Amylyx Pharmaceuticals' recently approved Relyvrio, an amyotrophic lateral sclerosis drug that's priced at $158,000 for an annual supply, is the latest example of drugmakers inflating medication costs, critics told The Wall Street Journal.
It's unlikely ALS patients will end up paying the full price for Relyvrio. An Amylyx spokesperson told Becker's the drugmaker is working with commercial insurers to bring the copay to $0, and it plans to provide underinsured and uninsured ALS patients the drug for free.
Despite payers footing most of the bill, the precedent Amylyx set of listing the ALS treatment about $150,000 more than what the Institute for Clinical and Economic Review predicted it should cost could result in higher insurance premiums.
"It's probably not the patients with ALS that you're harming directly from this," David Rind, MD, chief medical officer at ICER, told the Journal, "but you're harming a whole bunch of other people in the system."
The increased premiums could push people off of their insurance plans, the Journal reported.
In response to pushback to Relyvrio's listed price, Amylyx co-CEOs Justin Klee and Josh Cohen told Politico Oct. 4 that the "price balances the needs of and input from the ALS community, will be supported by insurers, allows Amylyx to sustain programs to ensure that anyone who can benefit from Relyvrio can access it, and enables us to continue our mission."
In March, an FDA panel voted 6-4 against Relyvrio after debating whether it worked based on a phase 2 trial. Then, in September, another independent panel voted 7-2 in favor of approval based on additional analyses of the same trial. The clinical study of 137 participants found that Relyvrio patients lived 10 months longer than the placebo group.
The FDA approved the ALS treatment in late September, and Mr. Klee has previously said Amylyx will pull the drug off the market if its phase 3 trial doesn't support previous data.