Abstract
Human visceral leishmaniasis (VL) is a severe and potentially fatal parasitic disease if not correctly diagnosed and treated. Brazil is one of the three countries most endemic for VL and, like most countries affected by this disease, has a large budget constraint for the incorporation of new health technologies. Although different diagnostic tests for VL are currently available in the country, economic studies evaluating diagnostic kits are scarce. The objective of this study was to conduct a cost-effectiveness analysis of the nine available diagnostic tests for human VL in HIV-infected and uninfected patients in Brazil. The perspective of analysis was the Brazilian public health system, and the outcome of interest was "cases diagnosed correctly". The costs of the tests were estimated using the microcosting technique, and comparisons were performed with decision trees. Sensitivity analyses were explored applying variations in cost and effectiveness values. For VL diagnosis among HIV-uninfected patients, using blood samples for the rapid tests (RDTs), the noncommercial direct agglutination test (DAT-LPC) and IT-LEISH were cost-effective tests compared with the baseline OnSite test, but they presented different incremental cost-effectiveness ratios (ICER) of US$7.04 and US$ 205.40, respectively. Among HIV-infected patients, DAT-LPC was the most cost-effective diagnostic test. Comparisons among the tests with the same methodology, based on the low ICER values, revealed that IT-LEISH was the most cost-effective test among the RDTs and the Ridascreen Leishmania Ab among the ELISA tests. These results confirm that cost-effectiveness analyses can provide useful information to support the incorporation of new health technologies within a known scenario and willingness to pay threshold. It was observed that tests based on the same methodologies presented different cost-effectiveness ratios for the same group of patients and that different tests should be recommended for different patient groups. DAT-LPC was an important cost-effective strategy for all patients, requiring minimum laboratorial infrastructure, and IT-LEISH was the cost-effective test for VL screening in HIV-uninfected patients. IT-LEISH and DAT-LPC have complementary profiles and should both be provided by the Brazilian health system.
Highlights
Visceral leishmaniasis (VL) is an important public health problem that mainly affects lowincome populations in countries with precarious social and economic development
90% of the cases registered in Latin American occur in Brazil, where more than 7% of cases are human immunodeficiency virus (HIV)-infected, and the public health system sustains the costs of illness
Considering the importance of correct diagnosis for visceral leishmaniasis (VL) control and for the optimal use of limited public health resources, we present a cost-effectiveness analysis of the available tests in Brazil up to 2019, stratified according to HIV status
Summary
Visceral leishmaniasis (VL) is an important public health problem that mainly affects lowincome populations in countries with precarious social and economic development. Diagnosis of VL is performed by the combination of epidemiological information and clinical findings in addition to parasitological or serological tests, especially rapid diagnostic tests (RDTs). Parasitological examinations of bone marrow aspirate, immunofluorescence antibody test (IFAT—IFI Leishmaniose Humana Fiocruz) and RDTs are performed and/or made available by public health services in Brazil [7]. After 2014, IFAT was used in the same 46% of confirmed VL cases, according to the Brazilian diseases reporting system (SINAN), RDT was performed in more than 50% of VL cases [7]. A progressive reduction in the use of parasitological examination has been observed in Brazil, the percentage of this invasive test of approximately 34% of VL cases in 2017 reveals that the strategy of rapid tests is not reaching its target
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