1.1 Cemiplimab is recommended for use within the Cancer Drugs Fund as an option for treating locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate. It is recommended only if the conditions in the managed access agreement are followed.
1.2 Treatment with cemiplimab should be continued until disease progression or for up to 24 months (whichever is sooner).
1.3 These recommendations are not intended to affect treatment with cemiplimab 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
Living with advanced unresectable cutaneous squamous cell carcinoma is physically and emotionally challenging, and there is a high unmet need for new treatments. Cemiplimab trial data are promising but uncertain.
The cost-effectiveness estimates for cemiplimab are above what is normally considered a cost-effective use of NHS resources. The evidence on life expectancy with current treatments and how long life might be prolonged with cemiplimab is very uncertain. Because of this it is not known for certain whether the end-of-life criteria apply. So cemiplimab cannot be recommended for routine use in the NHS.
However, if more mature data become available from an ongoing trial of cemiplimab, and more data on life expectancy with current treatments are obtained, this could confirm the expectation that the end-of-life criteria apply. If this is the case, there is plausible potential for cemiplimab to be a cost-effective treatment. Therefore, cemiplimab is recommended for use within the Cancer Drugs Fund.