![]() We simulated 10,000 adults aged 18–64 years with class 2 or class 3 obesity (i.e., BMI > = 35 kg/m 2) and who had no contraindications for PIGB use. This model allowed us to capture variation in weight loss effects across patients which in turn, influenced the timing of switch to bariatric surgery (if any) in the two hybrid strategies as described below. We developed an individual patient-level Markov microsimulation model to compare the costs and quality-adjusted life years (QALYs) of the 6 strategies. In addition to a direct comparison of cost-effectiveness of these treatments, we examine two hybrid strategies in which PIGB is offered as a first-line treatment prior to gastric bypass or sleeve gastrectomy. This study fills this knowledge gap by examining the cost-effectiveness of PIGB compared with the two most commonly performed bariatric surgeries (i.e., gastric bypass and sleeve gastrectomy) and no treatment among patients with morbid obesity. To our knowledge, there is not yet evidence on the cost-effectiveness of PIGBs (and IGBs more generally) relative to bariatric surgery to shed light on this question. Given the vast unmet need for obesity treatment and the unique advantages of PIGBs relative to other IGBs and bariatric surgery, albeit with lower weight loss than bariatric surgery, an important question for policymakers and clinicians is whether treatment with PIGB is cost-effective-either as stand-alone treatment or as bridge to bariatric surgery. Furthermore, while long-term evidence on weight loss effects of PIGB is lacking, limited evidence (at 12 months after treatment initiation) suggests that patients regain weight after balloon removal. ![]() For instance, percentage of body weight lost on average with PIGB was 14% after 1 episode of treatment (lasting 4 months) compared with 32% in 1–2 years after gastric bypass. As with other IGBs, however, a key limitation of PIGB is that it generates lower weight loss than bariatric surgery. Moreover, unlike bariatric surgery, existing studies of PIGB have not reported any mortality associated with the intervention. Second, adverse events with PIGB are less likely and in most cases of a major complication, the balloon can be endoscopically removed. First, as it is non-invasive, intervention costs of PIGB are lower than bariatric surgery. PIGB also offers several advantages compared with bariatric surgery. Further, weight loss effects of PIGB are similar to or higher than other FDA-approved IGBs. ![]() Consequently, it eliminates the costs and risks associated with endoscopy and sedation. ![]() Unlike previous balloons, PIGB does not require endoscopy for either insertion or removal. It is currently being used in over 30 countries across Europe, Asia and Latin America and the process for its pre-market approval by the US FDA is ongoing. The latest innovation in the field of IGBs is the Elipse™ balloon, which is unique in that it is the first procedure-less intragastric balloon (PIGB). In addition to being used as stand-alone treatment to achieve modest weight loss in patients with mild or moderate obesity, recent studies have examined use of IGBs as a potential bridge to bariatric surgery to achieve pre-operative weight loss. This technique has recently gained popularity after the US Food and Drug Administration (FDA) approved two IGBs: Orbera ® (fluid-filled balloon) in 2015 and Obalon ® (gas-filled balloon) in 2016. Intragastric balloon (IGB) therapy–which involves placing gas- or saline-filled balloon inside the stomach-is an alternative procedure that can induce temporary weight loss. However, access to bariatric surgery is extremely limited owing to financial and insurance constraints and shortage of bariatric surgeons for instance, only 0.5% of eligible patients in the United States (US) have access to bariatric surgery each year. Bariatric surgery is the most effective and cost-effective treatment for obesity compared with other obesity treatments.
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