Budget Impact of Microbial Cell-Free DNA Testing Using the Karius® Test as an Alternative to Invasive Procedures in Immunocompromised Patients with Suspected Invasive Fungal Infections

Abstract

Background Invasive fungal infection is a major source of morbidity and mortality. The usage of microbial cell-free DNA for the detection and identification of invasive fungal infection has been considered as a potential alternative to invasive procedures allowing for rapid results. Objective This analysis aimed to assess the budget implications of using the Karius ® Test in patients suspected of invasive fungal infection in an average state in the USA from a healthcare payer perspective. Methods The analysis used a decision tree to capture key stages of the patient pathway, from suspected invasive fungal infection to either receiving treatment for invasive fungal infection or being confirmed as having no invasive fungal infection. The analysis used published costs and resource use from a targeted review of the literature. Because of the paucity of published evidence on the reduction of diagnostic tests displaced by the Karius Test, the analysis used a 50% reduction in the use of bronchoscopy and/or bronchoalveolar lavage. The impact of this reduction was tested in a scenario analysis. Results The results of the analysis show that the introduction of the Karius Test is associated with a cost saving of US$2277 per patient; when multiplied by the estimated number of cases per year, the cost saving is US$17,039,666. The scenario analysis showed that the Karius Test only had an incremental cost of US$87 per patient when there was no reduction in bronchoscopy and bronchoalveolar lavage. Conclusions The Karius Test may offer a valuable and timely option for the diagnosis of invasive fungal infection through its non-invasive approach and subsequent cost savings.

Cell‐free next‐generation sequencing impacts diagnosis and antimicrobial therapy in immunocompromised hosts: A retrospective study

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Unusual Presentation of Disseminated Mycobacterium kansasii Infection in Renal Transplant Recipients and Rapid Diagnosis Using Plasma Microbial Cell-free DNA Next-generation Sequencing

“… 42 The cost of the test ($2000 per test) can also be prohibitive, although it has been demonstrated to be cost effective in certain settings. 45 More studies are needed in SOT to evaluate its real-world cost-effectiveness.…”

Biomarker-Based Assessment for Infectious Risk Before and After Heart Transplantation

“…The turnaround time for this testing can be as low as 48 h, which may reduce length of hospital stay for patients awaiting diagnostic procedures. In a published cost-comparison modeling by Karius® for invasive fungal infections, savings were realized through a reduction in the requirement for bronchoscopy, projected reduced duration of hospitalization, and an expected reduction of adverse events during hospital course [ 47 ]. At what stage during an occult infectious evaluation that cf-DNA testing for pathogens be utilized to optimize any cost benefits remains to be determined.…”