[A18-63] Palbociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Last updated 22.03.2019

Project no.:

Commission awarded on 01.08.2018 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:


Patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer after prior endocrine therapy

Result of dossier assessment:

PALOMA-3 study unsuitable for the derivation of an added benefit due to inadequate implementation of appropriate comparator therapy; 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)

2019-03-22 A G-BA decision was published.

G-BA documents on this decision


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