1 Recommendations

1.1 Relugolix–estradiol–norethisterone acetate is recommended, within its marketing authorisation, as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age.

Why the committee made these recommendations

Treatment options for symptoms of uterine fibroids include a levonorgestrel-releasing intrauterine system or combined hormonal contraception. For moderate to severe symptoms, injectable gonadotrophin-releasing hormone (GnRH) agonists are often used before surgical options. Relugolix–estradiol–norethisterone acetate, taken orally, is another treatment option for moderate to severe symptoms.

Clinical trial evidence shows that relugolix–estradiol–norethisterone acetate is more effective than placebo for reducing heavy menstrual bleeding. It has only been indirectly compared with GnRH agonists and this suggests it is similarly effective to them, but the results are uncertain.

The cost-effectiveness estimates for relugolix–estradiol–norethisterone acetate are mostly within the range normally considered by NICE to represent an acceptable use of NHS resources. There are also likely additional benefits of the treatment not captured in the economic model, including that:

  • it is an effective non-surgical treatment

  • it is taken orally

  • there is no restriction on treatment duration in the marketing authorisation (in contrast to GnRH agonists)

  • it is well tolerated

  • it preserves the uterus (in contrast to surgical options).

So, despite the uncertainty in the clinical evidence, taking these benefits into account, all the cost-effectiveness estimates for relugolix–estradiol–norethisterone acetate are likely within what NICE normally considers an acceptable use of NHS resources. It is therefore recommended.

  • National Institute for Health and Care Excellence (NICE)