AUTHOR=Liu Zheng , Diao Sha , Zeng Linan , Liu Dan , Jiao Xuefeng , Chen Zhe , Cheng Xiao , Ni Xiaofeng , He Siyi , Wu Bin , Kang Deying , Wan Chaomin , Zhao Rongsheng , Wang Huiqing , Zhang Lingli 

TITLE=Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation

JOURNAL=Frontiers in Public Health

VOLUME=Volume 11 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1105857

DOI=10.3389/fpubh.2023.1105857

ISSN=2296-2565

ABSTRACT=Objectives: Recombinant Mycobacterium tuberculosis fusion protein (EC) was anticipated for scale-up of clinical application for diagnosis of Mycobacterium tuberculosis infection in China, but lacking economic evaluation based on the Chinese population. This study aimed to estimate the cost-utility and the cost-effectiveness of EC and tuberculin pure protein derivative (TB-PPD) for diagnosis of Mycobacterium tuberculosis infection in the short term.

Methods: From a Chinese societal perspective, 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 base case analysis, and scenario analysis was conducted to evaluate the difference in the charging method.

Results: 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 QALYs gained, and with incremental cost-effectiveness ratio (ICER) of saving 7,263.53 CNY per misdiagnosis rate reduction. Besides, 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 similarly 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 scenario analysis indicated cost-utility in EC and cost-effectiveness in TB-PPD.

Conclusion: 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.