Bariatric Surgery for Adults With Class I Obesity and Difficult-to-Manage Type 2 Diabetes: A Health Technology Assessment.

Background: Many individuals with type 2 diabetes are classified as either overweight or obese. A patient may be described as having difficult-to-manage type 2 diabetes if their HbA1c levels remain above recommended target levels, despite efforts to treat it with lifestyle changes and pharmacotherapy. Bariatric surgery refers to procedures that modify the gastrointestinal tract. In patients with class II or III obesity, bariatric surgery has resulted in substantial weight loss, improved quality of life, reduced mortality risk, and resolution of type 2 diabetes. There is some evidence suggesting these outcomes may also be possible for patients with class I obesity as well. We conducted a health technology assessment of bariatric surgery for adults with class I obesity and difficult-to-manage type 2 diabetes, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding bariatric surgery, and patient preferences and values.

Methods: We performed a systematic clinical literature review. We assessed the risk of bias of each included study, using the Cochrane Risk of Bias tool for randomized controlled trials, the Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tool for cohort studies, and the Risk of Bias in Systematic Reviews (ROBIS) tool for systematic reviews; we assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature review and conducted a cost-utility analysis of bariatric surgery in comparison with nonsurgical usual care over a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding bariatric surgery for adults with class I obesity and difficult-to-manage type 2 diabetes in Ontario. To contextualize the potential value of bariatric surgery, we spoke with people with obesity and type 2 diabetes who had undergone or were considering this procedure.

Results: We included 14 studies in the clinical evidence review. There were large increases in diabetes remission rates (GRADE: Low to Very low) and large reductions in body mass index (GRADE: Low to Very low) with bariatric surgery than with medical management. Bariatric surgery may also reduce the use of medications for type 2 diabetes (GRADE: Low) and may improve quality of life for people with class I obesity and difficult-to-manage type 2 diabetes compared with medical management. (GRADE: Low)Our economic evidence review included 5 cost-effectiveness studies; none were conducted in a Canadian setting, and 4 were considered partially applicable to our research question. Most studies found bariatric surgery to be cost-effective compared to standard care for patients with class I obesity and type 2 diabetes; however, the applicability of these results to the Ontario context is uncertain due to potential differences in clinical practice, resource utilization, and unit costs.Our primary economic evaluation found that over a lifetime horizon, bariatric surgery was more costly (incremental cost: $8,151 per person) but also more effective than current usual care (led to a 0.339 quality-adjusted life-year [QALY] gain per person). The cost increase was driven by costs associated with surgery (before, after, and during surgery), and the QALY gain was due to life-years gained. Results were sensitive to the bariatric surgery cost and assumptions regarding its long-term benefits with respect to weight loss and diabetes remission.Publicly funding 50 bariatric surgeries in year 1, and gradually increasing to 250 surgeries in year 5, for people with class I obesity and difficult-to-manage type 2 diabetes would lead to budget increases of $0.55 million in year 1 to $2.45 million in year 5, for a total of $7.63 million over 5 years.The people with obesity and type 2 diabetes with whom we spoke reported that bariatric surgery was generally seen as a positive treatment option, and those who had undergone the procedure reported positively on its value as a treatment to manage their weight and diabetes.

Conclusions: For adults with class I obesity and difficult-to-manage type 2 diabetes, bariatric surgery may be more clinically effective and cost-effective than medical management. Compared with medical management in people with class I obesity and difficult-to-manage type 2 diabetes, bariatric surgery may result in large increases in diabetes remission rates, large reductions in BMI, and reduced medication use for type 2 diabetes, improved quality of life. Over a lifetime horizon, bariatric surgery led to a cost increase and QALY gain. Bariatric surgery can result in postsurgical complications that are not faced by those receiving medical management. The cost-effectiveness of bariatric surgery depends on its long-term impacts on obesity-related and diabetes-related complications, which could be uncertain.Our budget impact analysis suggests that publicly funding bariatric surgery in Ontario for people with class I obesity and difficult-to-manage type 2 diabetes would lead to a budget increase of $7.63 million over 5 years.For people with obesity and type 2 diabetes, bariatric surgery was seen as a potential positive treatment option to manage their weight and diabetes.