pembrolizumab (Keytruda)

Following a resubmission assessed under the end of life process:

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

Indication under review: in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations.

SMC restriction: in patients whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.

The addition of pembrolizumab to pemetrexed and platinum chemotherapy significantly improved progression-free survival and overall survival in patients with metastatic non-squamous NSCLC with no EGFR or ALK mutations.

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 PAS in NHSScotland or a list price that is equivalent or lower.

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