A SUPER-powered WP Engine Atlas Test Site

Joe&#039;s Atlas Experimentation Site

<a href="https://www.amylyx.ca/">Amylyx Pharmaceuticals Canada</a> has entered into product listing agreements with Quebec and Ontario to publicly reimburse <a href="https://www.amylyx.ca/document/albrioza-product-monograph.pdf">Albrioza</a> (sodium phenylbutyrate and ursodoxicoltaurine), which was recently approved for <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS).
The oral therapy, which is marketed in the U.S. as <a href="https://alsnewstoday.com/amx0035/">Relyvrio</a>, has been added to the list of medications reimbursed under the Regie de l&#8217;assurance maladie du Quebec and Ontario&#8217;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&#8217;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 <a href="https://alsnewstoday.com/news/amx0035-oral-als-therapy-called-albrioza-approved-canada/">conditionally approved</a> by Canadian authorities last year. Albrioza was made <a href="https://alsnewstoday.com/news/amx0035-albrioza-oral-als-therapy-available-canada/">commercially available</a> in Canada in August 2022, but patients couldn&#8217;t be reimbursed because it wasn&#8217;t yet listed on most public health plans.
&#8220;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,&#8221; Chris Aiello, general manager and head of Canada at Amylyx, said in a <a href="https://finance.yahoo.com/news/ontario-publicly-reimburse-albrioza-treatment-173000313.html">company press release</a>.
[recommended-reading id=85277]
<h3>Efforts to extend access to Albrioza underway</h3>
Tammy Moore, CEO of the <a href="https://als.ca/?gclid=CjwKCAjwwb6lBhBJEiwAbuVUSlSGBZ85o5pxjkqSwQ9xOLMulkJnNlsXFzy_CM4RpxQnbNNBz8ozahoC9LcQAvD_BwE">ALS Society of Canada</a>, said: &#8220;We congratulate the Ontario government on its decision to reimburse this treatment in such a timely manner following pCPA negotiations.&#8221;
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.
&#8220;We are grateful for the Quebec government&#8217;s collaboration and its support of people living with ALS by providing public coverage for Albrioza,&#8221; Aiello said in another <a href="https://www.newswire.ca/news-releases/government-of-quebec-to-cover-albrioza-tm-for-the-treatment-of-als-820413417.html">press release</a>. &#8220;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.&#8221;
Albrioza is a fixed-dose combination sodium phenylbutyrate and tauroursodeoxycholic acid that&#8217;s thought to protect nerve cells from the cellular stress-induced damage implicated in ALS. It&#8217;s taken twice daily by mouth or via a feeding tube.
&#8220;The decision to include Albrioza on Quebec&#8217;s list of publicly covered medications is welcome news,&#8221; said Genevieve Matte, assistant clinical professor, department of neurosciences a the University of Montreal. &#8220;There have been so few treatment options for ALS and so it&#8217;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.&#8221;
The decision to approve Albrioza in Canada was based on data from the <a href="https://classic.clinicaltrials.gov/ct2/show/NCT03127514">CENTAUR Phase 2 clinical trial (NCT03127514)</a> and its <a href="https://classic.clinicaltrials.gov/ct2/show/NCT03488524">open-label extension study (NCT03488524)</a>, 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.
&#8220;Our work is by no means done,&#8221; Aiello said. &#8220;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.&#8221;
&#8220;I look forward to news of Albrioza&#8217;s listing on other public drug plan formularies for eligible Canadians coast to coast,&#8221; said Christen Shoesmith, MD, medical director of the ALS clinic at the London Health Sciences Centre and current Canadian ALS Research Network (CALS) chair.

Quebec, Ontario add Albrioza to public reimbursement list

Albrioza, the approved treatment for <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) formerly known as AMX0035, is one giant step closer to being eligible for reimbursement under public drug plans in Canada, according to its developer, Amylyx Pharmaceuticals.
<a href="https://www.amylyx.com/">Amylyx</a> has reached an agreement with the pan-Canadian Pharmaceutical Alliance, or pcPA — a government partnership in Canada that collaborates on various public drug plan initiatives — for terms under which ALS patients in the country can be reimbursed for Albrioza.
The negotiations began after the therapy, marketed as <a href="https://alsnewstoday.com/amx0035/">Relyvrio</a> in the U.S., was <a href="https://alsnewstoday.com/news/amx0035-oral-als-therapy-called-albrioza-approved-canada/">conditionally approved</a> by Canadian authorities a year ago. While Albrioza became <a href="https://alsnewstoday.com/news/amx0035-albrioza-oral-als-therapy-available-canada/">commercially available</a> in the country in August 2022, it hasn&#8217;t yet been listed on most public health plans — meaning patients on those plans couldn&#8217;t be reimbursed for its costs.
Amylyx has now signed off on its intentions to honor the new agreement in a letter of intent (LOI), which, if finalized, will enable eligible patients to avoid high out-of-pocket costs for the medication.
“Today marks a major milestone for people living with ALS and their caregivers in Canada. With this signed LOI, eligible Canadians living with this rapidly progressive disease who rely on public coverage are one step closer to accessing Albrioza,” Chris Aiello, general manager and head of Canada at Amylyx, said in a <a href="https://www.businesswire.com/news/home/20230615926630/en/Amylyx-Pharmaceuticals-Completes-Negotiation-Process-and-Signs-Letter-of-Intent-with-the-pCPA-for-ALBRIOZA%E2%84%A2-for-the-Treatment-of-ALS">company press release</a>, adding, however, “Our work is by no means done.”
[recommended-reading id=78571]
<h3>Advocates cite lengthy delay in getting treatment for ALS covered</h3>
With the LOI now in place, the company will move forward to work individually with federal, provincial, and territorial drug plans to finalize the agreements, which will enable Albrioza to be listed for reimbursement on those plans.
Although the news is welcome, some believe it did not come fast enough for patients, many of whom see rapid declines in the first few years after disease onset.
“While it is good news that Canadians living with ALS are closer to accessing this innovative treatment, some people living with ALS have been waiting a year to access this therapy, and they will continue to wait,” said Tammy Moore, CEO of the <a href="https://als.ca/">ALS Society of Canada</a>.
“People with ALS do not have the luxury of time,” Moore said.
[quote align=&#8221;center&#8221;]We believe there are opportunities to streamline the multiple steps and lengthy processes involved in achieving public reimbursement for treatments like Albrioza in Canada. The time is now for equitable and expedited access to approved treatments for ALS, and we will continue advocating on behalf of the ALS community to improve their access to care.[/quote]
The process of a therapy being listed on public health plans involves sometimes lengthy discussions between pcPA and the company that markets the therapy. The pcPA has to negotiate the price of the treatment on behalf of public drug payers, including both federal and local governments, along with determining which patients will be eligible for reimbursement.
Additional discussions then ensue with each individual public drug payer to work out the details.
“We believe there are opportunities to streamline the multiple steps and lengthy processes involved in achieving public reimbursement for treatments like Albrioza in Canada,” Moore said.
“The time is now for equitable and expedited access to approved treatments for ALS, and we will continue advocating on behalf of the ALS community to improve their access to care,” Moore added.
[recommended-reading id=82805]
<h3>Treatment for ALS facing regulatory hurdles in EU</h3>
Albrioza is a fixed-dose oral combination of two small molecules — tauroursodeoxycholic acid and sodium phenylbutyrate — that together are thought to protect nerve cells against forms of cellular stress implicated in ALS. As such, the therapy is expected to slow ALS progression.
Canadian authorities conditionally approved the treatment based on findings from the <a href="https://clinicaltrials.gov/ct2/show/NCT03127514">Phase 2 CENTAUR trial (NCT03127514)</a> and its <a href="https://clinicaltrials.gov/ct2/show/NCT03488524">extension study (NCT03488524)</a>. Their findings indicated that Albrioza significantly <a href="https://alsnewstoday.com/news-posts/2020/09/03/amx0035-safe-effective-in-slowing-als-functional-decline-trial-data-shows/">slowed functional declines</a> and <a href="https://alsnewstoday.com/news-posts/2022/05/06/amx0035-survival-als-patients-centaur-clinical-trial-analysis-amylyx/">extended survival time</a> for ALS patients.
A full, final approval in the country is contingent upon results from the global <a href="https://clinicaltrials.gov/ct2/show/NCT05021536">Phase 3 PHOENIX trial (NCT05021536)</a>, which is now seeking to confirm the benefits of Albrioza against a placebo in a larger group of patients. That trial, which <a href="https://alsnewstoday.com/news/phoenix-trial-approved-als-therapy-relyvrio-amx0035-enrolled/">completed enrollment</a> earlier this year, is expected to finish in 2024.
The therapy’s path to approval has not been as straightforward elsewhere.
In the U.S., it came under scrutiny by a U.S. Food and Drug Administration (FDA) advisory committee that initially voted that existing data <a href="https://alsnewstoday.com/news-posts/2022/04/01/fda-committee-votes-against-recommending-als-therapy-amx0035/">were not sufficient</a> to support the treatment’s clinical efficacy.
While that opinion is not binding, the FDA takes it into account when deciding about whether to approve a therapy.
Following a rare second review after Amylyx submitted additional trial data, the committee <a href="https://alsnewstoday.com/news/fda-committee-reversal-favors-amx0035-approval-als/">later reversed course</a>. The FDA ultimately <a href="https://alsnewstoday.com/news/relyvrio-amx0035-approved-us-als-treatment/">approved</a> the therapy, as Relyvrio, in September.
Now, the treatment faces similar hurdles in the European Union, where it&#8217;s under review. The European Medicines Agency (EMA)&#8217;s Committee for Medicinal Products for Human Use (CHMP) noted earlier this year that it was leaning toward <a href="https://alsnewstoday.com/news/amylyxs-als-therapy-amx0035s-facing-possible-no-from-chmp/">not recommending</a> the therapy for approval. In March, CHMP sought <a href="https://alsnewstoday.com/news/european-approval-amx0035-als-faces-new-hurdle-review/">more information</a> from Amylyx, noting there were still objections to the therapy that needed to be addressed.
As with an FDA advisory committee, the CHMP&#8217;s opinion is not binding, but will inform the final decision made by the EMA. The CHMP is expected to give its final opinion in coming days.

Tag: reimbursement

Quebec, Ontario add Albrioza to public reimbursement list

Amylyx agrees to deal for Albrioza reimbursement in Canada for ALS