New non-hormonal treatment for menopausal hot flushes recommended by NICE

A new non-hormonal treatment option for menopausal hot flushes and night sweats can be used by the NHS when hormone-replacement therapy (HRT) is not suitable, according to NICE.

Fezolinetant has been recommended to treat moderate-to-severe symptoms, with NICE issuing its final draft guidance today. Around 500,000 people are eligible to benefit from the treatment.

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.’

Related Article: 200 cervical cancer deaths prevented by HPV vaccine in England

‘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.’

The guidance from NICE was 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.

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.

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.’

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.

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.

Related Article: Warning issued over advertising new prescription-only weight loss pill

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.

Dr Vikram Talaulikar, associate specialist, reproductive medicine, University College London (UCL) Hospitals and honorary associate professor at 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.’

Related Article: Carers of people with dementia report reaching ‘breaking point’

Anita Powell, founder of The Menopause Alliance, said: ‘In community settings, I meet women every week who are struggling with debilitating menopausal symptoms and limited treatment options. NICE’s guidance recognises this reality. The next step must be ensuring that local services are equipped to deliver timely, informed care so women do not continue to fall through the gaps.’

A version of this article was first published on our sister title, The Pharmacist.