A new treatment option for menopausal hot flushes and night sweats can now be used in the NHS when HRT is not suitable, with around 500,000 eligible to benefit. Fezolinetant is recommended to treat moderate to severe symptoms in final draft NICE guidance published today.
Hot flushes and night sweats can hugely affect daily life by disrupting sleep, concentration, relationships and the ability to work. When HRT is not suitable, options have previously been limited. The fezolinetant 45 mg tablet is taken once a day and is a non-hormonal treatment that works by blocking the nerve pathways in the brain that trigger hot flushes and night sweats.
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.”
Mr Paul Simpson, BMS Chair Elect, said:
“Great news! The BMS welcomes the decision by NICE to support NHS use of fezolinetant for treating moderate to severe vasomotor symptoms. Whilst hormonal treatment is appropriate for many women, it is not suitable for all – having NHS funded access to a new class of non-hormonal medication will offer the opportunity for symptom relief in these circumstances. The positive impact this class of drug can have on menopause care has been on the horizon for some time, with many women patiently awaiting this approval. The next steps are to integrate this medication into primary and secondary care settings through our local formularies and care pathways.”
Dr Sue Mann, National Clinical Director in Women’s Health for NHS England, said:
“Symptoms of menopause including hot flushes and night sweats can affect every part of a women’s life, so this is very welcome news especially for women who are unable to or don’t wish to take hormone replacement therapy. It’s another vital treatment option which could help hundreds of thousands of women experiencing menopause to better manage their symptoms and feel more in control of their health.”
HRT remains the first-line treatment option and, given its established benefits and the range of formulations now available, it’s likely most people with moderate to severe vasomotor symptoms would continue take it. However, fezolinetant addresses a real and important need for those who cannot or do not wish to use HRT.
Fezolinetant 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. Those who do not wish to take HRT are also eligible for this treatment.
Fezolinetant is not recommended for those with current breast cancer, other estrogen-dependent cancers, or liver disease. Those who have previously had breast cancer or estrogen-dependent cancers and have completed treatment should undergo an individual risk assessment before being considered for fezolinetant, as clinical trial data in this group is not yet available.
Liver function monitoring is required before starting treatment and regularly thereafter.
The final draft NICE guidance is available on the NICE website.