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Dossier assessment

Lenvatinib (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-57
Last updated

Report documents

  1. Extract of dossier assessment

    Lenvatinib (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 135 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 135 kB, EN, not accessible)

  2. Dossier assessment

    Lenvatinib (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy

Result of dossier assessment:

Added benefit not proven for the 2 subindications (no liver cirrhosis or stage Child-Pugh A, Child-Pugh B)

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.
A18-57
Commission
Commission awarded on 19.09.2018 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

The current version 1.1 of the dossier assessment replaces version 1.0 published on 2019-01-02.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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