pembrolizumab (Keytruda)

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

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

Indication under review: as monotherapy, for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS)≥10.

In an open label, non-comparative phase II study of adults with advanced / metastatic urothelial cancer who had no previous treatment for advanced / metastatic disease and who were ineligible for first line cisplatin based therapy, treatment with pembrolizumab was associated with an objective response in 47% of patients with strongly positive PD-L1 expression (CPS≥10).

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 clinical and economic analysis to gain acceptance by SMC.

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