Economic Impact of PromarkerD In Vitro Diagnostic Testing on the Management of Chronic Kidney Disease in Type 2 Diabetes: A Budget Impact Analysis.

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.