A NOVEL BIOMARKER FOR THE EARLY DETECTION OF DIABETIC KIDNEY DISEASE: A BUDGET IMPACT ANALYSIS
Author(s)
Pin-Yu Huang, Master, Hui-Chu Lang, MPH, PhD;
National Yang Ming Chiao Tung University, Taipei, Taiwan
National Yang Ming Chiao Tung University, Taipei, Taiwan
OBJECTIVES: Diabetic kidney disease (DKD) is the primary cause of end-stage renal disease (ESRD) in Taiwan, representing a substantial portion of National Health Insurance (NHI) expenditures. This study aims to evaluate the 5-year budget impact of integrating DNlite-IVD103, a novel urinary biomarker, into the NHI system for risk stratification among early-stage type 2 DKD (T2DKD; KDIGO categories G1-2) patients.
METHODS: Following ISPOR Budget Impact Analysis Good Practices, we developed an economic model combining a decision tree and a Markov framework to simulate outcomes over a 5-year horizon from the NHI payer perspective. Two strategies were compared: (1) Standard of Care (SOC) utilizing eGFR/UACR; and (2) SOC add-on DNlite-IVD103 for CKD G1-G2 patients with proteinuria to facilitate early, intensive renal-protective interventions. Epidemiological parameters, including baseline CKD distributions and annual eGFR decline rates, were derived from a real-world longitudinal cohort of 15,428 T2DM adults (MJ Health Database, 2003-2022) with ≥2 follow-up visits. Clinical efficacy and costs were synthesized from prior literature and clinical studies. Model assumptions included: (1) one-time DNlite-IVD103 testing over five years with 30% uptake; (2) 80% medication adherence; and (3) a 20% relative reduction in DKD progression.
RESULTS: National projections estimate that the T2DM population in Taiwan will expand to 2.42 million by 2030, with the target screening cohort (G1-G2) accounting for approximately 9.07% of this group. Over five years, nationwide implementation is projected to incur an incremental cost of NT$612.4 million, driven primarily by intensified preventive management for high-risk patients (NT$548.7 million) and DNlite-IVD103 testing among eligible G1-G2 patients with proteinuria (NT$63.7 million). The intervention is expected to generate net savings of NT$1.22 billion for the NHI, mainly attributable to delayed dialysis initiation and avoided ESRD-related treatments. Sensitivity analysis confirmed net savings remained positive even at 5% progression reduction.
CONCLUSIONS: Early biomarker-based stratification is expected to reduce dialysis-related NHI expenditures in Taiwan.
METHODS: Following ISPOR Budget Impact Analysis Good Practices, we developed an economic model combining a decision tree and a Markov framework to simulate outcomes over a 5-year horizon from the NHI payer perspective. Two strategies were compared: (1) Standard of Care (SOC) utilizing eGFR/UACR; and (2) SOC add-on DNlite-IVD103 for CKD G1-G2 patients with proteinuria to facilitate early, intensive renal-protective interventions. Epidemiological parameters, including baseline CKD distributions and annual eGFR decline rates, were derived from a real-world longitudinal cohort of 15,428 T2DM adults (MJ Health Database, 2003-2022) with ≥2 follow-up visits. Clinical efficacy and costs were synthesized from prior literature and clinical studies. Model assumptions included: (1) one-time DNlite-IVD103 testing over five years with 30% uptake; (2) 80% medication adherence; and (3) a 20% relative reduction in DKD progression.
RESULTS: National projections estimate that the T2DM population in Taiwan will expand to 2.42 million by 2030, with the target screening cohort (G1-G2) accounting for approximately 9.07% of this group. Over five years, nationwide implementation is projected to incur an incremental cost of NT$612.4 million, driven primarily by intensified preventive management for high-risk patients (NT$548.7 million) and DNlite-IVD103 testing among eligible G1-G2 patients with proteinuria (NT$63.7 million). The intervention is expected to generate net savings of NT$1.22 billion for the NHI, mainly attributable to delayed dialysis initiation and avoided ESRD-related treatments. Sensitivity analysis confirmed net savings remained positive even at 5% progression reduction.
CONCLUSIONS: Early biomarker-based stratification is expected to reduce dialysis-related NHI expenditures in Taiwan.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE406
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Urinary/Kidney Disorders, STA: Personalized & Precision Medicine