Cigna Restricts Coverage for Amylyx Pharmaceutical’s ALS Drug Relyvrio

Cigna will not cover Amylyx Pharmaceutical’s (Amylyx) amyotrophic lateral sclerosis (ALS) drug Relyvrio, according to a recent national formulary coverage policy issued by the company.  Cigna considers Relyvrio to be “experimental, investigational or unproven” for any use.

Cigna said that due to the lack of clinical efficacy data and unclear clinical benefit, approval for medical necessity is not recommended for Relyvrio. The policy decision date is effective as of February 1, 2023 and the next review date will be February 1, 2024.

Cigna changed its policy for Relyvrio, deciding not to cover it due to “a lack of clinical efficacy data.” Previously, the insurer had covered Relyvrio if patients met a list of eight criteria and had been prescribed the drug by a physician who specializes in ALS treatment.

Amylyx states that its drug Relyvrio (sodium phenylbutyrate and taurursodiol) and Albrioza (sodium phenylbutyrate and ursodoxicoltaurine) are the first drug to show statistically significant functional benefit and observed survival benefit in ALS. Albrioza is commercially available in Canada. ALS is a global disease that affects at least 200,000 people worldwide.

Relyvrio is administered orally or via a feeding tube. The recommended dosage for the first 3 weeks of treatment is 1 packet daily, increasing to 2 packets daily starting at the beginning of week 4.

Amylyx set Relyvrio’s price tag at $158,000 per year. 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.

Takeaway: Cigna’s new policy is another example of insurers restricting or excluding coverage for orphan drugs