[A20-81] Alpelisib (breast cancer) - Benefit assessment according to §35a Social Code Book V

Last updated 01.12.2020

Project no.:

Commission awarded on 01.09.2020 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:


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


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)

2021.02.18 A G-BA decision was published.

G-BA documents on this decision


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