sorafenib (Nexavar)

following a 2nd resubmission under the end of life and orphan process

sorafenib (Nexavar®) is accepted for restricted use within NHS Scotland.

Indication under review: the treatment of hepatocellular carcinoma.

SMC restriction: in patients with advanced hepatocellular carcinoma who have failed or are unsuitable for surgical or loco-regional therapies.

In a phase III study in patients with advanced hepatocellular carcinoma, sorafenib was superior to placebo in terms of overall survival, but not for time to symptomatic progression.

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