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Abstract
Purpose
Given the lack of economic evaluation study of molecular testing in Thailand, this study aimed to evaluate the cost-utility of molecular testing algorithms including Xpert MTB/RIF and the loop-mediated isothermal amplification (TB-LAMP) in the general population suspected of having pulmonary TB based on a societal perspective.
Methods
A hybrid decision tree Markov model using a 1-month cycle length was used to evaluate costs and outcomes of five TB diagnostic algorithms: 1) sputum smear microscopy (SSM) with culture and drug susceptibility testing (DST), 2) Xpert MTB/RIF add-on, 3) Xpert MTB/RIF initial, 4) TB-LAMP add-on, and 5) TB-LAMP initial during a lifetime period. All costs were calculated in 2021 Baht, and results were presented as an incremental cost-effectiveness ratio (ICER) for molecular testing compared with SSM with culture. One-way sensitivity and probability analyses were used to evaluate uncertainty input parameters.
Results
TB-LAMP was less expensive overall (6565 Baht) than Xpert MTB/RIF (7010 Baht) and SSM with culture (6845 Baht). Molecular testing was projected to improve quality adjusted life year (QALY) by 0.53 to 0.94 years. In comparison to SSM with culture and DST, providing an initial TB-LAMP test was the most preferred choice. Xpert MTB/RIF Initial had the lowest ICER (197 Baht per QALY gained), followed by TB-LAMP Add-on (993 Baht per QALY gained) and Xpert MTB/RIF Add-on (3940 Baht per QALY gained). One-way sensitivity analysis uncovered that sensitivity of TB-LAMP was greater than that of other parameters.
Conclusion
Providing molecular testing including Xpert MTB/RIF and TB-LAMP as either initial or add-on test for TB diagnosis was more cost-effective than SSM with culture and DST in the general population with suspected pulmonary TB in Thailand. Our study could provide useful evidence to policymakers advocating for inclusion of molecular testing in the universal health coverage benefit package in Thailand.
Ethics Approval
Our study used data related to quality of life as well as direct medical and non-medical costs from published studies. The Institutional Review Boards (IRB) of Mahidol University approved this study (COA. No. MU-DT-PY-IRB 2019/02.0701) through the expedited review procedure. The need for informed consent for this study was waived by the ethics committees, as all data were obtained from published studies. All procedures performed in the study were in compliance with international guidelines for human research protection such as Declaration of Helsinki, the Belmont Report.
Acknowledgments
The authors would like to appreciate the Division of Tuberculosis, Department of Disease Control ministry of Public Health Thailand for support, providing epidemiological TB data, and giving guidance about data. This study was funded by the Health System Research Institute (HSRI), Thailand. The funder had no involvement with analysis, results, conclusion, or preparation of manuscript. The first author acknowledges the Thailand Science Research and Innovation under the Ministry of Higher Education, Science, Research and Innovation for providing the Royal Golden Jubilee Ph.D. scholarship for NC and UC (grant no. PHD/0104/2559).
Disclosure
The authors report no conflicts of interest in this work.