cemiplimab (Libtayo)

following reassessment under the end of life and orphan equivalent medicine process:

cemiplimab (Libtayo®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

In a phase II study of cemiplimab in patients with metastatic or locally advanced CSCC the objective response rate was 45%.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

SMC previously accepted cemiplimab for use in this indication on an interim basis (SMC2216). This supersedes that advice.