Effects of Empagliflozin on Health Care Use and Quality of Life in CKD in the United Kingdom: Results from EMPA-KIDNEY

Background: In EMPA-KIDNEY, empagliflozin reduced the risk of the primary composite outcome of kidney disease progression or cardiovascular death in patients with chronic kidney disease at risk of progression. We aimed to estimate the effects on within-trial healthcare use and health-related quality of life (QoL). Methods: 6609 participants were randomly assigned to empagliflozin 10 mg daily or placebo and followed for a median of 2.0 (IQR 1.5-2.4) years. We estimated the effects of allocation to empagliflozin on healthcare use and costs (2022 UK£), including hospital admissions, concomitant medications, and kidney replacement therapy, and on QoL using shared parameter (analyzing outcomes together with time to death) or negative binomial models. These models informed estimates of the net effects of empagliflozin on healthcare use and costs and quality-adjusted life years (QALYs) over 2.5 years using 3.5%/year discount rate. Results: Allocation to empagliflozin resulted in fewer hospital admissions (hazard ratio 0.86, 95% confidence interval 0.78-0.95). There were fewer days on (rate ratio (RR) 0.98, 0.95-1.00) and lower cost of (RR 0.90, 0.85-0.96) concomitant medications. Only a small number of participants initiated kidney replacement therapy and there was no statistically significant difference in these costs (RR 0.74, 0.33-1.69). Overall over 2.5 years, the estimated net cost of healthcare use was £353 (8-698) and additional QALYs were 0.016 (0.001-0.032) per participant allocated empagliflozin (Table). Conclusion: In EMPA-KIDNEY and based on UK costs, allocation to empagliflozin over 2.5 years reduced other healthcare related costs, offsetting about two-thirds of empagliflozin costs. Ongoing post-trial follow-up will provide useful information on longer-term effects. Funding: Commercial Support - EMPA-KIDNEY was funded by a grant to the University of Oxford from Boehringer Ingelheim and Eli Lilly. Effects of empagliflozin on healthcare use and quality-adjusted life years (QALYs) over 2.5 years in EMPA-KIDNEY - Days per person over 2.5 years, Mean (95%CIs) Costs or QALY per person over 2.5 years, Mean (95%CIs) Empagliflozin Placebo Difference Empagliflozin Placebo Difference Total healthcare use (including empagliflozin) - - - £4438 (4215, 4660) £4084 (3834, 4335) £353 (8, 698) Hospital admissions 5.22 (4.61, 5.83) 6.24 (5.46, 7.01) -1.01 (-2.09, 0.07) £1222 (1088, 1357) £1490 (1326, 1655) -£268 (-499, -37) Individual concomitant medications* 4312 (4228, 4396) 4396 (4309, 4483) -84 (-216, 47) £1505 (1434, 1576) £1663 (1584, 1741) -£158 (-258, -57) Kidney replacement therapy 9.78 (7.52, 12.00) 12.60 (10.29, 14.92) -2.82 (-6.04, 0.40) £694 (532, 856) £931 (759, 1104) -£237 (-472, -2) Study empagliflozin 790 (765, 815) - 790 (765, 815) £1016 (1006, 1026) - £1016 (1006, 1026) Quality-adjusted life years (QALYs) - - - 2.014 (2.000, 2.029) 1.998 (1.983, 2.013) 0.016 (0.001, 0.032) *Each day on individual medication contributes a ‘medication day’ (e.g. a person on 5 medications/day accumulates 5 medication days).