Notice: Multiple Additions to the Prescription Drug List (PDL) [2023-03-08]
March 8, 2023
Our file number: 23-101719-215
The purpose of this Notice of Amendment is to notify about the addition of cangrelor, ciltacabtagene autoleucel, deucravacitinib, pegcetacoplan and tirzepatide to the Prescription Drug List (PDL) for human and veterinary use.
The new medicinal ingredients will be added to the PDL as the following:
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Cangrelor or its salts or derivatives | N/A | N/A |
| Ciltacabtagene autoleucel | N/A | N/A |
| Deucravacitinib or its salts | N/A | N/A |
| Pegcetacoplan | N/A | N/A |
| Tirzepatide | N/A | N/A |
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.
Carvykti (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T-cell immunotherapy indicated for:
- the treatment of adult patients with multiple myeloma, who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and who are refractory to their last treatment.
Empaveli (pegcetacoplan) is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor.
Kengrexal (cangrelor) is indicated for reducing the risk of thrombotic cardiovascular events (periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST)) in patients with coronary artery disease undergoing percutaneous coronary intervention who have not been treated with an oral P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
Mounjaro (tirzepatide injection) is indicated for once-weekly administration as an adjunct to diet and exercise to improve glycemic control for the treatment of adult patients with type 2 diabetes mellitus.
Sotyktu (deucravacitinib tablets) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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
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