Dossier assessment
Acalabrutinib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Acalabrutinib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Acalabrutinib (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V
Dossier assessment
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.
Additional information
Federal Joint Committee (G-BA)
2021.06.04 A G-BA decision was published.
Project details
- Project no.
- A20-103
- Commission
- Commission awarded on 30.11.2020 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.
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