enfortumab vedotin (Padcev)

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

enfortumab vedotin (Padcev®) is accepted for restricted use within NHSScotland.

Indication under review: in combination with pembrolizumab, for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.

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

In a phase III, open-label study, enfortumab vedotin in combination with pembrolizumab was associated with statistically significant improvements in progression-free survival and overall survival compared with platinum-based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma.

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.