Background and AimsThe spread of duodenoscope-related infections has led to the recognition that reprocessing of duodenoscopes using high-level disinfection (HLD), if done perfectly, narrowly meets the advised thresholds of endoscope decontamination. In 2019, the US Food and Drug Administration (FDA) recommended a transition to duodenoscopes designed to pose less risk, including the use of disposable duodenoscopes. The Exalt Model D (Boston Scientific Corp, Marlborough, MA) single-use duodenoscope (EXALT) has been shown to be substantially equivalent to reusable duodenoscopes for clinical use. The aim of this study was to estimate the cost-effectiveness of EXALT in the United States healthcare system. MethodsA cost-effectiveness model was developed comparing HLD, culture-and-quarantine (CQ), Ethylene oxide sterilization (ETO), and EXALT in a simulated cohort undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) for choledocholithiasis. Published information was leveraged describing clinical estimates, infectious outbreaks, and hospital costs. ResultsIn a base analysis, HLD was the least costly ($962), and EXALT was the costliest ($3000), but yielded the most QALYs (0.0172 incremental QALYs). The incremental cost-effectiveness ratio was $38,461 for ETO gas sterilization and $62,185 for EXALT. However, with the availability of device-specific reimbursement for EXALT in the US in the form of transitional pass-through payment (TPT) and new technology add-on payment (NTAP), EXALT provided the highest cost-savings to the hospital versus alternative strategies by maintaining QALY gains while decreasing estimated net costs. Probabilistic sensitivity analyses showed EXALT to be preferred compared to HLD over a range of willingness-to-pay. ConclusionEXALT is a viable and cost-effective strategy that should be strongly considered for ERCP.
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