OBJECTIVES:

To estimate the incremental cost-effectiveness ratio and budget impact of incorporating High Resolution Melting (HRM) for the screening of resistance-associated mutations in M leprae in leprosy patients with suspected relapse associated with resistance in the Brazilian Public Healthcare System.

METHODS:

Based on a conceptual model of leprosy, we undertook a hybrid model containing decision tree and transitional states. The model compared the current scenario, in which genomic sequencing (GS) is used in all patients who present suspected relapse associated with resistance, and a proposed scenario, in which HMR is used as a screening method. Cost and accuracy (number of correct diagnoses) data were obtained from the literature and from Lauro de Souza Lima Institute. The model was subjected to internal and dependent external validation. BI analysis had a horizon of 5 years and the CE analysis considered a lifetime horizon with a discount of 5% for costs. Probabilistic sensitivity analyses were performed to explore parametric uncertainties.

RESULTS:

In the base case, HRM as a screening method presents lower total cost, without prejudice to accuracy. The probability of HRM being cost-effective is above 95% even at thresholds in the range of R $ 40,000 of willingness to pay. The incorporation of HRM as screening method and subsequent GS in patients who present positive results for resistant bacilli results in savings, which varies from over BRL -512,000 in the first year to BRL -530,000 in the fifth year . All the deterministic analyzes were corroborated by the probabilistic analyses.

CONCLUSIONS:

The screening based on HRM does not change the number of correct diagnoses obtained and promotes financial savings compared to the current strategy. Other benefits, as the speed of the test, which allows a larger volume of samples to be tested with the existing infrastructure, must be highlighted.