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Dossier assessment

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

Status
Status: Commission completed
Project no.
A19-73
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF-Dokument, 455 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 455 kB, EN, PDF)

  2. Dossier assessment

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

    published on
    Document type
    PDF-Dokument, 1 MB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 1 MB, DE, PDF)

Dossier assessment

Indication:

Adults with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein of ≥ 400 ng/mL and who have been previously treated with sorafenib

Result of dossier assessment:

Negative effects in some side effects do not call into question the major advantage in overall survival; overall proof of considerable added benefit

Additional information

Federal Joint Committee (G-BA)

2020-02-20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-73
Commission
Commission awarded on 29.08.2019 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.

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