Loading ...

The National Institute for Health and Care Excellence (NICE) has recommended linzagolix (Yselty, Theramex) for treating endometriosis in selected patients.

The decision applies to women for whom previous medical or surgical treatments have not alleviated their symptoms.

The drug is a gonadotropin-releasing hormone (GnRH) antagonist taken orally, allowing patients to self-administer the treatment at home.

It must be used alongside hormonal add-back therapy to help reduce potential side effects.

Routine NHS Use Approved

In final draft guidance, NICE said there was sufficient evidence to show that linzagolix with hormonal add-back therapy provides clinical benefits and value for money.

As a result, the treatment will be made available on the NHS in England.

NICE estimated that up to 1000 women a year could benefit from the treatment.

Endometriosis affects around 1.5 million women in the UK. Linzagolix offers a non-injectable alternative to existing options.

It is already approved for treating moderate to severe symptoms of uterine fibroids.

The hormonal add-back therapy includes oestradiol 1 mg and norethisterone acetate 0.5 mg to help mitigate potential side effects.

Current therapeutic options for endometriosis include surgery, GnRH agonists such as leuprorelin acetate, and relugolix-oestradiol-norethisterone acetate (relugolix combination therapy [CT]).

Clinical Evidence Supports Use

NICE said that clinical trial evidence showed that linzagolix with hormonal add-back therapy demonstrated statistically significant reductions in both dysmenorrhoea and non-menstrual pelvic pain compared with placebo.

Indirect comparisons suggested that the combination offers similar pain relief to leuprorelin acetate and relugolix CT.

Relugolix CT became the first long-term pill licensed to treat endometriosis following NICE’s approval for NHS use in March.

Cost and NHS Impact

The cost of linzagolix was judged comparable to relugolix CT and considered acceptable against standard care options such as surgery or leuprorelin. NICE found that the cost-effectiveness of linzagolix with hormonal add-back therapy to be within its acceptable range.

In a press release, Helen Knight, director of Medicines Evaluation at NICE, described the drug as “a valuable addition to the options available for this often painful and disruptive condition.” She noted the convenience of once-daily dosing at home and its potential to ease pressure on NHS services.

Availability and Safety

Linzagolix is supplied as 200-mg film-coated tablets. A 28-tablet pack is priced at £80.

The hormonal add-back therapy costs £13.20 for a pack of 84 tablets. Annual treatment costs are estimated at £1100, although discounts may apply.

The most common side effects reported in trials include hot flushes (6.3%) and headache (5.7%).

Linzagolix is subject to additional monitoring to allow quick identification of new safety information. Treatment should be supervised by a physician experienced in the diagnosis and treatment of endometriosis.

Final guidance is due to be published on 25 June. The NHS in England must make the treatment available within 90 days of publication.

Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.