REVIEW OF RECOMMENDATIONS OF HEALTH TECHNOLOGY ASSESSMENTS ON ORLISTAT AND SIBUTRAMINE
Author(s)
Jensen RCØ1, Adalsteinsson E1, Toumi M2, Hemels M11Novo Nordisk A/S, Søborg, Denmark, 2University Claude Bernard Lyon I, Villeurbanne Cedex, France
OBJECTIVES: To review recommendations of Health Technology Assessment (HTA) reports on sibutramine and orlistat in the treatment of obesity from France (HAS), UK (NICE), Sweden (TLV), Belgium (KCE) and Canada (CADTH). METHODS: HTA reports were identified by searching each HTA agency’s homepages using "sibutramine" OR "orlistat" as keywords. Results were categorised as Recommended, Restricted recommended and Not Recommended in comparison to the indication for marketing authorisation given by EMEA. RESULTS: A total of eleven HTA reports were identified; six assessing orlistat and five sibutramine. Four HTA-reports on orlistat gave a positive recommendation while the remaining HTA reports did not recommend use/funding. Reasons for not recommending orlistat included; insufficient data to quantify obesity-related morbidity and mortality, uncertainties in compliance due to side effects, treatment effect was not maintained after discontinuation, lack of long term safety data, and poor definition of indication “metabolic syndrome”. For sibutramine, three reports concluded Recommended, one Restricted recommended and one Not recommended. Reasons for a negative and restricted recommendation included; insufficient data to quantify obesity-related morbidity and mortality, and lack of long term safety data. CONCLUSIONS: Quantity of effect of weight loss on morbidity and mortality, defining an appropriate indication for initiating pharmacological treatment and adequate provision of data on long-term safety and effectiveness appears to be main issues driving a negative recommendation. These issues must be addressed in the development of a clinical documentation of future pharmacological treatments of obesity. It is interesting to notice that similar evidences lead to very contradictory outcome reflecting broader way to scrutinize evidences for HTA decision making.
Conference/Value in Health Info
2009-10, ISPOR Europe 2009, Paris, France
Value in Health, Vol. 12, No. 7 (October 2009)
Code
PSY59
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Diabetes/Endocrine/Metabolic Disorders