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 Notice of Compliance with Conditions 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.
INESSS invites citizens, patients, caregivers, and healthcare professionals, as well as their associations and groups, to take part in the consultation on drugs. ALS Quebec will submit our community’s feedback. Quebecers are invited to do so individually as well : https://www.inesss.qc.ca/en/themes/medicaments/drug-products-undergoing-evaluation-and-evaluated/comment-on-a-drug-product.html
To read Biogen Canada’s full press release.