2000. Rapid, Point-of-care Diagnosis of Tuberculosis with Novel Truenat Assay: Cost-Effectiveness and Budgetary Impact Analysis for India’s Public Sector

Abstract

Background. Point-of-care (POC) tuberculosis (TB) diagnostics may dramatically improve TB outcomes. Truenat is a new, battery-powered RT-PCR device that rapidly detects TB and rifampin resistance. Due to its portability, it may be valuable in peripheral healthcare settings. We evaluated the cost-effectiveness of Truenat in peripheral laboratories (designated microscopy centres [DMCs]) and public healthcare facilities in India. Methods. We used the CEPAC-International microsimulation model to compare four TB diagnostic strategies for adult, HIV-negative patients with suspected TB: (1) sputum smear microscopy in DMCs (SSM); (2) Xpert MTB/RIF in DMCs (Xpert); (3) Truenat in DMCs (Truenat DMC); and (4) Truenat in public healthcare facilities (Truenat POC). We projected life expectancy (LE), costs, incremental cost-effectiveness ratios (ICERs), and 5y budget impact of full scale-up. A strategy was cost-effective if its ICER was <50% of India annual per capita GDP). Model inputs included: TB prevalence, 20%; sensitivity for TB detection, 92% for Xpert and 89% for Truenat; costs per test, $12.70 for Xpert and $13.20 for Truenat; linkage to care afer diagnosis, 84% for DMC-based tests and 95% for POC. We varied these parameters in sensitivity analyses. Results. Compared with SSM, other strategies increased TB case detection by >6%; Truenat POC increased LE by ∼0.3 years with ICER $210/YLS (Table 1). Compared with Xpert, Truenat DMC decreased LE and cost, but Truenat POC improved LE by 0.05 years and was cost-effective. In multi-way sensitivity analysis at 5 years horizon, Truenat POC, at 89% diagnostic sensitivity and linkage to care >86%, was cost-effective and sometimes cost-saving compared with Xpert (Figure 1). The cost-effectiveness of Truenat, relative to Xpert, depended on the interplay of sensitivity and linkage to care. Public-sector implementation of Truenat POC increased healthcare expenditures by $360 million compared with full scale-up of Xpert (Figure 2). Treatment costs, not diagnostic test costs, accounted for most of the diference. Conclusion. When used at the point of care, Truenat for TB diagnosis should improve linkage to care, increase LE, and be cost-effective compared with SSM or Xpert and, thus, should be more widely utilized in India.