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Abstract
Background
Approximately 24% of hospitalized stage 2–3 acute kidney injury (AKI) patients will develop persistent severe AKI (PS-AKI), defined as KDIGO stage 3 AKI lasting ≥3 days or with death in ≤3 days or stage 2 or 3 AKI with dialysis in ≤3 days, leading to worse outcomes and higher costs. There is currently no consensus on an intervention that effectively reverts the course of AKI and prevents PS-AKI in the population with stage 2–3 AKI. This study explores the cost-utility of biomarkers predicting PS-AKI, under the assumption that such intervention exists by comparing C-C motif chemokine ligand 14 (CCL14) to hospital standard of care (SOC) alone.
Methods
The analysis combined a 90-day decision tree using CCL14 operating characteristics to predict PS-AKI and clinical outcomes in 66-year-old patients, and a Markov cohort estimating lifetime costs and quality-adjusted life years (QALYs). Cost and QALYs from admission, 30-day readmission, intensive care, dialysis, and death were compared. Clinical and cost inputs were informed by a large retrospective cohort of US hospitals in the PINC AI Healthcare Database. Inputs and assumptions were challenged in deterministic and probabilistic sensitivity analyses. Two-way analyses were used to explore the efficacy and costs of an intervention preventing PS-AKI.
Results
Depending on selected costs and early intervention efficacy, CCL14-directed care led to lower costs and more QALYs (dominating) or was cost-effective at the $50,000/QALY threshold. Assuming the intervention would avoid 10% of PS-AKI complications in AKI stage 2–3 patients identified as true positive resulted in 0.066 additional QALYs and $486 reduced costs. Results were robust to substantial parameter variation.
Conclusion
The analysis suggests that in the presence of an efficacious intervention preventing PS-AKI, identifying people at risk using CCL14 in addition to SOC is likely to represent a cost-effective use of resources.
Data Sharing Statement
The data supporting the economic evaluation have been cited in the body of the manuscript and Supplemental Materials.
The present economic model has not been registered on clinical.trials.gov.
Ethics Approval and Informed Consent
Ethics committee approval and patient informed consent were not required for this analysis. The analysis was conducted using patient characteristics and treatment effects from published studies, for which ethics approval had previously been obtained. No direct patient contact or primary collection of individual patient data were required.
Acknowledgments
We thank Dr. Michael Blackowicz for his contributions during the early design phase of the economic model.
The results presented in this paper have not been published previously in whole or in part. The present economic analysis was funded by Baxter Healthcare Corporation. This publication was subject to review by internal employees from Baxter Healthcare Corporation prior to submission for protection of Confidential Information. However, the Authors retain full responsibility for the content of this publication.
Author Contributions
All authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
RM is an employee for Global Market Access Solutions and has received consulting fees from Baxter Healthcare Corporation for developing the present economic model.
JE and KH are full-time employees of Baxter International with ownership interest.
JLK has received consulting fees from Baxter and bioMerieux during the conduct of the current study; personal fees from SeaStar Medicine, Mallinckrodt, Guard Therapeutics, Novartis, and from Alexion, outside the submitted work
JPK and PM were full-time employees of Astute Medical (a bioMerieux company) which manufactures in vitro diagnostics, including the NEPHROCLEAR CCL14 Test when this work was conducted. They have a patent PCT/US2015/056462 issued to Astute Medical/bioMerieux, a patent PCT/US2018/013561 issued to Astute Medical/bioMerieux, a patent PCT/US2020/034400 pending to Astute Medical/bioMerieux, a patent PCT/US2021/059897 pending to Astute Medical/bioMerieux, a patent PCT/US23/63524 pending to Astute Medical/bioMerieux.
JT is a full-time employee of bioMerieux, Inc. The authors report no other conflicts of interest in this work.