Dossier assessment

Abemaciclib (breast cancer) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A22-51
Last updated

Report documents

  1. Extract of dossier assessment

    Abemaciclib (breast cancer) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 1 MB, EN, PDF
  2. Dossier assessment

    Abemaciclib (breast cancer) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 2 MB, DE, PDF

Dossier assessment

Indication:

Adjuvant treatment of patients with HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence

Result of dossier assessment:
  • Premenopausal women: hint of minor added benefit
  • Postmenopausal women: added benefit not proven
  • Men: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2022-10-20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A22-51
Commission
Commission awarded on 29.04.2022 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.

The current version 1.1 of the dossier assessment replaces version 1.0 published on 2022-10-10.

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