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Dossier assessment

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

Status
Status: Commission completed
Project no.
A18-36
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 164 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 164 kB, EN, not accessible)

  2. Dossier assessment

    Olaparib (ovarian, fallopian tube, peritoneal 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:

Patients with platinum-sensitive relapsed high-grade ovarian cancer

Result of dossier assessment:

Serous epithelial ovarian cancer: hint of minor added benefit. Non-serous epithelial ovarian cancer: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2018-12-06 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-36
Commission
Commission awarded on 05.06.2018 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 pages of the G-BA website: Nutzenbewertungsverfahren zum Wirkstoff Olaparib (neues Anwendungsgebiet: high-grade epitheliales Ovarialkarzinom, Eileiterkarzinom oder primäres Peritonealkarzinom) and Nutzenbewertungsverfahren zum Wirkstoff Olaparib (Aufhebung des Orphan-Drug-Status).

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