[A19-77] Ibrutinib (new therapeutic indication, chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V
Last updated 20.02.2020
Project no.:
A19-77
Commission:
Commission awarded on 02.09.2019 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Adults with previously untreated chronic lymphocytic leukaemia
Patients for whom treatment with fludarabine in combination with cyclophosphamide and rituximab (FCR) is not an option: hint of minor added benefit. For both other subindications (FCR therapy is an option; chemo-immunotherapy is not an option due to 17p deletion, TP53 mutation or other reasons): added benefit not proven.
The current version 2.0 of the dossier assessment replaces version 1.0 published on 2019-12-02.
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.