The Canadian Agency for Drugs and Technologies in Health (CADTH) recently posted an open call for patient input on Radicava (edaravone). This is an additional step along the approval and affordability pathway for the drug, which is currently being reviewed by Health Canada.

In response to CADTH’s call for patient input, ALS Canada is working in coordination with ALS Societies across Canada to prepare a submission on behalf of the ALS community. The submission will be based on the input of Canadians living with ALS, their caregivers (past or current) and family members – so please consider making your voice heard by completing the survey we have developed for this purpose.

What is CADTH?
While Health Canada reviews the safety of new drugs, CADTH through its Common Drug Review examines the clinical and cost effectiveness of a new therapy. In Quebec, this process is managed by the Institut national d’excellence en santé et en services sociaux, or INESSS.

  • It results in recommendations and advice that are used by federal, provincial and territorial drug plans to make decisions about whether the cost of the drug, if approved, will be covered through publicly-funded programs. At the conclusion of the Common Drug Review, one of the following recommendations is made:
  • That the drug be reimbursed by publicly-funded programs
  • That the drug be reimbursed by publicly-funded programs, with clinical criteria and/or conditions, or
  • That the drug not be reimbursed.

Why is patient input requested?
A key part of the Common Drug Review is hearing from the community about their experiences with the disease for which the therapy has been developed, as well as their expectations for the therapy if it were to be approved. CADTH issues open calls for patient input as part of their process, in order to better understand the realities of the disease when evaluating the cost value of the drug.

CADTH has a formal process for the submission of patient input that includes a template of specific questions for organizations to complete on behalf of, and with the input of, the community they represent. These questions explore:

  • Lived experience with the disease
  • Lived experience with current or previous therapies
  • Lived experience with the drug being reviewed
  • Expectations for the drug being reviewed

Patient input does not guarantee that CADTH will issue a recommendation that the drug be reimbursed (either with or without submissions), but it does ensure that the perspectives of the community are considered in their evaluation and analysis.

How can you complete the survey?

If you are interested in sharing your experiences, perspectives and expectations to inform the submission that ALS Canada will be making on behalf of the ALS community and in coordination with ALS Societies across Canada, please complete this survey:

We will also be conducting focus groups for those interested in sharing their experiences in greater detail – the survey provides a place for you to identify if you would like to be contacted about a focus group.

The survey and focus groups are open to:

  • People living with ALS
  • Caregivers and family members for someone living with ALS
  • Caregivers and family members who have lost someone to ALS

You do not need to have specific experience with Radicava (edaravone) to participate. The survey will be open from June 11 to June 24 at 11:59pm Eastern Time.

We will update this post with the final submission to CADTH once it is complete.

More information
You can find more information on how new drugs become approved and available in Canada here.

Posted in: Advocacy