The Potential Health Economic Value of Adding Magnetomotive Ultrasound to Current Diagnostic Methods for Detecting Lymph Node Metastases in Rectal Cancer.

Background: Local resection of early rectal cancer (RC) is a desirable treatment option compared with surgery, offering reduced morbidity, mortality, health care costs and avoidance of stoma. However, local resection is restricted to cases without suspicion of lymph node metastases (LNM). Current methods to diagnose LNM and risk estimations based on histopathology cannot reliably identify patients eligible for local resection. The NanoEcho diagnostic system is based on a novel method for lymph node staging in RC. The aim of this study was to perform a health economic analysis at an early stage of clinical development to estimate the potential value of adding NanoEcho diagnostics to current diagnostic methods in RC.

Methods: A Markov model for RC diagnosis was developed where the costs and health outcomes, including quality-adjusted life years (QALYs), for adding the NanoEcho diagnostics to current diagnostic methods were compared with current diagnostic methods alone. The diagnostic performance of the NanoEcho diagnostic system is still unknown and the base-case analysis was performed at an assumed 85% sensitivity and 85% specificity. Two testing strategies corresponding to two alternative ways of implementing the diagnostic test in clinic were evaluated: (1) examine all patients diagnosed with RC and (2) examine only patients diagnosed with clinical stages T1 and T2.

Results: Adding the NanoEcho diagnostic system resulted in a gain of 0.032 life years and 0.124 QALYs per patient in the target population compared with current diagnostic methods alone. At a cost-neutral level, the estimated justifiable price of NanoEcho diagnostics was SEK 6995 in the first testing strategy and SEK 50,658 in the second testing strategy. The justifiable price of the NanoEcho diagnostics at a willingness to pay of 500,000 SEK/QALY was SEK 10,654 in the first testing strategy and SEK 65,132 in the second testing strategy.

Conclusion: The results indicate that adding NanoEcho diagnostics to standard of care can potentially reduce healthcare costs and increase quality of life in RC patients, assuming a sensitivity and specificity of 85%.