Qalsody CDA final reimbursement recommendations

December 11, 2025 – Canada’s Drug Agency (CDA) has released its final reimbursement recommendation for Qalsody (tofersen), advising that the therapy be reimbursed with conditions for adults living with SOD1-ALS.

This decision is an important step forward in the pathway to public reimbursement for Canadians living with SOD1-ALS. Qalsody was approved by Health Canada in March 2025 and it is the first therapy indicated in Canada to target a genetic cause of ALS.

ALS Canada welcomes this decision and the recognition of the ALS community’s advocacy throughout the health technology assessment review process. We are particularly encouraged that the restriction on combination therapy included in CDA’s draft recommendation did not appear in the final version.

This change reflects key feedback from patient groups and clinicians, including ALS Canada’s submission, which emphasized the importance of shared decision-making of patients and clinicians for treatment planning and avoid setting an exclusionary precedent.

ALS Canada provided input at two key stages of the review to ensure that the perspectives and experiences of people affected by ALS were represented:

• Patient Input Submission
• Feedback on Draft Recommendation

With CDA’s final recommendation issued, the process now moves to the pan-Canadian Pharmaceutical Alliance (pCPA), where public reimbursement negotiations with the manufacturer will take place. After negotiations conclude, each province and territory will determine whether to add Qalsody to its public drug formulary and under what conditions.

ALS Canada will continue to advocate for timely and equitable access to approved therapies. We will continue to engage with the pCPA and other stakeholders throughout the reimbursement process to ensure that the priorities of the ALS community are at the forefront of their decision-making.

We will keep you updated as the process moves forward.

You can read more in Biogen Canada’s press release.

To learn more about Qalsody, visit our frequently asked questions page on this topic.