OBJECTIVES: Treatment for highly resistant tuberculosis (HDR-TB) with bedaquiline-linezolid-based regimen is costly, takes a long time to complete, and has potentially life-threatening adverse effects. Recent clinical findings reported improvement in clinical outcomes of HDR-TB with the pretomanid-based regimen (with shortened treatment duration). This study aimed to evaluate the cost-effectiveness of the pretomanid-based regimen for HDR-TB treatment from the perspective of healthcare provider in the US.

METHODS: A 2-year decision-analytic model was constructed to simulate potential treatment outcomes of (1) bedaquiline-pretomanid-linezolid (BPaL) regimen), and (2) bedaquiline-linezolid (B-L) based regimen in a hypothetical cohort of adult patients with active HDR-TB. The model inputs were retrieved from literature and public data. Primary model outputs were TB-related direct medical cost, disability-adjusted life-years (DALYs), and incremental cost per DALY averted (ICER). Base-case and sensitivity analyses were performed.

RESULTS: In the base-case analysis, the BPaL regimen averted 2.5511DALYs and saved cost by USD53,502 when compared to the B-L-based regimen. No influential parameter with threshold value was identified in the one-way sensitivity analysis. In the probabilistic sensitivity analysis of 10,000 Monte Carlo simulations, the BPaL regimen reduced DALYs by 2.2974 (95%CI 2.2802-2.3146; p<0.001) with a cost saving of USD53,072 (95%CI USD51,366-USD54,778; p<0.001). The BPaL regimen reduced DALYs at lower cost in 75.51% of the time, and averted DALYs at higher cost with ICER less than willingness-to-pay (WTP) threshold (100,000 USD/DALY) in 24.08% of the simulations. The probability of the BPaL regimen to be cost-effective was higher than the B-L-based regimen throughout the variation of WTP, and it was 99.59% at the WTP threshold of 100,000 USD/DALY.

CONCLUSIONS: The BPaL therapy appeared to be effective in averting DALYs at reduced cost, with a high probability to be accepted as the preferred cost-effective option for HDR-TB treatment from the perspective of US healthcare provider.