pembrolizumab (Keytruda)

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

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

Indication under review: in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express programmed death ligand 1 (PD-L1) with a combined positive score (CPS)≥1.

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

In a phase III study, the addition of pembrolizumab to chemotherapy with or without bevacizumab was associated with a significant improvement in progression-free survival and overall survival in patients with persistent, recurrent or metastatic cervical cancer with PD-L1 CPS≥1.

This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS) arrangements delivering the cost-effectiveness results upon which the decision was based, or PAS/ list prices that are equivalent or lower.

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