ALS Action Canada urges the Government of Alberta and Health Canada to swiftly approve new ALS drug therapeutic AMX0035
Published May 26, 2021
The Honourable Jason Kenney, M.L.A
Premier of the Province of Alberta
Office of the Premier
307 – 10800 97 Avenue
Edmonton, AB T5K 2B6
The Honourable Tyler Shandro, M.L.A.
Minister of Health
307 – 10800 97 Avenue
Edmonton, AB T5K 2B6
May 26, 2021
Dear Mr. Kenney and Mr. Shandro,
We are writing on behalf ALS Action Canada, a patient-led advocacy organization formed in 2020. Like I AM ALS 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, 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 Alberta:
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 Alberta 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, 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:
- That Health Canada swiftly review and approve AMX0035 upon its submission.
- That the Government of Canada move forward on the bi-partisan petition e-2971, 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.
- 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.
- That Health Canada enter into an agreement with the international peers to use the model of Project Orbis, 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 provincial drug program by the Alberta government in June 2020, 20 months after it had been approved by Health Canada in October, 2018.
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, Alberta families with ALS simply do not have this kind of time to wait.
We are calling upon you now to do better.
Albertans 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 Alberta can work quickly when there is a will to do so and an understanding of the urgency.
Albertans 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, 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 Albertans living with ALS.
Captain Deane Gorsline, CD, BEng, PMP, rmc
Royal Canadian Engineers
Director, ALS Action Canada
Diagnosed with ALS 2018, age 29
159 McCurdy Drive
Kanata, ON K2L 2Z7
250 991 2626
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
Cc: Dr. Deena Hinshaw, Chief Medical Officer of Health
Dr. Andre Corriveau, Deputy Chief Medical Officer of Health
Dr. Jing Hu, Deputy Medical Officer of Health
Christopher Thresher, Chief of Staff, Minister of Health
Paul Wynnyk, Deputy Minister of Health
Allison Pfeifer, Acting Chief of Staff, Deputy Minister of Health
Bryce Stewart, Associate Deputy Minister of Health
Chris Bourdeau, Communications Director, Ministry of Health
Graham Statt, Assistant Deputy Minister, Pharmaceutical and Supplementary Benefits Division
Chad Mitchell, Executive Director, Pharmaceutical and Health Benefits Branch
Stephanie Minnema, Acting Director, Policy and Advisory Unit
Donna Manuel, Executive Director, Health Insurance Programs Unit
Dr. Evan Lundall, Medical Advisor, Health Insurance Programs Unit
Catherine Douglas, Manager, Advocate Representative, Office of the Alberta Health Advocates
Beverly Slusarchuk, Patient Rights Advocate
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.
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.