[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 (G-BA).
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 (G-BA) 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 G-BA 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.