— Evidence is rated as promising but inconclusive to determine whether fezolinetant provides a net health benefit for patients over the long term; however, using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 – $2,500 per year for women who cannot or choose not to take menopausal hormone therapy —

— At the December 16 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate over these treatments’ comparative clinical effectiveness, other potential benefits, and long-term value for money —

BOSTON, December 1, 2022 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of fezolinetant (Astellas Pharma Inc.) for the vasomotor symptoms (VMS) associated with menopause.

“While menopause is a part of normal aging for women, symptoms associated with menopause can last years and be disruptive,” said David Rind, MD, ICER’s Chief Medical Officer. “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 evidence-based options.”

This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest CEPAC) on December 16, 2022. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Clinical Findings

ICER rated the evidence promising but inconclusive (“P/I”) to determine whether fezolinetant provides a net health benefit over no pharmacologic treatment. When comparing fezolinetant to MHT, there is insufficient evidence to allow a clear comparison of the comparative net health benefits, leading to an ICER Evidence Rating of “Insufficient” (I).

Key Cost-Effectiveness Findings

Fezolinetant is not yet approved by the FDA, 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, ICER has calculated a health-benefit price benchmark (HBPB) for fezolinetant to be between $2,000 – $2,500 per year for women who cannot or who chose not to take MHT.    

ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.