Using a procedureless intragastric balloon (PIGB) as a first-line treatment for obesity is cost effective as either a standalone intervention or a bridge to bariatric surgery, according to a new simulation model study published in PLOS One.
PIGB boasts a noninvasive delivery mechanism in the form of a swallowable capsule. Upon reaching the stomach, the capsule is filled with fluid via a catheter. The clinician uses x-ray or fluoroscopy to confirm correct positioning of the balloon. After 4 months, the balloon’s release valve opens to drain the fluid, and the balloon is excreted naturally. If presented with a major complication, clinicians can typically remove PIGB endoscopically. This not only translates into much lower costs than bariatric surgery but also fewer adverse events.
The available evidence surrounding PIGB’s relative efficacy is less clear. Prior studies have shown that PIGB produces an average weight loss of 14.2% after a single, 4-month treatment episode, compared with 32% after bariatric surgery. When compared against other intragastric balloon devices, however, PIGB has been shown to lead to comparable or superior levels of weight loss. There is also limited evidence about PIGB’s long-term efficacy, but some data suggest that weight lost is generally regained after removal of the balloon.
To date, though, there had been no analysis of whether PIBG’s proposed advantages would make it more cost effective when measured against the superior outcomes of commonly performed bariatric surgeries.
Assessing the cost of PIGB
Researchers compared the cost-effectiveness of six regimens: PIGB; standalone gastric bypass or sleeve gastrectomy; PIGB as a bridge to gastric bypass or sleeve gastrectomy; and no treatment. The specific PIGB device the investigators assessed was the Elipse balloon (Allurion Technologies), which is approved in Europe, Asia, and Latin America, and is in the premarket approval process in the United States.
They then applied an individual patient-level Markov microsimulation model to compare these separate regimens in terms of costs and quality-adjusted life years (QALYs). The simulation incorporated data from 10,000 adults aged 18-64 with body mass index (BMI) ≥ 35, of which 44% had a BMI ≥ 40. The model assumed patients initially underwent treatment with PIGB, gastric bypass, or sleeve gastrectomy. Based on the predicted weight loss resulting from that intervention, the model then estimated how PIGB-only, gastric bypass–only, and sleeve gastrectomy–only patients transitioned to a new health state, ranging from no obesity to death. It also incorporated a hybrid strategy in which patients underwent bariatric surgery if their BMI was still ≥ 35. The researchers modeled complications in all groups as chance events, with a probability of occurrence based on BMI state.
The model determined that the most cost-effective approach was using PIGB as a bridge to sleeve gastrectomy, which had an incremental cost-effectiveness ratio (ICER) of $3,781 per QALY. PIGB alone was not cost effective versus bariatric surgery, but it did outperform no treatment (ICER, $21,711 per QALY).
The study investigators noted that there was a counterintuitive aspect to finding that PIGB was most cost effective when used as a bridge to surgery.
“Contrary to expectations that an add-on treatment to already expensive bariatric surgery would further increase health care costs, our results show that using PIGB as an add-on treatment reduces total costs and improves health outcomes, compared with bariatric surgery alone,” they wrote. “Consequently, as decision-makers look for ways to curb rising health care costs, it will be worthwhile to consider incorporating PIGB prior to bariatric surgery within the clinical care pathway.”
They also noted that initial PIGB may help patients achieve a lower BMI following surgery.
An appealing option
“This technique is very appealing to a lot of patients because you don’t need sedation, you can do it fairly quickly, and the risks and complications of endoscopy or surgery aren’t there with the procedureless balloon, at least on implantation,” said Reem Sharaiha, MD, associate professor of medicine and director of Bariatric & Metabolic Endoscopy at Weill Cornell Medicine, when asked to comment on the study’s results. “I believe that you need to offer a lot of options to tackle obesity as an epidemic and to give patients multiple treatment options, because it’s not going to be a one and done. It’s going to be multiple procedures in their lifetime.”
Dr. Sharaiha added that PIGB’s noninvasive qualities may make it a viable option for addressing a notable gap in obesity treatment; only about 2% of individuals who would qualify for surgery actually do so each year.
“A lot of people are reluctant to undergo it because of the fear of complications or the fear of invasiveness. They do not want to be off work for many weeks,” she said. “Many people come to see me and say, ‘I don’t want to tell anyone that I’ve had it done.’ Or, ‘I don’t want any scars.’ So, a lot of these [factors] come into play as well.”
Dr. Sharaiha is a consultant for Boston Scientific and has participated in trials conducted to seek Food and Drug Administration approval for the Elipse device.