[A21-153] Abemaciclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V
Last updated 01.03.2022
Project no.:
A21-153
Commission:
Commission awarded on 01.12.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Indication:
Patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer
Result of dossier assessment:
- Postmenopausal women, initial endocrine therapy: added benefit not proven
- Postmenopausal women who received prior endocrine therapy; patients with visceral metastases: proof of a considerable added benefit
- Postmenopausal women who received prior endocrine therapy; patients with non-visceral metastases: indication of minor benefit
Note:
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.
| Project no. | Title | Status |
|---|---|---|
| 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 |
| A22-137 | Abemaciclib (breast cancer; combination with an aromatase inhibitor) – Benefit assessment according to §35a Social Code Book V | Commission completed |
| A22-51 | Abemaciclib (breast cancer) – Benefit assessment according to §35a Social Code Book V | Commission completed |