Cost-effectiveness and value of information analysis of NephroCheck and NGAL tests compared to standard care for the diagnosis of acute kidney injury

Elisabet Jacobsen,Paul Manson,Callum Kaye,Lorna Aucott,Magaly Aceves-Martins,Amudha Poobalan,Dwayne Boyers,Miriam Brazzelli,Clare Robertson,Mari Imamura,Simon Sawhney,Graham Scotland

doi:10.1186/s12882-021-02610-9

Elisabet Jacobsen, Paul Manson + Show 10 more

Open Access

https://doi.org/10.1186/s12882-021-02610-9

Copy DOI

Abstract

BackgroundEarly and accurate acute kidney injury (AKI) detection may improve patient outcomes and reduce health service costs. This study evaluates the diagnostic accuracy and cost-effectiveness of NephroCheck and NGAL (urine and plasma) biomarker tests used alongside standard care, compared with standard care to detect AKI in hospitalised UK adults.MethodsA 90-day decision tree and lifetime Markov cohort model predicted costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) from a UK NHS perspective. Test accuracy was informed by a meta-analysis of diagnostic accuracy studies. Clinical trial and observational data informed the link between AKI and health outcomes, health state probabilities, costs and utilities. Value of information (VOI) analysis informed future research priorities.ResultsUnder base case assumptions, the biomarker tests were not cost-effective with ICERs of £105,965 (NephroCheck), £539,041 (NGAL urine BioPorto), £633,846 (NGAL plasma BioPorto) and £725,061 (NGAL urine ARCHITECT) per QALY gained compared to standard care. Results were uncertain, due to limited trial data, with probabilities of cost-effectiveness at £20,000 per QALY ranging from 0 to 99% and 0 to 56% for NephroCheck and NGAL tests respectively. The expected value of perfect information (EVPI) was £66 M, which demonstrated that additional research to resolve decision uncertainty is worthwhile.ConclusionsCurrent evidence is inadequate to support the cost-effectiveness of general use of biomarker tests. Future research evaluating the clinical and cost-effectiveness of test guided implementation of protective care bundles is necessary. Improving the evidence base around the impact of tests on AKI staging, and of AKI staging on clinical outcomes would have the greatest impact on reducing decision uncertainty.

Highlights

And accurate acute kidney injury (AKI) detection may improve patient outcomes and reduce health service costs
The reference baseline levels of serum creatinine are defined according to current clinical criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), Kidney disease: Improving Global Outcomes (KDIGO) and Acute Kidney Injury Network (AKIN))
The base case analysis showed that none of the tests achieved an Incremental cost-effectiveness ratio (ICER)

Summary

Introduction

And accurate acute kidney injury (AKI) detection may improve patient outcomes and reduce health service costs. This study evaluates the diagnostic accuracy and cost-effectiveness of NephroCheck and NGAL (urine and plasma) biomarker tests used alongside standard care, compared with standard care to detect AKI in hospi‐ talised UK adults. Acute kidney injury (AKI) incidence among the adult general population is estimated at about 150 per 10,000 per year [1]. Novel biomarkers are intended to help detect AKI earlier, allowing initiation of prompt treatment with a care bundle to protect the kidneys, thereby improving outcomes and reducing healthcare costs. This study uses a decision model to estimate the cost-effectiveness of four diagnostic biomarkers from a UK National Health Service (NHS) perspective. Value of information (VOI) analyses identify areas of greatest uncertainty where future research should be prioritised

Methods

Results

Discussion

Conclusion