[A18-89] Pembrolizumab (urothelial carcinoma, first line) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Last updated 01.04.2019

Project no.:
A18-89

Commission:
Commission awarded on 21.12.2018 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10

Result of dossier assessment:

Added benefit not proven due to lack of informative study data

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.

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

Project no. Title Status
A19-99 Pembrolizumab (combination with axitinib, renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-31 Pembrolizumab (squamous non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-30 Pembrolizumab (non-squamous non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-29 Pembrolizumab (melanoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-101 Pembrolizumab (head and neck squamous cell carcinoma, combination therapy) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-100 Pembrolizumab (head and neck squamous cell carcinoma, monotherapy) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-67 Pembrolizumab (head and neck squamous cell carcinoma) - 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
A17-06 Pembrolizumab (non-small cell lung cancer) - 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
A17-46 Pembrolizumab (urothelial carcinoma) - 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
A21-36 Pembrolizumab (colorectal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed

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