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Dossier assessment

Ribociclib (breast cancer, adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-124
Last updated

Report documents

  1. Extract of dossier assessment

    Ribociclib (breast cancer, adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 410 kB, EN, PDF
    DOI-Link
    https://doi.org/10.60584/A24-124_en
    Download file : Extract of dossier assessment (PDF-Dokument, 410 kB, EN, PDF)

  2. Dossier assessment

    Ribociclib (breast cancer, adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 695 kB, DE, PDF
    DOI-Link
    https://doi.org/10.60584/A24-124
    Download file : Dossier assessment (PDF-Dokument, 695 kB, DE, PDF)

Dossier assessment

Indication:

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

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

Additional information

Federal Joint Committee (G-BA)

2025-06-05 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A24-124
Commission
Commission awarded on 17.12.2024 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.

DOI
https://doi.org/10.60584/A24-124_en

Connected Projects

  1. Dossier assessment

    Ribociclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-22
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Ribociclib (breast cancer; combination with aromatase inhibitors) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-21
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A19-06
    Last updated

    Status: Commission completed

  4. Dossier assessment

    Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A17-45
    Last updated

    Status: Commission completed

  5. Addendum

    Ribociclib (breast cancer, adjuvant treatment) – Addendum to Project A24-124

    Project no.
    A25-51
    Last updated

    Status: Commission completed

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