ALS treatments in the Canadian drug access processes

This page explores information on ALS treatments currently within the drug access processes in Canada. To learn more about how drugs become approved and accessible in Canada, visit our blog post on this topic. 

Disclaimer: ALS Canada does not endorse or recommend any specific therapies. Please consult your ALS clinician for information and advice on specific therapies. 

ALBRIOZA (AMX0035) is combination of two compounds in the form of a powder dissolved in liquid used for the treatment of ALS developed by the drug company, Amylyx. 

Current status of the therapy 

On April 4, 2024, Amylyx Pharmaceuticals announced that they have started a process with Health Canada to discontinue the marketing authorization for ALBRIOZA. This means that ALBRIOZA will no longer be available for new patients in Canada. People currently on the therapy in Canada who, in consultation with their physician, wish to stay on treatment can be transitioned to a free drug program. 

ALBRIOZA was approved by Health Canada under the Notice of Compliance with Conditions (NOC/c) pathway in June 2022. Amylyx’s decision to remove ALBRIOZA from the market is based on the recent PHOENIX trial results of AMX0035, marketed as ALBRIOZA in Canada and RELYVRIO in the United States, which failed to show an effect on primary and secondary outcome measures.  

Our advocacy 

  • e-advocacy campaign: Soon after the pCPA negotiations concluded, our community used the e-advocacy tool developed by ALS Canada and emailed the Minister of Health in their province asking that ALBRIOZA be made accessible through public reimbursement without further delay. Over 800 Canadians sent letters as part of the campaign and utilized our “Advocacy in a Box” toolkit to approach government in your province and call for Health Canada-approved treatments to be reimbursed and available to Canadians living with ALS in a timeframe that more accurately reflects the urgency of loss faced by this community.
  • Canadian Agency for Drugs and Technologies in Health (CADTH): In October 2021, CADTH, the agency responsible for provincial reimbursement recommendations, posted a call for patient input on AMX0035. ALS Canada invited the community to contribute to the submission by sharing their experiences through a survey. More than 600 Canadians participated in the survey, the results of which informed the patient input submission. In July 2022, ALS Canada provided feedback as a patient group in response to CADTH’s reimbursement recommendations for ALBRIOZA to help ensure coverage criteria reflect the realities of the diagnosis and treatment of ALS.  
    • Read ALS Canada’s patient input submission.
    • ALS Canada’s patient group input submission.
  • Federal advocacy: Our community was disappointed that Health Canada did not grant ALBRIOZA a priority review. We raised our voices to highlight access to therapies as an urgent issue for people living with ALS and advocated for priority review status for all innovative ALS therapies. We remained engaged with Health Canada and the Federal Minister of Health to advocate for this vital issue.
    • ALS Canada also provided resources for the ALS community to make their voices heard using their social media channels. Our community raised their voices on social media and told the federal government that all ALS therapies must be granted priority review status.
  • The Time is Now: Within The Time is Now position paper, we propose that ALS treatments be reviewed for approval and public reimbursement through a single condensed timeframe. This pathway includes Health Canada priority review for all ALS therapies.    

Additional information:

Oral edaravone is an investigational liquid form of RADICAVA Oral Suspension (edaravone) developed by the drug company, Mitsubishi Tanabe Pharma Corporation (MTPC). 

Current status of the therapy

In November 2022, Health Canada approved RADICAVA Oral Suspension after a 180-day priority review. As of December 15, 2023, the therapy is available in all provinces through their public formularies. 

Our advocacy

  • e-advocacy campaign: Soon after the pCPA negotiations concluded, our community used the e-advocacy tool developed by ALS Canada and emailed the Minister of Health in their province asking that RADICAVA Oral Suspension be made accessible through public reimbursement without further delay. Over 800 Canadians sent letters as part of the campaign and utilized our “Advocacy in a Box” toolkit to approach government in your province and call for Health Canada-approved treatments to be reimbursed and available to Canadians living with ALS in a timeframe that more accurately reflects the urgency of loss faced by this community.
  • Canadian Agency for Drugs and Technologies in Health (CADTH): In early February 2022, CADTH posted a call for patient and clinician input on RADICAVA Oral Suspension. ALS Canada prepared a submission that reflects the diversity of perspectives and experiences of people living with ALS from across the country. 
    • Read ALS Canada’s patient input submission. 

 Additional information:

RADICAVA (edaravone) is an intravenous medication for the treatment of ALS distributed by the drug company, Mitsubishi Tanabe Pharma Corporation (MTPC). 

Current status of the therapy

Health Canada approved RADICAVA (edaravone) for use in Canada, and it is available in all provinces and territories through their public formularies. 

Our advocacy

Throughout the drug access processes for RADICAVA (edaravone), we have worked with the ALS community and ALS Societies across Canada to bring forward the experiences and perspectives of Canadians living with ALS.  

  • Canadian Agency for Drugs and Technologies in Health (CADTH): ALS Canada submitted a patient input submission to the CADTH as part of its clinical and economic review of RADICAVA (edaravone).  
    • Read ALS Canada’s patient input submission.
       
  • Ontario Public Drug Program: In December 2018, ALS Canada submitted a patient evidence submission to the Ontario Public Drug Program as part of its independent drug review process to make coverage decisions about RADICAVA (edaravone). The content of the submission was based on the CADTH patient input submission and a survey distributed to people living with ALS in Ontario who were accessing RADICAVA (edaravone) through the MTPC Edaravone Canadian Supply Programme.  
    • Read the Ontario Public Drug Program patient evidence submission.
       
  • e-advocacy campaign: Our advocates used the e-advocacy tool developed by ALS Canada and emailed the Minister of Health in their province asking that RADICAVA (edaravone) be made accessible through public reimbursement without further delay. Over 3,000 Canadians sent letters as part of the campaign.  

Additional information:

RILUTEK (riluzole) is an oral therapy in the form of a tablet available in tablet form for the treatment of ALS developed by the drug company, Sanofi-Aventis. 

Current status of the therapy

Health Canada approved RILUTEK (riluzole) for use in Canada and it is available in all provinces and territories through their public formularies. A generic version of RILUTEK (riluzole) is available as well. 

Additional information:

Tofersen is an antisense oligonucleotide that targets superoxide dismutase 1 (SOD1) mRNA to reduce the synthesis of SOD1 protein, for the treatment of ALS in adults who have a pathogenic variant (also known as a mutation) in the SOD1 gene, developed by the drug company, Biogen.

Current status of the therapy

Tofersen is currently available to eligible individuals through Health Canada’s Special Access Program (SAP).

In March 2024, Health Canada accepted a New Drug Submission (NDS) for tofersen.

What happens next

Health Canada’s acceptance triggered a thorough regulatory review of the therapy, which will result in the decision as to whether tofersen will be approved for use in Canada.

A regulatory decision on the New Drug Submission is expected in early 2025.

ALS Canada is in conversation with Health Canada and Biogen about the need for Canadians to have equitable, timely, and affordable access to this therapy and to advocate to ensure there are no gaps in access for people who are currently receiving tofersen through the Special Access Program (SAP). We will continue to keep our community updated as we learn more.

Additional information: