OBJECTIVES: In the EMPA-KIDNEY trial, empagliflozin demonstrated a significant reduction in kidney disease progression or CV death compared to standard of care (SoC) in patients with CKD. This study uses the Chronic Kidney Disease Progression Model (CKD-PM) to demonstrate the cost-effectiveness of empagliflozin for the treatment of CKD to the National Institute for Health and Care Excellence (NICE), from the perspective of the UK National Health Service (NHS) and personal social services (PSS).

METHODS: The CKD-PM is a patient-level (microsimulation) state-transition model with health states based on Kidney Disease Improving Global Outcomes (KDIGO) categories. The evolution of estimated glomerular filtration ratio (eGFR) and urine albumin-creatinine ratio (uACR) are used to project CKD progression and the occurrence of a broad range of complications. Patient baseline characteristics, distribution across KDIGO health states, and treatment effects health state-dependent in eGFR and uACR were derived from EMPA-KIDNEY trial. UK cost and utilities/disutilities were sourced from literature. One way and probabilistic sensitivity analyses and scenario analyses were conducted. Annual discounting rates of 3.5% were applied on costs and outcomes. The time horizon was 50 years.

RESULTS: Over lifetime, SoC resulted in per-patient costs of £93,407, 8.48 life years and 6.24 QALYs. Empagliflozin on top of SoC resulted in an incremental gain in life years (+1.06) and QALYs (+0.85), while decreasing per-patient costs by £5,460. Empagliflozin dominated SoC alone (more effective and less costly) with a net health benefit of 1.12 and with probability of being cost-effective at 99.8% at the willingness-to-pay threshold of £20,000. Empagliflozin remained highly cost-effective across sensitivity and scenario analyses, including in patients with and without T2DM.

CONCLUSIONS: Empagliflozin is a highly cost-effective treatment option for CKD compared to SoC in the UK. One way and probabilistic sensitivity analyses indicate robustness of these results.