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Cost-utility analysis of simultaneous initiation of finerenone and empagliflozin for type 2 diabetes mellitus complicated with chronic kidney disease
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DOI：10.3389/fphar.2026.1847907.png)
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Abstract
En 中文
BackgroundType 2 diabetes mellitus complicated with chronic kidney disease (T2DM-CKD) is a common and severe complication of T2DM that predisposes patients to end-stage renal disease (ESRD); substantially increasing mortality risk and long-term medical economic burden. Currently; SGLT-2 inhibitors are used as the foundational treatment regimen in clinical practice. As validated by the global multicenter randomized controlled CONFIDENCE trial; simultaneous initiation of finerenone plus an SGLT-2 inhibitor can further enhance renal protection and delay kidney disease progression. Despite these advancements; long-term pharmacoeconomic data supporting this combination regimen in the Chinese population remain limited.ObjectiveFrom the perspective of China’s healthcare system; this study aimed to evaluate the cost-utility of the simultaneous initiation of finerenone and empagliflozin versus empagliflozin monotherapy in T2DM-CKD patients; based on the CONFIDENCE trial design.MethodsA Markov model was constructed to simulate the natural history of T2DM-CKD. The model cycle was 1 year; with a simulation time horizon of 30 years. The willingness-to-pay (WTP) threshold was set at three times China’s 2025 per capita GDP (¥299; 100/QALY). Base-case analysis was performed; followed by one-way and probabilistic sensitivity analyses to assess the robustness of results.ResultsBase-case analysis revealed that the incremental cost-effectiveness ratio (ICER; a measure comparing the cost to the health benefit gained) of the finerenone plus empagliflozin regimen was ¥35; 082.44/QALY (quality-adjusted life year); well below the WTP (willingness-to-pay) threshold. One-way sensitivity analysis indicated that the kidney disease progression coefficient (which measures the rate of worsening kidney disease) and the cost of finerenone were the most influential parameters; all parameter fluctuations within reasonable ranges retained the cost-effectiveness advantage. Probabilistic sensitivity analysis showed that the combination regimen was acceptable in 99.1% of 1; 000 Monte Carlo simulations (computer-generated scenarios that model uncertainty); with all incremental QALYs positive; indicating highly robust results.ConclusionCompared with empagliflozin monotherapy; the combined initiation of finerenone plus empagliflozin offers significant cost-utility advantages in treating T2DM-CKD. These findings provide high-quality evidence for standardized clinical care; rational pharmacotherapy; the formulation of medical insurance policies; and optimal health resource allocation in Chinese patients with T2DM-CKD.
Keywords:
sensitivity analysis
Markov model
cost-utility analysis
CONFIDENCE trial
T2DM-CKD
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