The Honourable Doug Ford, M.P.P.
Premier of the Province of Ontario
Legislative Building
Queen’s Park
Toronto ON M7A 1A1

The Honourable Christine Elliott, M.P.P.
Minister of Health
Ministry of Health
5th Floor
777 Bay St.
Toronto, ON M7A 2J3

May 20, 2021

Dear Mr. Ford and Ms. Elliott,

We are writing on behalf ALS Action Canada,^[1] a patient-led advocacy organization formed in 2020. Like I AM ALS^[2] in the United States, we are part of a growing, global, patient-led movement to finally #EndALS within five years.

Our organization exists to advocate for:

• Rapid approvals of and swift, pan-Canadian access to promising new therapies for ALS, including Amylyx Pharmaceuticals Ltd.’s AMX0035^[3], which will soon be submitted to Health Canada;
• Increased access by people living with ALS to more, and better-designed clinical trials across Canada, including platform trials (which requires the establishment of three more top-tier ALS clinics in this country, beyond Sunnybrook Health Sciences Centre and the Montreal Neurological Institute-Hospital);
• Increased Government of Canada and provincial funding for ALS research in Canada.

We are writing today to ask the following of the Government of Ontario:

That your government work directly with federal Health Minister Patty Hajdu and applicable agencies (e.g. PMPRB, CADTH, pCPA), to swiftly review and approve health plan coverage in Ontario for the promising new ALS therapy, AMX0035, upon its approval by Health Canada.

On March 9, 2021, Cambridge, MA-based Amylyx Pharmaceuticals Ltd. announced its plans to submit a New Drug Submission (NDS) for AMX0035 for the treatment of ALS with Health Canada in the first half of 2021.

This decision is based on positive clinical data from Amylyx’s trial^[1], feedback from Health Canada, and the potential of access through a special access program with collaboration from the Canadian ALS Research Network. AMX0035 combines two already approved medicines, offers ample safety data, and is the first drug therapy proven to substantially slow the progression of ALS.

We want to make you aware that in addition to our request of your government, we have made the following requests of the Government of Canada:

1. That Health Canada swiftly review and approve AMX0035 upon its submission.
2. That  the Government of Canada move forward on the bi-partisan petition e-2971^[5], tabled in Parliament by Heather McPherson, M.P. (Edmonton Strathcona) on March 11, 2021, which gained over 25,000 signatures, that called on the Minister of Health to create a pilot project to reduce the delay in obtaining access to innovative, Health Canada-approved ALS treatments to maximum 3 to 6 months, Canada-wide.
3. That, beginning with AMX0035 and going forward, the Government of Canada better coordinate efforts with provincial and other stakeholders (including the Patent Medicines Prices Review Board, the Canadian Agency for Drugs and Technologies in Health, and the pan-Canadian Pharmaceutical Alliance) to position Canada as a world leader in clinical research, regulatory review, health technology assessment, and drug funding decisions that provide access to promising therapies that treat ALS.

In the case of the PMPRB, the changes due to come into effect on July 1, 2021 are a major obstacle for innovative pharmaceutical companies that would otherwise prioritize Canada as a destination for basic, translational, and applied research and, most importantly, commercialization of new ALS therapeutics.

4. That Health Canada enter into an agreement with the international peers to use the model of Project Orbis^[6], an initiative of Health Canada and the US FDA Oncology Centre of Excellence, which provides a framework for the concurrent submission and review of oncology products among international regulators, to share resources and approve new drug therapies for ALS in a faster, harmonized manner.

There are currently only two drug therapies available in Canada to ALS patients. The last therapy, Edavarone, was only added to the Exceptional Access Program by the Ontario government in May 2020, 19 months after it had been approved by Health Canada in October, 2018.^[1]

This length of time for approval and coverage was a bureaucratic failure that simply cannot be repeated with AMX0035. Given that ALS usually ends lives within three to five years of a diagnosis, Ontario families with ALS simply do not have this kind of time to wait.

We are calling upon you now to do better.

Ontarians have seen COVID-19 vaccines approved by Health Canada within a couple of weeks of submission, and made accessible Canada-wide almost immediately. The Government of Canada and the Government of Ontario can work quickly when there is a will to do so and an understanding of the urgency.

Ontarians living with ALS and their families have no time to waste. Most people diagnosed with ALS live no more than five years after diagnosis. The lives of people with ALS have no less value than those facing COVID-19 or cancer. New treatments like AMX0035 (and Toferesen^[2], by Biogen Pharmaceuticals) represent the best and only hope to date for people living with ALS.

We look forward to meeting with you at your earliest convenience to discuss the above recommendations, and learn more about your plans to ensure rapid access to AMX0035 (following its approval by Health Canada) for all Ontarians living with ALS.

Yours sincerely,

Captain Deane Gorsline, CD, BEng, PMP, rmc
Royal Canadian Engineers
ALS Action Canada Executive Committee
Diagnosed with ALS 2018, age 29
159 McCurdy Drive
Kanata, ON K2L 2Z7
250 991 2626
dgorsline@alsactioncanada.org

Mark Kirton
RE/MAX Aboutowne Realty, former NHL player
ALS Action Canada Executive Committee
Diagnosed with ALS 2018, age 60
1131 Nottinghill Gate, Suite 207
Oakville, ON L6M 1K5
905 483 0053
mark@markkirton.com
alsactioncanada@gmail.com

Diana Rogers
ALS Action Executive Committee
Diagnosed with ALS 2017, Age 47
Toronto, ON
416 559 7502
dianarogers100@gmail.com
alsactioncanada@gmail.com

Greg Gowe, BA, MA, LLB
Former Senior Counsel, TELUS
Director, ALS Action Canada
Diagnosed with ALS 2019, age 48
479 Saville Crescent
North Vancouver, BC V7N 3A9
604 341 9893
goweg@yahoo.ca
alsactioncanada@gmail.com

Cc:
Robin Martin, Parliamentary Assistant
Helen Angus, Deputy Minister
Joel Montesanti, Director, Policy and Delivery
Marysia Szymczak, Assistant Deputy Minister, Communications
Patrick Dicerni, Assistant Deputy Minister and Executive Officer, Drugs and Devices
Dr. David Williams, Chief Medical Officer of Health, Public Health, Office of Chief Medical Officer of Health, Public Health
Angie Wong, Director, Drug Programs Policy and Strategy
David Schachow, Director, Drug Programs Delivery

___________________________________________________________

ABOUT ALS ACTION CANADA

Formed in February 2020, ALS Action Canada is a patient-led organization advocating for urgent access to promising therapies for Canadians living with ALS, more and better clinical trials for ALS therapies in Canada, and increased federal and provincial funding for ALS research.

ALS Action Canada’s Executive Committee includes people and caregivers living with ALS from the professions of law, medicine, pharmacy, physiotherapy, accounting, engineering, and the military. With members from across the country, we are a strong network of Canadian ALS patients and supporters, dedicated to amplifying the voices of, and actively advocating for, the thousands of Canadian families and their communities living with this devastating disease.

www.alsactioncanada.org
Twitter: @ALSaction
Instagram: @ALSaction
Facebook: @ALSActionCanada
#EndALS
#ICBCRebateChallenge

___________________________________________________________

ABOUT ALS

ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease) is a disease that attacks cells in the body that control movement. It makes the brain stop talking to the muscles, causing increased paralysis over time. Ultimately, ALS patients become prisoners within their own bodies, unable to eat, breathe, or move on their own. Their minds, however, remain sharp, so they are completely aware of what’s happening to them.

Today, ALS is always fatal and patients typically live for 3 to 5 years after diagnosis. That’s because scientists have yet to identify a cure for ALS. The recent acceleration of research has ensured that this will change. It is now not a question of if, but when there will be a significant treatment breakthrough that brings a cure within reach.

^[1] www.alsactioncanada.org

^[2] www.iamals.org

^[3]https://www.businesswire.com/news/home/20210309005180/en/Amylyx-Pharmaceuticals-Plans-Regulatory_Filing-of-AMX0035-for-the-Treatment-of-ALS-in-Canada

^[4] https://www.nejm.org/doi/full/10.1056/NEJMoa1916945

^[5] https://petitions.ourcommons.ca/en/Petition/Details?Petition=e-2971

^[6] https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

^[7] https://www.als.ca/blogs/access-to-therapies-radicava-edaravone-update/

^[8] https://www.biogen.com/en_us/als-community-update.html