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使用泰国真实世界数据评估英夫利昔单抗及其生物类似药治疗难治性中重度克罗恩病的成本效果和预算影响分析。

Cost-effectiveness and budget impact analysis of infliximab and its biosimilar in patients with refractory moderate-to-severe Crohn's disease using real world evidence in Thailand.

机构信息

Division of Ambulatory Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

J Med Econ. 2020 Nov;23(11):1302-1310. doi: 10.1080/13696998.2020.1803889. Epub 2020 Aug 13.

Abstract

AIMS

This study aimed to conduct a cost-effectiveness analysis of infliximab and its biosimilar compared to conventional therapy in refractory moderate-to-severe Crohn's disease (CD) in Thailand.

MATERIALS AND METHODS

A Markov model was used to estimate lifetime costs and health benefits of infliximab from a societal perspective. Our analyses consisted of three choices of treatment (conventional therapy, infliximab originator, and biosimilar) and three treatment scenarios (infliximab 2 years and 3 years if relapse, infliximab 2 years and lifelong if relapse, and infliximab lifelong). The input parameters were obtained from the CD registry and systematic literature reviews. The results were reported as incremental cost-effectiveness ratios (ICERs) in 2017 USD per quality-adjusted life year (QALY) gained. The sensitivity analyses were performed to assess the influence of parameter uncertainty. Threshold sensitivity analyses were carried out to determine the optimal drug prices. Finally, budget impact analyses were conducted.

RESULTS

None of the scenarios was cost-effective at Thai willingness-to-pay threshold (4,706 USD/QALY gained). The lowest ICER of 30,121 USD/QALY gained was reported in the scenario that included only standard dose of infliximab biosimilar with the maximum of 5-year treatment. The drug prices need to be reduced by at least 72% to allow infliximab biosimilar to be cost-effective. The 5-year budget impact was only 695,958 USD for the current biosimilar price.

CONCLUSIONS

Infliximab for the treatment of refractory moderate-to-severe CD in Thailand would be cost-effective if the drug prices were significantly decreased. The best value for money strategy was infliximab biosimilar with a restricted duration of treatment. Key points The use of infliximab and its biosimilar in a restricted duration of maximum 5-year is not cost-effective for patients with moderate-to-severe Crohn's disease refractory to conventional therapy, unless their price was lowered around 72-90% in Thailand. The estimated budget impact for adopting infliximab or its biosimilar for such indication has potential financial feasibility. Policy makers may consider cost-effectiveness and budget impact findings as well as other aspects such as rarity of disease as a part of the decision making process.

摘要

目的

本研究旨在对英夫利昔单抗及其生物类似药与泰国中重度克罗恩病(CD)的常规治疗相比的成本效益进行分析。

材料与方法

采用马尔可夫模型从社会角度估计英夫利昔单抗的终生成本和健康效益。我们的分析包括三种治疗选择(常规治疗、英夫利昔单抗原研药和生物类似药)和三种治疗方案(如果复发,英夫利昔单抗使用 2 年和 3 年;如果复发,英夫利昔单抗使用 2 年和终生;以及终生使用英夫利昔单抗)。输入参数来自 CD 登记处和系统文献综述。结果以每增加一个质量调整生命年(QALY)的增量成本效益比(ICER)表示,单位为 2017 年美元。进行敏感性分析以评估参数不确定性的影响。进行阈值敏感性分析以确定最佳药物价格。最后,进行预算影响分析。

结果

在泰国可接受的支付意愿阈值(每增加一个 QALY 4706 美元)下,没有一种方案具有成本效益。在仅包括标准剂量英夫利昔单抗生物类似药且治疗最长 5 年的方案中,报告的最低 ICER 为 30121 美元/QALY。英夫利昔单抗生物类似药的价格需要降低至少 72%,才能使其具有成本效益。按照目前生物类似药的价格,5 年预算影响仅为 695958 美元。

结论

如果药物价格大幅下降,英夫利昔单抗治疗泰国中重度 CD 的成本效益将会提高。最具性价比的策略是限制治疗时间的英夫利昔单抗生物类似药。

关键点

对于常规治疗无效的中重度 CD 患者,在限制时间内(最长 5 年)使用英夫利昔单抗及其生物类似药不具有成本效益,除非其价格在泰国降低约 72-90%。采用英夫利昔单抗或其生物类似药治疗此类疾病的估计预算影响具有潜在的财务可行性。决策者可以将成本效益和预算影响的发现以及疾病的罕见性等其他方面作为决策过程的一部分。

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