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Cutaneous leishmaniasis (LC) is a complex and variable disease in terms of epidemiology, aetiology, pathology and clinical characteristics. The mainstay of treatment is still pentavalent antimony (Sbv) compounds administered systemically, despite their recognized toxicity. The advantages of antimony intralesional (IL) infiltration are the use of lower doses of Sbv and, therefore, less toxic effects. The objective of this study was to estimate the cost-effectiveness ratio of intralesional meglumine antimoniate therapy (IL-MA) compared with endovenous meglumine antimoniate therapy (EV-MA) for the treatment of CL in the context of the Brazilian National Health System (SUS). An analytical decision model (decision tree) was developed using TreeAge Pro 2018 software. Data from the open-label, uncontrolled phase II clinical trial evaluating IL-MA were used as a reference for posology, efficacy, and adverse event rates (AE). The same premises for the intravenous approach (EV-MA) were extracted from systematic literature reviews. Macro and micro calculations of spending were included in the analysis. The IL-MA and EV-MA strategies had a total cost per patient cured of US$330.81 and US$494.16, respectively. The intralesional approach was dominant, meaning it was more economic and effective than was endovenous therapy. The incremental cost-effectiveness ratio showed that IL-MA could result in savings of US$864.37 for each additional patient cured, confirming that the IL-MA strategy is cost effective in the context of the Brazilian public health scenario., Author summary Cutaneous leishmaniasis (LC) is a parasitic disease characterized by a non-fatal evolution but marked by significant morbidity resulting from lesions that are usually ulcerated, sometimes disfiguring, and distributed in exposed areas of the body. Pentavalent antimony compounds administered systemically (EV) are still considered the pillars of cutaneous leishmaniasis (CL) treatment despite its high toxicity. Other therapeutic approaches, including the intralesional infiltration of antimony derivatives have been proposed as an alternative as effective as the systemic route. In this study we performed a cost-effectiveness analysis of the meglumine antimoniate intralesional treatment (IL-MA) compared to systemic therapy with the same drug, from the perspective of the main source of pay in Brazil, Brazilian Public Health System (SUS). This is the first cost-effectiveness study evaluating the IL-MA approach compared to MA endovenously for the treatment of CL. Cost-effectiveness was expressed as the incremental costs per patient cured. In our model, IL-MA was more effective and led to substantially lower costs for the public health system. Analytical decision model showed that the IL-MA therapy could represent a cost saving of approximately US$ 877.64 per additional patient cured compared with the endovenous route, representing the more cost-effectiveness approach for treatment of selected CL cases in Brazil.

Introduction:The Brazilian public health system (SUS) provides technologies based on the best available scientific evidence. However, there is a large number of lawsuits against the government for access to non-standard technologies, a phenomenon called “judicialization of the right to health”, which disrupts the system's operating logic. The aspect of judicialization that most impacts the health system involves unregistered technologies without scientific evidence of superiority being comparing to the alternatives already offered in the country. The aim of this study is to report experience of the National Committee for Health Technology Incorporation in the Brazilian Health System (CONITEC) to mitigate the effects of the judiciary, with the elaboration of informative documents about technologies directed towards policy-makers, patient, users of system health, professional health and other stakeholders.Methods:The main judicialized technologies in the country were identified and then a meeting with experts was realized to discuss a more appropriate format for these documents. After defining the format, a review of the literature was carried out to identify the best available evidence of those health technologies.Results:A question-and-answer (QA) format document was drawn. The QA addressed information on the use of the technology for a specific clinical condition. Health registry and price in Brazil, if it has already been evaluated by CONITEC and its respective recommendation, as well as strategies of care and therapeutic alternatives available in the SUS were included. Their content has been adapted to a lay language and all of the documents were made available on the CONITEC website in the “Law and Health Section”.Conclusions:The availability of QA represents a strong link between evidence and actions in health. For, they enable broad access to quality information by the lay public and stakeholders who seek information to support evidence-based decision-making.

IntroductionThe National Committee for Health Technology Incorporation (CONITEC) evaluates health technologies to recommend their inclusion or exclusion within the Brazilian Public Health System (SUS), and uses the budget impact assessment to estimate costs to the system. The Ministry of Health (MS) guideline recommends treatment of phenylketonuria (PKU) with restricted phenylalanine diet and phenylalanine-free amino acid formula (PFAAf) supplementation. CONITEC evaluated the inclusion of sapropterin dihydrochloride for PKU in the SUS.MethodsThe population eligible for treatment was evaluated by the number of patients receiving PFAAf between 2014 and 2017 registered in the SUS. Patients were stratified by age/weight and a simple linear regression was performed to estimate the future population. The costs of treatment and testing the responsiveness of sapropterin dihydrochloride were estimated according to the recommended dosage guideline of the MS, leaflet and public purchasing prices. A univariate deterministic sensitivity analysis was performed to evaluate different prices, responsiveness test methods and variations in the reduction of formula use.ResultsThe incorporation of sapropterin dihydrochloride would generate an incremental budget impact in the SUS of around BRL 79 million (USD 21.7 million) in 2019 and BRL 300 million (USD 82.1 million) in five years (2019-2023). The univariate sensitivity analysis estimated that the incremental budget impact could be between BRL 66 and BRL 103 million (USD 18 and USD 28 million) in the first year and between BRL 251 and BRL 388 million (USD 69 and USD 106 million) in five years. Sensitivity analysis showed that the price of sapropterin dihydrochloride was the most sensitive variable in the model.ConclusionsThe incorporation of sapropterin dihydrochloride in the SUS represents a significant budgetary impact and covers a small number of patients. Sapropterin dihydrochloride was recommended by CONITEC for the treatment of women with PKU, with a positive drug responsiveness test, and who are in the preconception period or in the gestational period.

IntroductionThe National Committee for Health Technology Incorporation (CONITEC) evaluates health technologies to recommend their inclusion or exclusion within the Brazilian Public Health System (SUS), and uses the budget impact assessment to estimate costs to the system. This study estimated the budget impact of the supply of methionine-free amino acid formula (MFAAf) for patients with classical homocystinuria (HCU) in the SUS.MethodsThe incidence of one case per 250,000 live births in Brazil and the registration of a Brazilian association of patients with HCU was assumed to calculate the population. Mortality and responsiveness to pyridoxine rates were applied. The costs of treatment were estimated according to the recommended dosage in literature and public purchasing prices. For calculating the dose of MFAAf patients, a median age of 19 years and weight of 60 kg were assumed, according to Brazilian study data.ResultsThe annual cost of treatment was estimated at BRL 77,000 (USD 21,084) per patient. The incorporation of MFAAf for HCU would generate a budget impact in SUS of around BRL 37 million (USD 10.1 million) in 2019 and BRL 188 million (USD 51.5 million) after five years which considers the epidemiological data, and a budget impact of around BRL 6.4 million (USD 1.75 million) in 2019 and BRL 33 million (USD 9 million) after five years which considers the information of a Brazilian association of patients with HCU. The wide range of values in the incremental budgetary impact is due to the lack of information on the epidemiology of the disease in Brazil.ConclusionsThe incorporation of the MFAAf in the SUS represents an important budgetary impact and covers a small number of patients. CONITEC recommended the incorporation of the MFAAf in the SUS, according to clinical protocol.

O Brasil apresenta elevada prevalência de diabetes e uma longa tradição no uso de plantas medicinais. Este estudo avaliou o perfil de utilização de plantas medicinais e identificou fatores associados ao seu uso, em indivíduos com diabetes mellitus. Foi realizado um inquérito epidemiológico de base domiciliar em 63 municípios do estado de Minas Gerais, em 2014. Os dados foram coletados por meio de entrevistas, utilizando questionário estruturado. Regressão logística foi utilizada para identificar fatores associados ao uso de plantas medicinais. Foram entrevistados 2.620 diabéticos. Destes, 29,30% relataram o uso de plantas medicinais nos últimos 15 dias. As plantas mais utilizadas foram erva-cidreira, hortelã, camomila, chá mate e quiabo. Três casos de hipoglicemia foram relatados com o uso do chá conhecido popularmente como insulina vegetal. Observou-se que ser do sexo feminino, ter diabetes mellitus tipo II, praticar atividade física e ter menor escolaridade estão associados significativamente ao uso de plantas medicinais. O estudo confirmou alta frequência de utilização de plantas medicinais pelos diabéticos no Brasil, sendo recomendado que profissionais de saúde considerem a utilização dessa terapia pelos seus pacientes. Profile of use and factors associated with the use of medicinal plants in people with diabetes mellitus in Minas Gerais, Brazil Brazil has high prevalence of diabetes and a long tradition of using medicinal plants. This study evaluated the profile of use of medicinal plants and identified factors associated with its use in individuals with diabetes mellitus. An epidemiological survey of home-based was conducted in 63 municipalities in the state of Minas Gerais in 2014. Data were collected through interviews using a structured questionnaire. Logistic regression was used to identify factors associated with the use of medicinal plants. We interviewed 2,620 diabetics. Of these, 29.30% reported the use of medicinal plants in the last 15 days. The most used plants were lemon balm, mint, chamomile, tea, and okra. Three cases of hypoglycemia have been reported with the use of tea known popularly as plant insulin. We found that being female, having type II diabetes mellitus, physical activity and have less education are significantly associated with the use of medicinal plants. The study confirmed high frequency of use of medicinal plants by diabetics in Brazil, recommended that health professionals consider the use of this therapy for their patients.