Navegando por Palavras-chave "Avaliação da tecnologia biomédica"
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- ItemAcesso aberto (Open Access)Boletim brasileiro de avaliação de tecnologias em saúde: deferasirox para o tratamento da sobrecarga de ferro(Universidade Federal de São Paulo (UNIFESP), 2011-02-22) Silva, Marcus Tolentino [UNIFESP]; Atallah, Álvaro Nagib [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Objectives: to evaluate the evidence on efficacy and safety regarding deferasirox for treatment of iron overload relating to beta-thalassemia, sickle cell disease and myelodysplastic syndrome, in comparison with other iron chelators available in Brazil (deferoxamine and deferiprone). Methods: to produce a synthesis of the evidence, a search was conducted using reports from HTA agencies and systematic reviews in Medline (March 2009). Additionally, a search for clinical trials was conducted to update the information available. Among the references identified, the study by McLeod (2009) was selected because this was a systematic review and economic evaluation produced by a highly trustworthy HTA agency. Considering the local economic context and the availability of medications and laboratory supplies, the evidence was adapted and critically evaluated. Results: the evidence found was based on three clinical trials of low methodological quality that evaluated the use of deferasirox in relation to deferoxamine. No comparative studies between deferasirox and deferiprone were found. In the clinical trials identified, hepatic iron concentration (a test unavailable in Brazil) was taken to be the primary outcome, although in clinical practice, the iron levels were monitored by means of the serum ferritin concentration. The changes in serum ferritin concentration were more favorable among patients with beta thalassemia and sickle cell disease (highest prevalence in Brazil) who received deferoxamine than among those who received deferasirox. Previous economic evaluation suggests that deferasirox may be a cost-effective strategy. Conclusions: since deferasirox was only recently introduced onto the Brazilian market and is considered to be an alternative for treatment within the public healthcare system, drug surveillance information is required, particularly regarding the risks of kidney failure, cytopenia (agranulocytosis and thrombocytopenia) and gastrointestinal, hepatic, renal and blood disorders.
- ItemAcesso aberto (Open Access)Health technology assessment in Brazil: what do healthcare system players think about it?(Associação Paulista de Medicina - APM, 2011-01-01) Ferraz, Marcos Bosi [UNIFESP]; Soárez, Patricia Coelho de; Zucchi, Paola [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Universidade de São Paulo (USP)CONTEXT AND OBJECTIVES: The health technology assessment (HTA) process has been developed locally. The aim of this study was to describe, analyze and compare the opinions of participants in international health economics symposia about the HTA process used in Brazil. DESIGN AND SETTING: Observational cross-sectional study at the 2006 and 2008 International Health Economics Symposia, in São Paulo. METHODS: A structured questionnaire was applied. For the statistical analysis, the percentage distribution for each category was calculated, and variables were compared using tests for two-sample proportion hypotheses. RESULTS: Totals of 153 and 74 participants answered the 2006 and 2008 surveys, respectively. The response rate was better for the 2006 survey (67.1%) than for the 2008 survey (31.8%). Most interviewees were between the ages of 30 and 49 years and were managers in the healthcare system. Most of them considered that the current HTA process was incomplete and unable to meet the needs of the healthcare system. They mentioned the government, academia and experts as the three main groups of people who should be involved in the process, and selected efficiency/effectiveness, safety and disease relevance as the three main criteria to be considered in the HTA process. There is a trend towards developing decentralized regionalized HTA processes, with separate assessment and decision-making for the public and private systems. CONCLUSIONS: The HTA concept is well known. Healthcare system players feel that the process has methodological limitations. Additional surveys are needed to track the HTA process and its application in Brazil.