pembrolizumab (Keytruda)

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

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

Indication under review: as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults. This submission relates to use in adults previously untreated with ipilimumab.

In a phase III randomised open-label study, treatment with pembrolizumab (at unlicensed doses) extended median progression free survival and overall survival compared with other immune therapy in patients with advanced melanoma previously untreated with ipilimumab.

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 patient access scheme in NHS Scotland or a list price that is equivalent or lower.

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

SMC has also assessed pembrolizumab as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults previously treated with ipilimumab and has advised that it is not recommended for use within NHS Scotland in this setting.