Dossier assessment

Venetoclax (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-82
Last updated

Report documents

  1. Extract of dossier assessment

    Venetoclax (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 177 kB, EN, not accessible
  2. Dossier assessment

    Venetoclax (chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 291 kB, DE, not accessible

Dossier assessment

Indication:

Adult patients with chronic lymphocytic leukaemia who are unsuitable for or have failed treatments with a B-cell receptor pathway inhibitor or chemoimmunotherapy

Result of dossier assessment:

No comparisons with appropriate comparator therapy presented; added benefit neither proven for patients with 17p deletion or TP53 mutation nor for patients without 17p deletion or TP53 mutation

Project details

Project no.
A18-82
Commission
Commission awarded on 22.11.2018 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
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.

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