[A20-104] Acalabrutinib (chronic lymphocytic leukaemia; combination with obinutuzumab) - Benefit assessment according to §35a Social Code Book V
Last updated 04.06.2021
Project no.:
A20-104
Commission:
Commission awarded on 30.11.2020 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
Patients who have no 17p deletion or TP53 mutation and for whom treatment with FCR is an option: added benefit not proven.
Patients who have no 17p deletion or TP53 mutation and for whom treatment with FCR is not an option: hint of non-quantifiable added benefit.
Patients who have 17p deletion or TP53 mutation or for whom chemo-immunotherapy is not indicated for other reasons: 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.
| Project no. | Title | Status |
|---|---|---|
| A20-103 | Acalabrutinib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A20-105 | Acalabrutinib (chronic lymphocytic leukaemia; pretreated) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| G21-14 | Acalabrutinib (previously untreated chronic lymphocytic leukaemia; combination with obinutuzumab) - Second Addendum to Commission A20-104 | Commission completed |
| A21-53 | Acalabrutinib (previously untreated chronic lymphocytic leukaemia; combination with obinutuzumab) - Addendum to Commission A20-104 | Commission completed |
Federal Joint Committee (G-BA)
2021-06-04: A G-BA decision was published.