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达格列净在射血分数谱心力衰竭中的成本效果:基于 DELIVER 和 DAPA-HF 试验的汇总、个体参与者数据的经济评估。

Cost Effectiveness of Dapagliflozin for Heart Failure Across the Spectrum of Ejection Fraction: An Economic Evaluation Based on Pooled, Individual Participant Data From the DELIVER and DAPA-HF Trials.

机构信息

Division of Research Kaiser Permanente San Francisco Medical Center San Francisco CA USA.

Division of Cardiovascular Medicine Stanford University School of Medicine Palo Alto CA USA.

出版信息

J Am Heart Assoc. 2024 Mar 5;13(5):e032279. doi: 10.1161/JAHA.123.032279. Epub 2024 Feb 23.

Abstract

BACKGROUND

The sodium glucose cotransporter-2 inhibitors are guideline-recommended to treat heart failure across the spectrum of left ventricular ejection fraction; however, economic evaluations of adding sodium glucose cotransporter-2 inhibitors to standard of care in chronic heart failure across a broad left ventricular ejection fraction range are lacking.

METHODS AND RESULTS

We conducted a US-based cost-effectiveness analysis of dapagliflozin added to standard of care in a chronic heart failure population using pooled, participant data from the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trials. The 3-state Markov model used estimates of transitional probabilities, effectiveness of dapagliflozin, and utilities from the pooled trials. Costs estimates were obtained from published sources, including published rebates in dapagliflozin cost. Adding dapagliflozin to standard of care was estimated to produce an additional 0.53 quality-adjusted life years (QALYs) compared with standard of care alone. Incremental cost effectiveness ratios were $85 554/QALY when using the publicly reported full (undiscounted) Medicare cost ($515/month) and $40 081/QALY, at a published nearly 50% rebate ($263/month). The addition of dapagliflozin to standard of care would be of at least intermediate value (<$150 000/QALY) at a cost of <$872.58/month, of high value (<$50 000/QALY) at <$317.66/month, and cost saving at <$40.25/month. Dapagliflozin was of at least intermediate value in 92% of simulations when using the full (undiscounted) Medicare list cost in probabilistic sensitivity analyses. Cost effectiveness was most sensitive to the dapagliflozin cost and the effect on cardiovascular death.

CONCLUSIONS

The addition of dapagliflozin to standard of care in patients with heart failure across the spectrum of ejection fraction was at least of intermediate value at the undiscounted Medicare cost and may be potentially of higher value on the basis of the level of discount, rebates, and price negotiations offered.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01035255 & NCT01920711.

摘要

背景

钠-葡萄糖协同转运蛋白 2 抑制剂被指南推荐用于治疗各种射血分数的心力衰竭;然而,在广泛的射血分数范围内,将钠-葡萄糖协同转运蛋白 2 抑制剂添加到慢性心力衰竭的标准治疗中,缺乏经济评估。

方法和结果

我们使用 DAPA-HF(达格列净和预防心力衰竭不良结局)和 DELIVER(达格列净评估改善射血分数保留心力衰竭患者的生活)试验的汇总参与者数据,对纳入标准治疗的达格列净在慢性心力衰竭人群中的美国基于成本的效果分析进行了研究。该三状态马尔可夫模型使用来自汇总试验的过渡概率、达格列净的有效性和效用的估计值。成本估算来自已发表的来源,包括达格列净成本的已发表回扣。与单独的标准治疗相比,添加达格列净至标准治疗预计会产生额外的 0.53 个质量调整生命年(QALY)。当使用公开报告的全(未贴现)医疗保险成本(每月 515 美元)和 40081 美元/QALY 时,增量成本效益比为 85554 美元/QALY,在已发表的近 50%回扣(每月 263 美元)下。当达格列净的成本低于每月 872.58 美元时,添加达格列净至标准治疗将具有至少中等价值(<150000 美元/QALY),低于每月 317.66 美元时具有高价值(<50000 美元/QALY),低于每月 40.25 美元时具有成本节约。在概率敏感性分析中,当使用全(未贴现)医疗保险清单成本时,达格列净在 92%的模拟中至少具有中等价值。成本效果对达格列净的成本和对心血管死亡的影响最敏感。

结论

在射血分数谱内的心力衰竭患者中,将达格列净添加到标准治疗中,至少在未贴现医疗保险成本下具有中等价值,并且基于提供的折扣、回扣和价格谈判水平,可能具有更高的价值。

注册信息

网址:https://www.clinicaltrials.gov;唯一标识符:NCT01035255 和 NCT01920711。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d854/10944049/a5f7b5429136/JAH3-13-e032279-g002.jpg

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