British Columbia, Ontario approve access to gene therapy for hemophilia B
Montreal – April 3, 2026 – In the last few weeks, British Columbia and Ontario have approved access to HEMGENIX, gene therapy for hemophilia B. Decisions in other provinces are pending. In Quebec, the manufacturer, CSL Behring, has made a new submission to INESSS, the health technology evaluation agency, with the latest efficacy and safety data; consequently, access will be conditional on INESSS’ eventual recommendation.
The process for individuals to gain access to HEMGENIX will vary from province to province and be different—and more complicated—compared to what people with hemophilia have experienced with other coagulation products supplied through Canadian Blood Services.
The five main steps are:
- Shared decision-making: Discussions with the person’s hematologist and family about the risks and benefits of the therapy and a decision to go ahead or not.
- Determining individual eligibility: This will be done by a person’s hematologist. Important criteria include age (18 years and older) and severity (those who require prophylaxis). In addition, a recent AAV5 antibody test with results below a certain threshold (likely 900) will be required. Other medical exclusion criteria may apply.
- Enrollment in CSL Behring’s patient support program, CSL PLUS™: CSL PLUS™ is a patient support program for individuals prescribed HEMGENIX. The program offers reimbursement support, coordination of eligible travel reimbursement, and support for post treatment monitoring in collaboration with the patient’s care team.
- Enrollment in a province’s drug plan: In Ontario, this is the Trillium Drug Program. In BC, it is the Fair PharmaCare Program.
- Application by the person’s physician, adjudication and decision: This is done individually through a province’s established process for therapies that are provided on an exceptional basis. These processes vary from province to province. Acceptance is not automatic. In Ontario, it will be through the Exceptional Access Program; in BC, through Expensive Drugs for Rare Diseases.
For details about these programs, see …
Ontario
- Ontario Exceptional Access Program website: Exceptional Access Program
- Trillium Drug Program: A Guide to Understanding the Trillium Drug Program
British Columbia
- BC Pharmacare announcement: etranacogene_dezaparvovec_hemgenix_3992_dds.pdf
- BC Expensive Drugs for Rare Disorders website: Exceptional funding of EDRDs – Province of British Columbia
- Fair Pharmacare website: Fair PharmaCare plan – Province of British Columbia
- Fair Pharmacare assistance levels: Fair PharmaCare assistance levels
Hemophilia treatment centres have been informed about the access procedures and will be able to guide people through the process.
The Canadian Hemophilia Society will provide more information as it becomes available. For more information on the risks and benefits of gene therapy for hemophilia B, see www.hemophilia.ca/gene-therapy/ and www.chscontact.ca.