pembrolizumab (Keytruda)

following a full submission assessed under the end of life process:

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

Indication under review: in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma in adults.

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

In an open-label, phase III study, first-line treatment with pembrolizumab plus axitinib significantly improved progression-free and overall survival in adults with advanced renal cell carcinoma compared with a vascular endothelial growth factor (VEGF)-targeting tyrosine-kinase inhibitor (TKI).

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

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