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

Last updated 01.07.2021

Project no.:
A21-39

Commission:
Commission awarded on 01.04.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

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.
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.

Project no. Title Status
A20-121 Nivolumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A20-118 Nivolumab (non-small cell lung cancer, combination with ipilimumab) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-11 Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-53 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-40 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A17-29 Nivolumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A17-27 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A17-24 Nivolumab (squamous cell carcinoma of the head and neck) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-76 Nivolumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-35 Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-25 Nivolumab (new therapeutic indication) – Benefit assessment according to §35a SGB V Commission completed
A15-32 Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Commission completed
A15-27 Nivolumab – Benefit assessment according to §35a Social Code Book V (dossier assessment) Commission completed
A21-106 Nivolumab (melanoma, adjuvant) - Addendum to Commission A21-39 Commission completed
A21-89 Nivolumab (malignant pleural mesothelioma) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-59 Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A23-59 Nivolumab (melanoma in adolescents, adjuvant) – Benefit assessment according to §35a Social Code Book V Commission completed
A24-70 Nivolumab (unresectable or metastatic urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V Commission completed
A23-58 Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commission completed
A21-146 Nivolumab (gastric adenocarcinoma, adenocarcinoma of the gastroesophageal junction or the oesophagus) - Benefit assessment according to §35a Social Code Book V Commission completed
A22-54 Nivolumab (oesophageal squamous cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A23-74 Nivolumab (NSCLC, combination with platinum-based chemotherapy, neoadjuvant) – Benefit assessment according to §35a Social Code Book V Commission completed
A21-99 Nivolumab (colorectal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A22-55 Nivolumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A22-53 Nivolumab (urothelial carcinoma, adjuvant) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-108 Nivolumab (oesophageal or gastro-oesophageal junction cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A23-94 Nivolumab (melanoma, adjuvant, stage IIB or IIC) – Benefit assessment according to §35a Social Code Book V Commission completed

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

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