[A21-112] Relugolix/estradiol/norethisterone (uterine fibroid) - Benefit assessment according to §35a Social Code Book V
Last updated 18.02.2022
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
Adult women of reproductive age with moderate to severe symptoms of uterine fibroids
- 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
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.
| Project no. | Title | Status |
|---|---|---|
| A22-01 | Relugolix/estradiol/norethisterone (uterine fibroids) - Addendum to Commission A21-112 | Commission completed |
| A23-117 | Relugolix/estradiol/norethisterone acetate (endometriosis) – Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2022-02-18 A G-BA decision was published.