[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

Topic:
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.

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

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