[A25-148] Pembrolizumab (head and neck squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V

Last updated 02.03.2026

Project no.:
A25-148

Commission:
Commission awarded on 24.11.2024 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

Adult patients with resectable locally advanced head and neck squamous cell carcinoma whose tumours express programmed death-ligand 1 with a combined positive score ≥ 1

Result of dossier assessment:

Patients with a high postoperative risk profile for whom cisplatin-based therapy is suitable, or with a low postoperative risk profile; neoadjuvant and adjuvant therapy: hint of a minor added benefit
Patients with a high postoperative risk profile for whom cisplatin-based therapy is not suitable; neoadjuvant and adjuvant therapy: 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/A25-148

Project no.	Title	Status
A15-33	Pembrolizumab - Benefit assessment according to §35a Social Code Book V (dossier assessment)	Commission completed
A16-55	Pembrolizumab (non-small cell lung cancer) - 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
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
A18-67	Pembrolizumab (head and neck squamous cell carcinoma) - 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
A19-29	Pembrolizumab (melanoma) - 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
A19-31	Pembrolizumab (squamous non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V	Commission completed
A19-99	Pembrolizumab (combination with axitinib, renal cell carcinoma) - 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
A19-101	Pembrolizumab (head and neck squamous cell carcinoma, combination therapy) - 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
A21-144	Pembrolizumab (oesophageal cancer) - 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
A21-163	Pembrolizumab (renal cell carcinoma) - 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
A22-63	Pembrolizumab (breast cancer) - Benefit assessment according to § 35a Social Code Book V	Commission completed
A22-70	Pembrolizumab (cervical cancer) – Benefit assessment according to § 35a SGB V	Commission completed
A22-71	Pembrolizumab (renal cell carcinoma) – 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
A22-75	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
A24-01	Pembrolizumab (gastric or gastro-oesophageal junction adenocarcinoma, HER2-positive) – 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
A24-03	Pembrolizumab (biliary cancer) – Benefit assessment according to §35a Social Code Book V	Commission completed
A24-46	Pembrolizumab (NSCLC, neoadjuvant + adjuvant) – 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
A24-99	Pembrolizumab (urothelial cancer, first line) – Benefit assessment according to §35a Social Code Book V	Commission completed
A24-104	Pembrolizumab (TNBC, neoadjuvant and adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)	Commission completed
A24-110	Pembrolizumab (cervical cancer, combination with chemoradiotherapy) – Benefit assessment according to §35a Social Code Book V	Commission completed
A24-111	Pembrolizumab (endometrial carcinoma) – Benefit assessment according to §35a Social Code Book V	Commission completed
A25-53	Pembrolizumab (pleural mesothelioma) – Benefit assessment according to §35a Social Code Book V	Commission completed

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