Dossier assessment

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

Status
Status: Commission completed
Project no.
A18-63
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 161 kB, EN, not accessible
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 958 kB, DE, not accessible

Dossier assessment

Indication:

Patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer after prior endocrine therapy

Result of dossier assessment:

PALOMA-3 study unsuitable for the derivation of an added benefit due to inadequate implementation of appropriate comparator therapy; added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2019-03-22 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-63
Commission
Commission awarded on 01.08.2018 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.

Connected Projects

  1. Addendum

    Palbociclib (breast cancer) - Addendum to Commission A18-63

    Project no.
    A19-14
    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. Dossier assessment

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

    Project no.
    A22-66
    Last updated

    Status: Commission completed

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