Linzagolix for treating moderate to severe symptoms of uterine fibroids

  • Technology appraisal guidance
  • TA996
  • Published: 
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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:

  • it is intended to be used for longer-term treatment (normally for more than 6 months and not for people who need short-term treatment, for example, before planned surgery)

  • the following dosage is used:

    • with hormonal add-back therapy (ABT): 200 mg once daily

    • without hormonal ABT: 200 mg once daily for 6 months, then 100 mg once daily.

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 healthcare professional 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 hormonal 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. Indirect treatment comparisons of linzagolix compared with relugolix CT are highly uncertain.

Even when taking this uncertainty into account, linzagolix with or without hormonal ABT is cost effective, but only when it is intended to be used for longer-term treatment (normally for more than 6 months). It is not recommended for people who need short-term treatment, for example, before planned surgery. The economic analysis for short-term use did not compare linzagolix against all relevant comparators, so the committee was unable to determine whether linzagolix was cost effective in this population. So, it is only recommended for longer-term use.