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Early Cost–Utility Analysis Comparing the Sterile Single-Use Ambu ® aScope TM Duodeno to Reusable Duodenoscopes

Background: Multiple studies have shown that contaminated duodenoscopes can lead to infections involving multidrug-resistant organisms (MDROs). This will likely cause a decrease in the patients’ quality of life (QoL) and may lead to additional healthcare costs. Reusable duodenoscopes are difficult to clean due to their complex design, and single-use equipment has been proposed as a safer alternative for endoscopic retrograde cholangiopancreatography (ERCP) procedures. This study aimed to investigate the expected incremental costs and patient outcomes of using a reusable duodenoscope versus the single-use Ambu® aScopeTM Duodeno. 
 
Methods: A decision-analytic Markov model was designed to give an early estimate the costs and utility of aScope Duodeno compared to reusable duodenoscopes. A 10-year time horizon was applied to the model. The per-procedure cost for the reusable duodenoscopes and the cost of treating an infection were derived from a US multicenter micro-costing study. Infection risks, utilities, and other model parameters were obtained from the literature. Deterministic and probabilistic sensitivity analyses were carried out to assess the robustness of the base-case results. 
 
Findings: The base-case results indicate an additional cost of $28,525 per quality-adjusted life year (QALY), using an estimated cost of $1,995 per single-use duodenoscope. Thus, single-use duodenoscopes are cost-effective at a willingness-to-pay (WTP) threshold of $50,000 per QALY. The reusable duodenoscope-related infection risk was estimated at 1.21% based on the available literature. 
 
Discussion: This study highlights that a persistent healthcare issue exists and that the new and innovative single-use duodenoscope design should be considered standard of care, where feasible. Furthermore, while reusable duodenoscopes are still being used, systematic microbiological surveillance should be prioritized, and sterilization should be considered to decrease the risk of infection. 
 
Funding Statement: This study did not receive any funding. 
 
Declaration of Interests: HST, RVR, SA, and SL are employed by Ambu A/S, Ballerup, Denmark. NBL declared no conflicts of interest.