A new treatment option for menopausal
hot flushes and night sweats can be used in the NHS when HRT is
not suitable, with around 500,000 eligible to
benefit.
Fezolinetant (also
called Veoza and made by Astellas Pharma) is
recommended to treat moderate to severe symptoms in final
draft NICE guidance published today (11 March
2026).
Hot flushes and night
sweats 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.
The fezolinetant 45mg
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."
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
to 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 oestrogen-dependent
cancers, or liver disease. Those who have previously had
breast cancer or oestrogen-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.
-
For a full list of
contraindications and cautions
for HRT Clinical Knowledge Summary for prescribing information
for HRT
-
The final estimated eligible
patient number will be included in the resource
impact assessment tool published on the website
when the final guidance document is
published.
-
The final draft guidance: fezolinetant for treating
moderate to severe vasomotor symptoms caused by
menopause
