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