Availability without accessibility: ALS Action Canada calls on Canada to do better and make Albrioza available to more than 7% of people living with ALS
Published November 4, 2022
November 7, 2022
Availability without accessibility: ALS Action Canada calls on Canada’s federal and provincial ministers of health to do better by making Albrioza accessible to more than just 7% of Canadians living with ALS
VANCOUVER/COAST SALISH TERRITORY(CNW) – Following a ten-month wait for Health Canada approval, in June 2022 thousands of Canadians living with the swiftly fatal disease of amyotrophic lateral sclerosis (ALS) were finally given the hope of living longer when Health Canada became the first country in the world to approve Amylyx Pharmaceuticals’ new drug therapy for ALS, Albrioza (formerly AMX0035) 1. In clinical trials Albrioza significantly slowed disease progression and loss of functional decline in people living with ALS. We applaud this approval.
However, ALS families’ hopes were dashed in August 2022 when CADTH (Canada’s Drug and Health Technology Agency, which determines which types of patients can access a Health Canada-approved drug under provincial drug benefit plans) decided that only people who have had ALS symptoms for less than 18 months and meet other restrictive diagnostic criteria can have the cost of Albrioza covered by the provincial plans. .3
According to a recent analysis by the University of Calgary’s Department of Clinical Neurosciences,4 the application of these restrictive criteria likely means that 93% of Canadians living with ALS will be unable to access treatment with Albrioza.
CADTH’s recommendation was based on the fact that the <18-months since symptom onset was simply the criterion for participation in Albrioza’s clinical trial—it does not reflect the reality of how long it takes to receive a diagnosis of ALS in Canada, nor the fact that a person who has been diagnosed after 18 months could equally benefit from the drug.
In the US, where the average time from symptom onset to ALS diagnosis is 12 months,5 this under-18-months criterion would be less of a problem. In Canada however, the mean time to diagnosis is 20.7 months,6 meaning that many Canadians living with ALS will simply not be eligible to be prescribed Albrioza under provincial drug benefit plans.
“This kind of inequity of access for Canadians living with a disease that kills within three to five years is unacceptable. Canada and the provinces must do better,” says Bre Hamilton, ALS Action Canada’s Executive Director. “All Canadians living with ALS deserve access to a drug that could let them hug their kids, walk, or breathe without assistance for longer.”
The decision about who can receive Albrioza in Canada currently sits with the pan-Canadian Pharmaceutical Alliance (pCPA)7, the regulatory body that negotiates the cost of a drug before it is listed on (covered by) provincial drug plans. The Governing Council is made up of representatives from provincial and territorial health ministries.
ALS Action Canada is calling on all provincial and territorial ministers of health, who are responsible for overseeing the initiatives of the pCPA, as well as on the federal Minister of Health, Jean-Yves Duclos, to immediately ensure that all Canadians with ALS have equitable access to Albrioza and all future ALS drugs approved by Health Canada.
When faced with the death sentence that is ALS, the decision to take or not take a Health Canada-approved drug should rest with individual Canadians in consultation with their neurologists. These decisions should not be determined by a regulatory body like the pCPA that has no appeal process, and applies narrow research trial parameters that do not match the reality of lived clinical experience of ALS in Canada.
“Our study showed that a diagnosis of ‘Definite’ ALS 8 within 18 months of symptom onset is very uncommon,” says Dr. Gordon Jewett, Clinical Research Fellow and Neurologist at the University of Calgary and lead author of the study quoted above. “This criteria could significantly limit the number of people with ALS that are able to access Albrioza. All people with ALS are equally likely to benefit from Albrioza–not meeting ‘Definite’ criteria or being more than 18 months from diagnosis does not change that.”
Having a drug “available” in the Canadian market but not accessible to most people living with ALS because of how long it took them to get their diagnosis or how long they have had the disease is simply not acceptable. Canada can and must do better.
“I consider myself very lucky to have been treated with Albrioza last year through the Special Access Program, while it was still in the approval process with Health Canada,” says Diana Rogers, an Ontario resident and mother of three, diagnosed with ALS in 2017 at age 47. “I was at that point years past ‘18 months’. This disease wants to take everything from me. Every day I can still speak with and hug my children is a victory. I’d do or take anything that gives me more time with them. I worry for those Canadians who get this awful diagnosis and won’t be able to receive Albrioza like I did.”
5 https://www.als.org/navigating-als/resources/obtaining-als-diagnosis 6https://www.cambridge.org/core/journals/canadian-journal-of-neurological-sciences/article/provincial- differences-in-the-diagnosis-and-care-of-amyotrophic-lateral-sclerosis/BDD492C015B37186E065B6C 6E3AA21BA
6https://www.cambridge.org/core/journals/canadian-journal-of-neurological-sciences/article/provincial- differences-in-the-diagnosis-and-care-of-amyotrophic-lateral-sclerosis/BDD492C015B37186E065B6C 6E3AA21BA
8 Using revised El Escorial criteria
ABOUT ALS ACTION CANADA
Formed in February 2020, ALS Action Canada is Canada’s first and only ALS patient-led nonprofit 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–all to drive a cure for ALS.
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 communities living with this devastating, currently fatal disease.
Facebook: @ALSActionCanada #EndALS
Executive Director, ALS Action Canada firstname.lastname@example.org
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