cemiplimab (Libtayo)

following a full submission:

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

Indication under review: as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:

•   locally advanced NSCLC who are not candidates for definitive chemoradiation or
•   metastatic NSCLC

SMC restriction: for patients with locally advanced NSCLC who are not candidates for definitive chemoradiation. Treatment with cemiplimab is subject to a stopping rule of a maximum of 36 three-weekly cycles.

Evidence from an open-label phase III study demonstrated that cemiplimab monotherapy improved overall survival compared with chemotherapy. Results from the locally advanced subgroup were broadly consistent with those in the full study population.

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.