[A19-06] Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V
Last updated 04.07.2019
Project no.:
A19-06
Commission:
Commission awarded on 14.01.2019 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer
Postmenopausal women: survival advantages, but also higher frequency of severe side effects. Overall: added benefit not proven. Pre- and perimenopausal women: indication of lesser benefit than appropriate comparator therapy for one group of patients; other groups: 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.
| 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 |
| A17-45 | Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A19-46 | Ribociclib (breast cancer; combination with an aromatase inhibitor) - Addendum to Commission A19-06 | Commission completed |
| A19-45 | Ribociclib (breast cancer; combination with fulvestrant) - Addendum to Commission A19-06 | Commission completed |
Federal Joint Committee (G-BA)
2019-07-04 A G-BA decision was published.