[A22-01] Relugolix/estradiol/norethisterone (uterine fibroids) - Addendum to Commission A21-112
Last updated 18.02.2022
Project no.:
A22-01
Commission:
Commission awarded on 11.01.2022 by the Federal Joint Committee (G-BA).
Report type:
Addendum
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Digestion, metabolism and hormones
Indication:
Adult women of reproductive age with moderate to severe symptoms of uterine fibroids
Result of dossier assessment:
Unchanged after addendum:
- 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
Note:
If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.
| Project no. | Title | Status |
|---|---|---|
| A21-112 | Relugolix/estradiol/norethisterone (uterine fibroid) - 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.