ICER Questions Benefit of Fezolinetant for Hot Flashes

Fezolinetant, Astellas Pharma’s potential first-in-class treatment for menopausal hot flashes, shouldn’t cost more than $2,600 per year if approved, according to a cost-benefit analysis by the Institute for Clinical and Economic Review (ICER) based on the available trial data.

The ICER panel noted that none of the phase 3 data have yet been published in a peer-reviewed journal — a sticking point in the analysis — so there’s not enough evidence to demonstrate that fezolinetant exerts a net health benefit compared to no drug treatment.

The report offers insights into fezolinetant’s immediate future. The FDA’s target decision date on the drug is Feb. 22. Astella hopes its positive U.S. SKYLIGHT studies will carry the day, despite a failed parallel phase 3 trial in Asia.

In conducting the analysis, ICER set a $6,000 annual placeholder price for the drug. At that price, fezolinetant exceeded the cost-effectiveness benchmarks. But the results suggested that fezolinetant would be cost-effective if priced at between $2,000 and $2,600 annually.