Notice: Multiple additions to the Prescription Drug List (PDL) [2023-06-23]

June 23, 2023
Our file number: 23-105485-620

The purpose of this Notice of Amendment is to notify about the addition of concizumab, daridorexant, foscarbidopa, foslevodopa, glofitamab, setmelanotide, spesolimab, tirbanibulin, vatinoxan hydrochloride (veterinary) and vericiguat to the Prescription Drug List (PDL) for human and/or veterinary use.

The new medicinal ingredients will be added to the human and veterinary parts of the PDL as the following:

The new medicinal ingredient will be added to the veterinary part of the PDL as the following:

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.

Alhemo (concizumab injection) is indicated for the treatment of adolescent and adult patients (12 years of age or older) with hemophilia B (congenital factor IX [FIX] deficiency) who have FIX inhibitors and require routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Columvi (glofitamab for injection) is indicated for:

• the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy.

Imcivree (setmelanotide solution for subcutaneous injection) is indicated for weight management in adult and pediatric patients 6 years of age and older with obesity due to:

• Bardet-Biedl syndrome (BBS)
• Genetically confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency due to variants interpreted as pathogenic, likely pathogenic, or of uncertain significance

Onakta (tirbanibulin 1 % w/w ointment) is indicated for the topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (AK) (Olsen grade 1) on the face or scalp in adults.

Quviviq (daridorexant) is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Spevigo (spesolimab for injection) is indicated for the treatment of flares in adult patients with generalized pustular psoriasis (GPP).

Verquvo (vericiguat) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent heart failure decompensation event requiring hospitalization and/or intravenous diuretic therapy. Verquvo should be used in combination with standard of care therapy for heart failure.

Vyalev (foslevodopa/foscarbidopa solution) is indicated for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson's disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson's medicinal products.

Zenalpha (vatinoxan hydrochloride) is indicated for use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, and minor surgical procedures in dogs only.

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 regarding this notice, please contact:

Health Canada
Pharmaceutical Drugs Directorate
Bureau of Policy, Science and International Programs
Office of Science

Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca