Update to the Drug Benefit List - Winter 2017

The Non-Insured Health Benefits (NIHB) Program provides supplementary health benefits, including prescription and non-prescription drugs, for registered First Nations and recognized Inuit throughout Canada.

Benefit definitions

Open benefits:

Open benefits are the drugs listed in the NIHB Drug Benefit List (DBL) which do not have established criteria or prior approval requirements.

Limited use benefits:

Limited use drugs are those that have been found to be effective in specific circumstances, or which have quantity and frequency limitations. For drugs in this category, specific criteria must be met to be eligible for coverage.

Not added to the formulary:

Drugs not added to formulary are those which are not listed in the NIHB DBL after review by the national Common Drug Review (CDR)/pan-Canadian Oncology Drug Review (pCODR) processes and/or the NIHB Drugs and Therapeutics Advisory Committee (DTAC). These drugs will not be added to the NIHB drug list because published evidence does not support the clinical value or cost of the drug relative to existing therapies. Coverage may be considered in special circumstances upon receipt of a completed "Exception Drugs Request Form" from the attending licensed practitioner. These requests are reviewed on a case by case basis.

Exclusion:

Certain drug therapies for particular conditions fall outside the NIHB Program's mandate and will not be provided as benefits (e.g., cosmetic and anti-obesity drugs). As well, certain drugs will be excluded from the NIHB Program as recommended by the CDR and the DTAC because published evidence does not support the clinical value, safety or cost of the drug relative to existing therapies, or there is insufficient clinical evidence to support coverage.

Note: The appeal process and the emergency supply policy does not apply to excluded drugs. 

Additions to the Drug Benefit List

DIN
(Drug Identification Number)
MFR
(Manufacturer)
ST
(Short-Term Dispensing Policy Drug)

Open Benefits

Table 1 - Single-Source Drug Products
DIN MFR Brand Name Effective Date
02430932 VII TRIUMEQ 600/50/300MG TABLET 08-02-2017
02449277 TRI ST ASA 81MG TABLET   23-11-2016
02442256 ORM ST VIDEXTRA 2,000U CAPSULE           05-01-2017
02446561 GSK ARNUITY ELLIPTA 100MCG/BLD INHALER 17-02-2017
02446588 GSK ARNUITY ELLIPTA 200MCG/BLD INHALER 17-02-2017
02244290 PAL METADOL-D 10MG/ML O/L         08-02-2017
02213826 TEP REVIA 50MG TABLET                05-11-2016
01967878 SCH CLEAR AWAY PLANTAR WART SYSTEM 30-11-2016
99401033 UNK SHARPS NESTABLE YELLOW LARGE 22.7L 30-11-2016
01902776 SAO KAYEXALATE 100%               17-01-2017
Table 2 - Multi-Source Drug Products
DIN MFR Brand Name Effective Date
02454513 AUR AURO-ABACAV/LAMIVUD 600/300MG 11-01-2017
02458381 PMS PMS-ABACAV/LAMIVUD 600/300MG  27-01-2017
02452324 MAR MAR-AZITHROMYCIN 250MG TABLET    21-01-2017
02429063 SDZ VISTITAN 0.03%                11-01-2017
02447851 SAN ST BUSPIRONE 10MG TABLET 28-11-2016
80025360 JAP J-CAL-D 400 TABLET 19-12-2016
80065914 RIV RIVA-CAL D400 TABLET 20-12-2016
02450526 PDL ST CETIRIZINE 20MG TABLET 23-11-2016
02436914 AUR AURO-CLINDAMYCIN 300MG CAPSULE 11-01-2017
02454297 ATP ST ACT ESCITALOPRAM ODT 10MG TABLET 09-01-2017
02454300 ATP ST ACT ESCITALOPRAM ODT 20MG TABLET 09-01-2017
02398869 MYL ST INDAYO 0.15MG AND 0.03MG TABLET 06-12-2016
02448424 BMI ST BIO-FLUOXETINE 10MG CAPSULE 07-11-2016
02448432 BMI ST BIO-FLUOXETINE 20MG CAPSULE 07-11-2016
02423650 AUR ST AURO-LOSARTAN-HCTZ 100/12.5MG 28-11-2016
02423669 AUR ST AURO-LOSARTAN-HCTZ 100/25MG   28-11-2016
02423642 AUR ST AURO-LOSARTAN-HCTZ 50/12.5MG 28-11-2016
09991474 UNK NALOXONE NASAL SPRAY 22-12-2016
02444275 APX APO-NALTREXONE 50MG TABLET 04-11-2016
02448734 AUR ST AURO-OLANZAPINE ODT 10MG TABLET  30-11-2016
02448742 AUR ST AURO-OLANZAPINE ODT 15MG TABLET  30-11-2016
02448726 AUR ST AURO-OLANZAPINE ODT 5MG TABLET  30-11-2016
80033602 JAP ST JAMP-K EFFERVESCENT 25MMOL TABLET 07-12-2016
02424061 AUR ST AURO-PRAMIPEXOLE 0.25MG TABLET   30-11-2016
02424118 AUR ST AURO-PRAMIPEXOLE 1.5MG TABLET   30-11-2016
02424096 AUR ST AURO-PRAMIPEXOLE 1MG TABLET   30-11-2016
02442582 AUR ST AURO-ROSUVASTATIN 10MG TABLET    27-01-2017
02442590 AUR ST AURO-ROSUVASTATIN 20MG TABLET    27-01-2017
02442604 AUR ST AURO-ROSUVASTATIN 40MG TABLET    27-01-2017
02442574 AUR ST AURO-ROSUVASTATIN 5MG TABLET    27-01-2017
02453568 AUR ST AURO-TELMISARTAN 40MG TABLET 11-01-2017
02453576 AUR ST AURO-TELMISARTAN 80MG TABLET 11-01-2017
02456389 AUR ST AURO-TELMISARTAN-HCTZ 80/12.5 11-01-2017
02456397 AUR ST AURO-TELMISARTAN-HCTZ 80/25MG 11-01-2017
02432102 MAR ST MAR-TOPIRAMATE 100MG TABLET      06-12-2016
02432110 MAR ST MAR-TOPIRAMATE 200MG TABLET      06-12-2016
02432099 MAR ST MAR-TOPIRAMATE 25MG TABLET      06-12-2016
02454645 SAN VALACYCLOVIR 500MG TABLET        06-12-2016
02452855 AUR ST AURO-VENLAFAXINE XR 150MG CAPSULE 06-12-2016
02452839 AUR ST AURO-VENLAFAXINE XR 37.5MG CAPSULE 28-11-2016
02452847 AUR ST AURO-VENLAFAXINE XR 75MG CAPSULE 06-12-2016
02450488 MYL ST MYLAN-VERAPAMIL SR 180MG TABLET  07-11-2016

New limited use

Table 3 – Entecavir
DIN MFR Brand Name Effective Date
02448777 AUR AURO-ENTECAVIR 0.5MG TABLET 07-11-2016

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 4 – Mirabegron
DIN MFR Brand Name Effective Date
02402874 AST ST MYRBETRIQ 25MG TABLET            22-11-2016
02402882 AST ST MYRBETRIQ 50MG TABLET            22-11-2016

Limited Use (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 5 – Dapagliflozin
DIN MFR Brand Name Effective Date
02435470 AZE ST FORXIGA 10MG TABLET 08-02-2017
02435462 AZE ST FORXIGA 5MG TABLET 08-02-2017

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 6 – Eplerenone
DIN MFR Brand Name Effective Date
02323052 PFI INSPRA 25MG TABLET               16-12-2016
02323060 PFI INSPRA 25MG TABLET               16-12-2016

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.

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 7 – Fluticasone-Vilanterol
DIN MFR Brand Name Effective Date
02444186 GSK BREO ELLIPTA 200/25MCG INHALER               16-12-2016

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 8 – Idelalisib
DIN MFR Brand Name Effective Date
02438798 GIL ZYDELIG 150MG TABLET 30-01-2017
02438801 GIL ZYDELIG 150MG TABLET 30-01-2017

Limited use benefit (prior approval required).

Criteria for initial six month coverage of Zydelig:

  • 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 assessment every six months:

  • There is no objective evidence of disease progression.
Table 9 – Insulin Pump Supplies
DIN MFR Brand Name Effective Date
97799342 UNO INSET 30 INFUSION SETS, 43" 13-01-2017

Limited use benefit (prior approval required).

Patient has type 1 diabetes; AND The insulin pump is prescribed by an endocrinologist or a specialist prescriber with experience in the use of insulin pumps in children, adolescent and/or adults.

Table 10 – Intrauterine Device
DIN MFR Brand Name Effective Date
00970328 PRN FLEXI-T +300 IUD              06-02-2017
00970336 PRN FLEXI-T +380 IUD              06-02-2017

Limited use benefit (prior approval not required).

Coverage is granted for 1 device every 12 months.

Table 11 – Nintedanib
DIN MFR Brand Name Effective Date
02443066 BOE OFEV 100MG CAPSULE                16-12-2016
02443074 BOE OFEV 150MG CAPSULE                16-12-2016

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.
Table 12 – Pirfenidone
DIN MFR Brand Name Effective Date
02393751 HLR ESBRIET 267MG CAPSULE 23-12-2016

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.
Table 13 – Rifaximin
DIN MFR Brand Name Effective Date
02410702 SLX ZAXINE 550MG TABLET 09-11-2016

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 14 – Rizatriptan
DIN MFR Brand Name Effective Date
02441144 AUR AURO-RIZATRIPTAN 10MG TABLET 17-01-2017

Limited use benefit (prior approval not required).

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

Table 15 – Vitamin E
DIN MFR Brand Name Effective Date

00330191

JAM ST VITAMIN E 800IU NAT SOURCE CAPSULE 19-01-2017

Limited use benefit (prior approval required).

For use in malabsorption.

Criteria changes

Change in Coverage of Aptivus

Effective December 6, 2016, Aptivus became an open benefit

The following DINs were affected:

02273322
APTIVUS 250MG CAPSULE

Change in Coverage of Celsentri

Effective December 6, 2016, Celsentri became an open benefit

The following DINs were affected:

02299844
CELSENTRI 150MG TABLET

Change in Coverage of Intelence

Effective December 6, 2016, Intelence became an open benefit

The following DINs were affected:

02306778
INTELENCE 100MG TABLET
02375931
INTELENCE 200MG TABLET

Change in Coverage of Isentress

Effective December 6, 2016, Isentress became an open benefit

The following DINs were affected:

02301881
ISENTRESS 400MG TABLET

Change in Coverage of Bismuth in Tablets and Suspension (Pepto-bismol)

Effective January 3, 2017, bismuth products (Pepto-Bismol) in tablet and suspension form will have a frequency limit. The maximum amount will be 8 tablets per day for 14 days or 120mL per day of the liquid for 14 days. The NIHB Drugs and Therapeutics Advisory Committee recommended the change in listing status following the review of clinical evidence for bismuth. Evidence of efficacy was only found for the treatment of H. pylori infection for up to 14 days.

Change in Coverage of Zeldox

Effective January 20, 2017, Zeldox became an open benefit.

The following DINs were affected:

02298597
ZELDOX 20MG CAPSULE
02298600
ZELDOX 40MG CAPSULE
02298619
ZELDOX 60MG CAPSULE
02298627
ZELDOX 80MG CAPSULE

Change in Coverage of Abilify Maintena

Effective January 27, 2017, Abilify Maintena became an open benefit.

The following DINs were affected:

02420864
ABILIFY MAINTENA 300MG INJECTION
02420872
ABILIFY MAINTENA 400MG INJECTION
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