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巴西药物洗脱支架的当代背景:一项成本效用研究。

Contemporary Context of Drug-Eluting Stents in Brazil: A Cost Utility Study.

作者信息

Stella Steffan Frosi, Gehling Bertoldi Eduardo, Polanczyk Carísi Anne

机构信息

Graduate Program in Cardiology and Cardiovascular Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil (SFS, EGB, CAP)

National Institute of Science and Technology for Health Technology Assessment (IATS), CNPq, Brazil (SFS, EGB, CAP)

出版信息

Med Decis Making. 2016 Nov;36(8):1034-42. doi: 10.1177/0272989X16636054. Epub 2016 Mar 10.

DOI:10.1177/0272989X16636054
PMID:26964876
Abstract

BACKGROUND

Although drug-eluting stents (DES) have been widely incorporated into clinical practice in developed countries, several countries restrict their use mainly because of their high cost and unfavorable incremental cost-effectiveness ratios (ICER).

OBJECTIVE

To evaluate the cost-effectiveness of DES in comparison with bare-metal stents (BMS) for treatment of coronary artery disease (CAD).

DESIGN

Markov model.

DATA SOURCES

Published literature, government database, and CAD patient cohort.

TARGET POPULATION

Single-vessel CAD patients.

TIME HORIZON

One year and lifetime.

PERSPECTIVE

Brazilian Public Health System (SUS).

INTERVENTION

Six strategies composed of percutaneous intervention with a BMS or 1 of 5 DES (paclitaxel, sirolimus, everolimus, zotarolimus, and zotarolimus resolute).

OUTCOME MEASURES

Cost for target vessel revascularization avoided and cost for quality-adjusted life year gained.

BASE CASE ANALYSIS

In the short-term analysis, sirolimus was the most effective and least costly among DES (ICER of I$20,642 per target vessel revascularization avoided), with all others DES dominated by sirolimus. Lifetime cumulative costs ranged from I$18,765 to I$21,400. In the base case analysis, zotarolimus resolute had the most favorable ICER among the DES (ICER I$62,761), with sirolimus, paclitaxel, and zotarolimus being absolute dominated and everolimus extended dominated by zotarolimus resolute, although all the results were above the willingness-to-pay threshold of 3 times the gross domestic product per capita (I$35,307).

SENSITIVITY ANALYSIS

In deterministic sensitivity analysis, results were sensitive to cost of DES, number of stents used per patient, baseline probability, and duration of stent thrombosis risk. The probabilistic sensitivity analysis demonstrated a probability of 81% for BMS being the strategy of choice, with 9% for everolimus and 9% zotarolimus resolute, at the willingness-to-pay threshold.

CONCLUSION

DES is not a good value for money in SUS perspective, despite its benefit in reducing target vessel revascularization. Since the cost-effectiveness of DES is mainly driven by the stents' cost difference, they should cost less than twice the BMS price to become a cost-effective alternative.

摘要

背景

尽管药物洗脱支架(DES)已在发达国家广泛应用于临床实践,但一些国家主要因其成本高昂且增量成本效益比(ICER)不佳而限制其使用。

目的

评估DES与裸金属支架(BMS)相比治疗冠状动脉疾病(CAD)的成本效益。

设计

马尔可夫模型。

数据来源

已发表的文献、政府数据库和CAD患者队列。

目标人群

单支冠状动脉疾病患者。

时间范围

一年和终身。

视角

巴西公共卫生系统(SUS)。

干预措施

六种策略,包括使用BMS或五种DES(紫杉醇、西罗莫司、依维莫司、佐他莫司和佐他莫司强化型)之一进行经皮干预。

结局指标

避免靶血管血运重建的成本和获得质量调整生命年的成本。

基础病例分析

在短期分析中,西罗莫司在DES中最有效且成本最低(每避免一次靶血管血运重建的ICER为20,642雷亚尔),所有其他DES均被西罗莫司主导。终身累积成本在18,765雷亚尔至21,400雷亚尔之间。在基础病例分析中,佐他莫司强化型在DES中具有最有利的ICER(ICER为62,761雷亚尔),西罗莫司、紫杉醇和佐他莫司被绝对主导,依维莫司被佐他莫司强化型扩展主导,尽管所有结果均高于人均国内生产总值三倍(35,307雷亚尔)的支付意愿阈值。

敏感性分析

在确定性敏感性分析中,结果对DES成本、每位患者使用的支架数量、基线概率和支架血栓形成风险持续时间敏感。概率敏感性分析表明,在支付意愿阈值下,BMS作为首选策略的概率为81%,依维莫司为9%,佐他莫司强化型为9%。

结论

从SUS的角度来看,尽管DES在减少靶血管血运重建方面有益,但性价比不高。由于DES的成本效益主要由支架成本差异驱动,其成本应低于BMS价格的两倍才能成为具有成本效益的替代方案。

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