Notice - Prescription Drug List (PDL): Multiple Additions

(PDF Version - 305 K)

October 19, 2017
Our file number: 17-110956-588

The purpose of this Notice of Amendment is to notify about the additions of Defibrotide sodium, Glecaprevir/Pibrentasvir, Midostaurin, Ocrelizumab and Voxilaprevir to the Human and Veterinary Prescription Drug Lists (PDL). 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 Regulationsindicates that these drugs require prescription status.

Defibrotide sodium (DEFITELIO) solution for intravenous infusion is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following haematopoietic stem-cell transplantation (HSCT) therapy.

Glecaprevir/Pibrentasvir (MAVIRET) is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV genotype 1 infection who were previously treated with either a regimen of NS5A inhibitor or with a NS3/4A protease inhibitor but not both classes of inhibitors.

Midostaurin (RYDAPT) is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML).

Ocrelizumab (OCREVUS) is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.

Sofosbuvir/Velpatasvir/Voxilaprevir (VOSEVI) is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have:

• genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor;
• genotype 1, 2, 3, or 4 infection and have been previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

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
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca