Introduction:
Sodium glucose co-transporter 2 (SGLT2) inhibitors have been shown to be effective for preventing renal events regardless of presence of diabetes. The population of patients with chronic kidney disease (CKD) who may benefit from SGLT2 inhibitors was expanded by the results from the Study of Heart and Kidney Protection with Empagliflozin (EMPA-KIDNEY).However, considering a large number of indicated patients and the high cost of the drugs, a concern remains on the increased economic burden. Therefore, a cost-utility analysis was performed based on eGFR- and albuminuria-based subpopulations to investigate an effective treatment strategy for each group.
Methods:
A Markov model with microsimulation was used to evaluate the costs and the effectiveness of adding empagliflozin to the standard treatment for CKD in Japan over a 20 year-observation period. Total of 9 cohorts, each with a designated range of initial eGFR (CKD stage G3a: ≥45 but <60 ml/min per 1.73 m2, stage G3b: ≥30 but <45 ml/min per 1.73 m2, or CKD stage 4: ≥20 but <30 ml/min per 1.73 m2) and urine albumin-to-creatinine ratio (UACR) (negative albuminuria: <30 mg/g, microalbuminuria: ≥30 but <300 mg/g, or macroalbuminuria: ≥300 mg/g) were analyzed. The changes in eGFR were based on the EMPA-KIDNEY study and the event rates were based on a large Japanese database of patients with CKD. An incremental cost-effectiveness ratio (ICER) of <¥5,000,000 (approximately $35,500) per quality-adjusted life-year (QALY) was judged as cost-effective. One-way deterministic analyses, probabilistic sensitivity analyses and scenario analyses were conducted to ensure the robustness of the results.
Results:
The addition of empagliflozin to standard treatment decreased costs and increased QALYs in patients with macroalbuminuria and microalbuminuria, while the ICERs in the negative albuminuria cohorts were >\5,000,000 per QALY, regardless of the initial eGFR. The cases where empagliflozin was cost-effective were >84% of the simulated cases in the macroalbuminuria or microalbuminuria cohorts but <30% of those in the negative albuminuria cohorts. Scenario analyses considering the suppressive effect of empagliflozin on eGFR decline in the negative albuminuria cohorts implicated that the drug was cost-effective in the CKD stage G3b and G4 cohorts. Empagliflozin was not cost-effective in the patients with CKD stage G3a and microalbuminuria with an observation period of as short as 10 years.
Conclusions:
The addition of empagliflozin to the standard treatment of CKD was judged as cost-effective for patients with significant albuminuria but not for those without albuminuria in Japanese healthcare system.
I have potential conflict of interest to disclose.
M.O. and M.K. have nothing to disclose. H.N. received honoraria from Astellas, Astra Zeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Kowa, Kyowa Kirin, MSD, Ono, Tanabe Mitsubishi, and Torii outside the scope of the submitted work and research grant from Bayer, Boehringer Ingelheim, Kyowa Kirin, Novo Nordisk, and Tanabe Mitsubishi outside the scope of the submitted work. S.K. received honoraria from Astra Zeneca, Boehringer Ingelheim, Daiichi Sankyo, and Fukuda Denshi outside the scope of the submitted work and research grant from Nipro outside the scope of the submitted work. M.N. received honoraria and from Astellas, Astra Zeneca, Bayer, Boehringer Ingelheim, Kyowa Kirin, Tanabe Mitsubishi, and JT outside the scope of the submitted work and research grant from Boehringer Ingelheim, Kyowa Kirin, Tanabe Mitsubishi, Torii, Takeda, Daiichi Sankyo, and JT outside the scope of the submitted work. Boehringer Ingelheim is the maker of Jardiance (empagliflozin) and funded the EMPA-KIDNEY trial. Kyowa Kirin funded the CKD-JAC study.
I did not use generative AI and AI-assisted technologies in the writing process.