CAPECITABINE FOR ADVANCED GASTRIC CANCER

Capecitabine for advanced gastric cancer: an assessment based on the manufacturer’s submission to NICE

Background

The aim of this NICE STA was to appraise the clinical and cost-effectiveness of capecitabine within its licensed indication for for the first-line treatment, in combination with a platinum-based chemotherapy regimen, of advanced gastric cancer (aGC). CRD researchers together with researchers from the Centre for Health Economics (CHE) comprised the Evidence Review Group for this STA. The work involved a detailed assessment of the manufacturer’s submission to NICE on the clinical and cost-effectiveness of capecitabine.

This project assessed the manufacturer's submission (MS) to NICE on the use of capecitabine for the first-line treatment, in combination with a platinum-based chemotherapy regimen, of advanced gastric cancer (aGC).

Findings

The submission was considered to contain convincing evidence of the non-inferiority of capecitabine to 5-FU on the outcomes of OS and PFS; this evidence was considered to be applicable to UK practice. There was evidence of some differences in adverse event profiles, but there was no evidence of a poorer safety profile for capecitabine overall. There was also no evidence of any difference in QoL between the two fluoropyrimidines. The MS included a cost-minimisation analysis (CMA) which the ERG deemed to be an appropriate framework with which to analyse the current decision problem. Overall, cost estimates for the CMA were generated appropriately and were robust to uncertainties regarding assumptions and sources. The results of the manufacturers base-case analysis, one-way sensitivity analysis, scenario analysis and worst-case analysis showed that capecitabine regimens are cost saving compared with their equivalent 5-FUbased regimens.

Conducted by: Gill Norman1, Marta Soares2, Piia Peura2, Stephen Rice1, Dong Suh2, Kath Wright1, Mark Sculpher2, Alison Eastwood1

1. Centre for Reviews and Dissemination; 2. Centre for Health Economics, University of York

Further details

Project page on the NIHR HTA Programme website

Related guidance

Commissioned to inform NICE guidance: Capecitabine for the treatment of advanced gastric cancer. London: National Institute for Clinical Excellence; 2010

Publications

CRD and CHE Technology Assessment Group. Capecitabine for the treatment of advanced gastric cancer: a Single Technology Appraisal. CRD, 2010

Norman G, Soares M, Peura P, Rice S, Suh D, Wright K, Sculpher M, Eastwood A. Capecitabine for the treatment of advanced gastric cancer. Health Technol Assess. 2010; 14(Suppl. 2):11-7

Funding

Commissioned by the NIHR HTA Programme in support of NICE's Single Technology Appraisal process.

NICE’s single technology appraisal (STA) process is specifically designed for the appraisal of a single product, device or other technology, with a single indication. The STA process normally covers new technologies and is designed to provide recommendations in the form of NICE guidance soon after the technology is introduced into the UK market. The principal evidence in the STA process is submitted by the manufacturer or sponsor of the technology.