Amylyx Pharmaceuticals has priced its newly approved medicine for ALS, or amyotrophic lateral sclerosis, at $158,000 for a year’s supply, well above what one cost watchdog believes to be reasonable based on the drug’s performance in clinical testing.
The figure, which equates to just over $12,500 for a 28-day course of the medicine, called Relyvrio, is about $10,000 less than the list price of another ALS therapy that came onto the U.S. market five years ago. Amylyx executives said their decision factored in feedback from the ALS community and potential out-of-pocket costs for patients, as well as the company’s ability to invest in its mission.
Speaking on an investor call Thursday, executives said the list price is not what ALS patients with commercial insurance should expect to pay, and that Amylyx is “committed” to ensuring these patients have no copay costs. List prices don’t include any rebates or discounts Amylyx might negotiate with insurers in exchange for coverage.
For patients on government-funded insurance plans, the company is working to get them access to Relyvrio “as quickly as possible,” according to Margaret Olinger, Amylyx’s chief commercial officer. Olinger added that Amylyx intends to provide its drug at no cost to U.S. patients who are uninsured or underinsured, meet certain financial eligibility criteria and have exhausted all other options.
The company expects Relyvrio to become commercially available in the U.S. within the next four to six weeks. In Canada, where it was approved in June and is sold as Albrioza for a similar price, Amylyx has been negotiating with private insurers to get the drug covered.
The pricing of Relyvrio has become a point of contention in recent months as the drug moved closer to market. One day after Amylyx announced its approval in Canada, the Institute for Clinical and Economic Review, an influential watchdog group focused on drug costs, released a draft report claiming that Relyvrio would “far exceed” common measures of cost-effectiveness if sold at the price Amylyx has now set.
The group later said in a finalized report that an appropriate price for Relyvrio would be between $9,100 and $30,600 a year.
Some share ICER’s sentiment. Bruce Booth, partner at the life sciences investment firm Atlas Ventures, wrote on Twitter that Relyvrio’s approval is “a win for advocacy over data” and that its pricing “seems egregious.”
Doctors have also expressed concern about the potential costs of Relyvrio. “The only thing more frustrating than not having options to offer patients is having an option that is not accessible because their insurance company refuses to pay for it,” Rick Bedlack, director of the Duke ALS Clinic at Duke University, said in a September interview ahead of the FDA’s approval decision.
“Hopefully, the company is putting a lot of thought into this as far as patient assistance programs and things like that, so that anybody that wants this will be able to get it,” Bedlack added.
Amylyx executives note how they’ve established a team that will directly help patients secure Relyvrio as well as offer them financial support. “We know people with ALS and their families have no time to wait,” Olinger said.
In an emailed statement, the ALS Association, a prominent patient advocacy group, said it is “glad that Amylyx is offering a financial assistance program” and expects the company to “work with payers to ensure everyone can access [Relyvrio], regardless of their financial situation.”
For Amylyx, the launch of its first product will also be a key test of business operations. On Friday’s call, for example, executives were questioned about when Relyviro will start to generate revenue for the company.
Jim Frates, Amylyx’s chief financial officer, said the company anticipates revenue will start to build over the first six months of 2023. Between January and June this year, Amylyx recorded a net loss of $102 million.
Executives were also asked about an ongoing clinical trial named PHOENIX, which is larger and set to last longer than the roughly 140-person study that served as the main body of evidence supporting Relyvrio’s approval. Originally, the FDA hadn’t planned on reviewing Amylyx’s approval application until data from this larger trial became available, but it reconsidered following immense pushback from patient advocacy groups.
At the request of a top FDA official, Amylyx earlier this month committed to voluntarily pull Relyvrio from the U.S. market if the PHOENIX study were to fail. While noting that this trial “is not a formal commitment” given the way in which the FDA approved Relyvrio, the company still intends to run it.
“To be clear, we will always do what is right for patients and right for the community,” Justin Klee, Amylyx’s co-founder and co-CEO, said during Friday’s investor call. “Why would we keep a drug on the market that doesn't help people?”