Interventions of Interest:

  • fezolinetant (Astellas Pharma Inc.)

The independent appraisal committee voted that evidence is not yet adequate to demonstrate a net health benefit for fezolinetant when compared to no pharmacological treatment. Using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 – $2,600 per year for women who cannot or choose not to take menopausal hormone therapy.

All stakeholders have a responsibility and an important role to play in ensuring that women have access to effective new treatment options for symptoms of menopause.

Final Documents

ICER’s Chief Medical Officer, David Rind, MD stated:

“While menopause is a part of normal aging for women, symptoms associated with menopause can last years and be disruptive. Vasomotor symptoms include flushing and sweating, and when frequent and/or severe, or when sleep is affected, can harm quality of life. 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 effective and safe options. 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.”

For questions, please contact info@icer.org.

View the Key Stakeholder List.