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.
The drug is now commercially available in Canada.Canadian Agency for Drugs and Technologies in Health (CADTH) and L’Institut national d’excellence en santé et en services sociaux (INESSS) released its reimbursement recommendations.
As of June 15, 2023, Amylyx and the pCPA have successfully concluded negotiations for ALBRIOZA and entered into a Letter of Intent (LOI) for the terms and conditions under which ALBRIOZA would qualify for reimbursement through federal, provincial, and territorial public drug plans in Canada.
As of August 1, 2023, the following provinces have made decisions regarding the public reimbursement of ALBRIOZA:
Ontario: With criteria under the Ontario Drug Benefit Formulary (Exceptional Access Program)
Québec: Under the Régie de l’assurance maladie du Québec (RAMQ) formulary (special authorization)
British Columbia: Under BC PharmaCare Formulary (special authorization)
New Brunswick: Under the New Brunswick Drug Plan (NBDP) formulary
Alberta: Under the Alberta Drug Benefit List
Nova Scotia: Under the Nova Scotia Pharmacare Program
Newfoundland and Labrador: Under the Newfoundland and Labrador Prescription Drug Program (NLPDP)
Manitoba: Under the Manitoba Drug Benefits and Interchangeability Formulary (special authorization)
Saskatchewan: Under the Saskatchewan Drug Plan Formulary
The remaining provinces have not yet made a reimbursement decision.
Our advocacy
Are you interesting in taking action for change? Visit our Reimbursement Campaign to learn more.
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.
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 TheTime is Nowposition 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. Now that the pCPA negotiations have concluded, each province/territory will do an independent review of the drug and decide if and how the public drug plan will cover the therapy.
ALS Canada is actively working to support the provincial drug programs to make informed and expedited reimbursement decisions by bringing forward the perspective and experiences of people affected by ALS.
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
Canadian Agency for Drugs and Technologies in Health (CADTH): In October 2022, CADTH, the agency responsible for provincial reimbursement recommendations, posted a call for patient and clinician input on masitinib.
The Time is Now:Within TheTime is Nowposition 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.
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 oral edaravone after a 180-day priority review.
As of July 20, 2023, MTPC and the pCPA have successfully concluded negotiations for oral edaravone and entered into a Letter of Intent (LOI) for the terms and conditions under which the therapy would qualify for reimbursement through federal, provincial, and territorial public drug plans in Canada.
As of November 7, 2023, following provinces have made decisions regarding the public reimbursement of RADICAVA Oral Suspension (edaravone):
Ontario: With criteria under the Ontario Drug Benefit Formulary (Exceptional Access Program)
Alberta: Under the Alberta Drug Benefit List
Quebec: Under the Régie de l’assurance maladie du Québec (RAMQ) formulary (special authorization)
British Columbia: Under the British Columbia PharmaCare (special authority)
New Brunswick: Under the New Brunswick Drug Plan (NBDP) formulary (special authorization)
Nova Scotia: Under the Nova Scotia Formulary (exceptional status)
Saskatchewan: Under the Saskatchewan Drug Plan Formulary (Exception Drug Status)
Newfoundland and Labrador: Under the Newfoundland and Labrador Prescription Drug Program (NLPDP) (special authorization)
Prince Edward Island: Under the Prince Edward Island (PEI) Pharmacare Formulary (special authorization)
We urge all remaining provinces and territories to reimburse RADICAVA Oral Suspension (edaravone) without delay.
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.
Approval is just one step in making a new therapy available and accessible in Canada. Now that the pCPA negotiations have concluded, each province/territory will do an independent review of the drug and decide if and how the public drug plan will cover the therapy.
ALS Canada is actively working to support the the provincial drug programs to make informed and expedited reimbursement decisions by bringing forward the perspective and experiences of people affected by ALS.
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).
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.
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.
