TRASTUZUMAB FOR GASTRIC CANCER

Trastuzumab for the treatment of HER2 positive 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 trastuzumab within its licensed indication for the treatment of HER2 positive advanced gastric cancer. 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 trastuzumab.

Findings

The manufacturer's submission (MS) included a de-novo economic evaluation based on the eligibility of the application for end-of life status. The ERG found that a number of assumptions behind the manufacturer’s model may be optimistic and could mean that the incremental costs per QALY gained were underestimated. Additional analysis carried out by the ERG concluded that the incremental cost-effectiveness ratio (ICER) is expected to be around £20,000 to £30,000. The addition of potential long-term cardiac events could increase ICER to above £30,000, although there is no long-term evidence to date surrounding this issue. Also, the small study excluded from the manufacturer’s submission raises the possibility of an equally effective but shorter regimen, incurring lower cost and toxicity and with greater patient convenience.

Conducted by: Gill Norman1, Stephen Rice1, Eldon Spackman2, Lisa Stirk1, Anthony Danso-Appiah1, Dong Suh2, Stephen Palmer2, Alison Eastwood1

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

Further details

Project page on NIHR HTA Programme website

Related guidance

Commissioned to inform NICE Technology Appraisal Guidance: Trastuzumab for the treatment of HER2 positive advanced gastric cancer. London: National Institute for Clinical Excellence; 2010

Publications

Spackman E, Rice S, Norman G, Suh DC, Eastwood A, Palmer S. Trastuzumab for the treatment of HER2-positive metastatic gastric cancer : a NICE Single Technology Appraisal. Pharmacoeconomics 2013;31(3):185-94

Norman G, Rice S, Spackman E, Stirk L, Danso-Appiah A, Suh D, Palmer S, Eastwood A. Trastuzumab for the treatment of HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. Health Technol Assess 2011;15(Suppl 1):33-43

CRD and CHE Technology Assessment Group. Trastuzumab for the treatment of HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. Centre for Reviews and Dissemination / Centre for Health Economics, 2010

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.