RIMONABANT FOR OBESITY

Rimonabant for the treatment of overweight and obese patients: 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 rimonabant within its licensed indication as an adjunct to diet and exercise. 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 rimonabant.

Findings

The submission’s main evidence came from four randomised controlled trials. Rimonabant resulted in a significantly greater benefit than placebo for all primary weight loss outcomes. Improvements were maintained over two years with rimonabant, but data are lacking on the effectiveness and safety of rimonabant beyond two years. Withdrawal of rimonabant at 1 year resulted in a reduction in weight loss until there was no difference from placebo at two years. Psychiatric adverse events including depression were notably higher with rimonabant than placebo. Pairwise comparisons of showed beneficial effects of rimonabant over orlistat and sibutramine for weight loss outcomes.

The adequacy of the cost-effectiveness modelling and assumptions regarding strategies utilising response hurdles for rimonabant and comparator treatments was a key concern. Also, the use of external evidence on the HRQoL impact of BMI independent of longer-term clinical events rather than estimates from the trials, and the choice of this external evidence, were key issues. The lack of evidence on the effect of rimonabant on 'hard' end points, such as CVD, diabetes and mortality, was a major limitation. In addition, the appropriateness of incorporating the link between BMI reductions and a lower risk of diabetes and CVD and the choice of evidence to inform this link were questionable.

The incremental cost-effectiveness ratio (ICER) of rimonabant versus diet and exercise, orlistat, or Sibutramine were all below the threshold for cost-effectiveness. In subgroup analysis and in reanalyses by the manufacturer and the ERG none were above the threshold.

Conducted by: J Burch1, C McKenna2, S Palmer2, G Norman1, J Glanville1, M Sculpher2, N Woolacott1

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

Further details

Project page on HTA Programme website

Related guidance

Commissioned to inform NICE Technology Appraisal 144: Rimonabant for the treatment of overweight and obese patients. London: National Institute for Clinical Excellence; 2008

Publications

Burch J, McKenna C, Palmer S, Norman G, Glanville J, Sculpher M, Woolacott N. Rimonabant for the treatment of overweight and obese people. Single Technology Appraisals: A supplement to Health Technol Assess. 2009; 13 (Supplement 3): 14-22

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.