Skoupa Jana, Kasak Viktor, Klimes Jiri, Valena Tomas
CZECHTA Institute o.p.s., Prague, Czech Republic.
Department of Respiratory Diseases, LERYMED Ltd., Prague, Czech Republic.
Value Health Reg Issues. 2018 Sep;16:112-118. doi: 10.1016/j.vhri.2018.09.002. Epub 2018 Oct 27.
Chronic obstructive pulmonary disease (COPD) represents an illness with significant healthcare and societal impacts. Fixed combinations of long-acting beta-agonists (LABA) and inhaled corticosteroids have been used for COPD treatment as the standard of care for many years. A daily dose of indacaterol and glycopyrronium (IND/GLY) at 110/50 µg has recently been gaining attention due to its improved efficacy and tolerability versus the standard of care.The study aims to evaluate the cost-effectiveness of once daily IND/GLY vs. twice daily salmeterol/fluticasone propionate (SFC) at 50/500 µg in COPD patients.
A microsimulation model in MS Excel was adapted to the Czech setting. Effectiveness data and disease severity stages were obtained from the FLAME study, which is a head-to head trial comparing IND/GLY vs. SFC. Quality of life data were derived from a literature review. Costs (medication, monitoring and complications) were taken from published Czech sources. The incremental cost-effectiveness ratio (ICER) was expressed as cost per quality-adjusted life year (QALY) gained. Costs and outcomes were discounted at 3 %. A lifetime horizon was used for the analysis. Cost-effectiveness was studied from the perspective of a health care system in the Czech Republic.
Mean QALYs were higher in the IND/GLY arm (difference 0.167 QALYs). The ICER of IND/GLY compared with SFC was €13,628 per QALY gained. Deterministic sensitivity analyses and probabilistic sensitivity analyses confirmed the base-case result to be robust.
From the perspective of the Czech health care system, managing COPD using IND/GLY is cost-effective in this analysis because the base-case is clearly below the willingness-to-pay threshold in the Czech Republic, which is automatically set at 3 times GDP/capita (approximately €44,000/ QALY). This is the first available economic analysis utilizing FLAME study results in the Central East European (CEE) countries showing IND/ GLY as a highly cost-effective investment into COPD patients.
慢性阻塞性肺疾病（COPD）是一种对医疗保健和社会有重大影响的疾病。长效β受体激动剂（LABA）与吸入性糖皮质激素的固定复方制剂多年来一直作为COPD治疗的标准护理方案使用。每日剂量为110/50μg的茚达特罗格隆溴铵（IND/GLY）最近因其相对于标准护理方案疗效和耐受性的改善而受到关注。本研究旨在评估COPD患者每日一次使用IND/GLY与每日两次使用50/500μg沙美特罗/丙酸氟替卡松（SFC）的成本效益。
在MS Excel中建立的微观模拟模型适用于捷克的情况。有效性数据和疾病严重程度阶段来自FLAME研究，该研究是一项比较IND/GLY与SFC的头对头试验。生活质量数据来自文献综述。成本（药物、监测和并发症）取自已发表的捷克资料。增量成本效益比（ICER）表示为每获得一个质量调整生命年（QALY）的成本。成本和结果按3%进行贴现。分析采用终身视角。从捷克共和国医疗保健系统的角度研究成本效益。
IND/GLY组的平均QALY更高（差值为0.167 QALY）。与SFC相比，IND/GLY的ICER为每获得一个QALY 13,628欧元。确定性敏感性分析和概率敏感性分析证实了基础案例结果的稳健性。
从捷克医疗保健系统的角度来看，在本分析中，使用IND/GLY管理COPD具有成本效益，因为基础案例明显低于捷克共和国的支付意愿阈值，该阈值自动设定为国内生产总值人均的3倍（约44,000欧元/QALY）。这是中东欧（CEE）国家首次利用FLAME研究结果进行的经济分析，表明IND/GLY是对COPD患者极具成本效益的投资。
