Dossier assessment

Relugolix/estradiol/norethisterone (uterine fibroid) - Benefit assessment according to §35a Social Code Book V

Report documents

Indication:

Adult women of reproductive age with moderate to severe symptoms of uterine fibroids

Result of dossier assessment:

Women for whom watchful waiting is the best individual choice: hint of considerable added benefit.
Women for whom symptom-oriented treatment (with gestagens or ulipristal acetate) or an invasive treatment option is the best individual choice: added benefit not proven

Federal Joint Committee (G-BA)

2022-02-18 A G-BA decision was published.

Project no.: A21-112
Commission: Commission awarded on 31.08.2021 by the Federal Joint Committee (GBA).
Report type: Dossier assessment
Status: Commission completed
Department/Division: Drug Assessment
Topic: Digestion, metabolism and hormones
Note: After completion of the assessment by IQWiG the Federal Joint Committee (GBA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the GBA website.

The current version 1.1 of the dossier assessment replaces version 1.0 published on 2021-12-01.

Press contact

+49 221 356850

press@iqwig.de

Info Service (German)

Subscribe to daily updated information on projects, calls for tender, current vacancies and events as well as our press releases.

Contact form

Questions about commissions, publications and press releases can be sent to us via this form.