NICE backs new non-hormonal drug fezolinetant for menopausal hot flushes

GPs are to be given a new non-hormonal prescribing option for menopausal hot flushes and night sweats, as NICE has expressed its support for fezolinetant.

Final NICE draft guidance issued today recommends fezolinetant to treat moderate-to-severe symptoms, where hormonal treatment is contraindicated.

The clinical guidelines body estimates that 500,000 people will be eligible to benefit from the treatment.

Although NICE stressed that hormone-replacement therapy (HRT) remains the first-line treatment option and that it is likely most people with moderate to severe vasomotor symptoms would continue to take it, it said the new drug ‘addresses and important need’ for women unable or unwilling to take HRT.

The fezolinetant 45mg tablet is taken once daily and reduces the frequency and intensity of hot flushes and night sweats by selectively blocking a neurotransmitter (neurokinin B) in the brain that is involved in causing hot flushes.

More than two million people in the UK are affected by moderate-to-severe hot flushes and night-sweats associated with menopause. These symptoms can hugely affect daily life by disrupting sleep, concentration, relationships, and the ability to work, and when HRT is not suitable, options have previously been limited.

Fezolinetant is the first neurokinin targeted therapy (NK-3 receptor antagonist) to be recommended by NICE and can be used when HRT is medically contraindicated – for example, in cases of deep vein thrombosis or pulmonary embolism. It can also be used following a clinical risk assessment in some cases of diabetes or heart disease, and by those who do not wish to take HRT.

Nevertheless, fezolinetant is not recommended for individuals with current breast cancer, other oestrogen-dependent cancers, or liver disease – with liver function monitoring required before starting treatment and regularly thereafter.

Furthermore, it’s recommended that those who have previously had breast cancer or oestrogen-dependent cancers should undergo an individual risk assessment before being considered for fezolinetant, as clinical trial data in this group is not yet available.

The new guidance is based on data from the BRIGHT SKY programme conducted by Astellas Pharma, which included three randomised phase 3 clinical trials as part of a development programme that collectively enrolled over 2,800 people across Europe, the USA, and Canada.

Explaining its decision in the draft guideline, NICE said: ‘Clinical trial evidence suggests that fezolinetant decreases the frequency and severity of moderate to severe vasomotor symptoms compared with placebo.’

However it cautioned: ‘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.’

Helen Knight, director of medicines evaluation at NICE said: ‘We know that menopausal hot flushes and night sweats can have a profound impact on quality of life and significantly affect overall wellbeing.’

‘For those who are unable to take HRT for varying reasons, options have historically been limited, and we have heard clearly from patients how difficult that can be.’

‘The evidence shows fezolinetant can meaningfully reduce symptoms, and was found to be cost effective, offering value for the taxpayer. This decision will give much-needed relief to those for whom HRT is unsuitable.’

Dr Katie Barber, GP and registered menopause specialist, said: ‘Every month, women with debilitating symptoms, where HRT is not recommended or desired, come to me saying ‘I’ve been told there’s nothing else for me.’ NICE’s decision introduces an effective choice for a sizeable number of women who have had limited options to date.’

Dr Vikram Talaulikar, associate specialist in reproductive medicine at University College London (UCL), said: ‘Despite progress, the sad reality is that many women continue to suffer in silence as not all current treatments meet their specific needs.’

‘NICE’s decision means that NHS doctors now have an alternative treatment that was specifically designed and studied to improve particular symptoms of menopause. It is excellent news for the furtherment of women’s health in the UK and provides women with a wider choice of options.’

The news comes as the NHS is currently working on incorporating menopause questions in the NHS Health Check, meaning millions of women will be asked if they suffer symptoms.

Asking about the menopause as a matter of routine will raise awareness of symptoms and give women the confidence to seek help, health secretary Wes Streeting said.

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