[A22-51] Abemaciclib (breast cancer) – Benefit assessment according to §35a Social Code Book V
Last updated 20.10.2022
Project no.:
A22-51
Commission:
Commission awarded on 29.04.2022 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Adjuvant treatment of patients with HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence
- Premenopausal women: hint of minor added benefit
- Postmenopausal women: added benefit not proven
- Men: 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 2022-10-10.
| Project no. | Title | Status |
|---|---|---|
| A21-153 | Abemaciclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A20-32 | Abemaciclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A18-72 | Abemaciclib in combination with an aromatase inhibitor (breast cancer) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A18-73 | Abemaciclib in combination with fulvestrant (breast cancer) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A22-96 | Abemaciclib (breast cancer; adjuvant treatment) - Addendum to Commission A22-51 | Commission completed |
| A22-137 | Abemaciclib (breast cancer; combination with an aromatase inhibitor) – Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2022-10-20 A G-BA decision was published.