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Dossier assessment

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

Status
Status: Commission completed
Project no.
A19-88
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 546 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 546 kB, EN, not accessible)

  2. Dossier assessment

    Niraparib (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:

Maintenance treatment of platinum-sensitive relapsed high-grade serous ovarian, fallopian tube, or primary peritoneal cancer with complete or partial response to platinum-based chemotherapy

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2020-04-02 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-88
Commission
Commission awarded on 15.10.2019 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.

Connected Projects

  1. Addendum

    Niraparib (ovarian cancer) - Addendum to Commission A19-88

    Project no.
    A20-16
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Niraparib (ovarian cancer) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

    Project no.
    G17-15
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Niraparib (first-line maintenance treatment in advanced ovarian cancer) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-98
    Last updated

    Status: Commission completed

  4. Dossier assessment

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

    Project no.
    A21-17
    Last updated

    Status: Commission completed

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