[A22-132] Zanubrutinib (chronic lymphocytic leukaemia, relapsed/refractory) – Benefit assessment according to §35a Social Code Book V
Last updated 15.03.2023
Project no.: A22-132
Commission: Commission awarded on 12.12.2022 by the Federal Joint Committee (G-BA).
Report type: Dossier assessment
Status: Commission completed
Department/Division: Drug Assessment
Topic: Cancer
Indication:
Patients with relapsed/refractory chronic lymphocytic leukaemia
Result of dossier assessment:
- who have not yet received a Bruton tyrosine kinase (BTK) inhibitor and/or B-cell lymphoma-2 (BCL-2) inhibitor< 65 years: hint of major added benefit≥ 65 years: hint of minor added benefit
- after prior therapy with at least one BTK inhibitor: added benefit not proven
- after prior therapy with at least one BCL-2 inhibitor: added benefit not proven
- after prior therapy with at least one BTK inhibitor and one BCL-2 inhibitor: 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.