Cost-effectiveness of gastric band surgery for overweight but not obese adults with type 2 diabetes in the U.S.
Introduction
Type 2 diabetes (T2D) is a major determinant of ill-health and accounts for a significant and increasing proportion of health resources.1 Each year, type 2 diabetes costs the US economy over $245 billion.2 This enormous economic burden highlights the need to appraise the cost-effectiveness of different diabetes treatment strategies.
Bariatric surgery is an effective weight loss therapy for obese people with type 2 diabetes that delivers superior glycemic outcomes when compared to standard diabetes care.3., 4., 5. Economic modeling of observational trial outcome data shows that bariatric surgery for obese people with T2D is cost-effective, with a cost-effectiveness ratio of less than $15,000 per quality-adjusted life-year (QALY).6., 7. In addition, our analysis of two-year outcome data from a randomized trial of gastric band (GB) surgery in obese people with recently-diagnosed diabetes showed that surgery was likely to be cost-saving in the Australian setting.8 However, the cost-effectiveness of GB surgery compared to usual care in non-obese people, who comprise around a third of diabetic adults in the U.S.,9., 10. has not been assessed.
We previously reported 2-year outcomes of a randomized trial of GB surgery in overweight but not obese adults with recently-diagnosed type 2 diabetes who received multidisciplinary diabetes care vs. multidisciplinary diabetes care alone.11 GB surgery delivered mean weight loss of 12 kg (95% CI 9 to 14 kg) and an incremental diabetes remission rate at 2 years of 44% (17 to 71%).
The aim of this evaluation was to describe the in-trial and projected U.S. cost-effectiveness of GB surgery combined with usual diabetes care versus usual care alone if the costs and results found in the trial population were extrapolated to the U.S. diabetes population.
Section snippets
Patient Data
The inclusion criteria for the randomized trial were patients aged between 18 and 65 years, with type 2 diabetes (T2D) of less than 5 years' duration and a BMI between 25 and 30 kg/m2. Participants were randomized between November 2009 and June 2013 and were required to attend at least one consultation with a diabetes educator and a dietician, as well as at least six consultations with the study endocrinologist (JMW) over the first two years. The method of clinical and biochemical data collection
In-Trial Outcomes and Health Costs at Two Years
Table 1 describes resource utilization over the 2-year duration of the trial. Of the 48 participants who completed the study, 25 received usual diabetes care (control group) and 23 were assigned to receive gastric band surgery combined with usual care (GB group). One GB participant who declined surgery following randomization was included in the GB group according to the intention to treat convention. The higher hospital costs of GB participants reflected the up-front cost of surgery whereas
Discussion
We present the first analysis of the cost-effectiveness of bariatric surgery in an overweight but not obese population with T2D. The within-trial cost-effectiveness analysis of the original Australian study reveal GB surgery is not cost effective, with the ICER two years after surgery exceeding $90,000 per QALY gained. However, when the benefits of GB surgery were assumed to last beyond 5 years, the ICER decreased to below $50,000 per QALY gained for the U.S.-based analysis. Sensitivity analyses
Author Contributions
JMW, KMD, PMC and LN devised the study, JMW and FS collected and analyzed the data, and JMW, LN and PMC prepared the manuscript. All authors helped revise the manuscript.
Ethical Approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed Consent
Informed consent was obtained from all individual participants included in the study.
Acknowledgements
We are grateful to the trial participants. This work was supported by the Australian National Health and Medical Research Council (CRE 1078106 Fellowship to J.M.W.). This work was made possible through Victorian State Government Operational Infrastructure Support and Australian National Health and Medical Research Council Research Institute Infrastructure Support Scheme. NL is supported by a National Institutes of Health K23 DK097283.
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Conflict of interest statement: None of the authors has a relevant conflict of interest to declare.