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[A24-99] Pembrolizumab (urothelial cancer, first line) – Benefit assessment according to §35a Social Code Book V

Last updated 03.04.2025

Project no.:
A24-99

Commission:
Commission awarded on 24.09.2024 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

First-line treatment of adult patients with unresectable or metastatic urothelial carcinoma

Result of dossier assessment:
  • Patients for whom cisplatin-based therapy is a suitable treatment option: hint of non-quantifiable added benefit.
  • Patients for whom cisplatin-based therapy is not a suitable treatment option: hint of major added benefit.
  • Patients for whom cisplatin-based and carboplatin-based therapy is not a suitable treatment option: 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/A24-99_en

Project no. Title Status
A24-46 Pembrolizumab (NSCLC, neoadjuvant + adjuvant) – Benefit assessment according to § 35a Social Code Book V Commission completed
A24-03 Pembrolizumab (biliary cancer) – Benefit assessment according to §35a Social Code Book V Commission completed
A24-02 Pembrolizumab (gastric cancer, HER2-negative) – Benefit assessment according to §35a Social Code Book V Commission completed
A24-47 Pembrolizumab (NSCLC, adjuvant) – Benefit assessment according to § 35a Social Code Book V Commission completed
A24-01 Pembrolizumab (gastric or gastro-oesophageal junction adenocarcinoma, HER2-positive) – Benefit assessment according to §35a Social Code Book V Commission completed
A22-71 Pembrolizumab (renal cell carcinoma) – Benefit assessment according to § 35a SGB V Commission completed
A22-75 Pembrolizumab (colorectal cancer) – Benefit assessment according to § 35a SGB V Commission completed
A22-76 Pembrolizumab (endometrial cancer) – Benefit assessment according to §35a Social Code Book V Commission completed
A22-77 Pembrolizumab (gastric cancer) – Benefit assessment according to §35a Social Code Book V Commission completed
A22-78 Pembrolizumab (small bowel cancer) – Benefit assessment according to §35a Social Code Book V Commission completed
A22-79 Pembrolizumab (bile cancer) – Benefit assessment according to § 35a SGB V Commission completed
A22-70 Pembrolizumab (cervical cancer) – Benefit assessment according to § 35a SGB V Commission completed
A22-72 Pembrolizumab (melanoma, adjuvant) – Benefit assessment according to § 35a SGB V Commission completed
A22-73 Pembrolizumab (melanoma, advanced) – Benefit assessment according to § 35a SGB V Commission completed
A22-63 Pembrolizumab (breast cancer) - Benefit assessment according to § 35a Social Code Book V Commission completed
A21-164 Pembrolizumab (endometrial carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-163 Pembrolizumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-145 Pembrolizumab (breast cancer, triple-negative, locally recurrent/metastatic, in combination with chemotherapy) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-36 Pembrolizumab (colorectal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-34 Pembrolizumab (urothelial carcinoma first line treatment) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A21-35 Pembrolizumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-89 Pembrolizumab (urothelial carcinoma, first line) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Commission completed
A18-67 Pembrolizumab (head and neck squamous cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A17-46 Pembrolizumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A17-23 Pembrolizumab (classical Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A17-06 Pembrolizumab (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-55 Pembrolizumab (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A15-33 Pembrolizumab - Benefit assessment according to §35a Social Code Book V (dossier assessment) Commission completed
A24-104 Pembrolizumab (TNBC, neoadjuvant and adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A25-23 Pembrolizumab (urothelial cancer, first line treatment, combination with enfortumab vedotin) – Addendum to Project A24-99 Commission completed
A24-111 Pembrolizumab (endometrial carcinoma) – Benefit assessment according to §35a Social Code Book V Commission completed
A24-110 Pembrolizumab (cervical cancer, combination with chemoradiotherapy) – Benefit assessment according to §35a Social Code Book V Commission completed

Federal Joint Committee (G-BA)

2025-04-03 A G-BA decision was published.

G-BA documents on this decision

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