pembrolizumab (Keytruda)

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

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

Indication under review: In combination with platinum and fluoropyrimidine based chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS≥10.

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

In a phase III study, pembrolizumab in combination with chemotherapy was associated with 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.

SMC advice relating to patients with HER2-negative gastro-oesophageal adenocarcinoma expressing PD-L1 has been superseded by SMC2660. SMC advice relating to patients with carcinoma of the oesophagus expressing PD-L1 remains valid.