Dossier assessment

Encorafenib (melanoma) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-61
Last updated

Report documents

  1. Extract of dossier assessment

    Encorafenib (melanoma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 139 kB, EN, not accessible
  2. Dossier assessment

    Encorafenib (melanoma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 813 kB, DE, not accessible

Dossier assessment

Indication:

Adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation

Result of dossier assessment:

Added benefit not proven for pretreated or treatment-naive patients

Press releases

Melanoma: dabrafenib and trametinib have added benefit

The drug combination showed longer survival and fewer or later recurrences.

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.
A18-61
Commission
Commission awarded on 27.09.2018 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
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

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    Encorafenib (melanoma) - Addendum to Commission A18-61

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    Status: Commission completed

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    Binimetinib and encorafenib (NSCLC) – Benefit assessment according to §35a Social Code Book V

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  3. Dossier assessment

    Encorafenib (colorectal cancer) - Benefit assessment according to §35a Social Code Book V

    Project no.
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    Last updated

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  4. Dossier assessment

    Encorafenib (colorectal cancer, first line) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-88
    Last updated

    Status: Commission completed

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