The cost-effectiveness of dapagliflozin in treating high-risk patients with type 2 diabetes mellitus: An economic evaluation using data from the DECLARE-TIMI 58 trial.

Aims Despite the growing body of evidence for dapagliflozin demonstrating favourable clinical outcomes, that occur independently of changes in HbA1c, cost effectiveness analyses have not considered event rates driven by these factors and consequently, the cost-effectiveness of dapagliflozin may have been previously underestimated. The objective of this study was to undertake a cost-effectiveness analysis of dapagliflozin in treating high risk patients with type 2 diabetes mellitus (T2DM), utilising both directly observed events in the DECLARE-TIMI 58 trial and surrogate risk factors to predict endpoints not captured within the trial. Methods An established T2DM model was adapted to integrate survival curves derived from the DECLARE-TIMI 58 trial, and extrapolated over a lifetime for all-cause mortality, hospitalisation for heart failure, stroke, myocardial infarction, hospitalisation for unstable angina, and end-stage kidney disease. The economic analysis considered the overall DECLARE trial population, as well as reported patient subgroups. Total and incremental costs, life years and quality-adjusted life years associated with dapagliflozin versus placebo were estimated from the perspective of the UK healthcare payer. Results In the UK setting, treatment with dapagliflozin compared to placebo was estimated to be dominant with an expected increase in quality-adjusted life-years from 10.43 to 10.48 (+0.06) and reduction in lifetime total costs from £39 451 to £36 899 (-£2552). Across all patient subgroups, dapagliflozin was estimated to be dominant with the greatest absolute benefit in the prior heart failure subgroup (incremental lifetime costs -£4150 and quality adjusted life years +0.11). Conclusions The results of this study demonstrate that dapagliflozin compared to placebo appears to be cost-effective, when considering evidence reported from the DECLARE-TIMI 58 trial, at established UK willingness to pay thresholds. The findings highlight the potential of dapagliflozin to have a meaningful impact in reducing the economic burden of T2DM and its associated complications across a broad T2DM population. This article is protected by copyright. All rights reserved.