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Dossier assessment

Palbociclib (breast cancer) – Benefit assessment according to § 35a SGB V

Status
Status: Commission completed
Project no.
A22-66
Last updated

Report documents

  1. Extract of dossier assessment

    Palbociclib (breast cancer) – Benefit assessment according to § 35a SGB V

    published on
    Document type
    PDF document, 841 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 841 kB, EN, not accessible)

  2. Dossier assessment

    Palbociclib (breast cancer) – Benefit assessment according to § 35a SGB V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Postmenopausal patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer in first-line therapy

Result of dossier assessment:

Proof of lesser benefit

Press releases

Palbociclib combination in advanced breast cancer: again only disadvantages

For postmenopausal women with hormone receptor-positive, HER2-negative breast cancer, there is no survival advantage in the first-line setting, but disadvantages in the form of severe side effects - as was already the case in the first assessment in 2017.
Press release

Additional information

Federal Joint Committee (G-BA)

2022-12-15 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A22-66
Commission
Commission awarded on 01.07.2022 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.

Connected Projects

  1. Dossier assessment

    Palbociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    Project no.
    A18-63
    Last updated

    Status: Commission completed

  2. Dossier assessment

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

    Project no.
    A16-74
    Last updated

    Status: Commission completed

  3. Addendum

    Palbociclib (breast cancer, combination with an aromatase inhibitor) – Addendum to Commission A22-66

    Project no.
    A22-120
    Last updated

    Status: Commission completed

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