3 months due to severe adverse reactions.

7. For the treatment of adult patients with moderately to severely active ULCERATIVE COLITIS who meet the following:

  • Prescribed by expert in gastroenterology
  • Partial Mayo score > 4
  • Inadequate response to conventional therapies:

- 5-ASA 4grams/day for 6 weeks; PLUS

- Glucocorticoids equivalent to prednisone 40 mg/day for a minimum of 2 weeks OR treatment discontinued due to intolerance or contraindication.

Table: INFLIXIMAB (INFLECTRA)
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Powder For Solution 02419475 INFLECTRA HOS
100MG Powder For Solution 02470373 RENFLEXIS UNK

INFLIXIMAB (REMICADE)

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for an initial three doses of 3 mg/kg, administered at 0, 2 and 6 weeks.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX; AND
  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond the initial three doses will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of moderately to severely active CROHN`S DISEASE

Coverage is provided for an initial three doses of 5 mg/kg, administered at 0, 2 and 6 weeks.

  • Prescribed by a gastroenterology specialist

Patient meets the following criteria:

  • Glucocorticoids equivalent to prednisone 40 mg/day for a minimum of 2 weeks OR treatment discontinued due to intolerance or contraindication;

PLUS

  • Azathioprine 2 mg/kg/day for a minimum of 12 weeks; OR
  • 6-mercaptopurine 1 mg/day for a minimum of 12 weeks; OR
  • MTX (oral or parenteral) 15 mg per week for a minimum of 12 weeks.

Coverage beyond the initial three doses will be based on improvement in the CDAI or HBI scores.

  • At least a 100-point reduction in the Crohn's Disease Activity Index (CDAI) OR at least a 3-point reduction in the Harvey Bradshaw Index (HBI).

3. For the treatment of FISTULIZING CROHN?S DISEASE

Coverage is provided for an initial three doses of 5 mg/kg, administered at 0, 2 and 6 weeks.

  • Prescribed by a gastroenterology specialist

Patient meets all the following criteria:

  • Patients with actively draining perianal or enterocutaneous fistulae that are refractory to a course of appropriate antibiotic therapy (e.g. ciprofloxacin with or without metronidazole for a minimum of 3 weeks);

PLUS

Patient has failed a trial of one (1) immunosuppressive agent:

  • Azathioprine 2 to 2.5 mg/kg/day for a minimum of 3 months or treatment discontinued at < 3 months due to severe adverse: reactions. OR
  • 6-mercaptopurine 50-70 mg/day for a minimum of 3 months or treatment discontinued at <3 months due to severe adverse reactions.

Coverage beyond the initial three doses will be based on improvement or closure of actively draining fistulae

  • Closure of individual fistulae as evidenced by no, or minimal, fistulae drainage and bleeding.
Table: INFLIXIMAB (REMICADE)
Drug strength and dosage form DIN Brand name Manufacturer code
100MG/VIAL Powder For Solution 02244016 REMICADE JSO

SARILUMAB

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for an initial period of one year at a MAXIMUM dose of 200 mg s/c once every two weeks. A reduced dose of 150 mg once every two weeks is recommended for patients with neutropenia, thrombocytopenia or with elevated liver enzymes. See product monograph for further prescribing information.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX;

AND

  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond one year will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.
Table: SARILUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Solution 02460521 KEVZARA SAC
150MG Solution 02472961 KEVZARA SAC
200MG Solution 02460548 KEVZARA SAC
200MG Solution 02472988 KEVZARA SAC

TOCILIZUMAB (IV)

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for 16 weeks at an initial dose of 4 mg/kg/dose every 4 weeks.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX;

AND

  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond 16 weeks, at a dose of up to 8 mg/kg/dose (maximum dose of 800 mg per infusion) every 4 weeks, is based on a 20% improvement from baseline in swollen and tender joint counts, plus a 20% improvement in 2 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of active SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

Initial 16-week coverage is provided at a dose of 12 mg/kg once every two weeks for children weighing < 30 kg and 8 mg/kg for children weighing ≥ 30 kg.

  • Prescribed by a rheumatologist

In patients two to seventeen years of age and older who meet the following criteria:

  • Have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids (with or without methotrexate), due to intolerance or lack of efficacy.

Coverage beyond 16 weeks is based on a >30% improvement in 3 of 6 baseline clinical parameters

Patient has experienced 3 of 6 of the following variables:

  • >30% reduction in the number of active joints
  • >30% reduction in the number of joints with loss of range of motion
  • >30% improvement in the Physician Global Assessment scale
  • >30% improvement in the Patient or Parent Global Assessment scale
  • >30% improvement in the Child Health Assessment Questionnaire (CHAQ)
  • >30% reduction in ESR

AND

  • No more than one of these variables has worsened by greater than 30%

3. For the treatment of severely active polyarticular JUVENILE IDIOPATHIC ARTHRITIS

Initial 16-week coverage is provided at a dose of 10 mg/kg once every four weeks for children weighing < 30 kg and 8 mg/kg for children weighing ≥ 30 kg.

  • Prescribed by a rheumatologist

In patients two years of age and older who meet the following criteria:

  • ≥ 5 swollen joints; AND
  • ≥ 3 joints with limited range of motion and/or pain/tenderness; AND
  • Condition is refractory to an adequate trial of a therapeutic dose of methotrexate.

Coverage beyond 16 weeks is based on a >30% improvement in 3 of 6 baseline clinical parameters

Patient has experienced 3 of 6 of the following variables:

  • >30% reduction in the number of active joints
  • >30% reduction in the number of joints with loss of range of motion
  • >30% improvement in the Physician Global Assessment scale
  • >30% improvement in the Patient or Parent Global Assessment scale
  • >30% improvement in the Child Health Assessment Questionnaire (CHAQ)
  • >30% reduction in ESR; AND
  • No more than one of these variables has worsened by greater than 30%
Table: TOCILIZUMAB (IV)
Drug strength and dosage form DIN Brand name Manufacturer code
80MG/4ML Solution 02350092 ACTEMRA HLR
200MG/10ML Solution 02350106 ACTEMRA HLR
400MG/20ML Solution 02350114 ACTEMRA HLR

TOCILIZUMAB (SC)

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage is provided for an initial period of one year. Initial approvals for patients < 100 kg will be for a dose of 162 mg every other week up to a maximum dose of 162 mg every week (Maximum 51 doses). For patients weighing 100 kg or more, coverage is provided at a dose of 162 mg weekly (Maximum 52 doses).

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX;

AND

  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond the initial three doses will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of GIANT CELL ARTERITIS in adults

Coverage is limited to 52 weeks per treatment course at a dose of 162 mg s/c weekly. Treatment can be repeated if relapse occurs.

  • Patient has been diagnosed with new-onset or relapsing active giant cell arteritis; AND
  • Patient is receiving moderate- to high-dose oral corticosteroids (equivalent to prednisone 20 mg to 60 mg daily).
Table: TOCILIZUMAB (SC)
Drug strength and dosage form DIN Brand name Manufacturer code
162MG Solution 02424770 ACTEMRA HLR

TOFACITINIB CITRATE

Limited use benefit (prior approval required).

1. For the treatment of severely active RHEUMATOID ARTHRITIS

Coverage of tofacitinib in adult patients ≥ 18 years is provided at a MAXIMUM dose of 10mg daily for an initial period of one year.

  • Prescribed by a rheumatologist

Coverage is provided, in combination with methotrexate (MTX) or other disease modifying anti-rheumatic drugs (DMARDs), for the reduction in signs and symptoms of severely active RA in adult patients ≥ 18 years who have failed:

  • MTX (oral or parenteral) at a dose ≥ 20 mg weekly (≥ 15 mg weekly if patient is ≥ 65 years) for a minimum of 12 weeks of continuous treatment. Note: Patients who do not exhibit a clinical response to oral MTX or who experience gastrointestinal intolerance may consider a trial of parenteral MTX;

AND

  • MTX in combination with at least two other DMARDS, such as sulfasalazine and hydroxychloroquine, for a minimum of 12 weeks of continuous treatment;

OR, if the patient has a contraindication, failure, or intolerance to MTX:

  • A combination of at least two DMARDS, such as sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, or cyclosporine, for a minimum of 12 weeks of continuous treatment.

Coverage beyond the initial three doses will be based on a 20% improvement in 3 of 5 baseline clinical parameters.

  • >20% reduction in number of tender and swollen joints; PLUS
  • >20% improvement in Physician Global Assessment scale; PLUS either
  • >20% improvement in Patient Global Assessment scale; OR
  • >20% reduction in the acute phase as measured by ESR or CRP.
Table: TOFACITINIB CITRATE
Drug strength and dosage form DIN Brand name Manufacturer code
5MG Tablet 02423898 XELJANZ PFI
11MG Tablet (Extended Release) 02470608 XELJANZ XR PFI

92:44.00 IMMUNOSUPPRESSIVE AGENTS

ALEMTUZUMAB

Limited use benefit (prior approval required).

Coverage is provided for two years (i.e. two treatment courses/eight doses) for adult patients who meet ALL of the following criteria:

  • For the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence; AND
  • Prescribed by a specialist with experience in the treatment of multiple sclerosis; AND
  • Active disease defined by clinical and imaging features (i.e. significant increase in T2 lesion load compared with that from a previous MRI scan OR at least one gadolinium-enhancing lesion); AND
  • Failure to respond to full and adequate courses of at least ONE initial trial of at least 6 months of interferon, glatiramer, dimethyl fumarate or teriflunomide therapy OR documented intolerance to at least 2 therapies; AND
  • At least one relapse while on at least six months of a disease modifying therapy (an interferon, glatiramer, dimethyl fumarate or teriflunomide) within the last 10 years; AND
  • At least two attacks (first episode or relapse) in the previous two years, with at least one attack in the previous year; AND
  • An Expanded Disability Status Scale (EDSS) score of five (5) or less.
Table: ALEMTUZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
12MG Solution 02418320 LEMTRADA GEE

CYCLOSPORINE

Limited use benefit (prior approval required).

For transplant therapy.

Table: CYCLOSPORINE
Drug strength and dosage form DIN Brand name Manufacturer code
ST10MG Capsule 02237671 NEORAL NVR
ST25MG Capsule 02150689 NEORAL NVR
ST25MG Capsule 02247073 SANDOZ CYCLOSPORINE SDZ
ST50MG Capsule 02150662 NEORAL NVR
ST50MG Capsule 02247074 SANDOZ CYCLOSPORINE SDZ
ST100MG Capsule 02150670 NEORAL NVR
ST100MG Capsule 02242821 SANDOZ CYCLOSPORINE SDZ
ST100MG/ML Solution 02244324 APO-CYCLOSPORINE APX
ST100MG/ML Solution 02150697 NEORAL NVR

MEPOLIZUMAB

Limited use benefit (prior approval required).

For initial 12-month coverage:

For the adjunctive treatment of severe eosinophilic asthma in adults who are inadequately controlled with high-dose inhaled corticosteroids plus one or more additional asthma controller(s) (e.g. long-acting beta-agonist);

AND

  • Have had a blood eosinophil count of ≥0.15x109/L before initiation of Nucala (levels must have been drawn within 3 months of the start of treatment); OR
  • Have had a blood eosinophil count of ≥0.3x109/L within the 12-month period prior to starting Nucala

AND

  • Show reversibility on spirometry (a rise in FEV1of at least 12% AND at least 200 mL);

AND

  • Have experienced two or more clinically significant asthma exacerbations* in the past 12 months period prior to starting Nucala;or
  • Have received maintenance therapy with daily oral corticosteroids for at least 3 months prior to starting Nucala.

For 12-month renewal coverage:

For the adjunctive treatment of severe eosinophilic asthma in adult patients who have experienced a decrease in clinically significant exacerbations with mepolizumab treatment as demonstrated by:

  • Patient has experienced a decrease in clinically significant asthma exacerbations* with Nucala treatment; OR
  • Patient`s oral corticosteroid maintenance dose decreased by at least 25 % from the pre-treatment dose.

Coverage for Nucala is provided for a maximum dose of 100 mg every four weeks.

* A clinically significant asthma exacerbation is defined as worsening of asthma such that the treating physician elected to administer systemic glucocorticoids for at least three days or the patient visited an emergency department or was hospitalized.

Table: MEPOLIZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Powder For Solution 02449781 NUCALA GSK

MYCOPHENOLATE MOFETIL

Limited use benefit (prior approval required).

For transplant therapy.

Table: MYCOPHENOLATE MOFETIL
Drug strength and dosage form DIN Brand name Manufacturer code
ST250MG Capsule 02383780 ACH-MYCOPHENOLATE ACC
ST250MG Capsule 02352559 APO-MYCOPHENOLATE APX
ST250MG Capsule 02192748 CELLCEPT HLR
ST250MG Capsule 02386399 JAMP-MYCOPHENOLATE JMP
ST250MG Capsule 02457369 MYCOPHENOLATE MOFETIL SAN
ST250MG Capsule 02371154 MYLAN-MYCOPHENOLATE MYL
ST250MG Capsule 02320630 SANDOZ MYCOPHENOLATE SDZ
ST250MG Capsule 02364883 TEVA-MYCOPHENOLATE TEV
ST200MG Powder For Suspension 02242145 CELLCEPT HLR
ST500MG Tablet 02352567 APO-MYCOPHENOLATE APX
ST500MG Tablet 02237484 CELLCEPT HLR
ST500MG Tablet 02380382 JAMP-MYCOPHENOLATE JMP
ST500MG Tablet 02378574 MYCOPHENOLATE ACC
ST500MG Tablet 02457377 MYCOPHENOLATE MOFETIL SAN
ST500MG Tablet 02370549 MYLAN-MYCOPHENOLATE MYL
ST500MG Tablet 02313855 SANDOZ MYCOPHENOLATE SDZ
ST500MG Tablet 02348675 TEVA-MYCOPHENOLATE TEV

MYCOPHENOLATE SODIUM

Limited use benefit (prior approval required).

For transplant therapy.

Table: MYCOPHENOLATE SODIUM
Drug strength and dosage form DIN Brand name Manufacturer code
ST180MG Tablet (Enteric Coated) 02372738 APO-MYCOPHENOLIC ACID APX
ST180MG Tablet (Enteric Coated) 02264560 MYFORTIC NVR
ST360MG Tablet (Enteric Coated) 02372746 APO-MYCOPHENOLIC ACID APX
ST360MG Tablet (Enteric Coated) 02264579 MYFORTIC NVR

SIROLIMUS

Limited use benefit (prior approval required).

Coverage will be provided as a second line therapy for patients failing mycophenolate mofetil.

Table: SIROLIMUS
Drug strength and dosage form DIN Brand name Manufacturer code
ST1MG/ML Solution 02243237 RAPAMUNE PFI
ST1MG Tablet 02247111 RAPAMUNE PFI

TACROLIMUS MONOHYDRATE

Limited use benefit (prior approval required).

For transplant therapy.

Table: TACROLIMUS MONOHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST0.5MG Capsule 02243144 PROGRAF AST
ST0.5MG Capsule 02416816 SANDOZ TACROLIMUS SDZ
ST1MG Capsule 02175991 PROGRAF AST
ST1MG Capsule 02416824 SANDOZ TACROLIMUS SDZ
ST5MG Capsule 02175983 PROGRAF AST
ST0.5MG Capsule (Extended Release) 02296462 ADVAGRAF AST
ST1MG Capsule (Extended Release) 02296470 ADVAGRAF AST
ST3MG Capsule (Extended Release) 02331667 ADVAGRAF AST
ST5MG Capsule (Extended Release) 02296489 ADVAGRAF AST
ST5MG Capsule (Immediate Release) 02416832 SANDOZ TACROLIMUS SDZ
5MG/ML Solution 02176009 PROGRAF AST

VEDOLIZUMAB

Limited use benefit (prior approval required).

1. For the treatment of moderately to severely active CROHN`S DISEASE

Coverage is provided for an initial period of 14 weeks at a dose of 300 mg weeks zero, two and six and then every eight weeks. Maintenance therapy is provided at a dose not exceeding 300 mg every eight weeks.

  • Prescribed by a gastroenterology specialist

Patient meets the following criteria:

  • Glucocorticoids equivalent to prednisone 40 mg/day for a minimum of 2 weeks OR treatment discontinued due to intolerance or contraindication;

PLUS

  • Azathioprine 2 mg/kg/day for a minimum of 12 weeks; OR
  • 6-mercaptopurine 1 mg/day for a minimum of 12 weeks; OR
  • MTX (oral or parenteral) 15 mg per week for a minimum of 12 weeks.

Coverage beyond the initial 14 week period will be based on improvement in the CDAI or HBI scores.

  • At least a 100-point reduction in the Crohn's Disease Activity Index (CDAI) OR at least a 3-point reduction in the Harvey Bradshaw Index (HBI).

2. For the treatment of adult patients with moderately to severely active ULCERATIVE COLITIS who meet the following:

Coverage is provided for an initial period of 14 weeks at a dose of 300 mg at weeks zero, two and six and then every eight weeks. Maintenance therapy is provided at a dose not exceeding 300 mg every eight weeks.

  • Prescribed by expert in gastroenterology
  • Partial Mayo score > 4; AND
  • Inadequate response to conventional therapies:

- 5-ASA 4grams/day for 6 weeks; PLUS

- Glucocorticoids equivalent to prednisone 40 mg/day for a minimum of 2 weeks OR treatment discontinued due to intolerance or contraindication.

Coverage beyond the initial 14 week period will be based on improvement in the partial Mayo score of ≥ 2 points.

Table: VEDOLIZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
300MG Powder For Solution 02436841 ENTYVIO TAK

92:92.00 OTHER MISCELLANEOUS THERAPEUTIC AGENTS

ABOBOTULINUMTOXINA

Limited use benefit (prior approval required).

Treatment of cervical dystonia (spasmodic torticollis) in adults; OR

Symptomatic treatment of focal spasticity affecting upper limbs in adults; OR

Lower limb spasticity in patients 2 years of age and older.

Table: ABOBOTULINUMTOXINA
Drug strength and dosage form DIN Brand name Manufacturer code
300U Powder For Solution 02460203 DYSPORT THERAPEUTIC IPS
500U Powder For Solution 02456117 DYSPORT THERAPEUTIC IPS

INCOBOTULINUMTOXINA

Limited use benefit (prior approval required).

For the treatment of:

  • strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorder in patients 12 years of age or older; OR
  • cervical dystonia (spasmodic torticollis).
Table: INCOBOTULINUMTOXINA
Drug strength and dosage form DIN Brand name Manufacturer code
50UNIT/VIAL Powder For Solution 02371081 XEOMIN MEZ
100U/VIAL Powder For Solution 02324032 XEOMIN MEZ

ONABOTULINUMTOXINA

Limited use benefit (prior approval required).

For the treatment of:

  • strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorder in patients 12 years of age or older; OR
  • cervical dystonia (spasmodic torticollis); OR
  • urinary incontinence due to neurogenic detrusor over activity resulting from neurogenic bladder associated with MS or subcervical spinal cord injury; OR
  • overactive bladder.
Table: ONABOTULINUMTOXINA
Drug strength and dosage form DIN Brand name Manufacturer code
50IU Injection 09857386 BOTOX ALL
200IU Injection 09857387 BOTOX ALL
100IU Powder For Solution 01981501 BOTOX ALL

94:00 DEVICES

94:00.00 DEVICES

SPACER DEVICE

Limited use benefit with quantity and frequency limits (prior approval is not required).

Coverage is granted for 2 spacer devices every 12 months.

Table: SPACER DEVICE
Drug strength and dosage form DIN Brand name Manufacturer code
Device 96899962 AEROCHAMBER AC BOYZ TRU
Device 96899963 AEROCHAMBER AC GIRLZ TRU
Device 96899969 AEROCHAMBER PLUS FLOWVU LARGE TRU
Device 96899970 AEROCHAMBER PLUS FLOWVU MEDIUM TRU
Device 96899968 AEROCHAMBER PLUS FLOWVU MOUTH TRU
Device 96899971 AEROCHAMBER PLUS FLOWVU SMALL TRU
Device 96899977 AEROTRACH PLUS UNK
Device 96899956 COMPACT SPACE PLUS LARGE MASK MIN
Device 96899955 COMPACT SPACE PLUS MEDIUM MASK MIN
Device 96899953 COMPACT SPACE PLUS NO MASK MIN
Device 96899954 COMPACT SPACE PLUS SMALL MASK MIN
Device 99400507 E-Z SPACER WEP
Device 99400511 E-Z SPACER (MASK ONLY) WEP
Device 99400508 E-Z SPACER WITH SMALL MASK WEP
Device 00901012 INSPIRA CHAMBER W LARGE MASK LUP
Device 00900003 INSPIRA CHAMBER W MEDIUM MASK LUP
Device 00900001 INSPIRA CHAMBER W MOUTHPIECE LUP
Device 00900002 INSPIRA CHAMBER W SMALL MASK LUP
Device 99400501 OPTICHAMBER AUC
Device 96899961 OPTICHAMBER DIAMOND (CHAMBER) AUC
Device 96899958 OPTICHAMBER DIAMOND LARGE MASK AUC
Device 96899959 OPTICHAMBER DIAMOND MEDIUM MASK AUC
Device 96899960 OPTICHAMBER DIAMOND SMALL MASK AUC
Device 99400504 OPTICHAMBER LARGE MASK AUC
Device 99400503 OPTICHAMBER MEDIUM MASK AUC
Device 99400502 OPTICHAMBER SMALL MASK AUC
Device 99400505 OPTIHALER AUC
Device 99400787 POCKET CHAMBER MCA
Device 99400791 POCKET CHAMBER WITH ADULT MASK MCA
Device 99400788 POCKET CHAMBER WITH INFANT MASK MCA
Device 99400790 POCKET CHAMBER WITH MEDIUM MASK MCA
Device 99400789 POCKET CHAMBER WITH SMALL MASK MCA
Device 96899974 RESPICHAMBER SILICONE MEDIUM MASK TRU
Device 96899973 RESPICHAMBER SILICONE SMALL MASK TRU
Device 96899972 RESPICHAMBER VHC W MOUTHPIECE TRU

94:01.00 DEVICES (DIABETIC)

INSULIN PUMP SUPPLIES

Limited use benefit (prior approval required).

  • Insulin pump supplies are approved for NIHB clients following the approval of an insulin pump by NIHB; OR
  • Insulin pump supplies are approved for NIHB clients with Type 1 diabetes if an insulin pump was partially or totally covered by another insurance.
Table: INSULIN PUMP SUPPLIES
Drug strength and dosage form DIN Brand name Manufacturer code
COMFORT ANGLED Device 97799682 COMFORT ANGLED INFSET 17MM UNK
COMFORT ANGLED Device 97799683 COMFORT ANGLED INFSET 17MM UNK
COMFORT SHORT ANGLED Device 97799678 COMFORT SRT ANGLED INFSET 13 UNK
COMFORT SHORT ANGLED Device 97799679 COMFORT SRT ANGLED INFSET 13 UNK
CONTACT DETACH Device 97799672 CONTACT DETACH 90 DEGREE 6MMX60CM UNK
CONTACT DETACH Device 97799610 CONTACT DETACH 90 DEGREE 8MMX60CM UNK
Device 97799674 CARTRIDGE FOR IR200 UNK
Device 97799342 INSET 30 INFUSION SETS UNK
Device 99401038 INSULIN PUMP BATTERY AUC
Device 09991458 IV3000 SMW
INSET II Device 97799685 INSET II 90 DEGREE 6MMX110CM UNK
INSET II Device 97799687 INSET II 90 DEGREE 6MMX60CM UNK
INSET II Device 97799684 INSET II 90 DEGREE 9MMX110CM UNK
INSET II Device 97799686 INSET II 90 DEGREE 9MMX60CM UNK
MIO Device 97799491 MIO BLUE 6MMX18 MDT
MIO Device 97799438 MIO BLUE 6MMX23 MDT
MIO Device 97799490 MIO CLEAR 6MMX32 MDT
MIO Device 97799489 MIO CLEAR 9MMX32 MDT
MIO Device 97799492 MIO PINK 6MMX18 MDT
MIO Device 97799437 MIO PINK 6MMX23 MDT
OMNIPOD Device 09991327 PODS UNK
PARADIGM SILHOUETTE Device 97799715 PARADIGM SILHOUETTE 13MMX 43 MDT
PARADIGM SILHOUETTE Device 97799485 PARADIGM SILHOUETTE 13MMX18" MDT
PARADIGM SILHOUETTE Device 97799716 PARADIGM SILHOUETTE 13MMX23 MDT
PARADIGM SILHOUETTE Device 97799484 PARADIGM SILHOUETTE 13MMX32" MDT
PARADIGM SILHOUETTE Device 97799718 PARADIGM SILHOUETTE 17MMX23 MDT
PARADIGM SILHOUETTE Device 97799483 PARADIGM SILHOUETTE 17MMX32" MDT
PARADIGM SILHOUETTE Device 97799719 PARADIGM SILHOUETTE 17MMX43 MDT
PARADIGM SILHOUETTE Device 97799529 PARADIGM SILHOUETTE CANNULA 13MM MDT
PARADIGM SILHOUETTE Device 97799528 PARADIGM SILHOUETTE CANNULA 17MM MDT
QUICK-SET Device 97799486 QUICK-SET 6MMX18 MDT
QUICK-SET Device 97799744 QUICK-SET 6MMX23 TUBING MDT
QUICK-SET Device 97799487 QUICK-SET 6MMX32 MDT
QUICK-SET Device 97799743 QUICK-SET 6MMX43 TUBING MDT
QUICK-SET Device 97799742 QUICK-SET 9MMX23 TUBING MDT
QUICK-SET Device 97799488 QUICK-SET 9MMX32 MDT
QUICK-SET Device 97799741 QUICK-SET 9MMX43 TUBING MDT
RAPID-D Device 97799650 RAPID-D 10MM/110CM ROD
RAPID-D Device 97799652 RAPID-D 10MM/60CM ROD
RAPID-D Device 97799651 RAPID-D 10MM/80CM ROD
RAPID-D Device 97799656 RAPID-D 6MM/110CM ROD
RAPID-D Device 97799658 RAPID-D 6MM/60CM ROD
RAPID-D Device 97799657 RAPID-D 6MM/80CM ROD
RAPID-D Device 97799653 RAPID-D 8MM/110CM ROD
RAPID-D Device 97799655 RAPID-D 8MM/60CM ROD
RAPID-D Device 97799654 RAPID-D 8MM/80CM ROD
SURE-T Device 97799521 PARADIGM SURE-T 29G 6MMX18 MDT
SURE-T Device 97799520 PARADIGM SURE-T 29G 6MMX23 MDT
SURE-T Device 97799519 PARADIGM SURE-T 29G 8MMX23 MDT
TENDER "MINI" Device 97799647 TENDER-1 MINI INF SET 13MM/110CM ROD
TENDER "MINI" Device 97799649 TENDER-1 MINI INFSET 13MM/60CM ROD
TENDER "MINI" Device 97799648 TENDER-1 MINI INFSET 13MM/80CM ROD
TENDER "MINI" Device 97799641 TENDER-2 MINI INF SET 13MM/110CM ROD
TENDER "MINI" Device 97799643 TENDER-2 MINI INFSET 13MM/60CM ROD
TENDER "MINI" Device 97799642 TENDER-2 MINI INFSET 13MM/80CM ROD
TENDER Device 97799644 TENDER-1 17MM/110CM ROD
TENDER Device 97799646 TENDER-1 17MM/60CM ROD
TENDER Device 97799645 TENDER-1 17MM/80CM ROD
TENDER Device 97799638 TENDER-2 17MM/110CM ROD
TENDER Device 97799640 TENDER-2 17MM/60CM ROD
TENDER Device 97799639 TENDER-2 17MM/80CM ROD
ULTRAFLEX Device 97799665 ULTRAFLEX 1 10MM/110CM ROD
ULTRAFLEX Device 97799667 ULTRAFLEX 1 10MM/60CM ROD
ULTRAFLEX Device 97799666 ULTRAFLEX 1 10MM/80CM ROD
ULTRAFLEX Device 97799668 ULTRAFLEX 1 8MM/110CM ROD
ULTRAFLEX Device 97799670 ULTRAFLEX 1 8MM/60CM ROD
ULTRAFLEX Device 97799669 ULTRAFLEX 1 8MM/80CM ROD
643MMX" Device 09991616 INSET 6MMX43" UNK
Dress 09991615 IV3000 STANDARD SMW
3ML Needle 00951417 T : SLIM X2 CARTRIDGE (SK) UNK
Patch 09991614 MMT-174 ADHESIVE UNK
Syringe 97799707 RESERVOIR PARADIGM 5X1.8ML MDT
Syringe 97799706 RESERVOIR PARADIGM 7X3.0ML MDT

LANCET

Limited use benefit (prior approval not required).

The number of lancets that will be covered by the NIHB Program will depend on the client's medical treatment:

  • Clients managing diabetes with insulin will be allowed 800 lancets per 100 days.
  • Clients managing diabetes with high risk of causing hypoglycemia will be allowed 400 lancets per 365 days.
  • Clients managing diabetes medication with low risk of causing hypoglycemia will be allowed 200 lancets per 365 days.
  • Clients managing diabetes through diet/lifestyle therapy only (no insulin or anti-diabetes medications) will be allowed 200 lancets per 365 days.

Please note that the test strip limit is 800/100 days. Due to lancet pack sizes, 800 per 100 days will be reimbursed.

Table: LANCET
Drug strength and dosage form DIN Brand name Manufacturer code
Lancet 97799494 ACCU-CHEK FASTCLIK LANCET ROD
Lancet 97799495 ACCU-CHEK FASTCLIK LANCET ROD
Lancet 97799817 ACCU-CHEK MULTICLIX LANCET ROD
Lancet 97799946 ACCU-CHEK MULTICLIX LANCET ROD
Lancet 97799945 ACCU-CHEK SOFTCLIX LANCET ROD
Lancet 97799466 BG STAR LANCET SAC
Lancet 97799541 EZ HEALTH ORACLE LANCET TRE
Lancet 97799825 FINGERSTIX LANCET BAY
Lancet 97799292 FIRST CANADIAN HEALTH LANCETS ARA
Lancet 97799826 FREESTYLE LANCET BAY
Lancet 97799918 MICROLET LANCET BAY
Lancet 97799810 MPD THIN LANCET (NS) MPD
Lancet 97799811 MPD THIN LANCET (NS) MPD
Lancet 97799807 MPD ULTRA THIN LANCET (100) MPD
Lancet 97799808 MPD ULTRA THIN LANCET (200) MPD
Lancet 97799139 ONETOUCH DELICAPLUS 33G LANCET UNK
Lancet 97799970 ONETOUCH ULTRASOFT LANCET JAJ
Lancet 97799348 ULTILET CLASSIC LANCET UNK
21G Lancet 97799804 MONOLET 21G LANCET TYC
28G Lancet 97799232 DROPLET PERSONAL LANCET 28G SFA
28G Lancet 97799253 FIRST CANHEALTH 28G LANCET ARA
28G Lancet 97799766 ITEST SAFETY 28G LANCET AUC
28G Lancet 97799801 MONOLET THIN (MONOJECT) 28G TYC
30G Lancet 97799254 FIRST CANHEALTH 30G LANCET ARA
30G Lancet 97799388 MEDI+SURE SOFT 30G TWIST MEC
30G Lancet 97799389 MEDI+SURE SOFT 33G TWIST MEC
30G Lancet 97799431 ONE TOUCH DELICA 30G LANCET JAJ
33G Lancet 97799690 BD ULTRAFINE 33G LANCET BTD
33G Lancet 97799234 DROPLET PERSONAL LANCET 33G SFA
33G Lancet 97799255 FIRST CANHEALTH 33G LANCET ARA
33G Lancet 97799767 ITEST ULTRA-THIN 33G LANCET AUC
33G Lancet 97799501 ONETOUCH DELICA 33G LANCET JAJ

96:00 PHARMACEUTICAL AIDS

96:00.00 PHARMACEUTICAL AIDS

BASES-EMULSIONS

Limited use benefit (prior approval required).

For the treatment of atopic dermatitis in children 0 to 18 years old.

Coverage is limited to 450 grams per month.

Table: BASES-EMULSIONS
Drug strength and dosage form DIN Brand name Manufacturer code
ST Cream 99000385 EMOLLIENT FOR CHILDREN WPC

DEVICE (METHADONE)

Limited use benefit (prior approval is not required).

Coverage is granted for 1 device.

Table: DEVICE (METHADONE)
Drug strength and dosage form DIN Brand name Manufacturer code
Miscellaneous 91500016 METHADONE LOCK BOX UNK

INFANT FORMULATION

Limited use benefit (prior approval required).

Infant formula coverage for children < 1 year of age (corrected gestational age for prematurity).

Coverage for infant formula is provided for medically necessary conditions until the first year of gestational age. Examples of medically necessary conditions include: cow's milk protein allergy, failure to thrive, contraindications for breast feeding, prematurity or low birth weight. On an exception basis, other conditions will be considered with the appropriate rationale for medically necessary.

Table: INFANT FORMULATION
Drug strength and dosage form DIN Brand name Manufacturer code
Oral Liquid 95900000 ALIMENTUM ABB
Oral Liquid 95900001 ALIMENTUM UNK
Oral Liquid 95900003 ENFAMIL A+ MJO
Oral Liquid 95900007 ENFAMIL A+ READY TO FEED MJO
Oral Liquid 95900152 ENFAMIL ENFACARE A+ MJO
Oral Liquid 95900012 ENFAMIL LOWER IRON RTF MJO
Oral Liquid 95900026 NUTRAMIGEN A+ MJO
Powder 95900047 ALIMENTUM PDR (400G) ABB
Powder 95900164 ENFAMIL A+ 663G PDR MJO
Powder 95900009 ENFAMIL ENFACARE A+ 363G PDR MJO
Powder 95900155 ENFAMIL LOW IRON FORMULA 900GM MJO
Powder 95900025 NEOCATE W/ DHA & ARA 400G PDR UNK
Powder 95900027 NUTRAMIGEN A+ LGG 561G PDR MJO
Powder 95900035 PURAMINO A+ PDR MJO
Powder 95900036 SIMILAC ADVANCE NEOSURE 363G UNK
Powder 95900044 SIMILAC PM 60/40 450G PDR UNK
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