ALS Canada Advocacy Update, January – March 2025

QALSODY Health Canada Approval

• On March 3, 2025, Health Canada approved QALSODY (tofersen) under a Notice of Compliance with Conditions (NOC/c) for the treatment of ALS in adults who have a pathogenic variant/mutation in the superoxide dismutase 1 (SOD1) gene. This means the drug will soon be made available and can be marketed in Canada with certain conditions.
• At this stage, the drug is not yet covered under public or private drug programs. We will continue our advocacy to ensure decision-makers in the reimbursement process work quickly to provide expedited and equitable access to the therapy for Canadians living with SOD1-ALS.

QALSODY – Canada’s Drug Agency Patient Input Submission

• In response to Canada’s Drug Agency (CDA)’s call for patient input on QALSODY, ALS Canada has submitted a patient input submission based on the experiences and perspectives of nearly 600 members of the ALS community who made their voice heard through our survey and focus groups.
• This submission is a crucial next step in ensuring the realities of ALS are reflected in the decision-making process.
  • Learn more about the next steps in the drug access process.

National Strategy for Drugs for Rare Diseases

• All provinces and territories have now signed bilateral agreements with the federal government under the National Strategy for Drugs for Rare Diseases. Each province will receive its share of $1.4 billion over three years to improve access to new drugs for rare diseases for its residents and to support enhanced access to existing drugs, early diagnosis, and screening for rare disease
  • Ontario: $535 million over three years (January 24, 2025)
  • British Columbia: $194 million over three years (July 23, 2024)
  • Saskatchewan: $40 million over three years (January 10, 2025)
  • Manitoba: $48 million over three years (February 27, 2025)
  • Nova Scotia: $39 million over three years (March 20, 2025)
  • Newfoundland and Labrador: $22 million over three years (November 15, 2024)
  • Prince Edward Island: $10 million over three years (March 7, 2025)
  • Yukon: $8.5 million over three years (March 13, 2025)
  • Northwest Territories: $7.8 million over three years (March 13, 2025)
  • Nunavut: $7.3 million over three years (March 13, 2025)
  • Quebec: $305 million over three years (March 21, 2025)
• We are pleased to see all provinces agreeing to the need for improved and faster access to drugs for people living with rare diseases. We hope the National Strategy will be a significant step forward in knowledge building and improving access to therapies for people living with rare diseases, including the ALS community.
• We remain committed to working with the federal and provincial governments to establish rare disease pathways in each province while advocating for swift action to meet the urgent needs of people affected by ALS.

Canada’s Drug Agency – Consultation on Improvements to Drug Reimbursement process

• ALS Canada participated in CDA’s consultation on Proposed Improvements to the Reimbursement Review Process bringing forward the importance of the need for disease-specific expertise and people with lived experiences, such as ALS neurologists and people affected by ALS, to be formally included in the health technology assessment of therapies and greater transparency around how patient input considered in the decision-making process.

Ontario Elections

• In February 2025, elections were held in Ontario and the Progressive Conservative party led by Premier Doug Ford was elected for a third majority government.
  • The Hon. Sylvia Jones remains as Minister of Health.
• We will continue engaging with Ontario elected officials and advocating for expedited and equitable access to approved therapies, appropriate healthcare resources, improved home and community care and highlighting the impact of the Ontario Provincial ALS Program for people living with ALS and work to ensure its sustainability into the future.

Ontario Health atHome

• ALS Canada continues to work closely with Ontario Health atHome (OHAH) to help ensure timely and streamlined access to home care services that meet the needs of Ontarians living with ALS.

Prorogation and New Prime Minister

• On January 6, 2025, former Prime Minister Justin Trudeau announced his resignation and prorogued Parliament until March 24 to allow the Liberal Party to choose a new leader. Prorogation postpones the meeting of Parliament without ending the session.
• Mark Carney became the leader of the Liberal Party and was sworn in as the new Prime Minister on March 14. Prime Minister Carney then called an election which will be held on April 28, 2025.
• To continue empowering your advocacy efforts, we have launched a practical resource you can utilize to engage with federal candidates about key priorities of the ALS community.

Canada Disability Benefit Regulation Published

• The government approved the regulations for the Canada Disability Benefit Act (CBD) which will come into effect on May 15, 2025. The purpose of the benefit is to financially support working-age people with disabilities.
• The eligibility in the regulations means individuals with the Disability Tax Credit (DTC) certificate who have filed their 2024 income tax return can apply for the CDB starting in June, with payments beginning in July 2025.

• On February 6, ALS Canada met with Dr. Supriya Sharma, Chief Medical Advisor, and other representatives at Health Canada to discuss the ALS drug landscape, and Canada’s position as a leading hub for ALS clinical trials.