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1 Recommendations

1.1

Linzagolix is recommended as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age only if:

  • they cannot have or do not want hormonal replacement add-back therapy (ABT),

  • it is not used as a short-term treatment (usually 6 months or less), for example before uterine fibroid surgery

  • the dosage used is 200 mg once daily up to 6 months, followed by 100 mg once daily.

Linzagolix is only recommended if the company provides it according to the commercial arrangement (see section 2).

1.2

This recommendation is not intended to affect treatment with linzagolix 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

Usual treatment for moderate to severe symptoms of uterine fibroids includes hormonal contraceptives and gonadotropin-releasing hormone (GnRH) receptor agonists and antagonists. GnRH antagonists, such as relugolix combination therapy (CT), may contain ABT. Other treatments include best-supportive care, for example iron supplements and painkillers.

Clinical trial evidence shows that linzagolix works better than placebo at treating moderate to severe symptoms of uterine fibroids. It has not been compared with relugolix CT in a clinical trial. An indirect comparison was too uncertain to conclude whether linzagolix has similar health benefits to relugolix CT. Because of this, there was not enough evidence to conclude that linzagolix is a clinically and cost-effective option for short-term use or longer-term use with ABT.

Linzagolix is only cost effective when it is used longer-term without ABT and a dosage of 200 mg once daily up to 6 months, followed by 100 mg once daily is used which was the dosage modelled in the evidence. So, linzagolix is recommended in this population.