Fezolinetant for moderate to severe vasomotor symptoms associated with menopause: effectiveness and value : final evidence report
- Collection:
- Health Policy and Services Research
- Author(s):
- Beaudoin, Francesca L., author Wright, Abigail, (Of Institute for Clinical and Economic Review), author Yeung, Kai, 1981- author Moradi, Ashton, author Herron-Smith, Serina, author Pearson, Steven D., author Rind, David M., author Lin, Grace A., author McQueen, R. Brett, author Gutierrez, Eric, (Of School of Pharmacy, University of Colorado), author
- Contributor(s):
- Institute for Clinical and Economic Review, issuing body. Midwest Comparative Effectiveness Public Advisory Council, issuing body.
- Publication:
- [Boston, Massachusetts] : Institute for Clinical and Economic Review, January 23, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Cost-Effectiveness Analysis Heterocyclic Compounds, 2-Ring Hot Flashes Menopause Thiadiazoles Vasomotor System United States
- Genre(s):
- Technical Report
- Abstract:
- A number of therapeutics (e.g., anti-depressants, gabapentinoids) have been investigated to treat VMS, with Menopausal Hormone Therapy (MHT) generally considered the mainstay of treatment. However, MHT may be medically contraindicated in some patients and not desired by others. Fezolinetant (Astellas Pharma Inc.), a selective neurokinin-3 inhibitor, is a once daily oral nonhormonal therapy under consideration by the FDA at a 45 mg dose for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. We compared the clinical and cost effectiveness of fezolinetant and MHT to no pharmacologic treatment and to each other. Fezolinetant was studied as part of two Phase III randomized controlled trials (RCTs) conducted primarily in the United States (Skylight 1 and 2). At both the 30 mg and 45 mg doses, fezolinetant demonstrated statistically significant improvements in VMS severity and frequency over twelve weeks. However, at the planned 45 mg dose, average improvement in VMS severity compared with placebo achieved a clinically meaningful difference in only one of the trials and the average reduction in VMS frequency failed to achieve a clinically meaningful difference in either trial. There were however higher proportions of treatment responders in the 45 mg trial arms compared to placebo. A separate trial of the fezolinetant 30 mg dose (Moonlight 1) reportedly did not show significant improvement in VMS symptoms, which conflicts with the findings in the Skylight trials. In terms of safety, fezolinetant was generally well tolerated, with headache as the most common adverse event; 2-3% of participants experienced elevated liver enzymes. Finally, when compared to placebo, MHT achieved clinically significant differences for both VMS frequency and severity.
- Copyright:
- Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
- Extent:
- 1 online resource (1 PDF file (various pagings))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918697386406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918697386406676