Dossier assessment
Alpelisib (breast cancer) - Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Alpelisib (breast cancer) - Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Alpelisib (breast cancer) - Benefit assessment according to §35a Social Code Book V
Dossier assessment
Indication:
| 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 |
Additional information
Federal Joint Committee (G-BA)
2021.02.18 A G-BA decision was published.
Project details
- Project no.
- A20-81
- Commission
- Commission awarded on 01.09.2020 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Cancer
- Note
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After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.