pembrolizumab (Keytruda)

Following a full submission assessed under the end of life and orphan medicine process:

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

Indication under review: as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

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

In a phase III study of patients with measurable urothelial carcinoma with progressive disease on or after platinum based chemotherapy, treatment with pembrolizumab was associated with a statistically significant improvement in overall survival when compared with investigator’s choice of single agent chemotherapy.

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 views from a Patient and Clinician Engagement (PACE) meeting.