pembrolizumab (Keytruda)

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

pembrolizumab (Keytruda®) is not recommended for use within NHSScotland.

Indication under review: in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.

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

The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

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