[A20-81] Alpelisib (breast cancer) - Benefit assessment according to §35a Social Code Book V
Last updated 01.12.2020
Project no.:
A20-81
Commission:
Commission awarded on 01.09.2020 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Indication:
| Men and postmenopausal women with HR-positive, HER2-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy |
Result of dossier assessment:
| For men: added benefit not proven; for women: hint of lesser benefit versus the comparator therapy |
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 |
|---|---|---|
| A21-05 | Alpelisib (breast cancer) - Addendum to Commission A20-81 | Commission completed |
Federal Joint Committee (G-BA)
2021.02.18 A G-BA decision was published.