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. 2025 Jun;42(6):2888-2905.
doi: 10.1007/s12325-025-03157-z. Epub 2025 Apr 29.

Cost-Effectiveness Analysis of SGLT2 Inhibitors for Cardio-Renal-Metabolic Disease Based on Data from Japanese Studies

Affiliations

Cost-Effectiveness Analysis of SGLT2 Inhibitors for Cardio-Renal-Metabolic Disease Based on Data from Japanese Studies

Ataru Igarashi et al. Adv Ther. 2025 Jun.

Abstract

Introduction: Cardiovascular, renal, and metabolic diseases, collectively known as cardio-renal-metabolic (CRM) disease, interact and exacerbate each other, creating serious clinical and economic burdens. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are important therapeutic agents in managing CRM disease. Despite proven clinical benefits, the economic benefits of SGLT2i in the management of CRM diseases remain unclear.

Methods: We developed Markov models representing the natural progression of disease for two populations: a type 2 diabetes mellitus (T2DM) population and non-diabetic chronic kidney disease (non-DM CKD) population. These models incorporated key complications, including heart failure, myocardial infarction, stroke, CKD (for the T2DM population), and end-stage renal disease. A systematic literature search was conducted to determine input parameters. For each model, we estimated the 10-year medical costs, quality-adjusted life years (QALY), and incremental cost-effectiveness ratio (ICER) for SGLT2i treatment compared with conventional treatment. A probabilistic sensitivity analysis (PSA) and scenario analyses with conservative assumptions were performed.

Results: In the base-case analysis, SGLT2i treatment was estimated to increase QALY by 0.177 (7.090 vs 6.913 QALY; T2DM population) and 0.457 (6.980 vs 6.523 QALY; non-DM CKD population), and increase total medical costs by Japanese yen (JPY) 99,060 (JPY 762,524 vs 663,463; T2DM population) and JPY 229,810 (JPY 3,378,873 vs 3,149,063; non-DM CKD population), compared with conventional treatment. The ICER was JPY 559,175/QALY in the T2DM population and JPY 503,123/QALY in the non-DM CKD population. The PSA revealed that the probability of ICER being below the threshold value of JPY 5,000,000/QALY was 100% in the T2DM population and 98.7% in the non-DM CKD population, and the ICERs were below this threshold in all scenario analyses.

Conclusion: SGLT2i treatment was demonstrated to be cost-effective in both the T2DM population and the non-DM CKD population, suggesting the potential of SGLT2i to offer significant clinical and economic benefits in the comprehensive management of CRM diseases.

Keywords: Cardio-renal-metabolic (CRM) diseases; Cardiovascular disease; Chronic kidney disease; Cost-effectiveness; Sodium–glucose cotransporter 2 inhibitors; Type 2 diabetes mellitus.

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Conflict of interest statement

Declarations. Conflict of Interest: Ataru Igarashi has received lecture fees from Astellas Pharma Inc., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Mitsubishi Tanabe Pharma Corporation, MSD Co., Ltd., Novartis Pharma K.K., and Ono Pharmaceutical Co., Ltd.; and belongs to the endowed department sponsored by Takeda Pharmaceutical Co., Ltd. Hisateru Tachimori belongs to the endowed department sponsored by Takeda Pharmaceutical Co., Ltd. Hiroyuki Takagi and Hiroki Akiyama are full-time employees of AstraZeneca K.K. Shun Kohsaka has received research funding from the Japan Society for the Promotion of Science and Pfizer, and has received consulting fees from Novartis and Bristol Myers Squibb, outside of the submitted work. Hiroaki Miyata has received research funding from AstraZeneca K.K. and Mitsubishi Tanabe Pharma Corporation. Keiko Maruyama-Sakurai, Yasumasa Segawa, and Naohiko Imai have no conflicts of interest to declare. Ethical Approval: This study is based on previously conducted studies and published literature and does not contain any new studies with human participants or animals.

Figures

Fig. 1
Fig. 1
Model structure. The T2DM (a) and non-DM CKD (b) models were constructed. All complications except for CKD were considered independent (i.e., a patient who developed one disease did not manifest another disease). CKD chronic kidney disease, ESRD end-stage renal disease, HF heart failure, MI myocardial infarction, non-DM non-diabetes mellitus, T2DM type 2 diabetes mellitus
Fig. 2
Fig. 2
Breakdown of costs. The breakdown of costs in the base-case analysis in the T2DM (a) and non-DM CKD (b) models. CKD chronic kidney disease, ESRD end-stage renal disease, HF heart failure, JPY Japanese yen, MI myocardial infarction, non-DM non-diabetes mellitus, SGLT2i sodium–glucose cotransporter 2 inhibitor, T2DM type 2 diabetes mellitus
Fig. 3
Fig. 3
Tornado diagram from one-way sensitivity analyses. The tornado plot shows the uncertainty in ICER for each input variable in the T2DM (a) and non-DM CKD (b) models. The maximum and minimum ICERs for each variable are shown as incremental NMB at the end of each bar. The results for variables with higher impact (top 16) on the ICER are shown. CKD chronic kidney disease, ESRD end-stage renal disease, EV equivalent variation, HF heart failure, ICER incremental cost-effectiveness ratio, MI myocardial infarction, NMB net monetary benefit, non-DM non-diabetes mellitus, QOL quality of life, SGLT2i sodium–glucose cotransporter 2 inhibitor, T2DM type 2 diabetes mellitus
Fig. 4
Fig. 4
ICER scatter plot from probabilistic sensitivity analysis. The scatterplot shows the incremental costs and QALY of the SGLT2i treatment compared with the conventional treatment in the Monte Carlo simulations in the T2DM (a) and non-DM CKD (b) models. The dotted line represents the WTP threshold of JPY 5,000,000/QALY. Green dots represent iterations with ICER values below the threshold, while red dots represent iterations with ICER values above the threshold. CKD chronic kidney disease, ICER incremental cost-effectiveness ratio, JPY Japanese yen, non-DM non-diabetes mellitus, QALY quality-adjusted life years, SGLT2i sodium–glucose cotransporter 2 inhibitor, T2DM type 2 diabetes mellitus, WTP willingness-to-pay

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