regorafenib (Stivarga)

following a full submission and assessed under the ultra-orphan and end of life process

regorafenib (Stivarga®) is accepted for use within NHS Scotland.

Indication under review: Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

In a study of patients with metastatic or unresectable GIST who had prior treatment with imatinib and sunitinib, treatment with regorafenib prolonged the median progression free survival by 3.9 months when compared with placebo.  

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of regorafenib and 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 the views from a Patient and Clinician Engagement (PACE) meeting.