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固定剂量联合疗法治疗慢性阻塞性肺疾病的成本效益分析。

Cost-Effectiveness of Fixed-Dose Combinations Therapies for Chronic Obstructive Pulmonary Disease Treatment.

机构信息

Astra Zeneca, Madrid, Spain.

Pharmacoeconomics and Outcomes Research Iberia (PORIB), Madrid, Spain.

出版信息

Clin Drug Investig. 2018 Jul;38(7):611-620. doi: 10.1007/s40261-018-0646-0.

Abstract

BACKGROUND AND OBJECTIVE

Chronic obstructive pulmonary disease (COPD), a progressive lung disorder associated with decline of respiratory function, affects 10.2% of Spanish adults (40-80 years of age). This study aimed to assess the cost-effectiveness of two fixed-dose combinations of long-acting muscarinic antagonist and long-acting β2-agonist therapies for COPD, with Spanish National Health System perspective.

METHODS

A Markov model with five health states based on severity levels defined by GOLD 2010 criteria was used to simulate in monthly cycles the evolution along a 5-year period of a cohort of moderate-to-severe COPD patients, treated with aclidinium-formoterol (ACL/FF) 400/12 µg or tiotropium-olodaterol (TIO/OLO) 5/5 µg fixed-dose combinations. Clinical data on lung-function improvement were obtained from a network meta-analysis and applied to mean baseline forced-expiratory-volume in 1 s (FEV) for the first 24-weeks period. Natural history for lung-function decline (41 ml/year) was applied until the end of simulation. Risk of exacerbation and pneumonia occurrence were considered. Pharmaceutical costs were calculated with dosages according to indication and public ex-factory prices. The health state-specific disease management and event costs, and utilities were derived from the literature. Total costs (€ 2016) and benefits [life-year-gained (LYG) and quality-adjusted-life-year (QALY)] were discounted (3.0% yearly). Sensitivity analyses were performed.

RESULTS

Both therapies provided the same outcomes (4.073 LYG and 2.928 QALY) at 5-year period. ACL/FF 400/12 µg provided marginally lower costs (€ - 332) compared to TIO/OLO 5/5 µg.

CONCLUSION

ACL/FF 400/12 µg was a cost-saving therapy in patients with moderate-to-severe COPD in Spain, and provided equivalent effects compared to TIO/OLO 5/5 µg.

摘要

背景和目的

慢性阻塞性肺疾病(COPD)是一种与呼吸功能下降相关的进行性肺部疾病,影响 10.2%的西班牙成年人(40-80 岁)。本研究旨在从西班牙国家卫生系统的角度评估两种长效抗毒蕈碱和长效β2-激动剂联合治疗 COPD 的固定剂量组合的成本效益。

方法

使用基于 GOLD 2010 标准定义的严重程度水平的五个健康状态的 Markov 模型,以每月周期模拟一组中重度 COPD 患者在 5 年内的演变,这些患者接受了阿地氯铵-福莫特罗(ACL/FF)400/12μg 或噻托溴铵-奥达特罗(TIO/OLO)5/5μg 固定剂量组合治疗。从网络荟萃分析中获得了关于肺功能改善的临床数据,并应用于前 24 周期间的平均基线用力呼气量(FEV)。应用自然病史中肺功能下降(41ml/年)直至模拟结束。考虑了加重和肺炎发生的风险。根据适应症和公共出厂价计算药物成本。从文献中得出特定健康状态的疾病管理和事件成本以及效用。总费用(2016 年€)和收益[生命年增加(LYG)和质量调整生命年(QALY)]按 3.0%的年贴现率贴现。进行了敏感性分析。

结果

两种治疗方法在 5 年内均产生相同的结果(4.073 LYG 和 2.928 QALY)。与 TIO/OLO 5/5μg 相比,ACL/FF 400/12μg 的成本略低(€-332)。

结论

在西班牙,中度至重度 COPD 患者使用 ACL/FF 400/12μg 是一种节省成本的治疗方法,与 TIO/OLO 5/5μg 相比,其效果相当。

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