Pembrolizumab can be used, within its marketing authorisation, as an option to treat resectable locally advanced head and neck squamous cell carcinoma in adults whose tumours express PD‑L1 with a combined positive score of 1 or more:
as neoadjuvant monotherapy
then as adjuvant treatment with radiotherapy, with or without cisplatin
then as monotherapy.
Pembrolizumab can only be used if the company provides it according to the commercial arrangement.
Pembrolizumab must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Pembrolizumab must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that pembrolizumab provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Usual treatment for resectable locally advanced head and neck squamous cell carcinoma is surgery. After surgery (known as adjuvant treatment) people can have radiotherapy with or without cisplatin. There are no treatments available before surgery (known as neoadjuvant treatment).
Clinical trial evidence shows that neoadjuvant and adjuvant pembrolizumab increases how long people have before their condition gets worse. The evidence also suggests that it may increase how long people live compared with usual treatment.
The most likely cost-effectiveness estimates for neoadjuvant and adjuvant pembrolizumab are within the range that NICE considers an acceptable use of NHS resources. So, it can be used.
For all the evidence, see the committee papers. For more information on streamlined evaluations, see NICE's technology appraisal and highly specialised technologies guidance manual.