pembrolizumab (Keytruda)

following a full submission assessed under the end of life and orphan medicine process

pembrolizumab (Keytruda®) is accepted for restricted use within NHS Scotland.

Indication under review: The treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) and who have received at least one prior chemotherapy regimen.

SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.

Pembrolizumab, compared with a standard taxane monotherapy, significantly improved overall survival in adults with advanced NSCLC tumours that express PD-L1 and have progressed after platinum-doublet chemotherapy.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

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