固定剂量噻托溴铵/奥达特罗与噻托溴铵治疗中国 COPD 患者的成本效果分析。
Cost-Effectiveness Analysis of Fixed-Dose Tiotropium/Olodaterol versus Tiotropium for COPD Patients in China.
机构信息
Department of Pharmacy, Affiliated Hospital of Southwest Jiaotong University, the Third People's Hospital of Chengdu, Chengdu, Sichuan, 610031, People's Republic of China.
West China School of Pharmacy, Sichuan University, Chengdu, People's Republic of China.
出版信息
Int J Chron Obstruct Pulmon Dis. 2023 Sep 21;18:2093-2103. doi: 10.2147/COPD.S425409. eCollection 2023.
PURPOSE
Tiotropium/olodaterol (TIO/OLO) fixed-dose combination (FDC) can improve lung function and quality of life for patients with chronic obstructive pulmonary disease (COPD), and is not inferior to other LAMA/LABAs. The aim of this study was to assess the cost-effectiveness of TIO/OLO FDC in patients with moderate to very severe COPD in China.
METHODS
A Markov model was developed to estimate the cost-effectiveness of TIO/OLO FDC versus TIO in the treatment of COPD from Chinese health system perspective. Four health states were based on 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD 2021), which included moderate (GOLD II, 50% ≤ FEV1 ≤ 80% of predicted), severe (GOLD III, 30% ≤ FEV1 ≤ 50% of predicted) and very severe (GOLD IV, FEV1 > 30% of predicted) COPD and death. The model simulated in cycles yearly. The indicators of total costs, number of COPD exacerbations, life years (LYs) and quality-adjusted life-years (QALYs) were used as the model output. Costs and outcomes were discounted at a 5% annual rate. A cost-effectiveness analysis was conducted over a 10-year time horizon. The threshold of incremental total cost per unit effectiveness gained (ICER) was 1.5 times of GDP per capita. Uncertainty was assessed by one-way and probabilistic sensitivity analysis.
RESULTS
TIO/OLO was 0.007 QALYs more than TIO but 0.012 LYs lower, which increased the total cost by $2268.17 per patient, but the total exacerbations number was less. Incremental cost effectiveness analysis had shown that the ICER exceeded the willingness to pay threshold. Results were robust under most parameter variation, except the parameters of total drug cost of TIO/OLO FDC in univariate sensitivity analyses.
CONCLUSION
Although TIO/OLO FDC could reduce the exacerbation risk, it was not cost-effective, and needed to be repriced.
目的
噻托溴铵/奥达特罗（TIO/OLO）固定剂量复方制剂（FDC）可改善慢性阻塞性肺疾病（COPD）患者的肺功能和生活质量，且不劣于其他 LAMA/LABA。本研究旨在评估噻托溴铵/奥达特罗 FDC 在中国中重度 COPD 患者中的成本效益。
方法
采用 Markov 模型从中国卫生系统角度评估噻托溴铵/奥达特罗 FDC 治疗 COPD 的成本效益。根据 2021 年全球慢性阻塞性肺疾病倡议（GOLD 2021），4 种健康状态包括中度（GOLD II，50%≤FEV1≤80%预计值）、重度（GOLD III，30%≤FEV1≤50%预计值）和极重度（GOLD IV，FEV1>30%预计值）COPD 和死亡。模型每年模拟一个周期。总成本、COPD 加重次数、寿命年（LYs）和质量调整寿命年（QALYs）作为模型输出。成本和结果按 5%的年利率贴现。10 年时间内进行成本效益分析。增量总成本与单位效果增量比（ICER）的阈值为人均国内生产总值的 1.5 倍。通过单因素敏感性分析和概率敏感性分析评估不确定性。
结果
与噻托溴铵相比，噻托溴铵/奥达特罗 FDC 多获得 0.007 个 QALY，但少获得 0.012 个 LY，导致每位患者的总费用增加 2268.17 美元，但总加重次数减少。增量成本效益分析显示，ICER 超过了支付意愿阈值。除了噻托溴铵/奥达特罗 FDC 的总药物成本参数在单变量敏感性分析中外，结果在大多数参数变化下均具有稳健性。
结论
尽管噻托溴铵/奥达特罗 FDC 可降低加重风险，但并不具有成本效益，需要重新定价。
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