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Draft guidance consultation

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1 Recommendations

1.1

Fezolinetant should not be used to treat moderate to severe vasomotor symptoms caused by menopause.

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 healthcare professional consider it appropriate to stop.

What this means in practice

Fezolinetant is not required to be funded in the NHS in England to treat moderate to severe vasomotor symptoms caused by menopause. It should not be used routinely in the NHS in England.

This is because there is not enough evidence to determine whether fezolinetant is value for money.

Why the committee made these recommendations

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 caused by menopause when hormone replacement therapy is unsuitable. This does not include everyone who it is licensed for.

Clinical trial evidence shows that fezolinetant decreases the frequency and severity of moderate to severe vasomotor symptoms compared with placebo. But there are uncertainties about the clinical evidence. This is because the people in the trials do not reflect everyone who would be eligible to have fezolinetant in the NHS. There is also no robust evidence to show how moderate to severe vasomotor symptoms change over time.

There are also uncertainties in the economic model because it does not adequately reflect:

  • vasomotor symptoms that are important to those experiencing symptoms

  • the impact of treatment on the severity of these symptoms

  • everyone who would be eligible for fezolinetant in the NHS.

Because of these uncertainties, it is not possible to use the model to reliably estimate whether fezolinetant is better than other treatment options. Because of the uncertainties in the clinical and economic evidence it is not possible to determine the most likely cost-effectiveness estimates for fezolinetant. So, it should not be used.

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