Abstract

Abstract Background and Aims Diabetes and its complications (e.g. chronic kidney disease [CKD] and cardiovascular disease [CVD]) impose significant clinical and financial burden. Recent large-scale randomized controlled trials have demonstrated cardiorenal benefit of the anti-diabetic drug sodium glucose co-transporter 2 (SGLT2) inhibitors, and they are approved for the treatment of CKD and/or heart failure (HF) in many countries. In the present study, we assessed the economic effectiveness of SGLT2 inhibitors for patients with type 2 diabetes (T2DM) using a cost-analysis model that adopts CKD-dependent increases in the risk of developing CVD. Method We constructed a natural history model for T2DM patients incorporating CKD, end-stage renal disease, and CVD including myocardial infarction, HF, and stroke as diabetic complications. All diseases except for CKD were considered independent (i.e., the development of CKD increases the risk of CVD manifestation but a patient who develops one disease does not present with another disease). By using a population-based microsimulation, we estimated the 10-year medical costs in Japanese Yen (JPY) and outcomes (development of complications and quality-adjusted life years [QALY]) for patients who initiated antidiabetic therapy with SGLT2 inhibitors or conventional therapy. Probabilistic sensitivity analysis (PSA) was performed with 1,000,000 iterations. Results The total medical costs per person were JPY 1,193,000 versus JPY 1,160,000 and the QALYs were 8.13 versus 8.02 years for the SGLT2 inhibitor strategy versus the conventional strategy, respectively. As a result, the incremental cost-effectiveness ratio (ICER) was 302,000 JPY/QALY, well below the threshold value of JPY 5,000,000/QALY. The PSA revealed that the probability of ICER being below the threshold was 97.7%. Conclusion We demonstrated that the use of SGLT2 inhibitors was cost-effective compared to the conventional strategy for treating patients with T2DM, and these results suggest clinical and financial benefit of SGLT2 inhibitors that can holistically approach T2DM and its renal and cardiovascular complications.

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