[A19-06] Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

Last updated 04.07.2019

Project no.:

Commission awarded on 14.01.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:


Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer

Result of dossier assessment:

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.

Federal Joint Committee (G-BA)

2019-07-04 A G-BA decision was published.

G-BA documents on this decision


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