A recently approved amyotrophic lateral sclerosis treatment will be $158,000 for a year's supply, the product's manufacturer said in a Sept. 30 investor conference call, according to The New York Times.
Amylyx Pharmaceuticals' ALS drug, Relyvrio, has had a bumpy path. In March, an FDA panel argued that the data submitted with the drug application did not prove it worked before voting 6-4 against it. Amylyx then tried again for the FDA's approval with additional analyses of the phase 2 data. The clinical study of 137 participants found that Relyvrio patients lived 10 months longer than the placebo group.
Based on the new data, an FDA advisory panel reversed its earlier decision and voted 7-2 in favor of approving Relyvrio in early September. The agency followed suit and approved it Sept. 29.
The next day, Amylyx disclosed on a Sept. 30 call the treatment's cost — which is nearly $150,000 more than what the Institute for Clinical and Economic Review said Relyvrio should cost.
In August, when the drug was coined as AMX0035, the ICER priced it to be between $9,100 and $30,600 per year.
"We believe this price balances the needs of and input from the ALS community," an Amylyx spokesperson told Becker's. The $158,000 figure "does not reflect the price people living with ALS can expect to pay" because of the company's efforts with commercial payers, Medicare and Medicaid, the spokesperson added.
There is no cure for the degenerative disease, which affects 30,000 people and kills patients within one to five years of symptoms presenting, but there are two other approved ALS treatments.
Relyvrio's competitors are riluzole, which costs less than $10,000 a year, and edaravone, which costs about $185,182 a year, according to the Times and the National Institutes of Health.