[A22-130] Zanubrutinib (chronic lymphocytic leukaemia, first line) – Benefit assessment according to §35a Social Code Book V
Last updated 15.06.2023
Project no.:
A22-130
Commission:
Commission awarded on 15.12.2022 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Indication:
Adult patients with previously untreated chronic lymphocytic leukaemia
Result of dossier assessment:
- Patients without genetic risk factors for whom therapy with FCR (= fludarabine + cyclophosphamide + rituximab) is not suitable: hint of non-quantifiable added benefit
- All other patients in the therapeutic indication: added benefit not proven
Note:
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 |
|---|---|---|
| A21-169 | Zanubrutinib (Waldenström macroglobulinaemia) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A22-131 | Zanubrutinib (marginal zone lymphoma) – Benefit assessment according to §35a Social Code Book V | Commission completed |
| A22-132 | Zanubrutinib (chronic lymphocytic leukaemia, relapsed/refractory) – Benefit assessment according to §35a Social Code Book V | Commission completed |
| A23-41 | Zanubrutinib (chronic lymphocytic leukaemia) – Addendum to Commission A22-130 | Commission completed |
| A23-130 | Zanubrutinib (follicular lymphoma) – Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2023-06-15 A G-BA decision was published.