Amylyx Pharmaceuticals’ new amyotrophic lateral sclerosis (ALS) drug Relyvrio (AMX0035) was approved by the US Food and Drug Administration (FDA) last week and has already landed the giant in hot water. Amylyx has set the annual price of the drug to $158,000, a number decried by many as exorbitant. According to the influential Institute for Clinical and Economic Review (ICER), the drug should be priced no higher than $30,000 a year until more evidence comes in regarding the drug’s efficacy.
According to Nicole Raleigh, “‘Clearer’ data isn’t expected until 2024, with results from a late-stage phase 3 PHOENIX trial of around 600 patients due at that time.
Back in September, ICER published a final report concluding that Amylyx Pharmaceuticals’ AMX0035 oral drug has a role to play in ALS treatment, but offers “low” long-term value for money at current pricing or price estimates. David Rind, Chief medical officer for ICER, stated that “the evidence suggests that AMX0035 extends life, but prices need to be greatly reduced to align with benefits”, continuing to add that the recommended price is “much too high a price for the therapy, despite the overwhelming need for treatments for this devastating disease.”