Evidence-based process for decision-making in the analysis of legal demands for medicines in Brazil

Legal actions have been playing a significant role as an alternative pathway to access to medicines in Brazil. These lawsuits demand medicines used in Primary Health Care as well as medicines that are still in clinical research and have not been market approved by the Brazilian National Agency for Sanitary Surveillance (ANVISA). The goal was to analyze medicines demanded through lawsuits brought to the judicial district which includes the city of Rio de Janeiro, Brazil, from July/2007 to June/2008. The medicines in 281 lawsuits were examined for their respective indications, classified according to their presence in publicly-funded lists, market approval by ANVISA, compliance with national clinical guidelines, existence of alternative therapies in lists and support of indication by scientific evidence. Six different categories were described, which are deemed useful to managers and the Judiciary in decision-making. The support of evidence is of utmost importance for medicines that are not included in public funding lists and also for those with no available therapeutic alternatives

Budget impact from the incorporation of positron emission tomography - computed tomography for staging lung cancers.

Objective: To estimate the budget impact from the incorporation of positron emission tomography (PET) in mediastinal and distant staging of non-small cell lung cancer. Methods: The estimates were calculated by the epidemiological method for years 2014 to 2018. Nation-wide data were used about the incidence; data on distribution of the disease's prevalence and on the technologies' accuracy were from the literature; data regarding involved costs were taken from a micro-costing study and from Brazilian Unified Health System (SUS) database. Two strategies for using PET were analyzed: the offer to all newly-diagnosed patients, and the restricted offer to the ones who had negative results in previous computed tomography (CT) exams. Univariate and extreme scenarios sensitivity analyses were conducted to evaluate the influence from sources of uncertainties in the parameters used. Results: The incorporation of PET-CT in SUS would imply the need for additional resources of 158.1 BRL (98.2 USD) million for the restricted offer and 202.7 BRL (125.9 USD) million for the inclusive offer in five years, with a difference of 44.6 BRL (27.7 USD) million between the two offer strategies within that period. In absolute terms, the total budget impact from its incorporation in SUS, in five years, would be 555 BRL (345 USD) and 600 BRL (372.8 USD) million, respectively. The costs from the PET-CT procedure were the most influential parameter in the results. In the most optimistic scenario, the additional budget impact would be reduced to 86.9 BRL (54 USD) and 103.8 BRL (64.5 USD) million, considering PET-CT for negative CT and PET-CT for all, respectively. Conclusions: The incorporation of PET in the clinical staging of non-small cell lung cancer seems to be financially feasible considering the high budget of the Brazilian Ministry of Health. The potential reduction in the number of unnecessary surgeries may cause the available resources to be more efficiently allocated

Instrumento de medida de carga de trabalho dos profissionais de Saúde na Atenção Primária: desenvolvimento e validação

RESUMO Objetivo Propor e validar um instrumento que contemple as intervenções/atividades realizadas pela equipe de saúde da família, como referência para o planejamento da força de trabalho. Método Pesquisa metodológica desenvolvida nas etapas: construção do instrumento; validação de conteúdo e teste piloto, em três unidades, localizadas na região sudeste do Brasil. Resultados Foram validadas 39 intervenções em um único instrumento de medida de carga de trabalho para médico, cirurgião-dentista, técnico/auxiliar de saúde bucal, enfermeiro, técnico/auxiliar de enfermagem e agente comunitário de saúde. No teste piloto, o instrumento contemplou 100% das intervenções observadas, atingindo 93,7% de concordância entre os observadores. Conclusão O instrumento proposto, inédito na sua configuração, subsidia o planejamento da força de trabalho em atenção primária

Cost analysis of18F-FDG PET-CT from the perspective of the Brazilian Unified National Health System as healthcare provider: a study in a public healthcare center in Rio de Janeiro, Brazil.

Positron emission tomography (PET) has been introduced recently in Brazil and requires costs analysis to support economic evaluation studies on its use. The current study analyzed the use of 18 F-FDG PET-CT and estimated its costs from the perspective of a public healthcare provider. The micro-costing technique was used, identifying, quantifying, and valuing all the inputs used to perform the procedure. Cost estimates considered 85 tests performed at the Brazilian National Cancer Institute from March to June 2012. Reference cases were defined as adult cancer patients, output of five tests per day, and one dose of 18 F-FDG per patient. Unit cost for the procedure was BRL 3,150.30 based on career wages under the Ministry of Science and Technology and BRL 2,927.19 based on Ministry of Health career wages. The factor with the heaviest cost impact was daily output of tests. Other factors that could impact the test's cost in public healthcare institutions were also examined