Notice: Prescription Drug List (PDL): Multiple Additions

Date: July 8, 2019
Our file number: 19-113709-160

The purpose of this Notice of Amendment is to notify about the additions of abemaciclib, cemiplimab, patisiran, and risankizumab to the Prescription Drug List (PDL) for 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.

LIBTAYO (cemiplimab) is indicated for treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

ONPATTRO (patisiran) is indicated for the treatment of polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).

SKYRIZI (risankizumab injection) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

VERZENIO (abemaciclib) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer:

• in combination with an aromatase inhibitor in postmenopausal women as initial endocrine-based therapy;
• in combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a gonadotropin-releasing hormone (GnRH) agonist;
• as a single agent in women with disease progression following endocrine therapy and at least 2 prior chemotherapy regimens. At least one chemotherapy regimen should have been administered in the metastatic setting, and at least one should have contained a taxane.

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

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