[A17-45] Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V
Last updated 15.12.2017
Project no.:
A17-45
Commission:
Commission awarded on 05.09.2017 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Initial endocrine therapy of HR-positive, HER2-negative, locally advanced or metastatic breast cancer in postmenopausal women
Surrogate outcome "progression-free survival" not validated; side effects: indication of greater harm. Overall, there is an indication of lesser benefit versus the comparator therapy
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 |
|---|---|---|
| A20-22 | Ribociclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A20-21 | Ribociclib (breast cancer; combination with aromatase inhibitors) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A19-06 | Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A18-07 | Ribociclib (breast cancer) – Addendum to Commission A17-45 | Commission completed |