Early budget impact analysis of magnetic balloon technology for facilitating the completion of difficult colonoscopies

BACKGROUND: Colonoscopy is one of the most frequently performed medical procedures worldwide, yet incomplete examinations remain common, leading to higher costs and delay in diagnosis and therapy. When a colonoscopy is not finished, a second procedure is recommended to complete the exploration of the large bowel such as another optical colonoscopy or virtual colonoscopy. Endorail® is a medical device accessory for colonoscopes, based on magnetic balloon technology, developed to facilitate colonoscopy completion. This study reports an early budget impact analysis to quantify the short-term financial impact on hospital and National Healthcare System (NHS) budgets considering the introduction of this innovative technology in the routine clinical practice. METHODS: We estimated the budget impact of using Endorail for the management of colonoscopies that would be declared incomplete according to the standard of care (SoC), in the clinical practice in Italy over the first five years of commercialization. The hospital perspective considered a micro-costing analysis, while the NHS perspective considered the national reimbursement rates for healthcare services and the costs due to possible diagnostic delays in patients with colon cancer. RESULTS: Diagnostic pathway per-patient costs for Endorail strategy (hospital perspective 252.97 €, NHS perspective 132.75 €) showed slight savings compared to SoC (hospital perspective 255.89 €, NHS perspective 138.63 €). Increasing the use of the device from 2% to 10% of incomplete colonoscopies in five years could lead to savings at national level of 633,449 € and 856,286 €, respectively in the hospital and NHS perspective. Savings occur already during the first year and are mainly due to avoided second procedures. The sensitivity analyses, by varying the model parameters, showed savings at national level up to 1,691,686 €. CONCLUSIONS: The early budget impact analysis indicates that Endorail can be considered a cost-neutral strategy for both hospital and NHS perspectives in Italy. Per-patient differences slightly favor Endorail, and a gradual increase in its use yields modest national savings that begin in the first year. In view of the model’s limitations, further research is required to validate the results and evaluate additional economic, organizational, and environmental effects. Moreover, evaluating patient perspectives and preferences may reveal further benefits of the technology, which is designed to improve both patient outcomes and experience by shortening procedure time, reducing discomfort, and minimizing the need for repeat examinations.