Notice: Prescription Drug List (PDL): Multiple additions - December 27, 2018

December 27, 2018
Our file number: 18-121421-216

The purpose of this Notice of Amendment is to notify about the additions of Pralatrexate, Elagolix, Dinutuximab, Suvorexant, Elvitegravir, Cobicistat and Burosumab to the Prescription Drug List (PDL) in both the human and veterinary parts.

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.

FOLOTYN (pralatrexate injection) which is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for FOLOTYN please refer to Health Canada’s Notice of Compliance with conditions - drug products web page.

ORILISSA (elagolix) is indicated for the treatment of moderate to severe pain associated with endometriosis.

UNITUXIN (dinutuximab for injection) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13 cis-retinoic acid (RA), for the treatment of high-risk neuroblastoma in pediatric patients who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

BELSOMRA™ (suvorexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) is indicated for use as a complete regimen for the treatment of adults aged 18 years and older infected with HIV-1 with no known mutations to the integrase inhibitor class, tenofovir or emtricitabine.

CRYSVITA (Burosumab injection) is indicated for the treatment of X-linked hypophosphataemia (XLH) in adult and pediatric patients 1 year of age and older.

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