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Dossier assessment

Olaparib (ovarian cancer) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A19-56
Last updated

Report documents

  1. Extract of dossier assessment

    Olaparib (ovarian cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 426 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 426 kB, EN, not accessible)

  2. Dossier assessment

    Olaparib (ovarian cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

Indication:

Women whose advanced BRCA1/2-mutated high-grade epithelial ovarian cancer has responded completely or partially to first-line platinum-based chemotherapy

Result of dossier assessment:

Several hints of greater harm regarding side effects; no informative results regarding overall survival. Added benefit not proven.

Project details

Project no.
A19-56
Commission
Commission awarded on 11.07.2019 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.

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