[A25-154] Nivolumab (urothelial carcinoma, adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Last updated 16.03.2026

Project no.:
A25-154

Commission:
Commission awarded on 15.12.2025 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

Adults with muscle invasive urothelial carcinoma with tumour cell PD-L1 expression ≥ 1% and a high risk of recurrence after undergoing radical resection, for whom cisplatin-containing therapy is not suitable or who have already received neoadjuvant treatment with cisplatin; adjuvant treatment

Result of dossier assessment:

Male patients: hint of a minor added benefit
Female patients: 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.

DOI:

https://doi.org/10.60584/A25-154

Project no.	Title	Status
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
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
A15-27	Nivolumab – Benefit assessment according to §35a Social Code Book V (dossier assessment)	Commission completed
A15-32	Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment)	Commission completed
A17-24	Nivolumab (squamous cell carcinoma of the head and neck) - 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
A23-59	Nivolumab (melanoma in adolescents, adjuvant) – 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
A25-88	Nivolumab (oesophageal or gastro-oesophageal junction cancer, adjuvant) – Benefit assessment according to §35a Social Code Book V	Commission completed
A24-23	Nivolumab (melanoma, adjuvant, stage IIB or IIC) – Addendum to Project A23-94	Commission completed
A25-81	Nivolumab (NSCLC, perioperative) – Benefit assessment according to §35a Social Code Book V	Commission completed
A25-80	Nivolumab (colorectal cancer with dMMR or MSI-H, first line, combination with ipilimumab) – Benefit assessment according to §35a Social Code Book V	Commission completed
A25-79	Nivolumab (hepatocellular carcinoma) – 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
A25-142	Nivolumab (oesophageal or gastro-oesophageal junction cancer, adjuvant) – Addendum to Project A25-88	Commission completed

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