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Dossier assessment

Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Status
Status: Commission completed
Project no.
A18-40
Last updated

Report documents

  1. Extract of dossier assessment

    Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF-Dokument, 129 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 129 kB, EN, PDF)

  2. Dossier assessment

    Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF-Dokument, 2 MB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 2 MB, DE, PDF)

Dossier assessment

Indication:

Treatment-naive adults with advanced (unresectable or metastatic) melanoma with BRAF V600 WT tumour

Result of dossier assessment:

Due to disadvantages in health-related quality of life and side effects, indication of lesser benefit in comparison with the appropriate comparator therapy (nivolomab alone)

Additional information

Federal Joint Committee (G-BA)

2018-12-20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-40
Commission
Commission awarded on 15.06.2018 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 page of the G-BA website.

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