ICER rates Astellas’ potential menopausal symptom drug as promising at about $2,000 per year

The Institute for Clinical and Economic Review (ICER) on Thursday published a new evidence report for Astellas Pharma’s fezolinetant, recommending that the potential oral, nonhormonal drug designed to treat vasomotor symptoms associated with menopause should be priced between $2,000 and $2,500 per year for women who can’t or who choose not to take menopausal hormone therapy.

The cost-effectiveness nonprofit said the jury is still out on the effectiveness of the drug, which is due for an FDA decision by Feb. 22, 2023. Clinical evidence is rated as promising but inconclusive to determine whether fezolinetant provides a net health benefit for patients in the long term over no pharmacologic treatment, according to ICER.

Not every woman is able to or wants to participate in menopausal hormone therapy, and fezolinetant is meant to fill that gap.

David Rind 

David Rind, ICER’s CMO, said in a statement, “Menopausal hormone therapy (MHT) can often effectively treat symptoms of menopause, including vasomotor symptoms, but some women have contraindications to MHT and others are concerned about side effects of MHT, including an increased risk of breast cancer. There is an important need for new evidence-based options.”

The evidence report for fezolinetant will be reviewed at a Dec. 16 virtual public meeting with one of ICER’s three independent evidence appraisal committees.

The drug is clearly a crucial part of the Japanese pharma’s pipeline as it disclosed that it paid about $97 million to get a priority review voucher to speed up the FDA’s review.

Three Phase III clinical trials of the oral, non-hormonal drug will be reviewed by the FDA, which was tested in more than 2,800 women across the US, Canada and Europe in the late-stage BRIGHT SKY studies. The European Medicines Agency in September also opened its review of the drug.

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