[A21-05] Alpelisib (breast cancer) - Addendum to Commission A20-81
Last updated 18.02.2021
Project no.:
A21-05
Commission:
Commission awarded on 12.01.2021 by the Federal Joint Committee (G-BA).
Report type:
Addendum
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
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
For men: added benefit still not proven; for women: now indication (instead of hint) of lesser benefit versus the comparator therapy
If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.
| Project no. | Title | Status |
|---|---|---|
| A20-81 | Alpelisib (breast cancer) - Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2021.02.18 A G-BA decision was published.