Benefit of Astellas' fezolinetant assessed by ICER

The US medicines cost effectiveness watchdog the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of Japanese drug major Astellas Pharma’s (TYO: 4503) fezolinetant for moderate-to-severe vasomotor symptoms (VMS) associated with menopause, finding that the evidence is not yet adequate to demonstrate a net health benefit to the drug when compared to no pharmacological treatment.

Fezolinetant is not yet approved by the Food and Drug Administration (FDA), although it is under review by the agency, and its manufacturer has not yet announced what the treatment’s US price will be if approved. Using point estimates from short-term clinical trials to generate longer-term analyses of cost-effectiveness, the ICER has calculated a health-benefit price benchmark (HBPB) for fezolinetant to be between $2,000 – $2,600 per year for women who cannot or who chose not to take MHT.

”While fezolinetant appears to be a promising treatment for women who cannot or do not wish to take MHT, there are still uncertainties about the magnitude of the benefit it provides and its long-term safety. All of the fezolinetant Phase III trials need to be peer reviewed and published,” said Dr David Rind, the ICER’s chief medical officer.