■重组结核分枝杆菌融合蛋白(EC)有望在中国用于诊断结核分枝杆菌感染的临床应用。但它缺乏基于中国人口的正面交锋的经济评估。本研究旨在评估EC和结核菌素纯蛋白衍生物(TB-PPD)在短期内诊断结核分枝杆菌感染的成本效用和成本效益。
■从中国社会的角度来看,基于临床试验和决策树模型,进行了成本效用分析和成本效果分析,以评估EC和TB-PPD一年的经济学。以质量调整生命年(QALYs)作为效用测量的主要结果和诊断表现(包括误诊率,遗漏诊断率,正确分类的患者数量,和避免的结核病例数量)作为有效测量的次要结局。进行了单向和概率敏感性分析,以验证基本情况分析的鲁棒性,并进行了情景分析,以评估EC和TB-PPD之间收费方法的差异。
■基本案例分析表明,与TB-PPD相比,EC是主导策略,其增量成本效用比(ICUR)为每QALY节省192,043.60元人民币,每减少误诊率,增量成本效益比(ICER)可节省7263.53元人民币。此外,漏诊率没有统计学差异,正确分类的患者数量,以及避免的结核病例数量,与TB-PPD(136.78元)相比,EC是一种类似的成本节约策略,测试成本(98.00元)更低。敏感性分析显示了成本效用和成本效果分析的稳健性。情景分析表明EC的成本效用和TB-PPD的成本效益。
■从社会角度进行的经济评估表明,与TB-PPD相比,在中国,欧共体在短期内可能是一种成本效用和成本效益高的干预措施。
Recombinant Mycobacterium tuberculosis fusion protein (EC) was anticipated to be used for the scale-up of clinical application for diagnosis of Mycobacterium tuberculosis infection in China, but it lacked a head-to-head economic evaluation based on the Chinese population. This study aimed to estimate the cost-utility and the cost-effectiveness of both EC and tuberculin pure protein derivative (TB-PPD) for diagnosis of Mycobacterium tuberculosis infection in the short term.
From a Chinese societal perspective, both cost-utility analysis and cost-effectiveness analysis were performed to evaluate the economics of EC and TB-PPD for a one-year period based on clinical trials and decision tree model, with quality-adjusted life years (QALYs) as the utility-measured primary outcome and diagnostic performance (including the misdiagnosis rate, the omission diagnostic rate, the number of patients correctly classified, and the number of tuberculosis cases avoided) as the effective-measured secondary outcome. One-way and probabilistic sensitivity analyses were performed to validate the robustness of the base-case analysis, and a scenario analysis was conducted to evaluate the difference in the charging method between EC and TB-PPD.
The base-case analysis showed that, compared with TB-PPD, EC was the dominant strategy with an incremental cost-utility ratio (ICUR) of saving 192,043.60 CNY per QALY gained, and with an incremental cost-effectiveness ratio (ICER) of saving 7,263.53 CNY per misdiagnosis rate reduction. In addition, there was no statistical difference in terms of the omission diagnostic rate, the number of patients correctly classified, and the number of tuberculosis cases avoided, and EC was a similar cost-saving strategy with a lower test cost (98.00 CNY) than that of TB-PPD (136.78 CNY). The sensitivity analysis showed the robustness of cost-utility and cost-effectiveness analysis, and the scenario analysis indicated cost-utility in EC and cost-effectiveness in TB-PPD.
This economic evaluation from a societal perspective showed that, compared to TB-PPD, EC was likely to be a cost-utility and cost-effective intervention in the short term in China.