A few months after receiving a landmark FDA approval for its amyotrophic lateral sclerosis (ALS) treatment Relyvrio, Amylyx is facing pushback from health insurance giant Cigna, who has decided not to cover the drug.
In the announcement made this week, Cigna cited a “lack of clinical efficacy data,” and said that the drug is “experimental, investigational, or unproven,” for the treatment of ALS. Specifically, Cigna is arguing that the preliminary data used to demonstrate clinical benefit are not convincing and have limitations in analysis.
The FDA was also skeptical of Relyvrio. An FDA Advisory Committee had initially met in March of last year and found that data from Amylyx’s initial trial was insufficient to prove that the drug slowed ALS progression, and voted 4-6 against the approval. After the FDA determined that additional analyses from clinical studies constituted major amendments to the application, a second AdComm meeting was scheduled for September. During the second meeting, the panel reversed its opinion and chose to recommend Relyvrio for approval.
While Cigna initially decided to cover Relyvrio if patients met specific criteria, its recent revision leaves patients to pay the full price for the treatment, at $158,000 a year.
