1.1
Fezolinetant can be used as an option to treat moderate to severe vasomotor symptoms associated with menopause when hormone replacement therapy is unsuitable.
1 Recommendation
1.2
This recommendation is not intended to affect treatment with fezolinetant that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
What this means in practice
Fezolinetant must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Fezolinetant must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that fezolinetant provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Why the committee made this recommendation
Usual treatment for vasomotor symptoms (hot flushes and night sweats) is hormone replacement therapy. For this evaluation, the company asked for fezolinetant to be considered only for vasomotor symptoms associated with menopause when hormone replacement therapy is unsuitable. This does not include everyone who it is licensed for.
Clinical trial evidence suggests that fezolinetant decreases the frequency and severity of moderate to severe vasomotor symptoms compared with placebo. Fezolinetant has not been directly compared with non-hormonal treatments. Indirect comparisons suggest that it may have similar effectiveness to non-hormonal treatments, but this is uncertain.
The cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, fezolinetant can be used.