Health Canada has approved QALSODY (tofersen injection) under a Notice of Compliance with Conditions (NOC/c) for the treatment of ALS in adults who have a pathogenic variant (also known as a mutation) in the superoxide dismutase 1 (SOD1) gene. This means the drug will soon be made available and can be marketed in Canada with certain conditions.
The NOC/c pathways allow for the authorization of treatments based on promising clinical data while requiring additional evidence to confirm the drug’s benefit. The authorization of QALSODY remains conditional and requires additional data from ongoing trials.
This approval is a positive step forward as QALSODY becomes the first therapy indicated in Canada to target a genetic cause of ALS. However, at this stage, the drug is not yet covered under public or private drug programs. As a next step, Canada’s Drug Agency (CDA) and Institut national d’excellence en santé et services sociaux (INESSS) in Quebec must complete its health technology assessment (HTA) of the therapy, informing whether it will be recommended for public reimbursement. Following this process, federal, provincial, and territorial drug plans, as well as private insurers, will determine if they will cover the costs associated with the drug.
ALS Canada remains actively engaged in the process. We are participating in CDA’s patient input process and working to support the pan-Canadian Pharmaceutical Alliance (pCPA) and the provincial drug programs to make informed and expedited reimbursement decisions by bringing forward the perspective and experiences of the ALS community. We are hopeful that pan-Canadian and provincial decision-makers in the reimbursement process will work quickly to provide expedited and equitable access for Canadians living with SOD1-ALS.
We will continue to post updates as they become available. To learn more about QALSODY, visit our frequently asked questions page on this topic.
You can read more in Biogen Canada’s press release and learn more about how drugs become approved and accessible in Canada by visiting our blog post on this topic.