Economic impact of PromarkerD in vitro diagnostic testing on the management of chronic kidney disease in type 2 diabetes: a budget impact analysis

Gareth C. Fernandez1 · Isabella A. Joubert1 · Kirsten E. Peters1 · Lianzhi K. Chen1 · Jacqueline S. Gray1 · Pearl L. Tan1 · Michael Shanik2,3 · Richard J. Lipscombe1

Abstract

Objectives: This study evaluated the clinical and economic impact of integrating Promarker^®D, a validated biomarker-based

blood test that predicts kidney function decline up to 4 years before clinical evidence of chronic kidney disease (CKD), into

routine management of patients with type 2 diabetes (T2D) from a US healthcare payer perspective.

Methods: A 10-year budget impact model simulated outcomes and costs of one million adults with T2D receiving standard

of care (SoC) alone or SoC plus PromarkerD testing providing risk-stratified management. Model inputs were derived from

published literature and included disease progression probabilities and healthcare costs associated with CKD, end-stage renal

disease (ESRD), PromarkerD testing, and sodium-glucose cotransporter 2 inhibitor (SGLT2i) therapy. Costs were discounted

at 3% annually. Scenario and one-way sensitivity analyses assessed parameter uncertainty. Results were translated to covered

lives and national diagnosed T2D populations using epidemiologic prevalence estimates.

Results: The model predicted that PromarkerD-guided early intervention delayed CKD progression, as reflected by reduced

transition to advanced CKD stages over time, reduced ESRD incidence by ~6.4%, and reduced mortality by ~5.1% within

10 years. The PromarkerD-guided intervention generated net savings of US $1.2 billion (net present value) per million

individuals over the study period. Annual savings began in year 4 (US $116 million), and cumulative savings became positive

by year 6 (US $288 million). Results were most sensitive to assumptions regarding treatment benefit in moderate-risk

individuals and baseline SGLT2i use but remained cost-offsetting across most scenarios.

Conclusions: In this model-based analysis, PromarkerD-guided risk stratification enabled earlier intervention, was associated

with delayed CKD progression, reduced ESRD incidence and mortality, and demonstrated long-term cost offsets from a US

payer perspective. The magnitude of economic impact depends on the timely implementation of treatment in response to

early risk identification in real-world practice.

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