NICE Single Technology Appraisal Guidance No 189

Sorafenib for the treatment of advanced hepatocellular carcinoma

This NICE guidance was published on 26 May 2010. The web reference for the appraisal and other related documents is:

NHSScotland should note that:

1. Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland.

2. NHS boards should adhere to the Scottish Medicines Consortium (SMC) advice.

SMC published a Statement of Advice (482/08) on this medication for this indication in January 2016. This stated that:

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.

Access the advice of SMC

3. There is a material difference between the recommendations of the NICE STA and SMC. NICE advises that sorafenib is not recommended for the treatment of advanced hepatocellular carcinoma in patients for whom surgical or locoregional therapies have failed or are not suitable.  

If you need further assistance, please contact Eleanor Brownlee in the first instance (tel 0141 225 6873 or email


Published Date: 26 May 2010