Orlistat in responding obese type 2 diabetic patients: meta-analysis findings and cost-effectiveness as rationales for reimbursement in Sweden and Switzerland

Abstract

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 Z5% 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 Z5%. 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 h14 000 in Sweden and h13 600 in Switzerland. CONCLUSION: The data presented here support the utilization and reimbursement of orlistat in overweight and obese diabetic patients who respond to the treatment.

What is the clinical effectiveness and cost-effectiveness of using drugs in treating obese patients in primary care? A systematic review.

“…Three studies 164,165,170 presented results for overweight cohorts with T2DM at baseline. Two studies 41,159 presented results for both of these, and one study 166 presented results for obese individuals aged between 20 and 70 years not previously treated for obesity.…”

“…Two studies 159,168 assumed a linear rate of regain over a 1-year period, based on data from RIO trials that showed a 1-year period to reach baseline weight after re-randomisation to placebo following rimonabant. 115 Four studies 161,163,165,170 modelled a linear regain over a 3-year period, based on a NICE recommendation, 38 whereas one 164 assumed a 5-year period for regain. 175 …”

“…157,159,161,163,165,166,[168][169][170] Many of the models were also sensitive to changes in the values used to estimate the QoL benefits attributed to weight changes 41,157,168,169 and the discount rates used. 41,157,159,170 Only one study 41 reported results comparing the pharmacological interventions.…”

“…They considered MI, stroke, angina and transient ischaemic attack (TIA), 41 and MI, ischaemic heart disease, stroke and congestive heart failure. 159 Three studies 164,165,170 included both micro-and macrovascular events (MI, stroke, peripheral vascular disease, heart failure, cataract extraction), and the sixth 166 included CHD and stroke. Five studies 41,159,164,165,170 used evidence from the UK Prospective Diabetes Study (UKPDS) to predict cardiovascular risk, based on treatment-induced changes in age, gender, lipids, blood pressure, smoking status and glycaemic control.…”

Economic evaluation of chemoprevention of breast cancer with tamoxifen and raloxifene among high-risk women in Japan

“…The prognosis of pulmonary embolism and hip fracture are taken from Sakuma et al (2004); Kitamura et al (1998) It is more preferable to adopt utility weights from a consistent study that assesses our six disease states in Japan, but there is no Japanese utility weight in the literature to date, which may be applied to any health states in our model. To illustrate the typical patient states, we adopt the weights assessed in developed countries considering them as the best available knowledge, and choosing them under the consensus of staff doctors at Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital (de Koning et al, 1991;Hillner et al, 1993;Smith and Hillner, 1993;Grann et al, 1998;Earle et al, 2000;Armstrong et al, 2001;Chau et al, 2003;Cykert et al, 2004;Naeim and Keeler, 2005;Ruof et al, 2005).…”