Is a neglected tropical disease that is fatal when left untreated, resulting in approximately 20–40,000 fatalities annually worldwide. The World Health Organization (WHO) predicts that the disease causes 50,000–90,000 new cases annually, with the majority of these cases occurring in seven countries: Brazil, Ethiopia, India, Kenya, Somalia, South Sudan, and Sudan. Based on data from the Global Burden of Disease (GBD) from 2016, a study that estimated the burden of leishmaniasis in Brazil discovered that the incidence rate of VL increased by 52.9% and Years of Life Lost (YLL) by 108% between 1990 and 2016. WHO and the Brazilian Ministry of Health (MoH) regard case detection and timely treatment as the most critical strategies for disease control, as there is no vaccine available for VL prevention and vector control has limited efficacy. Consequently, less complex and safer treatment regimens are required. Few studies have assessed the economic influence of VL, despite its burden 5-7. In Brazil, a cost study estimated the direct medical costs and indirect costs associated with productivity loss. The total cost of VL was approximately US$ 14 million in 2014, when 3453 VL cases were confirmed in the Notifiable Diseases Information System (Sistema de Informação de Agravos de Notificação [SINAN]) of the MoH. Of this amount, 80% was attributed to the loss of productivity caused by early mortality. Hospital care expenditures accounted for approximately 40% of direct costs, as a result of hospitalization for treatment.
Human visceral leishmaniasis (VL)
Amphotericin B deoxycholate (AMBD), liposomal amphotericin B (LAMB), and meglumine antimoniate (MA) are the medicines that are available in the Brazilian public health care system (Sistema Único de Saúde [SUS]) for the treatment of VL. 9. The Brazilian Ministry of Health (MoH) acquires these medicines and distributes them to the states and cities. In Brazil, the first-line drug for the treatment of VL, MA, may be administered in the hospital or as an outpatient, contingent upon the severity of the disease. Electrocardiographic and laboratory investigations are recommended during treatment in an outpatient setting due to their high toxicity. LAMB is currently recommended for patients aged <6 months and older than 50 years, expectant women, individuals with Leishmania-HIV coinfection, and patients with comorbidities. These patients should be treated in a hospital setting, as LAMB is administered to those who are at a higher risk of mortality. The AMBD is employed in cases where patients are hypersensitive to MA and do not meet any of the criteria for the use of LAMB.
The cost of MA and AMBD vials is lower than that of LAMB vials
However, the use of this medicine is associated with additional costs due to the long period of drug administration, which necessitates hospitalization or close monitoring of outpatients due to the risk of serious adverse events (SAE) 4, 11, 12. In addition to the expenses associated with treatment, it is imperative to ascertain the advantages that patients derive from the implementation of various therapeutic regimens. Clinical trials have been conducted in Asia and the African continent over the past decade using a combination of two pharmaceuticals to treat VL, with promising results 13-15. An effective approach to preventing the emergence of parasite resistance in anthroponotic endemic areas in Asia and Africa and enhancing efficacy in zoonotic endemic areas in Europe and the American continent could be the use of therapeutic regimens that combine medicines. Finally, patients who are HIV-VL-coinfected should make use of multi-drug strategies to mitigate the elevated relapse and lethality rates that are observed in this subgroup.
Economic assessment studies are pertinent when considering the potential inclusion of a new therapeutic regimen in the SUS 18 for first-line treatment of VL, given the efficacy and safety data on the use of various therapeutic regimens in Brazil. Interestingly, the therapeutic limb that assessed AMBD in the Romero et al. (2017) study was suspended in response to the data safety monitoring board's recommendation, as a result of safety concerns. Additionally, the efficacy and tolerability of AMDB in Brazil are limited to a single clinical trial that compared AMDB with MA in children aged 6 months to 12 years. Consequently, the objective of this investigation was to determine the cost-effectiveness of strategies for the treatment of VL in Brazil in order to facilitate decision-making within the public health system.
A description of the epidemiological parameters employed
in the decision-making model is provided in Table 1. The study determined the proportion of VL cases treated with MA in hospital by analyzing data from a study that devised a score system to predict the prognosis of death by VL 19. This was done in light of the fact that, according to the MoH, patients can be treated with MA as either an outpatient or inpatient. The other epidemiological parameters associated with the likelihood of cure, therapeutic failure, and adverse events were obtained from the VL randomised clinical trial 18. It is crucial to emphasize that patients were excluded from the clinical trial and, as a result, from this evaluation if they were solely administered liposomal amphotericin B, in accordance with the most recent recommendations of the Ministry of Health. The patient could be treated with any of the three therapeutic regimens considered after the VL diagnosis is confirmed. The patient was subjected to the probability of being treated as an inpatient (0.88) or not, followed by the probability of presenting SAE (0.306), which was based on the fact that the treatment was administered with MA.
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