Notice: Multiple additions to the Prescription Drug List (PDL)

June 17, 2022
Our file number: 22-107199-26

The purpose of this Notice of Amendment is to notify about the additions of amivantamab, belumosudil, bimekizumab, cariprazine, cilgavimab, lumasiran, pegvaliase and tixagevimab 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.

Bimzelx (bimekizumab injection) is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adult patients who are candidates for systemic therapy or phototherapy.

Evusheld (tixagevimab and cilgavimab) is indicated for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents (≥12 years of age weighing at least 40 kg), who have not had a known recent exposure to an individual infected with SARSCoV-2 and:

• Who are immune compromised and unlikely to mount an adequate immune response to COVID‐19 vaccination or
• For whom COVID-19 vaccination is not recommended.

Oxlumo (lumasiran) is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

Palynziq (pegvaliase injection) is indicated to reduce blood phenylalanine concentrations in patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite dietary management.

Rholistiq (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.

Rybrevant (amivantamab for injection) is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Vraylar (cariprazine) is indicated for the treatment of schizophrenia in adults.

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