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美国依折麦布与他汀类药物联合治疗的经济学评估。

Economic evaluation of ezetimibe treatment in combination with statin therapy in the United States.

作者信息

Davies Glenn M, Vyas Ami, Baxter Carl A

机构信息

a Merck & Co., Inc. , Kenilworth , NJ , USA.

b Department of Epidemiology , School of Public Health, Rutgers University , Piscataway , NJ , USA.

出版信息

J Med Econ. 2017 Jul;20(7):723-731. doi: 10.1080/13696998.2017.1320559. Epub 2017 May 15.

Abstract

AIMS

This study assessed the cost-effectiveness of ezetimibe with statin therapy vs statin monotherapy from a US payer perspective, assuming the impending patent expiration of ezetimibe.

METHODS

A Markov-like economic model consisting of 28 distinct health states was used. Model population data were obtained from US linked claims and electronic medical records, with inclusion criteria based on diagnostic guidelines. Inputs came from recent clinical trials, meta-analyses, and cost-effectiveness analyses. The base-case scenario was used to evaluate the cost-effectiveness of adding ezetimibe 10 mg to statin in patients aged 35-74 years with a history of coronary heart disease (CHD) and/or stroke, and with low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL over a lifetime horizon, assuming a 90% price reduction of ezetimibe after 1 year to take into account the impending patent expiration in the second quarter of 2017. Sub-group analyses included patients with LDL-C levels ≥100 mg/dL and patients with diabetes with LDL-C levels ≥70 mg/dL.

RESULTS

The lifetime discounted incremental cost-effectiveness ratio (ICER) for ezetimibe added to statin was $9,149 per quality-adjusted life year (QALY) for the base-case scenario. For patients with LDL-C levels ≥100 mg/dL, the ICER was $839/QALY; for those with diabetes and LDL-C levels ≥70 mg/dL, it was $560/QALY. One-way sensitivity analyses showed that the model was sensitive to changes in cost of ezetimibe, rate reduction of non-fatal CHD, and utility weight for non-fatal CHD in the base-case and sub-group analyses.

LIMITATIONS

Indirect costs or treatment discontinuation estimation were not included.

CONCLUSIONS

Compared with statin monotherapy, ezetimibe with statin therapy was cost-effective for secondary prevention of CHD and stroke and for primary prevention of these conditions in patients whose LDL-C levels are ≥100 mg/dL and in patients with diabetes, taking into account a 90% cost reduction for ezetimibe.

摘要

目的

本研究从美国医保支付方的角度,在假设依泽替米贝即将专利到期的情况下,评估依泽替米贝联合他汀类药物治疗与他汀类药物单药治疗的成本效益。

方法

使用了一个由28种不同健康状态组成的类马尔可夫经济模型。模型人群数据来自美国关联索赔和电子病历,纳入标准基于诊断指南。数据输入来自近期临床试验、荟萃分析和成本效益分析。基础病例情景用于评估在年龄35 - 74岁、有冠心病(CHD)和/或中风病史且低密度脂蛋白胆固醇(LDL-C)水平≥70mg/dL的患者中,在其一生中,将10mg依泽替米贝添加到他汀类药物中的成本效益,假设1年后依泽替米贝价格降低90%,以考虑到2017年第二季度即将到期的专利。亚组分析包括LDL-C水平≥100mg/dL的患者以及糖尿病且LDL-C水平≥70mg/dL的患者。

结果

基础病例情景下,添加依泽替米贝至他汀类药物治疗的终身贴现增量成本效益比(ICER)为每质量调整生命年(QALY)9149美元。对于LDL-C水平≥100mg/dL的患者,ICER为839美元/QALY;对于糖尿病且LDL-C水平≥70mg/dL的患者,ICER为560美元/QALY。单向敏感性分析表明,在基础病例和亚组分析中,模型对依泽替米贝成本变化、非致命性CHD发生率降低以及非致命性CHD的效用权重变化敏感。

局限性

未包括间接成本或治疗中断估计。

结论

考虑到依泽替米贝成本降低90%,与他汀类药物单药治疗相比,依泽替米贝联合他汀类药物治疗对于冠心病和中风的二级预防以及LDL-C水平≥100mg/dL的患者和糖尿病患者中这些疾病的一级预防具有成本效益。

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