ArticleFrontiers in pharmacology2026
Cost-utility analysis of simultaneous initiation of finerenone and empagliflozin for type 2 diabetes mellitus complicated with chronic kidney disease.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Type 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. Objective: From 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. Methods: A 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 Results: Base-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. Conclusion: Compared 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.
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