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[A23-59] Nivolumab (melanoma in adolescents, adjuvant) – Benefit assessment according to §35a Social Code Book V

Last updated 02.10.2023

Project no.:
A23-59

Commission:
Commission awarded on 30.06.2023 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Monotherapy for the adjuvant treatment of adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection

Result of dossier assessment:
  • Tumour stage III (involvement of lymph nodes): added benefit not proven
  • Tumour stage IV (metastatic 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
A23-58 Nivolumab (melanoma) – 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
A22-54 Nivolumab (oesophageal squamous cell carcinoma) - 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
A21-146 Nivolumab (gastric adenocarcinoma, adenocarcinoma of the gastroesophageal junction or the oesophagus) - 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
A21-99 Nivolumab (colorectal cancer) - Benefit assessment according to §35a Social Code Book V 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
A21-39 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
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
A16-24 Nivolumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book 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
A23-94 Nivolumab (melanoma, adjuvant, stage IIB or IIC) – Benefit assessment according to §35a Social Code Book V Commission completed

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