Abstract
BackgroundThe development of new diagnostic tools allows for faster detection of both tuberculosis (TB) and multidrug-resistant (MDR) TB and should lead to reduced transmission by earlier initiation of anti TB therapy. The research conducted in the Arkhangelsk region of the Russian Federation in 2012–14 included economic evaluation of Line Probe Assay (LPA) implementation in MDR-TB diagnostics compared to existing culture-based diagnostics of Löwenstein Jensen (LJ) and BacTAlert. Clinical superiority of LPA was demonstrated and results were reported elsewhere.Study aimThe PROVE-IT Russia study aimed to report the outcomes of the cost minimization analysis.MethodsCosts of LPA-based diagnostic algorithm (smear positive (SSm+) and for smear negative (SSm-) culture confirmed TB patients by Bactec MGIT or LJ were compared with conventional culture-based algorithm (LJ–for SSm- and SSm+ patients and BacTAlert–for SSm+ patients). Cost minimization analysis was conducted from the healthcare system, patient and societal perspectives and included the direct and indirect costs to the healthcare system (microscopy and drug susceptibility test (DST), hospitalization, medications obtained from electronic medical records) and non-hospital direct costs (patient’s travel cost, additional expenses associated with hospitalization, supplementary medicine and food) collected at the baseline and two subsequent interviews using the WHO-approved questionnaire.ResultsOver the period of treatment the LPA-based diagnostic corresponded to lesser direct and indirect costs comparing to the alternative algorithms. For SSm+ LPA-based diagnostics resulted in the costs 4.5 times less (808.21 US$) than LJ (3593.81 US$) and 2.5 times less than BacTAlert liquid culture (2009.61 US$). For SSm- LPA in combination with Bactec MGIT (1480.75 US$) vs LJ (1785.83 US$) showed the highest cost minimization compared to LJ (2566.09 US$). One-way sensitivity analyses of the key parameters and threshold analyses were conducted and demonstrated that the results were robust to variations in the cost of hospitalization, medications and length of stay.ConclusionFrom the perspective of Russian Federation healthcare system, TB diagnostic algorithms incorporating LPA method proved to be both more clinically effective and less expensive due to reduction in the number of hospital days to the correct MDR-TB diagnosis and treatment initiation. LPA diagnostics comparing conventional culture diagnostic algorithm MDR-TB was a cost minimizing strategy for both patients and healthcare system.
Highlights
In 2016, four diagnostic tests were reviewed and recommended by WHO: the Xpert MTB/RIF, the loop-mediated isothermal amplification test for TB (TB-LAMP), two line probe assays (LPAs) for the detection of resistance to the first line anti-TB drugs isoniazid and rifampicin, and an Line Probe Assay (LPA) for the detection of resistance to second-line anti-TB drugs [1]
For SSm+ LPA-based diagnostics resulted in the costs 4.5 times less (808.21 US$) than Lowenstein Jensen (LJ) (3593.81 US$) and 2.5 times less than BacTAlert liquid culture (2009.61 US$)
We presented an economic evaluation of the implementation of LPA as a molecular-genetic method for MDR-TB diagnostics compared to culture-based diagnostics (LJ and BacTAlert liquid culture)
Summary
In 2016, four diagnostic tests were reviewed and recommended by WHO: the Xpert MTB/RIF, the loop-mediated isothermal amplification test for TB (TB-LAMP), two line probe assays (LPAs) for the detection of resistance to the first line anti-TB drugs isoniazid and rifampicin, and an LPA for the detection of resistance to second-line anti-TB drugs [1]. The introduction of new molecular genetic methods for diagnosis of Mycobacterium tuberculosis (M.tb) and drug resistance speeds up the multidrug and extensively drug resistant (MDR/XDR) diagnosis and makes it possible to start an appropriate treatment regimen sooner. There is insufficient data on the test’s clinical effectiveness in the context of the healthcare systems of different countries [6,7,8,9,10] and a paucity of evidence on its cost minimization in diagnostics and treatment of MDR-TB in the Russian Federation or the former Soviet republics [11,12,13]. Clinical effectiveness and cost minimization of LPA in comparison to the standard diagnostic tests (Lowenstein Jensen (LJ) solid culture, BacTAlert and BACTEC liquid cultures) in Russia warrants further investigation. The PROVE-IT Russia study aimed to report the outcomes of the cost minimization analysis
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