Quebec, Ontario add Albrioza to public reimbursement list

Efforts underway to expand coverage to other Canadian provinces, territories

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by Mary Chapman |

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Amylyx Pharmaceuticals Canada has entered into product listing agreements with Quebec and Ontario to publicly reimburse Albrioza (sodium phenylbutyrate and ursodoxicoltaurine), which was recently approved for amyotrophic lateral sclerosis (ALS).

The oral therapy, which is marketed in the U.S. as Relyvrio, has been added to the list of medications reimbursed under the Regie de l’assurance maladie du Quebec and Ontario’s Exceptional Access Program.

Previously called AMX0035, the therapy has been shown to help slow disease progression and extend survival in people with ALS, a disorder that affects some 3,000 residents of Canada.

The drug became available through Ontario’s Drug Benefit Program June 22, shortly after Amylyx completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA), which negotiates prices with manufacturers on behalf of public payers.

Negotiations began after the treatment was conditionally approved by Canadian authorities last year. Albrioza was made commercially available in Canada in August 2022, but patients couldn’t be reimbursed because it wasn’t yet listed on most public health plans.

“We are thrilled Ontarians with public insurance who are living with ALS will now have access to Albrioza, and we are grateful for the collaboration of the Ontario government to make timely access possible,” Chris Aiello, general manager and head of Canada at Amylyx, said in a company press release.

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Efforts to extend access to Albrioza underway

Tammy Moore, CEO of the ALS Society of Canada, said: “We congratulate the Ontario government on its decision to reimburse this treatment in such a timely manner following pCPA negotiations.”

Quebec became the second province to provide public reimbursement of Albrioza under an agreement that became effective July 6. Amylyx is working with other provinces and territories, as well as federal drug plans, to make the therapy available to more people in Canada.

“We are grateful for the Quebec government’s collaboration and its support of people living with ALS by providing public coverage for Albrioza,” Aiello said in another press release. “Understanding the speed at which this disease progresses, our goal is to ensure that any eligible Canadian, no matter where they live, will have equitable access to this treatment. We are working closely with all other public drug plans to make this happen as soon as possible.”

Albrioza is a fixed-dose combination sodium phenylbutyrate and tauroursodeoxycholic acid that’s thought to protect nerve cells from the cellular stress-induced damage implicated in ALS. It’s taken twice daily by mouth or via a feeding tube.

“The decision to include Albrioza on Quebec’s list of publicly covered medications is welcome news,” said Genevieve Matte, assistant clinical professor, department of neurosciences a the University of Montreal. “There have been so few treatment options for ALS and so it’s vital that people living with ALS have timely access to new treatment that can slow disease progression and loss of functional decline. My hope is that access will be extended across Canada to all those who may benefit from this treatment.”

The decision to approve Albrioza in Canada was based on data from the CENTAUR Phase 2 clinical trial (NCT03127514) and its open-label extension study (NCT03488524), which indicated it significantly slowed functional decline in patients with rapidly progressing disease. It also extended survival by 6.9 months over a placebo, indicating a 43% lower risk of death.

“Our work is by no means done,” Aiello said. “We are dedicated to ensuring that all who rely on public coverage in Canada can also access the treatment as soon as possible. People living with ALS are on a different clock, and thus we are moving urgently to obtain timely, equitable access for all eligible Canadians.”

“I look forward to news of Albrioza’s listing on other public drug plan formularies for eligible Canadians coast to coast,” said Christen Shoesmith, MD, medical director of the ALS clinic at the London Health Sciences Centre and current Canadian ALS Research Network (CALS) chair.