NICE recommends innovative endometriosis pill

NICE has recommended the first daily oral pill on the NHS to treat endometriosis. The new final draft guidance from NICE follows its earlier negative recommendation of relugolix–estradiol–norethisterone (Ryeqo) relugolix combination therapy for this indication.

The treatment offers key benefits including its administration by patients at home. “Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home,” stated Helen Knight, Director of Medicines Evaluation, NICE.

Additionally, it works quicker compared to injectable alternative treatments, and “can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects,” stated Knight.

For instance, the guidance highlighted that as a daily treatment, relugolix–estradiol–norethisterone has a shorter half-life than GnRH agonists, and “it may be quicker [for patients] to return to normal hormonal levels after stopping treatment.”

Patients who have had failed medical or surgical treatment for endometriosis will be eligible for the relugolix combination therapy as an additional treatment option, NICE explained.

Clinical evidence for relugolix combination therapy in endometriosis

Ryeqo works by inhibiting certain hormones associated with endometriosis, while also providing necessary hormone replacement, the agency shared.

Findings from two similar Phase III trials (SPIRIT 1 and 2), comparing Ryeqo with placebo. A response was reported in 75 percent of participants compared with 27 percent and 30 percent in those given placebo at 24 weeks, in SPIRIT 1 and SPIRIT 2, respectively. Clinical evidence show that relugolix combination therapy reduced pain compared with placebo, NICE noted.

Based on direct comparative evidence, the committee concluded the treatment had higher efficacy over placebo in reducing dysmenorrhoea and non-menstrual pelvic pain associated with endometriosis.

“[relugolix combination therapy] marks a potential step-change in how we manage endometriosis, putting control back in patients’ hands while ensuring value for the taxpayer,” Knight asserted.