ALS Canada submits patient input submission for Canada’s Drug Agency’s review of QALSODY (tofersen)

ALS Canada has submitted the patient input submission for Canada’s Drug Agency (CDA)’s review of QALSODY (tofersen), a therapy recently approved by Health Canada. This submission is a crucial step in ensuring that voices of the ALS community are reflected in the decision-making process.

You can read the submission here.

In response to CDA’s call for patient input, we are incredibly grateful to nearly 600 members of the ALS community who shared their experiences and perspectives through our survey. Your input helped inform our submission, bringing forward the realities of ALS, the urgency for new treatment options, and the impact of currently available therapies.

What is next?

Now that we have submitted our patient input, CDA will review the clinical and economic evidence and the patient and clinician input submissions to assess the value of QALSODY and provide a reimbursement recommendation to federal, provincial, and territorial public drug plans. Here is a look at the process ahead:

• CDA will evaluate the evidence, and patient and clinician input before issuing a draft recommendation of whether the drug should be reimbursed.
• Once the draft recommendation is released, patients and clinicians will have an opportunity to submit feedback before the final recommendation is made.
• After considering patient and clinicians’ feedback, CDA will issue one of the following final recommendations:
  • That publicly funded programs reimburse the drug without any specific conditions;
  • That publicly funded programs reimburse the drug with specific clinical criteria and/or conditions; or
  • That the drug not be reimbursed.
• If the recommendation is for the public drug plans to reimburse the drug without or with conditions, pricing and reimbursement discussions will take place through the pan-Canadian Pharmaceutical Alliance (pCPA).

You can learn more about how drugs become accessible in Canada by visiting our blog post on this topic.

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

We will keep you updated as the process moves forward.

More information

To learn more about QALSODY, visit our frequently asked questions blog post on this drug.