1.1
Linzagolix with hormonal add-back therapy can be used within its marketing authorisation as an option to treat symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for their endometriosis.
1 Recommendation
What this means in practice
Linzagolix with hormonal add-back therapy must be funded in the NHS in England for the condition and population in the recommendation, if it is considered the most suitable treatment option. Linzagolix must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that linzagolix with hormonal add-back therapy provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Why this recommendation was made
Treatments for endometriosis aim to manage its symptoms but do not resolve the underlying condition. Options include surgery, gonadotropin-releasing hormone agonists (such as leuprorelin acetate) and relugolix–estradiol–norethisterone acetate (relugolix combination therapy [CT]).
Clinical trial evidence shows that linzagolix with hormonal add-back therapy reduces dysmenorrhoea (painful periods) and non-menstrual pelvic pain compared with placebo. Indirect comparisons suggest that linzagolix with hormonal add-back therapy gives similar pain relief to leuprorelin acetate and relugolix CT.
The cost-effectiveness estimates for linzagolix with hormonal add-back therapy compared with surgery, leuprorelin acetate and relugolix CT are within the range that NICE considers an acceptable use of NHS resources. So, linzagolix with hormonal add-back therapy can be used.
For all the evidence, see the committee papers. For more information on streamlined evaluations, see NICE's manual on health technology evaluations.