To evaluate the budget impact from implementing a proactive testing regime for chronic kidney disease in patients with type-2 diabetes (T2D). PromarkerD is an innovative biomarker-based blood test that predicts risk of diabetic kidney disease (DKD) and renal decline in T2D patients. This research aims to assess whether PromarkerD could reduce costs to US payers (currently $50 billion to the US healthcare system). This four-year model evaluated potential net savings to US payers from covering the PromarkerD test versus standard-of-care (SOC) in T2D patients with no/mild DKD (KDIGO categories G1-3b). Parameters were derived from prior literature and clinical studies, and included costs and frequency of testing, costs associated with changes to patient treatment strategies, and savings from slowing DKD progression and ESRD interventions (dialysis and kidney transplants). Model assumptions included testing rates (annual for low-risk, biannual for high-risk), 80% adherence to preventative medications, and a 20% decline in progression through DKD stages. Covering PromarkerD testing per million T2D patients could produce savings for US payers of $2.3 billion over four years, against costs of $1.5 billion (net savings: $846m). Savings arise from slower DKD stage progression ($1.4b), delayed dialysis and transplants ($667m), and fewer unplanned dialysis ($272m), while costs include testing ($665m), and preventative treatments in high-risk patients ($793m). Sensitivity analysis showed that if the decline in progression was set to 15%, net savings were still $353m. Changing SOC by implementing an alternative PromarkerD testing regime in T2D patients could reduce unnecessary adoption of new therapeutic interventions in low risk patients, and enable early intervention for high risk patients, thereby slowing progression and lessening the need for expensive dialysis and transplants. This study demonstrates substantial near-term savings to US payers in the treatment of DKD through early, accurate and cost-effective prognosis with the PromarkerD test.
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