regorafenib (Stivarga)

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

regorafenib (Stivarga®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib.

In a randomised, double-blind, phase III study in patients with hepatocellular cancer that had progressed on sorafenib treatment, regorafenib significantly improved overall survival compared with placebo on a background of best supportive care.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of regorafenib. 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.