Notice: Prescription Drug List (PDL): Casirivimab and Imdevimab (COVID-19)

Date: June 17, 2021
Our file number: 21-111549-461

The purpose of this Notice of Amendment is to notify about the addition of casirivimab and imdevimab 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	ncluding (but not limited to)	Qualifier
Casirivimab	-	-
Imdevimab	-	-

This addition is effective at the time of posting.

Rationale:

A scientific review of this drug against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these medicinal ingredients require prescription status.

Casirivimab and imdevimab, to be administered together, are indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who are at high risk for progressing to hospitalization and/or death.

Casirivimab and imdevimab are not authorized for use in patients:

• who are hospitalized due to COVID-19, OR
• who require oxygen therapy due to COVID-19, OR
• who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Treatment with the combination of casirivimab and imdevimab has not been shown to benefit patients hospitalized due to COVID-19.

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