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 (AM00X35)
- 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.
- ALBRIOZA was approved by Health Canada under the Notice of Compliance with Conditions (NOC/c) pathway in 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.
Provincial Updates
Ontario Provincial ALS Program
- On March 26, 2024, Ontario’s Minister of Finance, Peter Bethlenfalvy, presented the province’s 2024 Budget. While the initial budget announcement did not explicitly include a $6.6 million investment to implement the recommendations outlined in the Ontario Provincial ALS Program, we are actively continuing our discussions with key ministries and stakeholders.
- Our conversations are gaining depth and momentum. We appreciate your support as we work toward ensuring Ontarians living with ALS receive the care and support they rightly deserve. We will continue to keep you informed of any developments.
Provincial Cabinet Shuffle
- On June 6 2024, Ontario Premier Doug Ford shuffled his cabinet. Hon. Natalia Kusendova-Bashta is appointed as the new Minister of Long-Term Care.
Federal Updates
Letter to the Minister of Transport
- ALS Canada sent a letter to Federal Minister of Transport, the Honourable Pablo Rodriguez, highlighting the urgent need for accessible air travel for Canadians who rely on mobility devices like wheelchairs, including people living with ALS, and advocating for equitable access to air travel for all.
- Read our letter.
Government Meetings
- On April 3, ALS Canada met with Supriya Sharma, Chief Medical Advisor and Jeffrey Skene, Director, Bureau of Cardiology, Allergy and Neurological Science at Health Canada to discuss the ALS therapeutic pipeline.
- Throughout the quarter, ALS Canada met with stakeholders from the Ontario Ministry of Health, to discuss the implementation of the Ontario Provincial ALS Program to ensure Ontarians living with ALS and their loved ones receive the care and support they rightly deserve.
ALS Awareness Month
- On June 4, Sylvia Jones, Ontario’s Minister of Health introduced ALS Society of Canada as visitors at the Legislative Assembly and raised point of order for unanimous consent to allow members to wear pins in recognition of June being ALS Awareness Month at the Legislative Assembly.
- Throughout June, MPs and Ontario based MPPs voiced their support of people affected by ALS through videos published on ALS Canada’s social media channels.
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.
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
Masitinib
- AB Science announced that Health Canada has issued a Notice of Non-Compliance–Withdrawal (NON-W) for masitinib in ALS due to unresolved clinical concerns and data reliability issues.
ALBRIOZA (AM00X35)
- Amylyx Pharmaceuticals announced that the PHOENIX Phase 3 clinical trial of AMX0035, marketed as ALBRIOZA in Canada, did not meet its primary or secondary endpoints.
- ALBRIOZA is approved by Health Canada under the Notice of Compliance with Conditions (NOC/c) pathway, with conditions depending on the outcome of the PHOENIX trial.
Tofersen
- Biogen Canada announced that Health Canada accepted its New Drug Submission (NDS) for tofersen for the treatment of ALS in adults who have a pathogenic variant (also known as a mutation) in the superoxide dismutase 1 (SOD1) gene.
- This step triggers a thorough regulatory review of the therapy, which will result in the decision as to whether tofersen will be approved for use in Canada.
- ALS Canada will continue to provide updates as information becomes available. To learn more about tofersen, visit our frequently asked questions blog post on this topic.
Access to therapies
Meeting with the new pCPA leadership
- As a member of the Health Charities Coalition of Canada (HCCC) and HealthPartners, ALS Canada participated in a meeting with the first-ever CEO of the pan-Canadian Pharmaceutical Alliance (pCPA), Douglas Clark, to discuss pCPA’s top priorities and share our community’s perspective to inform the organization’s strategic plan.
Canadian Organization for Rare Disorders (CORD) – Rare Disease Day 2024 Summit
- To mark Rare Disease Day on February 29, ALS Canada attended the Canadian Organization for Rare Disorders’ Rare Disease Day 2024 Summit in Ottawa. During this time, we provided input on the experience of the ALS community during the multistakeholder expert panel discussing creating expanded, accelerated, and sustainable access to rare disease therapies.
Provincial Updates
ALS Canada’s Queen’s Park Day of Action
- On February 21, members of the ALS community joined ALS Canada at Queen’s Park, urging the Ontario government to invest $6.6 million of crucial funding in Budget 2024 to implement the Ontario Provincial ALS Program to support Ontarians living with ALS and their families with their clinical care and support needs.
- With participation from more than 40 MPPs, including the Minister of Health, Sylvia Jones, ALS Canada’s Queen’s Park Day of Action raised awareness of the current realities of the province’s health care system, which fails to meet the complex and urgent needs of people living with ALS, leaving more than 1,300 Ontarians without adequate care and support.
2024 Ontario Budget
- On March 26, Ontario’s Minister of Finance, Peter Bethlenfalvy, presented the province’s 2024 Budget.
- While the initial budget announcement did not explicitly include a $6.6 million investment to implement the recommendations outlined in the Ontario Provincial ALS Program, we will continue our discussions with the government and relevant ministries to seek clarification.
- Learn more about our 2024 Ontario Budget submission.
Government Meetings
- Throughout January and February, ALS Canada met with several Ontario MPPs, calling on the provincial government to implement the Ontario Provincial ALS Program in Budget 2024 to ensure Ontarians living with ALS and their loved ones receive the care and support they rightly deserve:
- Doug Ford, Premier of Ontario
- Office of the Minister of Health, Sylvia Jones
- MPP Dawn Gallagher Murphy, Parliamentary Assistant to the Minister of Health
- MPP David Smith, Parliamentary Assistant to the Minister of Labour, Immigration, Training and Skills Development
- Raymond Cho, Minister for Seniors and Accessibility
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.
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
RADICAVA Oral suspension (edaravone)
- Provincial Reimbursements: As of November 7, 2023, the following provinces have made decisions regarding the public reimbursement of RADICAVA Oral Suspension:
- Alberta: Under the Alberta Drug Benefit List
- British Columbia: Under the British Columbia PharmaCare (special authority)
- New Brunswick: Under the New Brunswick Drug Plan (NBDP) formulary (special authorization)
- Newfoundland and Labrador: Under the Newfoundland and Labrador Prescription Drug Program (NLPDP) (special authorization)
- Nova Scotia: Under the Nova Scotia Formulary (exceptional status)
- Ontario: Under the Ontario Drug Benefit Formulary (Exceptional Access Program)
- Prince Edward Island: Under the Prince Edward Island (PEI) Pharmacare Formulary (special authorization)
- Quebec: Under the Régie de l’assurance maladie du Québec (RAMQ) formulary (special authorization)
- Saskatchewan: Under the Saskatchewan Drug Plan Formulary (Exception Drug Status)
Access to therapies
e-advocacy Campaign
- ALS Canada’s e-advocacy campaign focused on expedited and equitable access to approved ALS therapies is ongoing.
- The campaign calls on participants to email their provincial or territorial government and urges them to implement the solutions outlined in our position paper, The Time is Now, by reimbursing ALBRIOZA and RADICAVA Oral Suspension (edaravone) 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.
Advocacy-in-a-Box Toolkit
- To continue empowering your advocacy efforts for the urgently needed solutions outlined in The Time is Now position paper, we’ve launched a new Advocacy-in-a-Box toolkit that contains resources to support advocacy to provincial governments for swift and equitable reimbursement of Health Canada-approved therapies.
- Grounded in The Time is Now position paper, the toolkit highlights the ALS community’s experience with ALBIOZA and RADICAVA Oral Suspension (edaravone) as an example of how Canada’s current approval and reimbursement processes do not meet the urgent needs of people living with ALS.
Provincial Updates
Regional 2024 Pre-Budget Consultations
- ALS Canada participated in the regional pre-budget consultation hosted by the Ontario Ministry of Finance in Richmond Hill and Vaughan, calling on the provincial government to implement the Ontario Provincial ALS Program in Budget 2024 to ensure Ontarians living with ALS and their loved ones receive the care and support they rightly deserve.
- ALS Canada will continue to engage with the Ontario government as part of the pre-budget consultation process through various mechanisms available.
Ontario Legislature Adjournment
- On December 14, the Ontario Legislature adjourned for the year. It is scheduled to resume sitting on February 20, 2024.
Government Meetings
- In October, ALS Canada, alongside a community member, met with the Non-Insured Health Benefits (NIHB) program to share the challenges faced by the First Nations community with access to healthcare for a timely ALS diagnosis and equitable access to therapies
- Throughout November and December, ALS Canada met with several Ontario MPPs to discuss a coordinated solution to ensure Ontarians living with ALS get the support for the vital care they require:
- MPP Dawn Gallagher Murphy, Parliamentary Assistant to the Minister of Health
- MPP Christine Hogarth, Parliamentary Assistant to the Solicitor General
- MPP Lorne Coe, Parliamentary Assistant to the Premier
- Office of the Minister of Seniors and Accessibility, Raymond Cho
- Office of the Minister of Health, Sylvia Jones
- Office of the Minister of Labour, Immigration, Training and Skills Development, David Piccini
- Office of the Premier, Doug Ford
- Office of the Minister of Finance, Peter Bethlenfalvy
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.
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
- pCPA: On June 15, 2023, Amylyx and the pan-Canadian Pharmaceutical Alliance (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.
- It is now up to individual provinces and territories to make a reimbursement decision for the therapy.
- Provincial Reimbursements: As of September 1, 2023, the following provinces have made decisions regarding the public reimbursement of ALBRIOZA:
- Alberta: Under the Alberta Drug Benefit List
- British Columbia: Under the British Columbia PharmaCare Formulary (special authorization)
- Manitoba: Under the Manitoba Drug Benefits and Interchangeability Formulary (special authorization)
- New Brunswick: Under the New Brunswick Drug Plan (NBDP) formulary
- Newfoundland and Labrador: Under the Newfoundland and Labrador Prescription Drug Program (NLPDP)
- Nova Scotia: Under the Nova Scotia Pharmacare Program
- Ontario: With criteria under the Ontario Drug Benefit Formulary (Exceptional Access Program)
- Québec: With criteria under the Régie de l’assurance maladie du Québec (RAMQ) formulary (special authorization)
- Saskatchewan: Under the Saskatchewan Drug Plan Formulary
RADICAVA Oral suspension (edaravone)
- pCPA: On July 20, 2023, Mitsubishi Tanabe Pharma Canada Inc. and the pCPA have successfully concluded negotiations for RADICAVA Oral Suspension (edaravone), also known as 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.
- It is now up to individual provinces and territories to make a reimbursement decision for the therapy.
- Provincial Reimbursements: As of September 1, 2023, the following provinces have made decisions regarding the public reimbursement of RADICAVA Oral Suspension:
- Alberta: Under the Alberta Drug Benefit List
- 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)
- Ontario: Under the Ontario Drug Benefit Formulary (Exceptional Access Program)
- Quebec: Under the Régie de l’assurance maladie du Québec (RAMQ) formulary (special authorization)
- Saskatchewan: Under the Saskatchewan Drug Plan Formulary (Exception Drug Status)
Access to therapies
pCPA Temporary Access Process (pTAP)
- ALS Canada participated in the pan-Canadian Pharmaceutical Alliance (pCPA)’s stakeholder engagement session to provide feedback on the draft conditions for the pCPA Temporary Access Process (pTAP) and highlighted the importance of implementing an expedited, transparent, and inclusive reimbursement process to address the needs of people living with ALS.
- ALS Canada will continue to work with the pCPA to lay the groundwork for swift reimbursement decisions to help ensure equitable access in a timeframe that meets the urgency of this disease.
e-advocacy Campaign
- ALS Canada’s e-advocacy campaign focused on expedited and equitable access to approved ALS therapies is ongoing.
- The campaign calls on participants to email their provincial or territorial government and urges them to implement the solutions outlined in our position paper, The Time is Now, by reimbursing ALBRIOZA and RADICAVA Oral Suspension (edaravone) 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.
Advocacy in a Box Toolkit
- To continue empowering your advocacy efforts for the urgently needed solutions outlined in The Time is Now position paper, we’ve launched a new Advocacy-in-a-Box toolkit that contains resources to support advocacy to provincial governments for swift and equitable reimbursement of Health Canada-approved therapies.
- Grounded in The Time is Now position paper, the toolkit highlights the ALS community’s experience with ALBIOZA and RADICAVA Oral Suspension (edaravone) as an example of how Canada’s current approval and reimbursement processes do not meet the urgent needs of people living with ALS.
Federal updates
2024 Federal Pre-Budget Consultation
- ALS Canada submitted to the House of Commons Standing Committee on Finance as part of their annual pre-budget consultation. Our submission 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.
New Cabinet Appointments
- On July 26, a new federal Cabinet was sworn in, with the Hon. Mark Holland appointed as the Minister of Health and the Hon. Ya’ara Saks as Minister of Mental Health and Addictions and Associate Minister of Health.
Government meetings
- On June 26, ALS Canada, alongside a community member, met with the Hon. Sylvia Jones, Ontario Minister of Health, to discuss the needs of people living with ALS in Ontario and the critical role the Ontario Government plays in taking action to make a difference for families affected by ALS.
- On July 5, ALS Canada, alongside a community member, met with the Ontario Ministry of Health bureaucracy to discuss the solutions outlined in ALS Canada’s The Time is Now position paper and the need for Ontarians living with ALS to have expedited and equitable access to therapies.
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.
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
Oral edaravone
- pCPA: On March 14, 2023, the pan-Canadian Pharmaceutical Alliance (pCPA) started the negotiation process for oral edaravone.
- While this is a positive step forward, Canadians living with ALS do not have the time to wait the months it can take for negotiations to conclude.
- ALS Canada will continue to work with the pCPA and the provincial drug programs to lay the groundwork for swift reimbursement decisions to help ensure equitable access in a timeframe that meets the urgency of this disease.
Qalsody (tofersen)
- On April 25, 2023, the U.S. Food and Drug Administration (FDA) approved Qalsody (tofersen) for the treatment of SOD1-ALS under the Accelerated Approval pathway.
- ALS Canada developed an FAQ on Qalsody, which explores information on the therapy and discusses what this approval means to the Canadian ALS community.
Access to therapies
e-advocacy Campaign
- ALS Canada’s e-advocacy campaign focused on expedited and equitable access to approved ALS therapies is ongoing.
- 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 and oral edaravone 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.
Advocacy in a Box Toolkit
- To continue empowering your advocacy efforts for the urgently needed solutions outlined in The Time is Now position paper, we’ve launched a new Advocacy-in-a-Box toolkit that contains resources to support advocacy to provincial governments for swift and equitable reimbursement of Health Canada approved therapies.
- Grounded in The Time is Now position paper, the toolkit highlights the ALS community’s experience with Albrioza as an example of how Canada’s current approval and reimbursement processes do not meet the urgent needs of people living with ALS.
Federal Updates
National Strategy for Drugs for Rare Diseases
- On March 22, the Federal Government announced the National Strategy for Drugs for Rare Diseases.
- We are pleased to see this strategy move forward and hope it will be a significant step in building knowledge and improving access to therapies for people living with rare diseases, including the ALS community.
- We remain committed to being a partner and 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.
Government meetings
- On March 30, ALS Canada met with MP Heather McPherson and MP Francis Drouin, ALS Caucus Co-Chairs, to provide an update on the recent developments with respect to access to new ALS therapies.
- On April 24, ALS Canada met with MPP Nolan Quinn to discuss the need for Ontarians living with ALS to have expedited and equitable access to therapies.
- On May 15, ALS Canada, alongside a community member, met with MLA Brendan Macguire (Nova Scotia) to discuss the critical role provincial governments across Canada play to ensure people living with ALS have expedited and equitable access to therapies.
- On June 7, ALS Canada, alongside a community member, met with MPP Adil Shamji to discuss the challenges Ontarians living with ALS face.
ALS Awareness Month
- Federal Minister of Health, Jean-Yves Duclos, published a statement recognizing June ALS Awareness Month.
- On June 1, Sylvia Jones, Ontario’s Minister of Health, acknowledged June ALS Awareness Month and introduced ALS Society of Canada as visitors at the Legislative Assembly.
- On June 6, MPP Bob Bailey delivered a Members’ Statement in the Legislative Assembly acknowledging June as ALS Awareness Month.
- On June 6, MPP Dawn Gallagher-Murphy raised point of order for unanimous consent to allow members to wear pins in recognition of June being ALS Awareness Month at the Legislative Assembly.
- Throughout June, MPs and Ontario based MPPs voiced their support of people affected by ALS through videos published on ALS Canada’s social media channels.
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.
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
Oral edaravone
- CADTH: In January, The Canadian Agency for Drugs and Technology in Health (CADTH) released its final reimbursement recommendations on oral edaravone with a recommendation to reimburse with conditions. This is another critical step in establishing an environment where Canadians living with ALS have access to multiple available therapies.
- Read ALS Canada’s feedback in response to the draft recommendations.
- INESSS: L’institut national d’excellence en santé et en services sociaux (INESSS), the agency responsible for Quebec’s reimbursement recommendations, released its final reimbursement recommendations on oral edaravone with a recommendation to reimburse with conditions.
- Market availability: In February, oral edaravone became commercially available in Canada for people living with ALS, meaning that clinicians are able to prescribe the therapy.
- The therapy has not yet started negotiations under pCPA or at the provincial level to determine whether it will be covered publicly.
- ALS Canada will continue to work with the pCPA and the provincial drug programs to lay the groundwork for swift reimbursement decisions to help ensure equitable access in a timeframe that meets the urgency of this disease.
Access to therapies
Advocacy in a Box Toolkit
- To continue empowering your advocacy efforts for the urgently needed solutions outlined in The Time is Now position paper, we’ve launched a new Advocacy-in-a-Box toolkit that contains resources to support advocacy to provincial governments for swift and equitable reimbursement of Health Canada approved therapies.
- Grounded in The Time is Now position paper, the toolkit highlights the ALS community’s experience with Albrioza as an example of how Canada’s current approval and reimbursement processes do not meet the urgent needs of people living with ALS.
PMPRB Regulations
- Following the consultation launched in October, the Patented Medicine Prices Review Board (PMPRB) announced that the proposed updates to the guidelines would not be implemented. Interim Guidelines issued on August 18, 2022, will remain in place until further notice.
Provincial updates
2023 Ontario Pre-Budget Submission
- In February, ALS Canada participated in the Ontario Government’s 2023 budget consultation. In our submission, we call on the Ontario Government to eliminate barriers preventing Ontarians from having timely, equitable and affordable access to approved ALS treatments and to establish an Ontario ALS Program that will reduce the burden on our healthcare system and improve the standard of care provided to people living with ALS.
Rare Disease Day
- On February 28, ALS Canada attended the Rare Disease Day 2023 Breakfast Reception at Queen’s Park hosted by the Canadian Organization for Rare Disorders (CORD) to start a dialogue about how the Ontario government can collaborate on the development of a provincial rare disease strategy to ensure people living with rare diseases can access new and emerging therapeutics in a timely and equitable way.
Government meetings
- On January 27, ALS Canada met with MP Heather McPherson, ALS Caucus Co-Chair, to provide an update on the recent developments with respect to access to new ALS therapies.
- On February 1, ALS Canada met once again with the pan-Canadian Pharmaceutical Alliance (pCPA) to discuss the status of ALS therapies in negotiations and reiterated the critical need for the Canadian ALS community to have equitable access to approved therapies.
- On March 13, ALS Canada met with MPP Chris Glover to discuss the need for Ontarians living with ALS to have expedited and equitable access to therapies.
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.
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)
- CADTH: On August 8, the Canadian Agency for Drugs and Technology in Health (CADTH) released its final recommendations on ALBRIOZA.
- In late June, ALS Canada and the Canadian ALS Clinical community both provided feedback in response to the CADTH’s draft reimbursement recommendations for ALBRIOZA to help ensure coverage criteria reflect the realities of the diagnosis and treatment of ALS.
- The focus of the feedback was on challenges surrounding the proposed eligibility criteria. The final recommendations reflected a nuanced change to the suggested reimbursement conditions, as requested by ALS Canada in our feedback.
- INESSS: On July 27, L’institut national d’excellence en santé et en services sociaux (INESSS), the agency responsible for Quebec’s reimbursement recommendations, issued a recommendation of “do not reimburse” for ALBRIOZA.
- ALS Canada sent a letter to the Quebec Minister of Health in late July encouraging a reimbursement decision from INESSS on ALBRIOZA.
- The ALS Society of Quebec and ALS Canada continue to advocate for the Minister of Health to reconsider and provide a positive reimbursement recommendation for ALBRIOZA.
- pCPA: As of August 9, ALBRIOZA is on the list of drugs in negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA).
- In July, ALS Canada met with the pCPA leadership team to discuss the need for an expedited negotiation process for ALBRIOZA.
- Following the meeting – and aligned with our advocacy – we are encouraged to see that pCPA started the negotiations a day after the final CADTH recommendations were released.
- Market access: In late July, ALBRIOZA (AMX0035) became commercially available in Canada for people living with ALS.
- Frequently Asked Questions (FAQ) Page: ALS Canada developed an FAQ on ALBRIOZA to empower our community to make informed decisions about the treatment.
Access to therapies
Tofersen FDA priority review
- In July, Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for tofersen under a priority review.
Final Report on Proposed framework for a potential Pan-Canadian Formulary | CADTH
- CADTH released its final report on Proposed Framework for a Potential Pan- Canadian Formulary.
- The report is intended to contribute to current conversations on potential pan-Canadian formulary within a national pharmacare program and the issues related to access and affordability.
- ALS Canada contributed to the consultation for the final report as a member of the Health Charities Coalition of Canada (HCCC) and highlighted the importance of making innovative medicines accessible to Canadians living with ALS in an affordable, timely and equitable manner.
New Web Page | ALS treatments in the Canadian drug access processes
- ALS Canada recently launched the ALS Treatments in the Canadian Drug Access Processes page.
- This page provides information on how long it takes for a drug to make its way through the drug access processes in Canada and how ALS Canada is advocating to change that reality.
Provincial updates
- Post-Election | New Cabinet Appointments
- On June 24, a new provincial cabinet was sworn into the Ontario Legislature. The Hon. Sylvia Jones is appointed as the Minister of Health and Hon. Paul Calandra is appointed as the Minister of Long Term Care.
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.
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)
- Health Canada approved ALBRIOZA (AMX0035) under a Notice of Compliance with Conditions (NOC/c). This means the drug is available and can be marketed in Canada under certain conditions.
- Health Canada’s approval is a positive step forward in the available treatment options for people living with ALS.
- Canada is also the first country to approve ALBRIOZA as a treatment for ALS – demonstrating the strength of the ALS community as an environment for innovative therapies.
- ALS Canada will continue to be involved in the CADTH Health Technology Assessment process and is actively working to support the pan-Canadian Pharmaceutical Alliance (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.
- You can read more in the press release from Amylyx Pharmaceuticals Inc. (English only).
Oral edaravone
- Health Canada accepted Mitsubishi Tanabe Pharma Canada, Inc.’s filing of a Supplement to a New Drug Submission (SNDS) for an investigational oral formulation of edaravone.
- This step triggers a thorough regulatory review of the therapy, which could result in the drug being approved in Canada.
- We are also encouraged to learn that Health Canada has granted a Priority Review of the therapy, which expedites the review timeline to six months.
- We believe any new innovative ALS therapy should be granted priority review status – and we are hopeful this decision sets an important precedent for all future ALS therapies.
- You can read more in MTP-CA’s press release.
- On May 12, 2022, the FDA approved an oral formulation of edaravone, also known as oral edaravone, for adults living with ALS.
- Read more about the decision.
Masitinib
- Health Canada accepted AB Science’s New Drug Submission (NDS) for masitinib.
- This step triggers a thorough regulatory review of the therapy under the Notice of Compliance with Conditions (NOC/c) pathway.
- You can read more in AB Science’s press release.
Access to therapies
PMPRB regulations
- On April 14, 2022, Hon. Jean-Yves Duclos, the Minister of Health, announced that the government will not proceed with the amendments related to the new price regulatory factors.
- The government’s decision not to proceed with the amendments that could create barriers for companies to bring innovative medicines to Canada indicates that by working together to approach decision-makers, we can make our voices heard.
- We thank the ALS community for their advocacy efforts in creating this change.
- ALS Canada will continue to advocate for Canadians living with ALS to access proven ALS therapies in a timely, equitable, and affordable way.
- Read more about the change here.
Biogen clinical trial
- Based on data from a Phase 1 clinical trial, Biogen and Ionis Pharmaceuticals are discontinuing the development of BIIB078, their experimental treatment candidate for ALS caused by mutations in the C9ORF72 gene.
- Although the trial will not continue, the results will help inform future research.
- Read more about the decision here.
Cytokinetics ALS Patient Advocacy Partner Summit
- ALS Canada participated in the Cytokinetics ALS Patient Advocacy Partner Summit.
- The summit’s purpose was to engage patient groups in a discussion on public policy and community advocacy priorities.
- Coming together with our international partners gives us an opportunity to elevate our current advocacy initiatives and leverage collaborative opportunities to voice the Canadian ALS community’s concerns.
- Other attendees included the International Alliance of ALS/MND Associations, Muscular Dystrophy Association, the ALS Association, I AM ALS, ALS Therapy Development Institute, and other organizations from across the U.S.
Federal Updates
National Strategy for Drugs for Rare Disease roundtable
- Tammy Moore, CEO, ALS Canada, took part in a roundtable as part of Health Canada’s consultation on creating a National Strategy for Drugs for Rare Diseases, where she provided comments on the What We Heard from Canadians Report.
- The roundtable was an opportunity to reiterate the urgent need to change how drugs are made available in Canada and for Canadians living with ALS to access approved therapies in a timely way.
- Please read our consultation submission from March 2021 to learn more.
Provincial Updates
Government meetings
- Prior to the election, ALS Canada met with the Ontario Ministry of Health bureaucracy to discuss the solutions outlined in ALS Canada’s The Time is Now position paper and the need for Ontarians living with ALS to have expedited and equitable access to therapies.
- This meeting helped lay the foundation for future conversations surrounding ALS therapies and the need for Ontario to provide swift reimbursement.
- We will continue to engage with MPPs and other key decision-makers when the Legislative Assembly is in session.
2022 Ontario Elections
- On June 2, Ontarians voted to re-elect a Conservative majority government, with New Democrats remaining as the official opposition. Full election results can be found at Elections Ontario here.
- Key next steps for the provincial government include appointing a new Cabinet and swearing-in of MPPs at the Ontario Assembly.
- ALS Canada will continue to monitor these developments and begin engaging with new and returning MPPs in the coming weeks to discuss issues surrounding access to therapies in Ontario.
- You can view our election blog post, Knowing the issues that matter to Ontario’s ALS Community: 2022 Ontario Election, to learn more about parties’ commitments to address issues affecting the ALS community.
ALS Awareness Month
- On June 2, Lou Gehrig Day – ALS Caucus Co-Chairs MPs Francis Drouin and Marie-Hélène Gaudreau delivered Members Statements in the House of Commons in recognition of ALS Awareness Month.
- On June 3, MP Bryan May recognized ALS Awareness Month in the House of Commons and shared his support for Canadians living with ALS.
- Throughout June, Ontario-based MPs voiced their support of people affected by ALS through videos published on ALS Canada’s social media pages.
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.
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.
Access to therapies
AMX0035 | CADTH
- In late October, the Canadian Agency for Drugs and Technology in Health (CADTH) posted a call for patient input on AMX0035.
- ALS Canada invited the community to contribute to the submission by sharing their experiences with ALS through a survey. More than 600 Canadians participated in the survey, bringing forward their perspectives.
- The patient input submission will help inform recommendations about public coverage of the therapy once approved.
- Read our submission
Oral Edaravone | CADTH
- In early February, Canadian Agency for Drugs and Technology in Health (CADTH) has 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.
- Input from the community continues to help us ensure that issues of importance to the ALS community are considered by decision-makers at CADTH, who ultimately recommend whether public drug plans should cover the drug if it is approved by Health Canada.
- Read our patient submission here.
- The ALS Clinical community also provided a written submission
Edaravone | Personal Importation
- After continued conversations, Health Canada has confirmed that people living with ALS can continue to access edaravone through personal importation beyond April 1, 2022. An extension has been granted until October 1, 2022.
Proposed framework for a potential Pan-Canadian Formulary | CADTH
- As a member of the Health Charities Coalition of Canada (HCCC), we responded to the Canadian Agency for Drugs and Technologies in Health (CADTH) ‘s consultation on a proposed framework for a potential pan-Canadian formulary.
- Our response brought forward the perspective of health charities across Canada and highlighted the importance of making innovative medicines accessible to Canadians living with ALS in an affordable, timely and equitable manner.
PMPRB Regulations Delayed
- The implementation of the Patented Medicines Prices Review Board (PMRPB) regulations has been delayed until July 1, 2022.
- We thank the ALS community for raising their voices. Your advocacy efforts helped government understand why further consultation is needed to understand the impact of the reforms on drug access in Canada.
- Read more about the decision.
Federal Updates
Government Meetings
- March 23 – Joined by ALS community advocates Mike and Carmen Cels, Tammy Moore, CEO and Lauren Poplak, Stakeholder Relations Manager, met with Sandenga Yeba (Senior Policy Advisor to the Office of the Minister of Health) to discuss the critical role the federal government plays in enabling the solutions outlined in our position paper, The Time Is Now.
- March 24 –Tammy Moore, CEO, met with Linsey Hollet (Director General at Health Canada) and Supriya Sharma (Chief Medical Advisor at Health Canada) to touch base on the personal importation of edaravone in Canada, resulting in an extension.
Liberal – NDP Agreement
- On March 22, Prime Minister Justin Trudeau announced that a multi-year agreement was reached by Liberal Party and the New Democratic Party (NDP).
- The parties agreed to prioritize certain policy areas and legislation, such as Pharmacare and Safe Long-Term Care Act, as part of the agreement.
- ALS Canada was an active participant in the consultation on the Implementation of National Pharmacare and Health Canada’s consultation on the development of a National Strategy for Drugs for Rare Diseases.
- ALS Canada will continue to explore the details of this agreement as we want to ensure any solutions put forward through this agreement respond to the needs of the ALS community.
Provincial Updates
Virtual Advocacy Week
- In early March, members of the ALS community joined ALS Canada for advocacy training and a week of meetings with Ministers and Members of Provincial Parliament (MPPs) in Ontario as part of ALS Canada’s first-ever Ontario Virtual Advocacy Week, taking place March 7 – 11.
- From people living with ALS and their caregivers and family members to volunteers and staff, our delegation of 27 people discussed the solutions outlined in our position paper, The Time Is Now, and made the following asks of the Ontario government:
- Upon Health Canada’s approval and the development of applicable clinical criteria/prescribing guidelines, all ALS treatments are publicly funded on an interim basis by public drug plans.
- All ALS treatments are approved, reviewed for public reimbursement, and publicly funded through a single condensed timeframe applicable to all jurisdictions in Canada.
- Our meetings were positive, with all MPPs expressing a shared concern for the challenges faced by the ALS community and an understanding of the urgent need for expedited and equitable access to ALS therapies.
- In response to the meetings, the MPPs committed to bringing forward the need for health policy change that would see therapies in the hands of people living with ALS in a timeframe that more accurately reflects the reality of the disease with the Minister of Health and in the legislative assembly.
- This has taken the form of letters to the Minister and in-person conversations.
- ALS Canada continues to engage with Ontario MPPs in the lead-up to the upcoming election.
Throughout the week, we met with:
Minister of Health, Hon. Christine Elliott (Newmarket-Aurora)
Solicitor General, Hon. Sylvia Jones (Dufferin-Caledon)
Speaker of the House, Hon. Ted Arnott (Wellington-Halton Hills)
Office of the Minister of Finance, Hon. Peter Bethlenfalvy (Pickering – Uxbridge)
Minister of Energy, Hon. Todd Smith (Bay of Quinte)
MPP Aris Babikian (Scarborough—Agincourt)
MPP Stephen Blais (Orléans)
MPP Will Bouma (Brantford-Brant)
MPP Stephen Crawford (Oakville)
MPP Rudy Cuzzetto (Mississauga—Lakeshore)
MPP John Fraser (Ottawa South)
MPP Jennifer French (Oshawa)
MPP France Gélinas (Nickel Belt) – Health Critic
MPP Joel Harden (Ottawa Centre)
MPP Natalia Kusendova (Mississauga Centre)
MPP Michael Mantha (Algoma – Manitoulin)
MPP Peggy Sattler (London West)
MPP Monique Taylor (Hamilton Mountain)
MPP Jamie West (Sudbury)
2022 Ontario Pre-Budget Consultation
- We participated in the 2022 Ontario Pre-Budget Consultations. We are calling on the Ontario government to implement the immediate and long-term drug access solutions outlined in our position paper, The Time is Now.
- Government has a critical role in eliminating the barriers preventing Ontarians living with ALS from having timely, fair and affordable access to the drugs they need.
- Read our Ontario 2022 .
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.
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.
Access to therapies
AMX0035 | CADTH
- In late October the Canadian Agency for Drugs and Technology in Health (CADTH) has posted a call for patient input on AMX0035.
- ALS Canada will be preparing a submission reflecting the perspectives of the ALS community and has 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 will inform the patient input submission to CADTH.
- The ALS clinical community will also be providing a written submission.
The Time is Now | ALS Position Paper & e-Advocacy Campaign Update
- The Time is Now position paper, which outlines two pathways for more timely and equitable access to approved ALS therapies via reimbursement, continues to gain momentum. As of December 7, 2021, more than 7,000 Canadians have participated in the e-campaign, telling their elected officials to help ensure that the solutions outlined in the paper are implemented.
Edaravone
- On October 8, Health Canada confirmed that people living with ALS can continue to access Edaravone through personal importation beyond October 1, 2021 until April 1, 2022.
- On November 23, the province of Prince Edward Island (PEI) announced it has listed Radicava (edaravone) on the public formulary under Special Authorization as a treatment for ALS. With this announcement, all provinces and territories across Canada – as well as Veterans Affairs Canada and Indigenous Services Canada – are now covering Radicava through their public formularies.
Health Canada ALS Patient Listening Session:
- ALS Canada joined five community advocates to participate in the first ever Patient Listening Session on the topic of ALS, hosted by Health Canada’s Office of Pediatrics and Patient Involvement (OPPI).
- OPPI is piloting the FDA’s patient listening session model to identify the components that would work best in the Canadian context, and the ALS community has been asked to support this effort.
Federal Updates
Government Meetings
- Shortly after the September 2021 federal election, ALS Canada began re-engaging with re-elected members of the all-party ALS Caucus to brief them on recent developments with respect to access to new ALS therapies:
- Nov. 16 – CEO Tammy Moore met with MP Francis Drouin (Glengarry—Prescott—Russell), Co-Chair of the ALS Caucus.
- Nov. 3 – Joined by ALS community advocates Mike and Carmen Cels, CEO Tammy Moore and Public Affairs Manager Lauren Poplak met with MP Pam Damoff (Oakville North—Burlington).
- Oct. 14 – Director of Community Services Kim Barry had a call with Minister Mona Fortier (Ottawa—Vanier), President of the Treasury Board.
- At these meetings, we raised the important need for the ALS community to have access to new therapies as quickly as possible, our concern with the Health Canada review decision for AMX0035, and our belief that all ALS therapies need to be granted priority review status by Health Canada going forward.
Post-Election | New Cabinet Appointments & Next Steps
- On October 26, a new federal Cabinet was sworn in, with the Hon. Jean-Yves Duclos appointed as the Minister of Health and the Hon. Carolyn Bennett as Minister of Mental Health and Addictions and Associate Minister of Health.
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.
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.
Access to therapies
PMPRB Regulations Delayed
- On June 29, the implementation of the Patented Medicine Prices Review Board (PMPRB)’s new regulations were delayed until January 1, 2022.
- Further, on July 15, the PMPRB announced another public consultation on three new amendments to the regulations with an August 31 deadline.
- ALS Canada is reviewing the proposed amendments and will be making a submission.
The Time is Now | ALS Position Paper & e-Advocacy Campaign Update
- ALS Canada’s The Time is Now e-advocacy campaign, aimed at highlighting two solutions to getting Health Canada approved therapies to Canadians living with ALS more quickly, is gaining tremendous momentum.
- As of August 18, 6,177 people participated in the e-campaign, telling their elected officials to help ensure that these solutions are implemented. A provincial breakdown is as follows:
- Alberta: 236 (English) 1 (French)
- British Columbia: 323 (English only)
- Manitoba: 204 (English) 1 (French)
- New Brunswick: 33 (English) 20 (French)
- Newfoundland and Labrador: 19 (English only)
- Nova Scotia: 41 (English only)
- Ontario: 4,097 (English) 84 (French)
- Quebec: 164 (English) 622 (French)
- Saskatchewan: 80 (English only)
- Yukon: 1 (English only)
- Alberta: 236 (English) 1 (French)
- Join the thousands of Canadians who support this campaign and send your letter today: www.als.ca/the-time-is-now.
Meeting with the pCPA
- On August 16, ALS Canada joined a meeting organized by ALS community advocate Norman MacIsaac with the pan-Canadian Pharmaceutical Alliance (pCPA).
- At the meeting we brought forward the Position Paper The Time is Now and raised solutions that will accelerate the reimbursement process for Health Canada-approved ALS treatments.
- This meeting is a starting place for ongoing discussions with the pCPA about the need for faster reimbursement times for ALS therapies coming down the pipeline. These conversations will in turn support timely and affordable access for a community that doesn’t have time to wait.
Federal updates
2021 Federal Election
- On August 15, on the advice of the Prime Minister, Her Excellency The Right Honourable Mary Simon, Governor General of Canada, dissolved Parliament and drew up writs for Canada’s 338 ridings – kicking off the start to the 2021 federal election campaign. The federal election date is September 20, 2021.
- During the campaign period, ALS Canada will be monitoring parties’ policy platforms for commitments that will improve the lives of Canadians living with ALS and will be reaching out to each major party asking for their response on specific issues of relevance to the ALS community and posting the responses on our blog.
ALS Canada Pre-Budget Submission
- On August 6, 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 will enable Canadian researchers to study why people experience ALS symptoms and progression so 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.
- The federal budget is typically tabled in March of each year.
Federal Bereavement Leave Update
- On June 29, Bill C-220 received Royal Assent which made An Act to amend the Canada Labour Code (bereavement leave) become law.
- This law increases the amount of bereavement days that federally regulated employees under the Canada Labour Code receive – these employees will now be entitled to 10 days instead of five.
- The law also expands eligibility for the bereavement leave to include federally regulated employees who, at the time a family member dies, are on compassionate care leave or leave related to critical illness in respect of the deceased person.
- The law does not come into effect until September 29, 2021 and updated eligibility information, with specific details for individuals interested in applying, has yet to be published.
Provincial updates (Ontario)
- Meeting with MPP Robin Martin
- On August 4, ALS Canada CEO Tammy Moore, Public Affairs Manager Lauren Poplak, Kim Barry, Director of Community Services, and community members Scott and Martha Williams met with MPP Robin Martin, Parliamentary Assistant to the Minister of Health, to discuss challenges facing Ontarians living with ALS.
- At the meeting we shared our specific solutions that will make meaningful differences in the lives of people living with ALS – especially as it relates to home and community care and access to therapies.
Provincial Cabinet Shuffle
- On June 18, Premier Doug Ford announced changes to the Executive Council of Ontario.
- Relevant changes to the ALS community include:
- Rod Phillips, MPP for Ajax, became Minister of Long-Term Care.
- Dr. Merrilee Fullerton, MPP for Kanata-Carleton, became Minister of Children, Community and Social Services.
- ALS Canada has been in touch with the new pertinent members of Cabinet to request meetings and raise the urgent needs of Ontario’s ALS community.
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.
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.
Access to therapies
The Time is Now | ALS Position Paper & e-Advocacy Campaign
- In consultation with the broader Canadian ALS community – ALS Canada has just released a Position Paper that offers two solutions to getting Health Canada approved therapies to Canadians living with ALS in a timeframe that more accurately reflects the urgent needs of this community.
- We also launched an e-advocacy campaign, enabling people to send a pre-written letter to elected officials, telling them to help to ensure that these solutions are implemented.
- Send your letter now: www.als.ca/the-time-is-now
Amylyx AMX0035 Update
- On June 14, Amylyx announced that it has filed a New Drug Submission (NDS) to Health Canada for its ALS therapy AMX0035.
- While this announcement does not yet mean Health Canada’s review of the drug has begun, Amylyx’s decision to pursue regulatory approval of AMX0035 is an important step forward. The next step would be for Health Canada to accept the company’s NDS, which would trigger a regulatory review.
Blog post: How new drugs become approved and accessible to Canadians
- With the news that Amylyx intends to apply to Health Canada for approval of their AMX0035 therapy for ALS, we’ve refreshed our blog post explaining how new drugs become accessible in Canada.
PMPRB Reforms
- With the revised Patented Medicine Prices Review Board (PMPRB) guidelines slated to come into effect next month, ALS Canada has joined other health charities and patient organizations in continuing to speak against the reforms: we have urged Health Minister Patty Hajdu to reconsider the new guidelines and, following news that the PMPRB has developed a communication strategy focused on discrediting patient groups, we have asked Prime Minister Trudeau to delay the guidelines’ implementation.
- On June 4, the Members of the House of Commons Standing Committee on Health (HESA) met to continue their study of the new Patented Medicine Prices Review Board (PMPRB) guidelines.
Federal updates
ALS Caucus Meeting
- On May 17, ALS Canada participated in the multi-party Parliamentary ALS Caucus meeting as an invited guest to discuss access to ALS therapies.
- Alongside ALS advocates and community members Norman MacIsaac, Mike Cels and Carmen Cels, we discussed the critical need for government to play role in reducing the time it takes for new therapies to be made available to Canadians living with ALS once they’re proven safe and effective.
- On June 11, the multi-party Parliamentary ALS Caucus sent an open letter to federal Health Minister Patty Hajdu, calling for the Government of Canada to reduce the Health Canada approval time for new ALS drugs from six months to three months and to work with the provinces and territories to accelerate the reimbursement timeline for new ALS therapies.
Provincial updates (Ontario)
- COVID-19 Vaccine Advocacy
- On June 4, as part of a coalition of health charities in Ontario, ALS Canada asked that vulnerable Ontarians and their caregivers be prioritized for a second doses of the vaccines, along with other high-risk populations.
New legislation to regulate Ontario PSWs
- On June 3, the Advancing Oversight and Planning in Ontario’s Health System Act, 2021 came into effect. This Act creates new measures to regulate education and training standards for personal support workers (PSWs), enhancing their capacity to provide care services to the province’s most vulnerable people.
- We are glad to see this Act come into effect, as we have been advocating for changes to the PSW sector for many years so that Ontarians living with ALS can receive improved home and community care.
PSW Temporary Wage Increase Extension
- On June 11, the government announced another extension to the temporary wage increase for personal support workers (PSWs). This will include approx. 150,000 PSWs working in home and community care, long-term care, public hospitals, and social services settings.
- Eligible PSWs will continue to receive the $3/hour wage increase ($2/hour increase for PSWs working in hospitals) until August 23, 2021.
Ontario Legislature Adjournment
- On June 3, the Ontario Legislature adjourned for the summer months. It is scheduled to resume sitting on September 13.
ALS Awareness Month
- On June 2 – Major League Baseball’s inaugural Lou Gehrig Day – ALS Caucus Co-Chairs MPs Francis Drouin, Heather McPherson, and Marie-Hélène Gaudreau delivered Members Statements in the House of Commons in recognition of ALS Awareness Month.
- At the Ontario Legislature, Robin Martin, Parliamentary Assistant to the Minister of Health, and Ms. Lucille Collard, MPP for Ottawa—Vanier, made Members Statements acknowledging ALS Awareness Month.
- Throughout the month of June, Ontario-based MPs and MPPs are voicing their support for people affected by ALS through videos that have been published on ALS Canada’s social media pages.
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.
Welcome to ALS Canada’s first Advocacy Update. This new 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.
Access to therapies
Government response to ALS community petition
- On April 26, the Government of Canada’s response to the ALS community-led e-petition to the Minister of Health was published.
- Led by ALS advocate Norman MacIsaac and MP Heather McPherson, the petition was presented in the House of Commons on March 11 after receiving over 25,000 signatures.
- While the government committed to continuing to consult with stakeholders, the response primarily highlighted previously announced health and drug policy initiatives and did not address the urgency faced by people living with the reality of an ALS diagnosis.
Extension of edaravone personal importation
- On April 1, Health Canada confirmed that Canadians living with ALS can continue to access edaravone through personal importation beyond April 1, 2021 until October 1, 2021. This marks the third extension to edaravone personal importation as a result of advocacy efforts.
Head of Canadian Drug Agency Transition Office announced
- On April 1, Health Canada announced Susan Fitzpatrick as the Head of the Canadian Drug Agency Transition Office. Formally announced in the Federal Government’s 2019 Budget, the Canadian Drug Agency will be a new national drug agency building on existing provincial and territorial approaches and taking a coordinated approach to assessing effectiveness and negotiating prescription drug prices on behalf of Canadians.
- ALS Canada has been in touch with Ms. Fitzpatrick, asking to meet to discuss ways the Canadian Drug Agency can be developed to meet the needs of the ALS community and reduce the time it takes for safe and effective therapies to be made available to Canadians.
Meetings with industry regarding access to therapies
- In April, ALS Canada met with six different pharmaceutical companies who are in the process of researching and developing new ALS treatments.
- Conversations focused on building relationships, highlighting the strengths of the Canadian ALS landscape and community, learning about the current state of their innovative research, and discussing how all parties can work together to ensure new therapies that are proven safe and effective can be made available to Canadians living with ALS as soon as possible.
Federal updates
Federal Budget
- On April 19, federal Finance Minister, Hon. Chrystia Freeland, tabled the Government of Canada’s 2021 Budget in the House of Commons.
- While there were new investments in health and supports for the charitable sector, we were disappointed not to see any direct funding for CAPTURE ALS, which will strengthen clinical trials, accelerate therapeutic development, and encourage new medical R&D investment in Canada.
- We had also hoped to see further progress and clarification on a framework for the development of a strategy for High-Cost Drugs for Rare Disease.
- A select few of the health and scientific investments that may be relevant to the ALS community include:
- A total $2.2 billion over seven years towards growing a vibrant domestic life sciences sector.
- $250 million over three years, starting in 2021-22, to the Canadian Institutes of Health Research (CIHR) to implement a new Clinical Trials Fund.
- $400 million over six years, starting in 2021-22, in support of a Pan-Canadian Genomics Strategy.
- $29.8 million over six years, starting in 2021-22, to Health Canada to advance the government’s palliative care strategy.
- $13.2 million over five years, beginning in 2021-22, with $2.6 million per year ongoing, to Health Canada to ensure that Canada’s medical assistance in dying framework is implemented consistently and with all appropriate safeguards.
Provincial updates (Ontario)
- New legislation to regulate Ontario PSWs
- On April 27, the Government of Ontario introduced new legislation at Queen’s Park that, if passed, will create new measures to regulate parts of Ontario’s health care workforce, including personal support workers (PSWs), physician assistants, and behaviour analysts.
- Entitled the Advancing Oversight and Planning in Ontario’s Health System Act, 2021, the bill would “establish a new legislative framework to support greater uniformity of education and training standards for personal support workers and would build on their capacity to provide care services to the most vulnerable Ontarians, including children, older adults and people with disabilities,” according to the government’s press release.
- ALS Canada has been advocating for improvements to the PSW workforce in Ontario for several years so that Ontario families living with ALS can have access to a better standard of home and community care that will meet their complex care needs.
- New legislation to regulate Ontario PSWs
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.