Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation
ObjectivesRecombinant 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...
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| Format: | Article |
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Frontiers Media S.A.
2023-05-01
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| Series: | Frontiers in Public Health |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpubh.2023.1105857/full |
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| author | Zheng Liu Zheng Liu Zheng Liu Zheng Liu Zheng Liu Sha Diao Sha Diao Sha Diao Sha Diao Linan Zeng Linan Zeng Linan Zeng Linan Zeng Dan Liu Dan Liu Dan Liu Dan Liu Dan Liu Xuefeng Jiao Xuefeng Jiao Xuefeng Jiao Xuefeng Jiao Zhe Chen Zhe Chen Zhe Chen Zhe Chen Zhe Chen Xiao Cheng Xiao Cheng Xiao Cheng Xiao Cheng Xiaofeng Ni Xiaofeng Ni Xiaofeng Ni Xiaofeng Ni Siyi He Siyi He Siyi He Siyi He Siyi He Bin Wu Deying Kang Chaomin Wan Chaomin Wan Rongsheng Zhao Huiqing Wang Lingli Zhang Lingli Zhang Lingli Zhang Lingli Zhang Lingli Zhang |
| author_facet | Zheng Liu Zheng Liu Zheng Liu Zheng Liu Zheng Liu Sha Diao Sha Diao Sha Diao Sha Diao Linan Zeng Linan Zeng Linan Zeng Linan Zeng Dan Liu Dan Liu Dan Liu Dan Liu Dan Liu Xuefeng Jiao Xuefeng Jiao Xuefeng Jiao Xuefeng Jiao Zhe Chen Zhe Chen Zhe Chen Zhe Chen Zhe Chen Xiao Cheng Xiao Cheng Xiao Cheng Xiao Cheng Xiaofeng Ni Xiaofeng Ni Xiaofeng Ni Xiaofeng Ni Siyi He Siyi He Siyi He Siyi He Siyi He Bin Wu Deying Kang Chaomin Wan Chaomin Wan Rongsheng Zhao Huiqing Wang Lingli Zhang Lingli Zhang Lingli Zhang Lingli Zhang Lingli Zhang |
| author_sort | Zheng Liu |
| collection | DOAJ |
| description | ObjectivesRecombinant 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.MethodsFrom 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.ResultsThe 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.ConclusionThis 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. |
| first_indexed | 2024-04-09T14:35:46Z |
| format | Article |
| id | doaj.art-5e556be4639c4a9ea1db78012bc5e4b0 |
| institution | Directory Open Access Journal |
| issn | 2296-2565 |
| language | English |
| last_indexed | 2024-04-09T14:35:46Z |
| publishDate | 2023-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Public Health |
| spelling | doaj.art-5e556be4639c4a9ea1db78012bc5e4b02023-05-03T13:39:17ZengFrontiers Media S.A.Frontiers in Public Health2296-25652023-05-011110.3389/fpubh.2023.11058571105857Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluationZheng Liu0Zheng Liu1Zheng Liu2Zheng Liu3Zheng Liu4Sha Diao5Sha Diao6Sha Diao7Sha Diao8Linan Zeng9Linan Zeng10Linan Zeng11Linan Zeng12Dan Liu13Dan Liu14Dan Liu15Dan Liu16Dan Liu17Xuefeng Jiao18Xuefeng Jiao19Xuefeng Jiao20Xuefeng Jiao21Zhe Chen22Zhe Chen23Zhe Chen24Zhe Chen25Zhe Chen26Xiao Cheng27Xiao Cheng28Xiao Cheng29Xiao Cheng30Xiaofeng Ni31Xiaofeng Ni32Xiaofeng Ni33Xiaofeng Ni34Siyi He35Siyi He36Siyi He37Siyi He38Siyi He39Bin Wu40Deying Kang41Chaomin Wan42Chaomin Wan43Rongsheng Zhao44Huiqing Wang45Lingli Zhang46Lingli Zhang47Lingli Zhang48Lingli Zhang49Lingli Zhang50Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaWest China School of Medicine, Sichuan University, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaWest China School of Pharmacy, Sichuan University, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaWest China School of Pharmacy, Sichuan University, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaWest China School of Pharmacy, Sichuan University, Chengdu, ChinaDepartment of Pharmacy, Renji Hospital Affiliated with the School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaChinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaDepartment of Pediatrics, West China Second University Hospital, Sichuan University, Chengdu, China0Department of Pharmacy, Peking University Third Hospital, Beijing, China1Medical Simulation Centre, West China Second University Hospital, Sichuan University, Chengdu, ChinaDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, ChinaEvidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, ChinaNMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, ChinaKey Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, ChinaChinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, ChinaObjectivesRecombinant 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.MethodsFrom 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.ResultsThe 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.ConclusionThis 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.https://www.frontiersin.org/articles/10.3389/fpubh.2023.1105857/fullrecombinant mycobacterium tuberculosis fusion proteintuberculin pure protein derivativesmycobacterium tuberculosis infectioneconomic evaluationdecision tree model |
| spellingShingle | Zheng Liu Zheng Liu Zheng Liu Zheng Liu Zheng Liu Sha Diao Sha Diao Sha Diao Sha Diao Linan Zeng Linan Zeng Linan Zeng Linan Zeng Dan Liu Dan Liu Dan Liu Dan Liu Dan Liu Xuefeng Jiao Xuefeng Jiao Xuefeng Jiao Xuefeng Jiao Zhe Chen Zhe Chen Zhe Chen Zhe Chen Zhe Chen Xiao Cheng Xiao Cheng Xiao Cheng Xiao Cheng Xiaofeng Ni Xiaofeng Ni Xiaofeng Ni Xiaofeng Ni Siyi He Siyi He Siyi He Siyi He Siyi He Bin Wu Deying Kang Chaomin Wan Chaomin Wan Rongsheng Zhao Huiqing Wang Lingli Zhang Lingli Zhang Lingli Zhang Lingli Zhang Lingli Zhang Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation Frontiers in Public Health recombinant mycobacterium tuberculosis fusion protein tuberculin pure protein derivatives mycobacterium tuberculosis infection economic evaluation decision tree model |
| title | Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation |
| title_full | Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation |
| title_fullStr | Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation |
| title_full_unstemmed | Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation |
| title_short | Recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection: a short-term economic evaluation |
| title_sort | recombinant mycobacterium tuberculosis fusion protein for diagnosis of mycobacterium tuberculosis infection a short term economic evaluation |
| topic | recombinant mycobacterium tuberculosis fusion protein tuberculin pure protein derivatives mycobacterium tuberculosis infection economic evaluation decision tree model |
| url | https://www.frontiersin.org/articles/10.3389/fpubh.2023.1105857/full |
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