Donnangelo L, Gadi SRV, Maselli D, Oneill F, Wooley C, Casey S, McGowan CE. Endoscopic sleeve gastroplasty vs lifestyle modification for weight loss: A real-world cost-effectiveness study. World J Gastrointest Surg 2025; 17(10): 111290 [DOI: 10.4240/wjgs.v17.i10.111290]
Corresponding Author of This Article
Christopher E McGowan, MD, AGAF, FASGE, Department of Gastroenterology, True You Weight Loss, 2001 Weston Parkway, Cary, NC 27513, United States. christopher.e.mcgowan@gmail.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Author contributions: Donnangelo L, Wooley C, and Casey S participated in study design, data collection and analysis; Donnangelo L and Gadi SRV prepared and edited the manuscript; Maselli D, Oneill F, and McGowan CE critically revised the manuscript; McGowan CE conceptualized and designed the study. All authors approved the final version to publish.
Institutional review board statement: The study was reviewed and approved for publication by WCG Institutional Review Board.
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrollment as part of undergoing the endoscopic sleeve gastroplasty at the institutions participating in this study.
Conflict-of-interest statement: Dr. McGowan reports personal fees from Boston Scientific, Intuitive Surgical, and Apollo Endosurgery, outside the submitted work.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author. Participants gave informed consent for data sharing, and presented data are anonymized and risk of identification is low.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Christopher E McGowan, MD, AGAF, FASGE, Department of Gastroenterology, True You Weight Loss, 2001 Weston Parkway, Cary, NC 27513, United States. christopher.e.mcgowan@gmail.com
Received: June 27, 2025 Revised: July 22, 2025 Accepted: August 29, 2025 Published online: October 27, 2025 Processing time: 119 Days and 11.4 Hours
Abstract
BACKGROUND
Obesity impacts 42% of United States adults and results in an estimated economic burden of nearly 1.4 trillion dollars annually. Endoscopic sleeve gastroplasty (ESG) is a United States Food and Drug Administration authorized procedure with an excellent safety, efficacy, and durability profile. The cost-effectiveness of ESG compared to lifestyle modification (LM) in real-world patients with class I-III obesity represents a critical knowledge gap.
AIM
To approximate the cost-effectiveness of ESG vs LM using a real-world dataset of 860 United States adults with class I-III obesity undergoing ESG.
METHODS
A 6-state Markov model was employed, including healthy weight, overweight, class I-III obesity, and death. The LM control group was built using transition states previously described in the literature, supplemented by expert opinion. Cycles lasted six-months in the model’s first year and twelve-months thereafter. Existing literature informed approximations of each health state utility, adverse event disutility, and incidence of obesity-associated comorbidities. One-way sensitivity and probabilistic sensitivity analyses were performed.
RESULTS
The base-case incremental cost-effectiveness ratio (ICER) for ESG vs LM was 5904 dollars per quality-adjusted life year (QALY). In a one-way sensitivity analysis, the utilities assigned to the three obesity classes most greatly influenced the ICER. Probabilistic sensitivity analysis estimated an increase in upper-bound ICER of 8038 dollars per QALY, well under the generally cited United States willingness to pay ratio of 100000 dollars per QALY.
CONCLUSION
The results of this model support that ESG is overwhelmingly cost-effective compared to LM across all obesity classes. Payors should consider expanding coverage for their members.
Core Tip: Endoscopic sleeve gastroplasty (ESG) is an endoscopic bariatric tool that offers patients a non-surgical option for weight loss. However, the cost effectiveness of ESG as compared to conventional lifestyle modification (LM) in real world patients needs further investigation. In this study, we aimed to estimate the cost-effectiveness of ESG vs LM. Our results showed that the base-case incremental cost-effectiveness ratio for ESG vs LM was 5904 dollars per quality-adjusted life year, suggesting that ESG is cost effective across all classes of obesity.
Citation: Donnangelo L, Gadi SRV, Maselli D, Oneill F, Wooley C, Casey S, McGowan CE. Endoscopic sleeve gastroplasty vs lifestyle modification for weight loss: A real-world cost-effectiveness study. World J Gastrointest Surg 2025; 17(10): 111290
Affecting more than 42% of adults in the United States, obesity negatively impacts metabolic and cardiovascular health, cancer risk, quality of life, and all-cause mortality[1]. These risks are further accentuated when stratifying obesity into class 1 [body mass index (BMI): 30-34.9], class 2 (BMI: 35-39.9), and class 3 (BMI: 40 or greater), with higher classes of obesity associated with worse health outcomes, and often requiring more intensive intervention[2]. Further, the estimated economic burden of obesity in the United States is nearly 1.4 trillion dollars–roughly 6.76% of gross domestic product-annually[3]. This estimate is expected to increase with rising disease prevalence and the emergence of costly incretin-based anti-obesity pharmacotherapies that obligate long-term use to maintain efficacy[4,5].
Lifestyle modification (LM), including nutrition and physical activity, is the foundation of obesity management. However, LM alone often produces suboptimal weight loss outcomes, generally falling short of clinically meaningful thresholds at which improvements in weight-related comorbidities are observed and largely inadequate to halt or reverse the chronic, progressive, and relapsing nature of obesity[6-8]. Sub-optimally managed disease leads to progression, greater comorbidity burden, and a rise in associated healthcare costs. A more effective treatment, such as endoscopic sleeve gastroplasty (ESG), could mitigate these costs.
Approved by the United States Food and Drug Administration for adults with BMI between 30-50 kg/m2, ESG is the most effective non-surgical weight loss procedure currently available. ESG is a same-day, per-oral procedure that reduces the length and width of the stomach with full-thickness, endoscopically placed sutures to enhance satiation and satiety, thereby facilitating up to 21% total body weight loss (TBWL) in 1 year[9-11]. ESG has an excellent efficacy, safety, and durability profile for patients with class I, II, and III obesity[12,13]. Furthermore, ESG reduces weight-related comorbidities[12,14,15] and maintains clinical effect for at least 3-5 years[13,14,16].
Despite this, widespread clinical adoption of ESG has lagged, and the major hurdle has been a need for more cost-effectiveness data leading to broader insurance coverage[17]. ESG provides several advantages hypothesized to favor cost-efficacy, including the one-time, same-day, outpatient nature of the procedure and downstream reductions in morbidity, mortality, and utilization of medications and healthcare resources as patients lose weight. While there are many hypothesized immediate and long-term benefits of ESG for patients and the healthcare system at large, there are considerable knowledge gaps regarding the economic impact of ESG in the United States. Saumoy et al[18] showed that ESG was cost-effective compared to LM for class I, II, and III obesity using a semi-Markov microsimulation in a hypothesized cohort of 40-year-old adults undergoing ESG. However, to date, no economic model has utilized a real-world cohort of patients who have undergone ESG in all obesity classes. This study aims to investigate the cost-efficacy of ESG compared to LM in a real-world population of adults with class I, II, and III obesity who underwent ESG with regular nutritional aftercare at a United States ambulatory center with expertise in bariatric endoscopy. It was hypothesized that ESG would be cost-effective compared to LM across all obesity classes.
MATERIALS AND METHODS
A Markov model comprised of 5 BMI group-based health states (healthy weight, overweight, and class I-III obesity) and an absorbing death state was used to conduct a cost-utility analysis comparing ESG to LM (Figure 1)[19]. A simulated cohort of 1000 patients entered the model as per baseline BMI, transitioning to the other model states depending on change in weight and risk of death. Clinical data was used to obtain baseline characteristics of age and sex, as well as the estimated probability of transition between health states at 6 months, 1 year, and 2 years.
Figure 1 Model schematic.
Patients enter the model in one of five body mass index (BMI)-group health states: Healthy weight, overweight, and class I-III obesity. Patients in the overweight to class III obesity health states receive either endoscopic sleeve gastroplasty + lifestyle modification or lifestyle modification alone. Patients cycle between health states (e.g., from overweight to class I, or from class III to class II) based on transition probabilities from real-world data, established BMI-group associated mortality risks and key opinion leader opinion, as included in the model. Patients could also move from any of the 5 BMI group-based health states to an absorbing (i.e., irreversible) mortality death state and would not be able to re-enter another state during a future cycle. Cycle length is set at twice yearly for the first year, and then yearly through 5 years in the base-case. Patients can move states each cycle. BMI: Body mass index.
To inform the model, real-world safety and clinical effectiveness for ESG (percentage TBWL) was collected from a single United States center (True You Weight Loss, Cary, NC, United States) in consecutive patients who underwent ESG from May 24, 2018 to December 31, 2021. ESG was performed with the OverStitch ESG System™ (Boston Scientific, Marlborough, MA, United States) as previously published[13]. All patients were discharged from the ambulatory surgical center on the day of their procedure. Patients were provided telemedicine support from a medical team (physicians and nurse practitioners) and a nutrition team comprised of registered dieticians for at least one year following ESG.
The model was conducted from the viewpoint of a United States commercial payor with a 5-year time horizon as per established methodological guidelines[20,21]. A cycle length of 6 months was used for the first year, and annual cycles were used thereafter. Direct healthcare costs were prioritized, and health effects were reported using quality-adjusted life years (QALY). The base case was assigned a standard 3% yearly discount rate, and the lower threshold incremental cost-effectiveness ratio (ICER) of 100000 dollars per QALY was chosen to assess for cost-effectiveness[21,22]. Reporting adhered to the Consolidated Health Economic Evaluation Reporting Standards Checklist 2022[23]. Study authors who perform ESG (Donnangelo L, Maselli D, and McGowan CE) provided internal validation of the model inputs and assumptions, as well as external validation of the likelihood of the modeled health outcomes. Key model clinical, utility, and cost inputs are summarized in Table 1. To account for weight regain, a gradual return to baseline BMI over the model’s lifetime was assumed in 20% of the sample, mirroring weight regain trends after bariatric surgery[19]. Weight loss was assumed to plateau at 2 years in the remaining 80% of patients after ESG, in accordance with a previous model of ESG cost-effectiveness published by Kelly et al[24].
LM was defined as standard nutritional and physical activity change with the intention of weight loss. Clinical inputs for the LM arm were extracted from the control arm of the MERIT trial for class I and II obesity, which featured a customized plan of a low-calorie diet and moderate-intensity physical activity, and expert clinical opinion for class III[12]. No adverse events were included for LM. All patients receiving LM were assumed to return to baseline BMI by 5 years, per a recent meta-analysis[25].
No deaths were reported in the clinical evidence for ESG or LM. Therefore, mortality was modeled using BMI-specific hazard ratios and applied to United States age-/sex-matched general population mortality rates[26,27]. All costs were defined using 2023 dollars, with older values adjusted for inflation in accordance with the National Consumer Price Index. ESG procedure costs were provided by institutional review at True You Weight Loss (Cary, NC, United States), and annual LM costs are based on previous economic models. BMI group-specific direct healthcare costs were based on values published by Cawley et al[28].
Health state utility values were derived from previously published literature[19,29]. In brief, short-form 36 data from the MERIT trial was mapped to EuroQol-5 Dimension (EQ-5D) for obesity (class I-III) health states within the model using a linear mixed effects model[12,30]. A large population-based cohort study informed utility for the healthy state[31]. Comorbidity-associated disutility was assumed to be already captured in the BMI-based health state utility values to avoid double counting.
The statistical components of this study were performed and reviewed by a biomedical statistician. One-way and probabilistic sensitivity analyses were performed to determine the impact of uncertainty. One-way sensitivity analyses were conducted by independently varying model parameters (keeping all other inputs at their base-case values) to upper and lower bounds calculated from 95% confidence intervals or clinical and expert opinion. Probabilistic sensitivity analysis with repeated sampling (10000 times) was conducted to characterize the likelihood of ESG cost-effectiveness at various willingness-to-pay thresholds. A complete list of model parameters, including uncertainties and distributions, is provided in the Supplementary Table 1.
Specific scenario analyses were conducted to explore differences in cost-effectiveness for each obesity class and structural aspects of the model, including an individual comorbidity costing approach and the impact of indirect costs. Finally, Common scenario analyses were conducted for time horizon and discount rate. Patients or the public were not involved in the design, conduct, reporting, or dissemination plans of our research.
RESULTS
Modeling was performed utilizing a real-world database of 860 ESG patients (mean age 46 years, 14.4% male) with class I-III obesity. Of these patients, 663 (77%) and 157 (18%) had complete data spanning one and two years, respectively. Of those patients with two-year data, 46 (29%) had class I obesity, 58 (37%) had class II obesity, and 58 (37%) had class III obesity. Average TBWL at 12 months was 17.7% ± 6.9% and at 24 months was 17.6% ± 9.2%. No serious adverse events or deaths from ESG were reported.
ESG increased cost by 1960 dollars, alongside gain of 0.332 QALYs, compared to LM, representing a deterministic ICER of 5904 dollars per QALY in base-case analysis (Table 2). Disaggregated outcomes for the base-case are provided in the Supplementary Tables 2 and 3. An ICER of 5904 dollars per QALY falls significantly below the most conservative United States willingness-to-pay threshold of 100000 dollars, suggesting that ESG is highly cost-effective compared to LM. Subgroup analysis showed that ESG remained cost-effective across all obesity classes, with ICERs of 13813 dollars per QALY, 8158 dollars per QALY, and 743 dollars per QALY for classes I, II, and III obesity, respectively (Table 2).
Table 2 Deterministic base-case and obesity subgroup results.
Utilities assigned to obesity classes had the most significant impact in one-way sensitivity analyses, but the model remained insensitive to variation in individual parameters ranging from 4603 dollars to 8038 dollars and remained extensively cost-effective. All other parameters demonstrated close intervals around the base-case estimate. These results are displayed in Figure 2. Probabilistic sensitivity analysis suggested that ESG is a cost-effective strategy in 99.9% of iterations (Figure 3). The model predicted cost-effectiveness of ESG would occur within 30 months and be maintained over 5 years, assuming procedural costs remained under 28500 dollars, representing the total ESG cost inclusive of the intervention, personnel, consumables, and operational expenses. ESG was strongly cost-effective in all other scenario analyses, including prolonged model time horizons of 10 years and lifetime (Table 3).
Figure 2 One-way sensitivity analysis.
The base-case value for the annual cost of the new intervention is 5904 dollars and is represented by the y axis. In one way sensitivity analysis (OWSA), this varies this cost from 4603 dollars to 8098 dollars and is comfortably below the commonly cited United States willingness-to-pay threshold of 100000 dollars per quality adjusted life year. Parameters included in the OWSA were age, sex, obesity class, mortality risk, intervention costs, and annual obesity-related direct healthcare costs. Model scenarios included in the OWSA were variable time horizons (5-year, 10-year, and lifetime) and annual discount rate for costs and health effects (0%, 3%, and 6%). ESG: Endoscopic sleeve gastroplasty; HR: Hazard ratio.
This study presents the first real-world evidence of robust and consistent cost-effectiveness of ESG compared to LM across all obesity classes. Additionally, it is the first to demonstrate the cost-effectiveness of ESG in class III obesity in the United States setting, which is particularly robust. The cost-effectiveness of ESG in this study is driven by clinical data from the largest single-center United States real-world database of ESG, using a well-validated model of obesity[19,29]. The higher QALY gain associated with ESG is attributable to superior weight loss and reduced comorbidity profile compared to LM. This is supported by established clinical data reporting a reduction in obesity-related comorbidities with ESG[32], while longer-term studies of LM offer no significant benefit[33]. The model findings are consistent with previous cost-effectiveness analyses reporting ESG is cost-effective compared to LM due to superior weight loss[18]. Moreover, study findings align with a recent publication by Sharaiha et al[29], which demonstrated that ESG is highly and consistently cost-effective compared to LM in class I-II obesity. The present study indicates that ESG can be even more cost-effective in the outpatient/ambulatory setting using real-world evidence and in a class III population. While randomized controlled trials remain the gold standard in assessing the efficacy and safety of an intervention, the enhanced generalizability of a real-world cohort is of significant importance to economic modeling and decision makers[34].
This study affirms that ESG is an overwhelmingly cost-effective treatment across all obesity classes. This trend is especially true with each higher class of obesity, with the ICER for class III obesity more than 18 times cheaper than that of class I obesity. This increased cost-effectiveness of ESG among patients with higher classes of obesity is likely due to greater degrees of weight loss and improved control of comorbid conditions, given that patients at a higher obesity class are at the highest risk for obesity-related complications. The implications on United States obesity management are significant. Commercial payors should include ESG in their obesity care algorithms as the clinical evidence for ESG is clear, and this study provides further economic support. Most importantly, patients suffering from this disease need greater access to more acceptable and economically viable treatment options. For example, only 1% of United States patients eligible for bariatric surgery elect to undergo this invasive treatment[35], and incretin-based anti-obesity pharmacotherapies such as semaglutide can be highly costly, poorly tolerated, and necessitate lifelong use[36]. The estimated incremental cost per QALY gained for semaglutide over a 30-year time horizon is between 23556 and 144296 dollars, far greater than the figures presented here for ESG[37].
Limitations of this study include a lack of control arm within the LM group; however, ample studies of LM have demonstrated minimal long-term benefit, and the model assumptions are more likely to underestimate the cost-effectiveness of ESG in this population[25]. Low rates of two-year follow-up among the ESG cohort limits our ability to more confidently extrapolate the durability of cost-effectiveness findings. While prior clinical studies suggest that ESG remains effective within the lifetime of our base-case analysis (5 years), more robust long-term data on the efficacy of ESG is still needed[16]. Finally, explicit modeling for metabolic comorbidities, such as type II diabetes and cardiovascular disease, may affect ICER outcomes and would provide further insight, but due to lack of direct evidence, this was unable to be modeled. However, every health state in each model cycle was estimated using BMI-specific prevalence rates for comorbidities, accounting for their impact using established methods[36]. Additionally, as EQ-5D data for this ESG cohort was not available, mapping of MERIT short-form 36 data to EQ-5D for obesity was performed. While baseline characteristics of age (47.3) and sex (12% male) in the MERIT ESG population do align with that of our study population[12], unmeasured misalignment between MERIT’s randomized clinical trial population and our real-world cohort could still bias QALY gains. Further, our real-world data is subject to center-specific ESG variables, such as operator expertise and costs, which may not translate directly to other practice settings. Future real-world comparative ESG cost-effectiveness studies should consider anti-obesity pharmacotherapies to replicate recent findings by Haseeb et al[38], which demonstrated that ESG is cost-effective compared to semaglutide.
CONCLUSION
ESG is an overwhelmingly cost-effective treatment across all obesity classes, and particularly in a class III cohort in which treatment with LM is expected to be inadequate. Payors should leverage the cost-effectiveness of ESG to expand coverage for their members.
Footnotes
Provenance and peer review: Unsolicited article; Externally peer reviewed.
Peer-review model: Single blind
Corresponding Author’s Membership in Professional Societies: American Society for Gastrointestinal Endoscopy, American Gastroenterological Association.
Specialty type: Gastroenterology and hepatology
Country of origin: United States
Peer-review report’s classification
Scientific Quality: Grade B, Grade C
Novelty: Grade B, Grade B
Creativity or Innovation: Grade B, Grade B
Scientific Significance: Grade B, Grade C
P-Reviewer: Li MN, Professor, China; Zhang G, PhD, Professor, China S-Editor: Wu S L-Editor: A P-Editor: Zhao YQ
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