3.1 The appraisal committee (section 6) considered evidence submitted by Bayer and a review of this submission by the evidence review group. This appraisal was a Cancer Drugs Fund reconsideration of the published NICE technology appraisal guidance on sorafenib for treating advanced hepatocellular carcinoma.
3.2 The company's original submission presented clinical effectiveness data from the SHARP study. SHARP was a multicentre, double-blind, placebo-controlled, randomised trial in patients with advanced hepatocellular carcinoma who had not received previous systemic treatment. The study included 602 patients and assessed the effect of sorafenib plus best supportive care (n=299) compared with placebo plus best supportive care (n=303). The primary outcomes in SHARP were overall survival and time to symptomatic progression.
3.3 Sections 4.1 to 4.17 reflect the committee's discussion of the evidence submitted in the original appraisal. Section 4.18 onwards reflects the committee's discussion of the additional evidence submitted for the Cancer Drugs Fund reconsideration, which focused on:
data from the key source of evidence, SHARP
observational data from Palmer et al. (2013) and the GIDEON study to validate survival extrapolations from the company's original submission
estimates of treatment duration using individual patient data for time on treatment from SHARP and GIDEON
updated resource use data
cost-effectiveness analyses using a new Commercial Medicines Unit price, providing sorafenib at a reduced cost (commercial in confidence)
estimates of how much sorafenib is wasted.
3.4 See the committee papers for full details of the Cancer Drugs Fund reconsideration evidence and the history for full details of the evidence used for NICE's original technology appraisal guidance on sorafenib for treating advanced hepatocellular carcinoma.