Health Economics and Outcomes Research Ltd, Cardiff, UK.
BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Diabetes Obes Metab. 2021 Apr;23(4):1020-1029. doi: 10.1111/dom.14308. Epub 2021 Jan 25.
To undertake a cost-effectiveness analysis of dapagliflozin in treating high-risk patients with type 2 diabetes mellitus (T2DM), using both directly observed events in the DECLARE-TIMI 58 trial and surrogate risk factors to predict endpoints not captured within the trial.
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, hospitalization for heart failure, stroke, myocardial infarction, hospitalization 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.
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 a 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).
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.
通过直接观察 DECLARE-TIMI 58 试验中的事件和预测试验未捕获终点的替代风险因素,对达格列净治疗 2 型糖尿病(T2DM)高危患者的成本效益进行分析。
对已建立的 T2DM 模型进行了改编,以整合 DECLARE-TIMI 58 试验中得出的生存曲线,并对所有原因死亡率、心力衰竭住院、卒中和心肌梗死、不稳定型心绞痛住院和终末期肾病的终生进行了外推。经济分析考虑了整个 DECLARE 试验人群以及报告的患者亚组。从英国医疗保健支付者的角度估计了达格列净与安慰剂相比的总费用和增量成本、生命年和质量调整生命年。
在英国,与安慰剂相比,达格列净治疗预计是主导治疗方案,预期质量调整生命年从 10.43 增加到 10.48(+0.06),终生总费用从 39451 英镑减少到 36899 英镑(-£2552)。在所有患者亚组中,达格列净预计是主导治疗方案,在既往心力衰竭亚组中获益最大(增量终生费用-£4150 和质量调整生命年+0.11)。
本研究结果表明,与安慰剂相比,达格列净在考虑 DECLARE-TIMI 58 试验报告的证据时,在英国既定的支付意愿阈值下,具有成本效益。研究结果突出了达格列净在降低广泛 T2DM 人群 T2DM 及其相关并发症的经济负担方面具有重要意义。