Dossier assessment

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

Status
Status: Commission completed
Project no.
A21-39
Last updated

Report documents

  1. Dossier assessment

    A21-39 - Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF-Dokument, 857 kB, EN, PDF
  2. Extract of dossier assessment

    A21-39 - Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF-Dokument, 313 kB, DE, PDF

Dossier assessment

Indication:

Adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection

Result of dossier assessment:
  • Stage IIIB/C and IV disease: hint of non-quantifiable added benefit.
  • Stage IIIA disease: added benefit not proven.

Additional information

Federal Joint Committee (G-BA)

2021-09-16 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A21-39
Commission
Commission awarded on 01.04.2021 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 (GBA) 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 GBA website.

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