[PSY59] Review of recommendations of Health Technology Assessments on orlistat and sibutramine

[PSY59] Review of recommendations of Health Technology Assessments on orlistat and sibutramine

2009 Value in health

Jensen, R.C.Ã | Adalsteinsson, E. | Toumi, M. | Hemels, M. | Volume: 12, Issue: 7, Pages: A386,

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 It
is interesting to notice that similar evidences lead to very
contradictory outcome reflecting broader way to scrutinize evidences for HTA decision
making.