Notice: Prescription Drug List (PDL): Multiple additions

August 9, 2016
Our file number: 16-108811-710

The purpose of this Notice of Amendment is to notify the additions of Alirocumab, Blinatumomab, Brivaracetam, Carfilzomib, Cobimetinib, Elbasvir, Finafloxacin, Grazoprevir, Lenvatinib, Lumacaftor, Mepolizumab, Selexipag and Sugammadex to the Human and Veterinary Prescription Drug List (PDL). Closantel sodium and Sarolaner will be added only to the Veterinary Prescription Drug List. These additions are effective on the date of this notice.

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.

Alirocumab (PRALUENT) is indicated for the treatment of adults with heterozygous familial hypercholesterolemia (heFH) or clinical atherosclerotic cardiovascular disease (CVD). heFH is a serious inherited disorder of lipid metabolism and CVD is a life threatening condition. Practitioner expertise in the diagnosis and management of these diseases is necessary.

Blinatumomab (BLINCYTO) is indicated for the treatment of adults with certain types of acute lymphoblastic leukemia. Acute lymphoblastic leukemia requires diagnosis by a Physician. Medical supervision is essential to mitigate and treat serious adverse reactions and to determine effectiveness of treatment with Blinatumomab.

Brivaracetam (BRIVLERA) is indicated as adjunctive therapy in the management of epilepsy. Patients need to be evaluated on an on-going basis for adverse reactions and effectiveness by a physician experienced in the treatment of seizures.

Carfilzomib (KYPROLIS) in combination with lenalidomide and dexamethasone is indicated for the treatment of patients with multiple myeloma. The diagnosis of multiple myeloma must be made by a physician and the treatment and careful monitoring of patients receiving Carfilzomib must be supervised strictly in case of life-threatening infusion reactions.

Closantel sodium (FLUKIVER) is an oral antiparasitic veterinary medication that is indicated for the treatment of Haemonchus contortus. This medication is selective for Haemonchus and an accurate diagnosis by a Veterinarian needs to be made or failure of treatment may result.

Cobimetinib (COTELLIC) is indicated for use in combination with ZELBORAF® (vemurafenib) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation. Prescription and administration of COTELLIC should be done under the supervision of a qualified physician who is experienced in the use of anti-cancer agents.

Elbasvir (in combination with Grazoprevir as part of the medication ZEPATIER) is fixed dose combination of two direct acting antiviral agents indicated for the treatment of chronic hepatitis C. This drug must be administered by a physician experienced in the management of chronic hepatitis C infections.

Finafloxacin (XTORO) is indicated for the treatment of acute otitis external caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus. Clinician diagnosis, treatment and monitoring is required for this drug.

Grazoprevir (in combination with Elbasvir as part of the medication ZEPATIER) is fixed dose combination of two direct acting antiviral agents indicated for the treatment of chronic hepatitis C. This drug must be administered by a physician experienced in the management of chroinic hepatitis C infections.

Lenvatinib (LENVIMA) is indicated for the treatment of patients with differentiated thyroid cancer. A practitioner's expertise is required to manage toxicity with dose modification and the use of concomitant medications in the use of this medication.

Lumacaftor (in combination with Ivacaftor as part of the medication ORKAMBI) is indicated for the treatment of cystic fibrosis. Practitioner supervision is necessary for treatment of patients to monitor potential liver function, blood pressure and respiratory adverse events while taking this medication.

Mepolizumab (NUCALA) is indicated as add-on maintenance treatment of severe asthma. Mepolizumab should only be used by physicians who have sufficient knowledge of the management of asthma.

Sarolaner (SIMPARICA) chewable tablets are indicated in dogs for the treatment and control of ticks and flea infestations. Veterinarian expertise is necessary to oversee this drugs administration in dogs due to the risk of potential adverse events and limited market experience with this new chemical class of pesticide.

Selexipag (UPTRAVI) is indicated for the long-term treatment of pulmonary arterial hypertension to delay disease progression. This disease can be diagnosed only by a cardiologist and only after some highly specialised investigations.

Sugammadex (BRIDION) is indicated for routine reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium. Neuromuscular blockers are used only by trained health care professionals in a health care facility equipped for resuscitation and life support. The adequacy of reversal should be assessed by trained professionals.

Additional information on how Health Canada now 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: 613-957-1058
Facsimile: 613-941-1812
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca