Cost-Effectiveness of Empagliflozin in CKD with or without Albuminuria.

KEY POINTS

Empagliflozin is cost-effective for the treatment of CKD in patients with an urine albumin-to-creatinine ratio of 30 mg/g or more. Empagliflozin is not cost-effective for the treatment of CKD in patients with an urine albumin-to-creatinine ratio <30 mg/g.

BACKGROUND

The Study of Heart and Kidney Protection with Empagliflozin (EMPA-KIDNEY) expanded the CKD population that may benefit from sodium-glucose cotransporter 2 inhibitors in terms of eGFR and urine albumin-to-creatinine ratio. This enables a cost-effectiveness analysis of empagliflozin in subgroups stratified by these two parameters.

METHODS

A cost–utility analysis using the Markov model was performed to evaluate the cost-effectiveness of adding empagliflozin to the standard treatment for CKD in Japan over 20 years of observation. Each cohort with the initial eGFR (≥45 but <60 ml/min per 1.73 m, ≥30 but <45 ml/min per 1.73 m, or ≥20 but <30 ml/min per 1.73 m) and urine albumin-to-creatinine ratio (<30 mg/g, ≥30 but <300 mg/g, or ≥300 mg/g) within the defined ranges was analyzed. The changes in eGFR were determined on the basis of the EMPA-KIDNEY study. An incremental cost-effectiveness ratio of <¥5,000,000 (approximately $35,500) per quality-adjusted life-year (QALY) was considered 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 the standard treatment was associated with lower costs and higher QALYs in the macroalbuminuria or microalbuminuria cohorts while the incremental cost-effectiveness ratios in the negative albuminuria cohorts were >¥5,000,000 per QALY, regardless of the initial eGFR. The probabilities of empagliflozin being cost-effective were >84% in the macroalbuminuria or microalbuminuria cohorts but <30% in the negative albuminuria cohorts. Scenario analyses where empagliflozin suppressed the eGFR decline in the negative albuminuria cohorts showed that the drug was cost-effective in CKD stage G3b and G4 cohorts. Empagliflozin was not cost-effective in patients with CKD stage G3a and microalbuminuria with the observation period of 10 years.

CONCLUSIONS

In patients meeting the enrollment criteria for the EMPA-KIDNEY trial, the addition of empagliflozin to the standard treatment of CKD was judged as cost-effective for patients with albuminuria but not for those without albuminuria in the Japanese health care system.