ALS Canada Advocacy Update – October – December 2022

This blog series is a place for the ALS community to learn about and stay updated on ALS Canada’s advocacy efforts as well as relevant developments within government. Please note that because ALS Canada advocates federally and provincially within Ontario, these updates will primarily feature updates from the federal and Ontario provincial levels of government.

Therapeutics updates

ALBRIOZA (AMX0035) 

• e-advocacy campaign: In late October, ALS Canada launched an e-advocacy campaign focused on expedited and equitable access to ALBRIOZA (AMX0035). The campaign calls on participants to email their provincial government and urges them to implement the solutions outlined in our position paper, The Time is Now, by reimbursing ALBRIOZA without delay and ensuring criteria are in place that will allow anyone who could benefit from the therapy – as determined by their ALS clinician – to have public coverage. Since its launch, over 450 Canadians have participated in the campaign.   
• FDA approval: In September, Amylyx Pharmaceuticals, Inc announced that ALBRIOZA (AMX0035) was approved by the U.S. Food and Drug Administration (FDA) under the name Relyvrio.
• Frequently Asked Questions (FAQ) Page: ALS Canada developed an FAQ on ALBRIOZA to empower our community to make informed decisions about the treatment. 

Oral edaravone

• Health Canada approval: In early November, Health Canada approved the oral formulation of edaravone after a priority review.
• CADTH: The Canadian Agency for Drugs and Technology in Health (CADTH) posted its draft recommendations on oral edaravone for stakeholder feedback.
  • ALS Canada provided feedback in response to the CADTH’s draft reimbursement recommendations for oral edaravone to help ensure coverage criteria reflect the realities of the diagnosis and treatment of ALS. 

Masitinib

• In December, ALS Canada submitted a patient input submission to the Canadian Agency for Drugs and Technology in Health (CADTH) for masitinib, which is currently undergoing a Health Canada Notice of Compliance with Conditions review.  
  • Our submission leveraged survey information collected from over 600 Canadians affected by ALS and focused on the reality of living with the disease. 

Access to therapies

PMPRB Regulations

• In October, the Patented Medicine Prices Review Board (PMPRB) released its new draft Guidelines and launched a consultation period with stakeholders. 
• ALS Canada submitted feedback on the consultation and sent a letter to Health Minister Duclos as a Protect Our Access coalition member. 

Federal updates

2023 Federal Pre-Budget Submission

• On October 7, ALS Canada submitted a written brief to the House of Commons Standing Committee on Finance as part of their annual pre-budget consultation. Our brief recommended that the Government of Canada invest $35 million over five years to expand CAPTURE ALS from a pilot initiative to a world-leading, self-sustainable Open Science platform.  
  • CAPTURE ALS enables Canadian researchers to study why people experience ALS symptoms and progression differently. This essential knowledge will help identify treatment targets, strengthen global clinical trials, and develop Canadian infrastructure to attract private-sector medical R&D investment. 

Government meetings

• On September 14, ALS Canada met with the pan-Canadian Pharmaceutical Alliance (pCPA) to discuss the status of ALBRIOZA (AMX0035) in negotiations and to reiterate the need for criteria that reflects the realities of the diagnosis and treatment of ALS.   
• On September 20, ALS Canada met with MPP Vincent Ke (Ontario) to discuss the urgent need for timely, affordable, and equitable access to innovative ALS therapies.   

• On October 28, Tammy Moore, CEO, met with Supriya Sharma, Chief Medical Advisor, at Health Canada to discuss the personal importation of edaravone. 

Note to readers: This blog is a source of information for the ALS community that provides an overview of advocacy efforts and current affairs for Canadians affected by ALS. While there are many topics presented in this blog update, they don’t represent ALS Canada’s official position on any particular issue, nor indicate a complete list of ALS Canada’s advocacy priorities. We’re also unable to share all details about certain engagements with industry stakeholders due to confidentiality reasons.

You can read past advocacy updates here.