Avaliação de tecnologias em saúde no Brasil: o que os atores do sistema de saúde pensam a respeito?

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.CONTEXTO E OBJETIVOS: O processo de avaliação de tecnologias em saúde (ATS) tem sido desenvolvido localmente. O objetivo deste estudo foi descrever, analisar e comparar as opiniões dos participantes dos simpósios internacionais de economia da saúde sobre o processo de ATS utilizado no Brasil. TIPO DE ESTUDO E LOCAL: Estudo observacional transversal, realizado nos Simpósios Internacionais de Economia da Saúde de 2006 e 2008, em São Paulo. MÉTODOS: Um questionário estruturado foi aplicado. A análise estatística calculou a distribuição percentual de cada categoria e comparou as variáveis com teste de hipóteses de proporções de duas amostras. RESULTADOS: Um total de 153 e 74 participantes responderam às pesquisas de 2006 e 2008, respectivamente. A taxa de resposta foi melhor na pesquisa de 2006 (67,1%) do que na pesquisa de 2008 (31,8%). A maioria dos entrevistados estava entre 30 e 49 anos e era composta de gestores do sistema de saúde. A maioria considerou o atual processo de ATS incompleto e incapaz de satisfazer as necessidades do sistema de saúde. Entrevistados mencionaram o governo, academia e especialistas como os três principais grupos de pessoas que deveriam estar envolvidos no processo, e eficiência/efetividade, segurança e relevância da doença como os três principais critérios a serem considerados no processo de ATS. Existe a tendência de desenvolvimento de um processo de ATS descentralizado e regionalizado com avaliações e decisões separadas para o sistema público e privado. CONCLUSÕES: O conceito ATS é conhecido. Os atores do sistema de saúde acham que o processo tem limitações metodológicas. Pesquisas adicionais são necessárias para acompanhar o processo de ATS e sua aplicação no Brasil

Patient and public involvement in health technology decision-making processes in Brazil

OBJECTIVE: The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil. METHODS: This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions. RESULTS: The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received. CONCLUSIONS: There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.OBJETIVO: Caracterizar e discutir os processos formais de participação social previstos e implementados pelas instituições Agência Nacional de Vigilância Sanitária (Anvisa), Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec) e Agência Nacional de Saúde Suplementar (ANS). MÉTODOS: Estudo exploratório, descritivo, comparativo, conduzido por meio de análise de documentos publicados até 2018 no sítio eletrônico e da legislação específica de cada instituição. RESULTADOS: Os espaços de participação social identificados incluem a representação em colegiados e participação direta por meio de uma demanda inicial ou em consultas públicas, audiências públicas e ouvidorias. A Anvisa conduziu 187 consultas públicas entre 1999 e 2018, e contabilizou 10.699 contribuições. Em 76 (41%) consultas públicas não há informações sobre as contribuições recebidas. A Conitec conduziu 234 consultas públicas, e recebeu 53.174 contribuições entre 2011 e 2018. Identificou-se que 70 (23%) recomendações da Conitec foram emitidas sem consulta pública, e 26 (8%) recomendações preliminares foram alteradas após consulta pública. As alterações de recomendação aconteceram especialmente em casos com grande volume de contribuições. A ANS conduziu 8 consultas públicas sobre o rol de procedimentos e eventos em saúde entre 2000 e 2018, e recebeu pelo menos 31.498 contribuições. Em três consultas públicas não há informações sobre o número de contribuições recebidas. CONCLUSÕES: Observa-se recente avanço normativo e de desempenho institucional em favor da participação social em espaços decisórios notadamente técnicos, embora de forma bastante heterogênea entre as instituições analisadas. O poder deliberativo da participação social de influenciar as decisões em saúde ainda necessita de estudo aprofundado, incluindo a caracterização dos participantes e a legitimidade das decisões subsequentes

Costs of mammogram campaigns in the Regional Health Division of Marília, São Paulo State, Brazil, 2005-2006

The aim of this study was to measure the direct costs of mammogram campaigns conducted by the Regional Health Division of Marília, São Paulo State, Brazil, in 2005 and 2006. A total of 11,952 mammograms were performed. Mammographic outcomes were classified according to BI-RADS. Cost analysis was based on the amount paid by the Brazilian Unified National Health System (SUS). Ten cases of breast cancer were diagnosed (0.84 per 1,000 mammograms), 70% of which between 50 and 69 years of age. The campaigns and follow-up cost a total of R$450,019 (U$280,000), with R$431,467 paid for 11,952 mammograms and R$18,552 for diagnosing 29 suspected cases and treating 3 cases of benign tumors and 6 cancer cases. Mean cost per diagnosed case was R$43,268. The high cost per diagnosed case highlights the need to implement effective screening programs and improve the quality of mammography services in this region of São Paulo State.O objetivo desse estudo foi apresentar os custos diretos dos mutirões de mamografias realizados nos anos de 2005 e 2006 na região da Direção Regional de Saúde de Marília, São Paulo, Brasil. Foram realizadas 11.952 mamografias. A classificação do resultado da mamografia foi feita pelo sistema padronizado BI-RADS e a análise de custos foi baseada nos valores pagos pelo SUS com base nas Tabelas SIA/SUS e SIH/SUS de 2005. Foram diagnosticados 10 casos de câncer de mama (0,84 por 1.000 mamografias), 70$ 450.019,91, sendo R$431.467,20 com o pagamento de 11.952 mamografias e R$ 18.552,71 para a investigação diagnóstica de 29 casos suspeitos, para o tratamento de três casos de tumores benignos e de 6 casos de câncer. O custo de cada caso diagnosticado foi de R$ 43.268,10. O alto custo de cada caso diagnosticado aponta para a necessidade de implementação de programas de rastreamento efetivos e de qualidade da mamografia nesta região do estado.Universidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaDepartamento Regional de Saúde de MaríliaUNIFESP, EPMSciEL

Impacto da metodologia nos resultados de avaliações econômicas de programas de vacinação da varicela: é importante para o processo de tomada de decisão?

This study aims to review the literature on economic evaluation of childhood varicella vaccination programs and to discuss how heterogeneity in methodological aspects and estimation of parameters can affect the studies' results. After applying the inclusion criteria, 27 studies published from 1980 to 2008 were analyzed in relation to methodological differences. There was great heterogeneity in the perspective adopted, evaluation of indirect costs, type of model used, modeling of the effect on herpes zoster, and estimation of vaccine price and efficacy parameters. The factor with the greatest impact on results was the inclusion of indirect costs, followed by the perspective adopted and vaccine price. The choice of a particular methodological aspect or parameter affected the studies' results and conclusions. It is essential that authors present these choices transparently so that users of economic evaluations understand the implications of such choices and the direction in which the results of the analysis were conducted.O presente trabalho tem por objetivo rever a literatura sobre avaliação econômica de programas de vacinação infantil contra varicela, e discutir como a heterogeneidade em aspectos metodológicos e na estimativa dos parâmetros pode afetar os resultados dos estudos. Após aplicação dos critérios de inclusão, 27 estudos do período de 1980 a 2008 foram analisados com relação às diferenças metodológicas. Observou-se grande heterogeneidade na perspectiva adotada, valoração dos custos indiretos, tipo de modelo empregado, modelagem do efeito no herpes zoster, e na estimativa dos parâmetros de preço e eficácia da vacina. O fator que mais impactou os resultados foi a inclusão dos custos indiretos seguido da perspectiva e preço de vacina adotados. A escolha de um determinado aspecto metodológico ou parâmetro afetou os resultados e conclusões dos estudos. É de fundamental importância que os autores apresentem essas escolhas com transparência para que os usuários das avaliações econômicas compreendam as repercussões dessas escolhas, e em qual direção os resultados das análises foram conduzidos

Hospitalizações por doença pneumocócica no Brasil, 2004 - 2006

OBJETIVO: Estimar las hospitalizaciones por enfermedad neumocócica con base en datos del Sistema de Informaciones Hospitalarias (SIH). MÉTODOS: Estudio descriptivo con base en datos del SIH de enero de 2004 a diciembre de 2006: números de hospitalizaciones y muertes por meningitis neumocócica, sepsis neumocócica, neumonía neumocócica y Streptococcus pneumoniae como causa de enfermedades ocurridas en Brasil. Datos de la Investigación Nacional por Muestras de Domicilios 2003 fueron utilizados para el sector privado. Casos y muertes por meningitis neumocócica notificados en el Sistema Nacional de Agravios de Notificación en el mismo período también fueron analizados. RESULTADOS: La enfermedad neumocócica fue responsable por 34.217 hospitalizaciones en el Sistema Único de Salud, (0,1% de todas las hospitalizaciones). Neumonía neumocócica fue responsable por 64,8% de tales hospitalizaciones. La distribución de las estimaciones de hospitalizaciones según grupo etáreo mostró curva en "U", con mayor frecuencia entre niños < 1 año (110-136,9/100.000 niños/año). La letalidad hospitalaria fue más alta entre ancianos, y entre casos de meningitis y sepsis. CONCLUSIONES: Enfermedad neumocócica es importante problema de salud pública en Brasil. Análisis basado en el SIH puede contribuir para la vigilancia epidemiológica de la enfermedad neumocócica y para la evaluación del impacto del programa de vacunación.OBJETIVO: Estimar as hospitalizações por doença pneumocócica com base em dados do Sistema de Informações Hospitalares (SIH). MÉTODOS: Estudo descritivo com base em dados do SIH de janeiro de 2004 a dezembro de 2006: números de hospitalizações e mortes por meningite pneumocócica, sepse pneumocócica, pneumonia pneumocócicca e Streptococcus pneumoniae como causa de doenças ocorridas no Brasil. Dados da Pesquisa Nacional por Amostras de Domicílios 2003 foram utilizados para o setor privado. Casos e mortes por meningite pneumocócica notificados no Sistema Nacional de Agravos de Notificação no mesmo período também foram analisados. RESULTADOS: A doença pneumocócica foi responsável por 34.217 hospitalizações no Sistema Único de Saúde (0,1% de todas as hospitalizações). Pneumonia pneumocócica foi responsável por 64,8% dessas hospitalizações. A distribuição das estimativas de hospitalizações segundo faixa etária mostrou curva em "U", com maior freqüência entre crianças < 1 ano (110-136,9/100.000 crianças/ano). A letalidade hospitalar foi mais alta entre idosos, e entre casos de meningite e sepse. CONCLUSÕES: Doença pneumocócica é importante problema de saúde pública no Brasil. Análise baseada no SIH pode contribuir para a vigilância epidemiológica da doença pneumocócica e para a avaliação do impacto do programa de vacinação.OBJECTIVE: To estimate hospitalization rates for pneumococcal disease based on the Brazilian Hospital Information System (SIH). METHODS: Descriptive study based on the Hospital Information System of Brazilian National Health System data from January 2004 to December 2006: number of hospitalizations and deaths for pneumococcal meningitis, pneumococcal sepsis, pneumococcal pneumonia and Streptococcus pneumoniae as the cause of diseases reported in Brazil. Data from the 2003 Brazilian National Household Survey were used to estimate events in the private sector. Pneumococcal meningitis cases and deaths reported to the Notifiable Diseases Information System during the study period were also analyzed. RESULTS: Pneumococcal disease accounted for 34,217 hospitalizations in the Brazilian National Health System (0.1% of all hospitalizations in the public sector). Pneumococcal pneumonia accounted for 64.8% of these hospitalizations. The age distribution of the estimated hospitalization rates for pneumococcal disease showed a "U"-shape curve with the highest rates seen in children under one (110 to 136.9 per 100,000 children annually). The highest hospital case-fatality rates were seen among the elderly, and for sepsis and meningitis. CONCLUSIONS: PD is a major public health problem in Brazil. The analysis based on the SIH can provide an important input to pneumococcal disease surveillance and the impact assessment of immunization programs

Cross-cultural adaptation of the NoMAD questionnaire to Brazilian Portuguese

BACKGROUND: The Normalization Measure Development (NoMAD) tool is used to determine the contextual determinants in the process of implementing complex health interventions. The aim of this study is to translate and culturally adapt NoMAD to Brazilian Portuguese. METHODS: The cross-cultural adaptation was performed in five steps: 1) translation of the questionnaire into Portuguese; 2) synthesis and creation of the first version; 3) back-translation of the instrument into the source language; 4) review of the instrument by a group of experts and target professionals; and 5) pretesting. A final version of the questionnaire was answered by users of a clinical monitoring system in specialist care services for people living with HIV/AIDS, and the internal consistency of the questionnaire was assessed using Cronbach's alpha. RESULTS: The questionnaire was answered by 188 health professionals, of which 87.7% were female, and the average age was 45.2 years. For the final version of the questionnaire, Cronbach's alpha was over 0.70 for the construct's coherence (0.74), collective action (0.70), cognitive participation (0.71), and reflexive monitoring (0.81). CONCLUSION: The NoMAD questionnaire was cross-culturally adapted and can be used to evaluate the implementation of complex health care interventions

Economic evaluations of colorectal cancer screening: A systematic review and quality assessment

Colorectal Cancer (CRC) is the third most common type of cancer worldwide and ranks second in mortality. Screening programs for early detection and treatment have been implemented in several countries. Economic evaluations are an important tool to support decision-making about reimbursement and coverage decisions in health systems and, therefore, to support efficient resource allocation. The article aims to review the up-to-date evidence on economic evaluations of CRC screening strategies. MEDLINE, EMBASE, Web of Science, SCOPUS, SciELO, Lilacs, CRD databases, and lists of references were reviewed to identify relevant literature regarding full economic evaluations of CRC screening in asymptomatic average-risk individuals over 40 years old. Searches were conducted with no restriction to language, setting, or date. Qualitative syntheses described CRC screening strategies and comparators (baseline context), study designs, key parameter inputs and incremental cost-effectiveness ratios. Seventy-nine articles were included. Most of the studies were from high-income countries and a third-party payer perspective. Markov models were predominantly used, although microsimulation has been increasingly adopted in the last 15 years. The authors found 88 different screening strategies for CRC, which differed in the type of technique, the interval of screening, and the strategy, i.e., isolated or combined. The annual fecal immunochemical test was the most predominant screening strategy. All studies reported cost-effective results in their scenarios compared to no screening scenarios. One-quarter of the publications reported cost-saving results. It is still necessary to develop future economic evaluations in Low- and Middle-Income Countries (LMICs), which account for the high burden of disease

Systematic Review of Health Economic Evaluations of Diagnostic Tests in Brazil: How accurate are the results?

The aim of this study is to identify and characterize the health economic evaluations (HEEs) of diagnostic tests conducted in Brazil, in terms of their adherence to international guidelines for reporting economic studies and specific questions in test accuracy reports. We systematically searched multiple databases, selecting partial and full HEEs of diagnostic tests, published between 1980 and 2013. Two independent reviewers screened articles for relevance and extracted the data. We performed a qualitative narrative synthesis. Forty-three articles were reviewed. The most frequently studied diagnostic tests were laboratory tests (37.2%) and imaging tests (32.6%). Most were non-invasive tests (51.2%) and were performed in the adult population (48.8%). The intended purposes of the technologies evaluated were mostly diagnostic (69.8%), but diagnosis and treatment and screening, diagnosis, and treatment accounted for 25.6% and 4.7%, respectively. Of the reviewed studies, 12.5% described the methods used to estimate the quantities of resources, 33.3% reported the discount rate applied, and 29.2% listed the type of sensitivity analysis performed. Among the 12 cost-effectiveness analyses, only two studies (17%) referred to the application of formal methods to check the quality of the accuracy studies that provided support for the economic model. The existing Brazilian literature on the HEEs of diagnostic tests exhibited reasonably good performance. However, the following points still require improvement: 1) the methods used to estimate resource quantities and unit costs, 2) the discount rate, 3) descriptions of sensitivity analysis methods, 4) reporting of conflicts of interest, 5) evaluations of the quality of the accuracy studies considered in the cost-effectiveness models, and 6) the incorporation of accuracy measures into sensitivity analyses

Annual national direct and indirect cost estimates of the prevention and treatment of cervical cancer in Brazil

OBJECTIVE: To estimate the annual direct and indirect costs of the prevention and treatment of cervical cancer in Brazil. METHODS: This cost description study used a "gross-costing" methodology and adopted the health system and societal perspectives. The estimates were grouped into sets of procedures performed in phases of cervical cancer care: the screening, diagnosis and treatment of precancerous lesions and the treatment of cervical cancer. The costs were estimated for the public and private health systems, using data from national health information systems, population surveys, and literature reviews. The cost estimates are presented in 2006 USD. RESULTS: From the societal perspective, the estimated total costs of the prevention and treatment of cervical cancer amounted to USD $1,321,683,034, which was categorized as follows: procedures (USD$213,199,490), visits (USD $325,509,842), transportation (USD$106,521,537) and productivity losses (USD $676,452,166). Indirect costs represented 51% of the total costs, followed by direct medical costs (visits and procedures) at 41% and direct non-medical costs (transportation) at 8%. The public system represented 46% of the total costs, and the private system represented 54%. CONCLUSION: Our national cost estimates of cervical cancer prevention and treatment, indicating the economic importance of cervical cancer screening and care, will be useful in monitoring the effect of the HPV vaccine introduction and are of interest in research and health care management