Dossier assessment

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

Status
Status: Commission completed
Project no.
A20-105
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 477 kB, EN, not accessible
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 607 kB, DE, not accessible

Dossier assessment

Indication:

Adult patients with previously treated chronic lymphocytic leukaemia (CLL)

Result of dossier assessment:

Patients after pretreatment who have no 17p deletion or TP53 mutation and for whom chemo-immunotherapy is indicated: added benefit not proven.

Patients after pretreatment who have 17p deletion or TP53 mutation or for whom chemo-immunotherapy is not indicated for other reasons: added benefit not proven.

Patients after at least 2 pretreatments: added benefit not proven.

Additional information

Federal Joint Committee (G-BA)

2021-08-05: A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A20-105
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

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.

Connected Projects

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

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    Status: Commission completed

  2. Dossier assessment

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  3. Addendum

    Acalabrutinib (pretreated chronic lymphocytic leukaemia) - Addendum to Commission A20-105

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  4. Addendum

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  6. Dossier assessment

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