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钠-葡萄糖共转运蛋白 2 抑制剂治疗射血分数保留的心力衰竭的成本效益。

Cost-effectiveness of Sodium-Glucose Cotransporter-2 Inhibitors for the Treatment of Heart Failure With Preserved Ejection Fraction.

机构信息

Division of Cardiology, Massachusetts General Hospital, Boston.

Harvard Medical School, Boston, Massachusetts.

出版信息

JAMA Cardiol. 2023 May 1;8(5):419-428. doi: 10.1001/jamacardio.2023.0077.

DOI:10.1001/jamacardio.2023.0077
PMID:36870047
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9985815/
Abstract

IMPORTANCE

Adding a sodium-glucose cotransporter-2 inhibitor (SGLT2-I) to standard-of-care treatment in patients with heart failure with preserved ejection fraction (HFpEF) reduces the risk of a composite outcome of worsening heart failure or cardiovascular mortality, but the cost-effectiveness in US patients with HFpEF is uncertain.

OBJECTIVE

To evaluate the lifetime cost-effectiveness of standard therapy plus an SGLT2-I compared with standard therapy in individuals with HFpEF.

DESIGN, SETTING, AND PARTICIPANTS: In this economic evaluation conducted from September 8, 2021, to December 12, 2022, a state-transition Markov model simulated monthly health outcomes and direct medical costs. Input parameters including hospitalization rates, mortality rates, costs, and utilities were extracted from HFpEF trials, published literature, and publicly available data sets. The base-case annual cost of SGLT2-I was $4506. A simulated cohort with similar characteristics as participants of the Empagliflozin in Heart Failure With a Preserved Ejection Fraction (EMPEROR-Preserved) and Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction (DELIVER) trials was used.

EXPOSURES

Standard of care plus SGLT2-I vs standard of care.

MAIN OUTCOMES AND MEASURES

The model simulated hospitalizations, urgent care visits, and cardiovascular and noncardiovascular death. Future medical costs and benefits were discounted by 3% per year. Main outcomes were quality-adjusted life-years (QALYs), direct medical costs (2022 US dollars), and incremental cost-effectiveness ratio (ICER) of SGLT2-I therapy from a US health care sector perspective. The ICER of SGLT2-I therapy was evaluated according to the American College of Cardiology/American Heart Association value framework (high value: <$50 000; intermediate value: $50 000 to <$150 000; and low value: ≥$150 000).

RESULTS

The simulated cohort had a mean (SD) age of 71.7 (9.5) years and 6828 of 12 251 participants (55.7%) were male. Standard of care plus SGLT2-I increased quality-adjusted survival by 0.19 QALYs at an increased cost of $26 300 compared with standard of care. The resulting ICER was $141 200 per QALY gained, with 59.1% of 1000 probabilistic iterations indicating intermediate value and 40.9% indicating low value. The ICER was most sensitive to SGLT2-I costs and effect of SGLT2-I therapy on cardiovascular death (eg, increasing to $373 400 per QALY gained if SGLT2-I therapy was assumed to have no effect on mortality).

CONCLUSIONS AND RELEVANCE

Results of this economic evaluation suggest that at 2022 drug prices, adding an SGLT2-I to standard of care was of intermediate or low economic value compared with standard of care in US adults with HFpEF. Efforts to expand access to SGLT2-I for individuals with HFpEF should be coupled with efforts to lower the cost of SGLT2-I therapy.

摘要

重要性

在射血分数保留的心力衰竭(HFpEF)患者中,将钠-葡萄糖共转运蛋白 2 抑制剂(SGLT2-I)添加到标准治疗中,可降低复合结局(心力衰竭恶化或心血管死亡率)的风险,但美国 HFpEF 患者的成本效益尚不确定。

目的

评估标准治疗加 SGLT2-I 与标准治疗相比在 HFpEF 个体中的终生成本效益。

设计、设置和参与者:在这项于 2021 年 9 月 8 日至 2022 年 12 月 12 日进行的经济评估中,状态转换马尔可夫模型模拟了每月的健康结果和直接医疗成本。住院率、死亡率、成本和效用等输入参数是从 HFpEF 试验、已发表的文献和公开可用的数据集提取的。基础病例 SGLT2-I 的年成本为 4506 美元。使用与 Empagliflozin 在射血分数保留的心力衰竭(EMPEROR-Preserved)和 Dapagliflozin 在射血分数轻度降低或保留的心力衰竭(DELIVER)试验参与者特征相似的模拟队列。

暴露

标准治疗加 SGLT2-I 与标准治疗。

主要结果和措施

该模型模拟了住院、急诊就诊以及心血管和非心血管死亡。未来的医疗费用和收益按每年 3%贴现。主要结果是质量调整生命年(QALYs)、直接医疗费用(2022 年美元)和从美国医疗保健部门角度来看 SGLT2-I 治疗的增量成本效益比(ICER)。根据美国心脏病学会/美国心脏协会价值框架(高价值:<50000 美元;中值:50000 美元至<150000 美元;低价值:≥150000 美元)评估 SGLT2-I 治疗的 ICER。

结果

模拟队列的平均(SD)年龄为 71.7(9.5)岁,12251 名参与者中有 6828 名(55.7%)为男性。与标准治疗相比,标准治疗加 SGLT2-I 增加了 0.19 个 QALYs 的质量调整生存,但成本增加了 26300 美元。由此产生的 ICER 为每获得 1 个 QALY 增加 141200 美元,1000 次概率迭代中有 59.1%表示中值,40.9%表示低值。ICER 对 SGLT2-I 成本和 SGLT2-I 治疗对心血管死亡的影响最为敏感(例如,如果假设 SGLT2-I 治疗对死亡率没有影响,则 ICER 增加到每获得 1 个 QALY 增加 373400 美元)。

结论和相关性

这项经济评估的结果表明,在 2022 年药物价格下,与标准治疗相比,在美国 HFpEF 成年人中,在标准治疗中添加 SGLT2-I 具有中值或低经济价值。努力扩大 SGLT2-I 对 HFpEF 患者的可及性应与降低 SGLT2-I 治疗成本的努力相结合。

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