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Relugolix–estradiol–norethisterone for treating symptoms of endometriosis

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1 Recommendations

1.1

Relugolix–estradiol–norethisterone (relugolix combination therapy [CT]) is not recommended, within its anticipated marketing authorisation, for treating symptoms of endometriosis in adults who have had medical or surgical treatment for their endometriosis.

1.2

This recommendation is not intended to affect treatment with relugolix CT that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

After pain relief and hormonal treatment, usual treatment options for endometriosis are gonadotropin-releasing hormone (GnRH) agonists and surgery. There is no cure for endometriosis, and there is an unmet need for long-term and non-invasive (non-surgical and not injected) treatments for its symptoms.

Clinical trial evidence shows that relugolix CT reduces pain compared with placebo. Relugolix CT has not been directly compared in a clinical trial with usual treatment. Indirect comparisons suggest that it is likely to reduce pelvic pain almost as well as GnRH agonists, but this is uncertain. It is also uncertain how well relugolix CT works compared with surgery.

There are also concerns about the economic model. This is because of uncertainty about the completeness of the clinical evidence, and the absence of evidence on other usual treatments.

Because of the uncertainties in the clinical evidence and economic model, it is not possible to determine the most likely cost-effectiveness estimates for relugolix CT. So, it is not recommended.