15-OR: Renal Outcomes from the DECLARE-TIMI 58 Trial: Quantifying the Health-Care Implications

Chronic kidney disease (CKD) and end stage renal disease (ESRD) pose a significant global health burden. Approximately 40% of people with type 2 diabetes develop CKD. The Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 trial showed a reduced rate of the composite endpoint of sustained decrease of ≥40% in estimated glomerular filtration rate (eGFR) to 2 , ESRD, or renal death when comparing dapagliflozin (DAPA) to placebo (PBO) (hazard ratio 0.53; 95% CI 0.43, 0.66). This study aimed to quantify the implications of renal outcomes from DECLARE-TIMI 58, in terms of direct healthcare costs and resource use. DECLARE-TIMI 58 event rates were used to characterize expected numbers of patients experiencing sustained decrease of ≥40% in eGFR to 2 (‘CKD progression’) or ESRD, per 1,000 patients over a 4-year time horizon. Renal replacement therapy (RRT) was assumed following the incidence of ESRD events only and the distribution of RRT modalities based on U.S. Renal Data. Published annual U.S. costs (2017 $) of ESRD and excess healthcare associated with CKD stage 3 versus CKD stage 2 were applied and discounted at 3% annually. Per 1,000 patients, PBO was associated with 25.6 CKD progression events and 2.4 ESRD events over four years, while DAPA was associated with 11.8 (-46%) and 1.6 (-67%) fewer events, respectively. Consequently, over 4 years DAPA was estimated to avoid 1,126 days of RRT per 1,000 patients, of which over 70% relate to a need for dialysis. The estimated cost of CKD progression and ESRD associated with PBO was $460,277 per 1,000 patients over 4 years, while costs associated with DAPA were an estimated $285,444 lower (-62% versus PBO). Economic modelling utilizing renal outcomes data from DECLARE-TIMI 58 indicate that treatment with DAPA may translate into renal cost savings within a short-term horizon. Potential delays to ESRD may have a more profound impact on patients’ quality of life, cost savings, and service delivery over the longer-term. Disclosure P. McEwan: Consultant; Self; AstraZeneca. Employee; Self; Health Economics and Outcomes Research Ltd. B. Kartman: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca. H. Bennett: Consultant; Self; AstraZeneca. Employee; Self; Health Economics and Outcomes Research Ltd. C. Edmonds: Employee; Self; AstraZeneca. I.A. Gause-Nilsson: Employee; Self; AstraZeneca. Funding AstraZeneca