Procedure-less intragastric balloon (PIGB) with the Elipse balloon (Allurion technologies) results in cost savings and improve health outcomes if used as a bridge to bariatric surgery and is cost-effective as a stand-alone treatment for patients lacking access or unwilling to undergo surgery, according to researchers from Memorial University of Newfoundland, St John’s, Canada. The findings were featured in the paper, ‘Cost-effectiveness of procedure-less intragastric balloon therapy as substitute or complement to bariatric surgery’, published in PLOS One.
The authors noted that the Elipse balloon does not require endoscopy for either insertion or removal and therefore eliminates the costs and risks associated with endoscopy and sedation. In addition, studies have shown that weight loss effects of Elipse balloon are similar to, or higher, than other FDA-approved intragastric balloons (the Orbera fluid-filled balloon, Apollo EndoSurgery and Obalon gas-filled balloon, ReShape Lifesciences).
The Elipse balloon is delivered using a swallowable capsule and upon reaching the stomach, the balloon is filled with 550ml of fluid using a delivery catheter and the catheter is then withdrawn; the position of the balloon is confirmed through an abdominal x-ray or fluoroscopy. Within the stomach, the balloon works by occupying stomach capacity, inducing satiety and thereby reducing food intake and stays in the stomach for four months after which a release valve opens, and the balloon is excreted naturally.
The researchers wanted to examine the cost-effectiveness of PIGB compared with the two most commonly performed bariatric surgeries - gastric bypass and sleeve gastrectomy - and no treatment among patients with morbid obesity. They also examined two hybrid strategies in which PIGB is offered as a first-line treatment prior to gastric bypass or sleeve gastrectomy.
The study estimated the cost-effectiveness of six strategies for weight loss:
PIGB + gastric bypass
PIGB + sleeve gastrectomy
No weight loss treatment
The researchers developed an individual patient-level Markov microsimulation model to compare the costs and quality-adjusted life years (QALYs) of the six strategies, allowing the researchers 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. They simulated 10,000 adults aged 18–64 years with class 2 or class 3 obesity (BMI>=35kg/m2) and who had no contraindications for PIGB use.
The estimated costs from the health system perspective were measured in terms of QALYs that captured both a patients’ length of life and their health-related quality of life (or utility). Cycle length was four months to match the length of an episode of PIGB treatment, and a lifetime horizon was used.
Weight loss effects for PIGB treatment were obtained from Ienca et al, a global multi-centre study of 1,770 patients, while weight loss effects for bariatric surgery were obtained from Alsumali et al, a recent cost-effectiveness analysis that presented long-term weight loss effects for gastric bypass (up to ten years post-surgery) and sleeve gastrectomy (up to eight years post-surgery).
The authors report that adding PIGB as a bridge to bariatric surgery is less costly and more effective than bariatric surgery alone. Specifically, PIGB + sleeve gastrectomy dominates sleeve gastrectomy only, and PIGB + gastric bypass dominates gastric bypass only.
“Even though adding PIGB treatment increases upfront procedure costs, eventual weight loss is greater than without PIGB treatment which lowers downstream health care costs and improves quality of life,” they noted.
The PIGB + sleeve gastrectomy strategy remained cost-effective or dominant relative to no treatment for all values of costs and utilities in the range of +/- 25% of base case values. The results for PIGB + sleeve gastrectomy vs PIGB + gastric bypass depend on procedure costs of gastric bypass and sleeve gastrectomy. If procedure cost of gastric bypass was lower or procedure cost of sleeve gastrectomy higher than that used in the base case analysis, the PIGB + gastric bypass strategy would become cost-effective relative to PIGB + sleeve gastrectomy. However, for most values of these parameters and for all values of the remaining costs and utilities in the ranges considered, PIGB + gastric bypass remained not cost-effective relative to the PIGB + sleeve gastrectomy.
PIGB + sleeve gastrectomy also remained the most cost-effective treatment when the authors assumed that the extent of weight regain in the long-term after PIGB treatment was equal to that after Orbera treatment, and when they used alternative data for weight loss effects for bariatric surgery.
When the authors varied the extent of weight regain after PIGB treatment between no weight regain and regain of 14% of weight loss per cycle, the PIGB + sleeve gastrectomy was the most cost-effective unless weight regain was very small.
The authors said that the findings have several implications for policy and clinical practice:
Using PIGB as an add-on treatment reduces total costs and improves health outcomes compared with bariatric surgery alone.
PIGB as a bridge therapy can be especially valuable for patients as it helps to achieve a lower BMI post-bariatric surgery.
Third treatment with PIGB alone is still cost-effective for patients who lack access to bariatric surgery and is likely to be of interest to patients who do not have bariatric surgery due to lack of insurance, fear of surgery-related risks or concerns over long-term weight regain after bariatric surgery.
“In conclusion, findings from this study suggest that offering PIGB as a first-line treatment to all patients with morbid obesity prior to bariatric surgery yields cost savings and better health outcomes compared with bariatric surgery alone,” the authors noted. “Furthermore, for patients who lack access to or are unwilling to undergo bariatric surgery, treatment with PIGB alone is cost-effective compared with no treatment.”
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