pembrolizumab (Keytruda)

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

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

Indication under review: in combination with chemotherapy, for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease.

SMC restriction: for use in combination with paclitaxel or nab-paclitaxel. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.

In one randomised, double-blind, phase III study, pembrolizumab plus chemotherapy significantly improved progression free survival and overall survival compared with chemotherapy alone.

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 the views from a Patient and Clinician Engagement (PACE) meeting.