pembrolizumab (Keytruda)

following a full submission:

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

Indication Under Review: in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor 2 (HER2)-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥ 1.

In a phase III study, the addition of pembrolizumab to a fluoropyrimidine and platinum-containing chemotherapy regimen was associated with a significant improvement in overall survival in adults with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1 with a CPS ≥ 1.

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 replaces advice in SMC2420 only relating to patients with HER2-negative gastro-oesophageal junction adenocarcinoma expressing PD-L1.