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 

In June 2022, ALBRIOZA was approved, with conditions, by Health Canada as a treatment for ALS.  

The drug is now commercially available in Canada. Canadian Agency for Drugs and Technologies in Health (CADTH) released its reimbursement recommendations 

ALBRIOZA is on the list of drugs in negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) as of August 11, 2022. 

However, whether provincial drug plans will cover it has not yet been determined. 

Our advocacy 

  • 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.
    • Read 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 ALS Canada 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.    

What happens next

Approval is just one step in making a new therapy available and accessible in Canada. CADTH released recommendations to reimbursement with conditions and it is currently on the list of drugs in active negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA). Following pCPA negotiations, each province/territory does an independent review of the drug and decides if and how the public drug plan will cover the therapy.

ALS Canada will continue to be involved in the CADTH Health Technology Assessment process and is actively working to support the pCPA and the provincial drug programs to make informed and expedited reimbursement decisions by bringing forward the perspective and experiences of people affected by ALS. 

Additional information:

Masitinib is an oral therapy in the form of a tablet for the treatment of ALS developed by the drug company, AB Science. 

Current status of the therapy

In May 2022, AB Science announced that Health Canada accepted its New Drug Submission (NDS) for masitinib as an add-on therapy. This step triggers a thorough regulatory review of the therapy under the Notice of Compliance with Conditions (NOC/c) pathway.   

Our advocacy

  • 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.    

What happens next

Health Canada has 200 days to review the application. If an approval with NOC/c is granted, the therapy will go through the reimbursement process.   

Recent updates

August 2022: The European Medicines Agency (EMA) has agreed to review an application seeking the conditional approval of masitinib, also referred to as Alsitek.

Additional information:

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

Current status of the therapy

In May 2022, Health Canada accepted a Supplement to a New Drug Submission (SNDS) for an oral formulation of edaravone under Priority Review.  

Our advocacy

  • Canadian Agency for Drugs and Technologies in Health (CADTH): In early February 2022, CADTH posted a call for patient and clinician input on oral edaravone. 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. 

What happens next

Health Canada’s acceptance triggered a thorough regulatory review of the therapy. The submission was accepted under priority review, which expedites the review timeline for the therapy to six months. A decision regarding approval is expected in late fall 2022.   

 Additional information:

RADICAVA (edaravone) is an intravenous medication for the treatment of ALS developed 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.  

Recent updates

November 2021: RADICAVA (edaravone) is available in all provinces and territories through the public formulary. 

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. 

Recent updates

September 2000: RILUTEK (riluzole) is available in all provinces and territories through the public formulary. 

Additional information: