Objective  To evaluate the economic value of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) powder for inhalation in the treatment of symptomatic chronic obstructive pulmonary disease patients with acute exacerbation risk from the perspective of the Chinese health system.

Methods  Based on subgroup analysis of the China cohort in the IMPACT trial, a four-state lifetime Markov model was established with a 3-month cycle. The model simulation period was 11 years. Clinical efficacy, health benefits, and cost data were obtained through published literature. The health outcomes included quality adjusted life year (QALY). Using 3 times China’s per capita gross domestic product (GDP) in 2023 as the willingness-to-pay threshold, the cost-utility analysis method was used for analysis the economic viability of FF/UMEC/VI. The scenario analysis, one-way sensitivity analysis and probability sensitivity analysis were used to verify the robustness of the results.

Results  Compared with fluticasone furoate/vilanterol (FF/VI), FF/UMEC/VI in the treatment of symptomatic chronic obstructive pulmonary disease patients with acute exacerbation risk saved costs 8  118.66 yuan and obtained an additional 0.000 06 QALYs, giving it an economic advantage. Compared with umeclidinium/vilanterol (UMEC/VI), FF/UMEC/VI treatment paid 2  784.41 yuan more and received 0.000 45 QALYs less, making UMEC/VI more cost-utility. The scenario analysis results further confirmed the robustness of the model. The sensitivity analysis results showed that when the drug cost of FF/UMEC/VI per cycle decreases to  637.29 yuan, FF/UMEC/VI had economic benefits under a willingness-to-pay threshold of 3 times China's per capita GDP in 2023.

Conclusion  For patients with symptomatic chronic obstructive pulmonary disease at risk of acute exacerbation, FF/UMEC/VI is more cost-utility than FF/VI. Compared with UMEC/VI, FF/UMEC/VI has economic viability after price reducing.

1.Singh D, Agusti A, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease: the GOLD science committee report 2019[J]. Eur Respir J, 2019, 53(5): 1900164. DOI: 10.1183/13993003.00164-2019.

2.WHO. Chronic obstructive pulmonary disease (COPD) [EB/ OL]. (2022-11-09) [2022-05-20]. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd).

3.IHME. GBD foresight visualization[EB/OL]. (2022-11-09) [2022-05-20]. https://vizhub.healthdata.org/gbd-foresight/#0.

4.Xu J, Ji Z, Zhang P, et al. Disease burden of COPD in the Chinese population: a systematic review[J]. Ther Adv Respir Dis, 2023, 17: 1-15. DOI: 10.1177/17534666231218899.

5.兰瑛,杨男,胡蝶,等. 吸入制剂治疗慢性阻塞性肺疾病的Markov模型构建方法学研究[J].药物流行病学杂志, 2022, 31(1): 50-59. [Lan Y, Yang N, Hu D, et al. Markov model construction methodology of inhaled preparation in the treatment of chronic obstructive pulmonary disease[J]. Chinese Journal of Pharmacoepidemiology, 2022, 31(1): 50-59.] DOI: 10.19960/j.cnki.issn1005-0698.2022.01.008.

6.何雯青, 王佳佳, 谢洋, 等. 慢性阻塞性肺疾病疾病负担测评方法概述[J]. 中国卫生经济, 2024, 43(2): 58-61, 66. [He WQ, Wang JJ, Xie Y, et al. An overview of methods for assessing the burden of chronic obstructive pulmonary disease[J]. Chinese Health Economics, 2024, 43(2): 58-61, 66.] https://med.wanfangdata.com.cn/Paper/Detail?id=PeriodicalPaper_zgwsjj202402014.

7.Agusti A, Celli BR, Criner G, et al. Global initiative for chronic obstructive lung disease: 2024 reports[EB/OL]. [2024-04-10]. https://goldcopd.org/2024-gold-report/.

8.Rosen OZ, Fridman R, Rosen BT, et al. Medication adherence as a predictor of 30-day hospital readmissions[J]. Patient Prefer Adherence, 2017, 11: 801-810. DOI: 10.2147/PPA.S125672.

9.Cazzola M, Tashkin DP. Combination of formoterol and tiotropium in the treatment of COPD: effects on lung function[J]. COPD, 2009, 6(5): 404-415. DOI: 10.1080/15412550903156333.

10.Pelaia C, Procopio G, Maria RD, et al. Real-life clinical and functional effects of fluticasone furoate/umeclidinium/vilanterol-combined triple therapy in patients with chronic obstructive pulmonary disease[J]. Respiration, 2021, 100(2): 127-134. DOI: 10.1159/000512064.

11.中华医学会呼吸病学分会慢性阻塞性肺疾病学组, 中国医师协会呼吸医师分会慢性阻塞性肺疾病工作委员会. 慢性阻塞性肺疾病诊治指南(2021年修订版) [J]. 中华结核和呼吸杂志, 2021, 44(3): 170-205. DOI: 10.3760/cma.j.cn112147-20210109-00031.

12.Zheng J, Zhong N, Wang C, et al. Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial[J]. Curr Med Res Opin, 2021, 37(1): 145-155. DOI: 10.1080/03007995.2020.1844646.

13.孙慧, 钱海燕. 三联制剂治疗慢性阻塞性肺疾病的药物经济学评价[J]. 实用药物与临床, 2023, 26(7): 609-614. [Sun H, Qian HY. Pharmacoeconomic evaluation of triple combination therapy for patients with chro-nic obstructive pulmonary disease[J]. Practical Pharmacy and Clinical Remedies, 2023, 26(7): 609-614.] DOI: 10.14053/j.cnki.ppcr.202307007.

14.Liu J, He X, Wu J. Economic evaluation of triple therapy with budesonide/glycopyrrolate/formoterol fumarate for the treatment of moderate to very severe chronic obstructive pulmonary disease in China using a semi-Markov model[J]. Appl Health Econ Health Policy, 2022, 20(5): 743-755. DOI: 10.1007/s40258-022-00732-1.

15.Zhou Y, Long E, Xu Q, et al. Cost-effectiveness analysis of triple combination preparations in the treatment of moderate-to-severe chronic obstructive pulmonary disease[J]. Front Public Health, 2021, 9: 713258. DOI: 10.3389/fpubh.2021.713258.

16.Nigris ED, Treharne C, Brighton N, et al. Cost-effectiveness of triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate versus dual therapies in moderate-to-very severe chronic obstructive pulmonary disease: United Kingdom analysis using the ETHOS study[J]. Int J Chron Obstruct Pulmon Dis, 2022, 17: 2987-3000. DOI: 10.2147/COPD.S381138.

17.国家统计局. 国家数据2023年度数据[DB/OL]. [2024-02-01]. https://data.stats.gov.cn/easyquery.htm?cn=C01.

18.Spencer M, Briggs AH, Grossman RF, et al. Development of an economic model to assess the cost effectiveness of treatment interventions for chronic obstructive pulmonary disease[J]. Pharmacoeconomics, 2005, 23(6): 619-637. DOI: 10.2165/00019053-200523060-00008.

19.Zhang J, Zheng J, Huang K, et al. Use of glucocorticoids in patients with COPD exacerbations in China: a retrospective observational study[J]. Ther Adv Respir Dis, 2018, 12: 1-7. DOI: 10.1177/1753466618769514.

20.湖北省公共资源交易中心. 湖北省药械集中采购服务平台药品集中采购系统[DB/OL]. [2024-02-19]. https://www.hbyxjzcg.cn:801/.

21.Liu G, Wu H, Li M, et al. Chinese time trade-off values for EQ-5D health states[J]. Value Health, 2014, 17(5): 597-604. DOI: 10.1016/j.jval.2014.05.007.

22.刘国恩, 主编. 中国药物经济学评价指南2020[M]. 北京: 中国市场出版社, 2020: 27.

23.李嘉琪, 张海霞, 陈杏凯, 等. 糠酸氟替卡松/乌美溴铵/维兰特罗三联粉雾剂治疗慢性阻塞性肺疾病的meta分析[J]. 中南药学, 2020, 18(12): 2054-2059. [Li JQ, Zhang HX, Chen XK, et al. Meta-analysis of fluticasone furoate/umeclidinium/vilanterol for COPD[J]. Central South Pharmacy, 2020, 18(12): 2054-2059.] DOI: 10.7539/j.issn.1672-2981.2020.12.023.

24.Ismaila AS, Haeussler K, Czira A, et al. Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy compared with other therapies for the treatment of COPD: a network meta-analysis[J]. Adv Ther, 2022, 39(9): 3957-3978. DOI: 10.1007/s12325-022-02231-0.

25.Balmaceda C, Espinoza MA, Abbott T, et al. Cost-effectiveness analysis: fluticasone furoate/umeclidinium/vilanterol for the treatment of moderate to severe chronic obstructive pulmonary disease from the perspective of the chilean public health system[J]. Expert Rev Pharmacoecon Outcomes Res, 2022, 22(5): 743-751. DOI: 10.1080/14737167.2022.2044308.

26.Paly VF, Vallejo-Aparicio LA, Martin A, et al. Cost-effectiveness of once-daily single-inhaler COPD triple therapy in Spain: IMPACT trial[J]. Int J Chron Obstruct Pulmon Dis, 2022, 17: 3097-3109. DOI: 10.2147/COPD.S366765.

27.Martin A, Shah D, Ndirangu K, et al. Is single-inhaler triple therapy for COPD cost-effective in the UK? the IMPACT trial[J]. ERJ Open Res, 2022, 8(1): 00333-2021. DOI: 10.1183/23120541.00333-2021.

28.Ismaila AS, Risebrough N, Schroeder M, et al. Cost-effectiveness of once-daily single-inhaler triple therapy in COPD: the IMPACT trial[J]. Int J Chron Obstruct Pulmon Dis, 2019, 29(14): 2681-2695. DOI: 10.2147/COPD.S216072.

29.Crim C, Dransfield MT, Bourbeau J, et al. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD[J]. Ann Am Thorac Soc, 2015, 12(1): 27-34. DOI: 10.1513/AnnalsATS.201409-413OC.

30.Bardsley S, Criner GJ, Halpin D, et al. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis[J]. Respir Med, 2022, 205: 107040. DOI: 10.1016/j.rmed.2022.107040.

31.Fenwick E, Martin A, Schroeder M, et al. Cost-effectiveness analysis of a single-inhaler triple therapy for COPD in the UK[J]. ERJ Open Res, 2021, 7(1): 00480-2020. DOI: 10.1183/23120541.00480-2020.

32.Schroeder M, Benjamin N, Atienza L, et al. Cost-effectiveness analysis of a once-daily single-inhaler triple therapy for patients with chronic obstructive pulmonary disease (COPD) using the FULFIL trial: a Spanish perspective[J]. Int J Chron Obstruct Pulmon Dis, 2020, 10(15): 1621-1632. DOI: 10.2147/COPD.S240556.