pembrolizumab (Keytruda)

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

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

Indication under review: As monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) with a ≥50% tumour proportion score (TPS) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations.

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

In a randomised, open-label, phase III study, treatment with pembrolizumab provided an additional 4.3 months of progression free survival compared to standard of care.

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 NHS Scotland or a list price that is equivalent or lower.

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