NICE Single Technology Appraisal Guidance No 189
Sorafenib for the treatment of advanced hepatocellular
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
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
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