OBJECTIVES: Accurate monitoring of blood lithium levels is crucial for optimal dose adjustment in patients with bipolar affective disorder. A new method, eLi12, evaluated in a proof-of-concept study, shows potential in estimating 12-hour lithium levels independent of blood test timings. Early economic evaluations, even without a solid evidence base like a randomized clinical trial, may indicate the value of emerging technologies and inform further research and development decisions by addressing uncertainties and potential benefits. The purpose of this study was to conduct an early economic evaluation of eLi12 in a Danish healthcare setting.

METHODS: An interactive economic model was developed to present outcomes in monetary and physical units, including user-defined sensitivity analyses. Outcomes of interest included yearly hospitalizations, intoxications, suicides, mood episodes, productivity loss, quality-adjusted life years lost, and net monetary benefit. The model utilized the best available evidence from literature and expert inputs on the efficacy, safety, and associated costs. A societal perspective was adopted, considering both direct and indirect costs. The model incorporated various estimates of the potential improvements in lithium treatment with eLi12 (ranging from 1%-15% improvement in metrics such as mood episodes, suicides, and hospitalizations) to address the uncertainties and assess the potential impact of eLi12.

RESULTS: The interactive early economic model indicates potential cost savings for the healthcare sector, along with reduced productivity costs and patient benefits with eLi12. The net monetary benefit was estimated to be between DKK 1,465-10,360 per patient annually. A major uncertainty was the patient’s ability to accurately record the precise time of lithium consumption.

CONCLUSIONS: Early economic evaluation is a valuable tool for supporting innovation in clinical research groups during the initial stages of medical device development. This study suggests that implementing eLi12 can result in significant cost savings, supporting the need for an implementation study and further investment.