Exploring the Cost-Utility of a Biomarker Predicting Persistent Severe Acute Kidney Injury: The Case of C-C Motif Chemokine Ligand 14 (CCL14)

Abstract

Jorge Echeverri,1 Rui Martins,2,3 Kai Harenski,4 J Patrick Kampf,5 Paul McPherson,5 Julien Textoris,6,7 Jay L Koyner8 1Global Medical Affairs, Baxter Healthcare Corporation, Deerfield, IL, USA; 2University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; 3Health Economics; Global Market Access Solutions, Saint Prex, Switzerland; 4Global Medical Affairs, Baxter Deutschland GmbH, Unterschleissheim, Germany; 5Biomarker Research, Astute Medical Inc. (a bioMerieux Company), San Diego, CA, USA; 6Medical Affairs; bioMerieux, SA, Lyon, France; 7Service d´Anesthésie et de Réanimation; Hospices Civils de Lyon, Lyon, France; 8Section of Nephrology, Department of Medicine, University of Chicago, Chicago, IL, USACorrespondence: Rui Martins, University Medical Center Groningen, University of Groningen, Groningen, 9713 GZ, the Netherlands, Email [email protected]: 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.Keywords: acute kidney injury, dialysis, biomarkers, nephrology, cost effectiveness

Keywords

• acute kidney injury
• dialysis
• biomarkers
• nephrology
• cost effectiveness.