Notice: Prescription Drug List (PDL): Multiple additions

October 1^st, 2018
Our file number: 18-112049-187

The purpose of this Notice of Amendment is to notify about the additions of:

• Baricitinib, Emicizumab, Erenumab, Tisagenlecleucel and Dalbavancin to the Prescription Drug List for human and veterinary use (PDL) and
• Prabotulinumtoxin A to the “including (but not limited to)” column of the botulinum toxin entry on the PDL for both human and veterinary use.

These additions are effective at the time of posting.

Rationale:

A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these drugs require prescription status.

OLUMIANT (baricitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). OLUMIANT may be used as monotherapy in cases of intolerance to MTX.

HEMLIBRA (emicizumab) is indicated for hemophilia A (congenital factor VIII deficiency) patients with factor VIII inhibitors as routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes.

AIMOVIG (erenumab) is indicated for prevention of migraine in adults who have at least 4 migraine days per month.

NUCEIVA (prabotulinumtoxin A) is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients less than 65 years of age.

KYMRIAH (tisagenlecleucel) is a CD19-directed genetically modified autologous T-cell immunocellular therapy indicated for:

• the treatment of pediatric and young adult patients 3 to 25 years with B-cell acute lymphoblastic leukemia (ALL) who are refractory, have relapsed after allogeneic stem cell transplant (SCT) or are otherwise ineligible for SCT, or have experienced second or later relapse, and
• the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

XYDALBA (dalbavancin for injection) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin susceptible strains).

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions on these amendments to the Prescription Drug List please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 343-998-9304
Facsimile: 613-941-1812
Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca