RIMONABANT FOR OBESITY
Rimonabant for the treatment of overweight and obese patients
Background
This project was undertaken as part of NICE’s single technology appraisal (STA) process. The 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.
The aim of this project was to critically evaluate the manufacturer's submission, evaluating the evidence for the clinical effectiveness, safety, tolerability and cost-effectiveness of rimonabant in its licensed indication as an adjunct to diet and exercise, relative to other licensed antiobesity drugs (orlistat and sibutramine) and diet and exercise alone.Findings
The adequacy of the cost-effectiveness modelling and assumptions regarding strategies utilising response hurdles for rimonabant and comparator treatments is 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, are key issues.
The lack of evidence on the effect of rimonabant on 'hard' end points, such as CVD, diabetes and mortality, is a major limitation. Data are
also lacking on the effectiveness and safety of rimonabant beyond 2 years. 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 are questionable.
There are concerns over the psychiatric morbidity associated with rimonabant and, given the lack of long-term data, the cumulative data on less common side-effects are uncertain. The generalisability to the UK overweight and obese population is uncertain, particularly in the broader diabetic population as there are no data on the effectiveness or safety of rimonabant in insulindependant diabetics
Conducted by: J Burch1, C McKenna2, S Palmer2, G Norman1, J Glanville1, M Sculpher2, N Woolacott11. Centre for Reviews and Dissemination; 2. Centre for Health Economics, University of York
Further details
Project page on HTA Programme websiteRelated guidance
Commissioned to inform NICE Technology Appraisal 144: Rimonabant for the treatment of overweight and obese patients. London: National Institute for Clinical Excellence; 2008Publications
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): 14-22Funding
Commissioned by the HTA programme on behalf of NICE
Status: Completed