Orlistat in responding obese type 2 diabetic patients: meta-analysis findings and cost-effectiveness as rationales for reimbursement in Sweden and Switzerland.
OBJECTIVE
The aim of this study is to review the clinical and economic rationale for the reimbursement of orlistat in responding obese patients with type 2 diabetes.


METHODS
Data from seven randomized controlled clinical trials of orlistat in overweight and obese patients with type 2 diabetes were pooled. A subgroup analysis involving patients who achieved a response (defined as a weight loss of >/=5% after 12 weeks of treatment) was conducted. The outcomes of the pooled analysis were then used to construct a Markov health economic model covering an 11-y period. The incidences of diabetes-related micro- and macrovascular complications were derived from the United Kingdom Prospective Diabetes Study. The effects of changes in body mass index, and the impact of micro- and macrovascular complications on utilities were derived from published sources. Publicly available cost data were used and are presented here in 2001 Euros. Discounting of 3% was applied. A probabilistic sensitivity analysis was conducted to examine the robustness of results.


RESULTS
A total of 1249 patients treated with orlistat and 1230 given placebo were eligible for the intent-to-treat analysis. At the end of the study period, 23% of orlistat patients achieved a weight reduction of >/=5%. These patients showed a mean decrease in HbA1C of 1.16%, a weight reduction of 8.6 kg, a reduction in total cholesterol of 5.3% and a reduction in systolic blood pressure of 5.2 mmHg. The base-case economic analysis revealed costs per quality-adjusted life year gained of euro14 000 in Sweden and euro13 600 in Switzerland.


CONCLUSIONS
The data presented here support the utilization and reimbursement of orlistat in overweight and obese diabetic patients who respond to the treatment.
Ruof
J
J
Health Services Research Unit, Division of Rheumatology, Center of Internal Medicine, Hannover Medical School, Hannover, Germany. joerg.ruof@roche.com
Golay
A
A
Berne
C
C
Collin
C
C
Lentz
J
J
Maetzel
A
A
D019440:Anti-Obesity Agents / Q000191:economics / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D003362:Cost-Benefit Analysis / Q000379:methods; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000191:economics; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics; D007783:Lactones / Q000191:economics / Q000627:therapeutic use*; D009765:Obesity / Q000188:drug therapy*; D000077403:Orlistat; D013548:Sweden; D013557:Switzerland; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
D019440:Anti-Obesity Agents; D006442:Glycated Hemoglobin; D007783:Lactones; D000077403:Orlistat