1 Recommendations

1 Recommendations

1.1 Cemiplimab is recommended as an option for treating metastatic or locally advanced cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not suitable, only if:

  • it is stopped at 24 months, or earlier if their disease progresses, and

  • the company provides cemiplimab according to the commercial arrangement.

Why the committee made these recommendations

This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund for cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma (NICE technology appraisal guidance TA592).

Standard care for people with advanced cutaneous squamous cell carcinoma is best supportive care so there is a need for effective and well-tolerated treatment options.

The new clinical evidence includes additional data from a clinical trial and from people having cemiplimab in the NHS while it was available in the Cancer Drugs Fund. People in the clinical trial and Cancer Drugs Fund followed a stopping rule which meant they stopped treatment at 22 months and 24 months respectively, or earlier if their disease progressed. There are no trials directly comparing cemiplimab with best supportive care. But an indirect comparison suggests that people taking cemiplimab are likely to live longer than people having best supportive care. There is still not enough data from the Cancer Drugs Fund and the trial to be certain by how much cemiplimab increases the length of time people live.

Because of the uncertainty with the clinical data, the cost-effectiveness estimates are also uncertain. The life expectancy of people with advanced cutaneous squamous cell carcinoma receiving best supportive care, and the evidence for how long life might be extended with cemiplimab, meet the end of life criteria. Therefore, the most likely cost-effectiveness estimates fall within what NICE considers an acceptable use of NHS resources. So, cemiplimab is recommended for routine use.

  • National Institute for Health and Care Excellence (NICE)