Draft NICE approval for new fibroid treatment

Around 4500 women in England and Wales will be eligible for a new oral treatment for uterine fibroids.

A woman leans on a desk holding her stomach in pain.
Symptoms of uterine fibroids include heavy menstrual bleeding, pelvic pain and fertility problems. | GETTY IMAGES

Draft NICE guidance recommends relugolix with estradiol and norethisterone acetate (Ryeqo) as a new treatment for women with moderate to severe symptoms of uterine fibroids.

Taken once daily as a single tablet containing 40mg relugolix, 1mg estradiol and 500 microgram norethisterone acetate, Ryeqo provides an alternative to surgery and injectable GnRH agonists. It works by inhibiting the release of hormones that control oestrogen and progesterone production by the ovaries.

Cost-effective

In its final appraisal document, NICE noted that clinical trial evidence shows that relugolix/estradiol/norethisterone acetate is more effective than placebo for reducing heavy menstrual bleeding. NICE acknowledged that the combination has only been indirectly compared with GnRH agonists and may be similarly effective to them, but this remains uncertain.

However, taking into account the potential additional benefits of relugolix/estradiol/norethisterone acetate as a well-tolerated oral treatment that can be used long term with no adverse effect on fertility, NICE concluded that the cost-effectiveness estimates for the treatment are likely to be acceptable.

Helen Knight, interim director of medicines evaluation in the NICE Centre for Health Technology Evaluation, said: 'Uterine fibroids can have a profound effect on quality of life. Along with the many debilitating symptoms, there is a real lack of long-term options.

'This treatment has the potential to improve quality of life. As well as effectively reducing symptoms, it can be taken at home and is therefore more convenient than the injectable treatment, given in a hospital setting.

'It can also be used long term, which could mean improved and sustained symptom relief, it is well-tolerated, and it will mean thousands of women can avoid invasive surgery which always carries some risk.'

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