Notice: Prescription Drug List (PDL): Multiple additions

January 8, 2016

Our file number: 15-113849-759

The purpose of this Notice of Amendment is to notify the addition of Dulaglutide, Evolocumab, Lubiprostone, Nivolumab, Polidocanol and Sacubitril to both the Human and Veterinary Prescription Drug List (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 Regulations indicates that these drugs require prescription status.

Dulaglutide (TRULICITY) is indicated for the treatment of type 2 diabetes mellitus. Regular monitoring of HbA1c and blood glucose of patients under the supervision of a practitioner is necessary to achieve better control of hyperglycemia and to prevent long term complications of diabetes, in particular when Dulaglutide is used in combination with insulin and sulfonylurea.

Evolocumab (REPATHA) is indicated as an adjunct to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of low density lipoprotein cholesterol (LDL-C).

Lubiprostone (AMITIZA) is indicated for the treatment of chronic idiopathic constipation (CIC) in adult patients in which laxative failed to provide adequate relief. Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. A healthcare professional should perform a thorough evaluation to confirm the absence of an obstruction prior to initiation treatment with Lubiprostone. Lubiprostone is an analog of Prostaglandin and will be listed under Prostaglandins or their salts or derivatives or analogues on the PDL.

Nivolumab (OPDIVO) is indicated for the treatment of unresectable or metastatic melanoma that is BRAF V600 wild-type and thus requires careful diagnosis by a medical oncologist. A qualified health practitioner is necessary to determine the specific weight based dosing of Nivolumab as well as to determine the need for dose holding that may be required based on adverse events.

Polidocanol (VARITHENA) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system, above and below the knee. Physicians administering Polidocanol must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of the product.

Sacubitril (in combination with Valsartan in ENTRESTO) is a prodrug that results in neprilysin inhibition. ENTRESTO (sacubitril/valsartan) is indicated for the treatment of heart failure with reduced ejection fraction (HFrEF) in patients to reduce the incidence of cardiovascular death and heart failure hospitalisation. Optimizing medical management of patients with HFrEF requires the skill of a physician experienced in the treatment of this condition.

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