1.1 Pembrolizumab is recommended as an option for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 1 or more. This is only if:
pembrolizumab is given as a monotherapy
pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if disease progresses, and
the company provides pembrolizumab according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with pembrolizumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Treatment of metastatic or unresectable recurrent HNSCC depends on where it starts. If it starts in the oral cavity (mouth), it is usually first treated with cetuximab combination therapy (cetuximab with platinum and 5‑fluorouracil [5-FU] chemotherapy). If it starts outside the oral cavity it is treated with chemotherapy (platinum and 5-FU) alone.
Clinical trial evidence from people who have HNSCC that expresses a biomarker called PD-L1 (with a CPS of 1 or more) shows that, if their cancer started in the oral cavity, pembrolizumab monotherapy works at least as well as cetuximab combination therapy and has lower overall costs. If their cancer started outside the oral cavity, pembrolizumab monotherapy works better than chemotherapy alone. It has higher overall costs but the cost-effectiveness estimates are within what NICE normally considers an acceptable use of NHS resources. Pembrolizumab monotherapy is therefore recommended for both types of HNSCC.
The cost-effectiveness estimates for pembrolizumab combination therapy compared with monotherapy, in both types of HNSCC, are higher than what NICE normally considers an acceptable use of NHS resources. Therefore it is not recommended.