Table_1_Cost-Effectiveness Analysis of Triple Combination Preparations in the Treatment of Moderate-to-Severe Chronic Obstructive Pulmonary Disease.docx

Objectives: This study analyzed the long-term cost-effectiveness of fluticasone/umeclidinium/vilanterol triple combination (FF/UMEC/VI) vs. budesonide/formoterol double combination (BUD/FOR) in the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD) and provides evidence for COPD treatment decisions.
Methods: From the perspective of the healthcare system, a Markov model was established that consists of four states—stable period, non-severely deteriorating period, severely deteriorating period, and death—according to real-world COPD progression. The model period comprises 6 months, with a cycle length of 14 years. The initial state, transition probabilities, costs, and utility data were collected from the FULFIL trial, published literature, hospital record surveys, and China Health Statistics Yearbook. The discount rate was 5%, and the threshold was set as the Chinese per capita GDP in 2020 (¥72,447). The cost, utility, transition probabilities, and discount rate were calculated through TreeagePro11 software. The results were analyzed via one-way factor analysis and probability sensitivity analysis.
Results: The baseline study shows that the 14-year treatment for FF/UMEC/VI and BUD/FOR groups are ¥199,765.55 and ¥173,030.05 with effectiveness at 8.54 quality-adjusted life years (QALYs) and 7.73 QALYs, respectively. The incremental cost-effectiveness ratio is ¥33,006.80/QALY, which is below the threshold. A tornado diagram of a one-way sensitivity analysis shows that the top three factors that affected the results are the non-severe deterioration rates of FF/UMEC/VI, the cost of FF/UMEC/VI and the non-severe deterioration rates of BUD/FOR. Probabilistic sensitivity analysis shows that FF/UMEC/VI (compared to BUD/FOR) can be made cost-effective under the willingness-to-pay (WTP) threshold (¥38,000). Furthermore, the likelihood of cost-effectiveness increases with a higher WTP.
Conclusions: Compared with the double combination (BUD/FOR), the triple combination (FF/UMEC/VI) is more cost-effective under the Chinese per capita GDP threshold.

研究目的：本研究分析了氟替卡松/乌美溴铵/维兰特罗三联疗法（FF/UMEC/VI）对比布地奈德/福莫特罗二联疗法（BUD/FOR）治疗中重度慢性阻塞性肺疾病（COPD）的长期成本效果，为COPD临床治疗决策提供依据。
研究方法：本研究从医疗卫生系统视角出发，基于真实世界COPD疾病进展路径，构建包含稳定期、非重度恶化期、重度恶化期及死亡四种状态的马尔可夫模型（Markov model）。模型周期为6个月，总模拟时长为14年。初始状态、转移概率、成本及效用数据均来源于FULFIL试验、已发表文献、医院病历调研及《中国卫生统计年鉴》。本研究采用5%的贴现率，阈值设定为2020年中国人均国内生产总值（GDP）（72447元人民币）。成本、效用、转移概率及贴现率均通过TreeagePro11软件进行测算。研究结果采用单因素分析及概率敏感性分析进行评估。
研究结果：基线分析显示，FF/UMEC/VI组与BUD/FOR组14年治疗总成本分别为199765.55元人民币及173030.05元人民币，对应的疗效分别为8.54个质量调整生命年（quality-adjusted life years, QALYs）与7.73个QALYs。两组的增量成本效果比（incremental cost-effectiveness ratio）为33006.80元人民币/QALY，低于预设阈值。单因素敏感性分析的龙卷风图显示，对研究结果影响排名前三的因素依次为FF/UMEC/VI的非重度恶化率、FF/UMEC/VI的治疗成本及BUD/FOR的非重度恶化率。概率敏感性分析结果表明，在意愿支付阈值（willingness-to-pay, WTP）下，FF/UMEC/VI对比BUD/FOR具有成本效果优势，且随着意愿支付阈值升高，该疗法具备成本效果的概率随之提升。
研究结论：基于中国人均GDP阈值，与布地奈德/福莫特罗二联疗法（BUD/FOR）相比，氟替卡松/乌美溴铵/维兰特罗三联疗法（FF/UMEC/VI）具备更优的成本效果。