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CER is a new term for the great majority of researches, health professionals, and policy makers. However, in the last three decades, CER activities described by various terms such as evidence-based medicine, and health economics (mainly... more
CER is a new term for the great majority of researches, health professionals, and policy makers. However, in the last three decades, CER activities described by various terms such as evidence-based medicine, and health economics (mainly economic evaluation of healthcare interventions) were performed as part of the health technology assessment (HTA) process to generate or synthesize evidence to allow policy makers to make evidence-based decisions. The majority of these activities were in the field of education and research development and implementation, especially in academic centers. Governmental activities in these fields of knowledge are recent and have been conducted on a regular basis only in the past 15 years. The Ministry of Health has fostered development of human resources through specialization and master’s programs in HTA and has developed several national information systems. To provide an in-depth view of the CER in Brazil, this chapter presents a brief description of the Brazilian Healthcare System; summarizes the initiatives on evidence-based medicine, health economics, and health technology assessment in the last 20–30 years; and describes the institutionalization of those initiatives in the Ministry of Health. This chapter also discusses the challenges in building human resources capacity and developing an infrastructure to conduct CER.
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Background: The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health... more
Background: The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health Technology Incorporation in the Unified Health System (Conitec) of Brazil and to identify factors associated with changes in Conitec’s recommendations following these PC. Methods: This cross-sectional study analysed all processes related to the adoption of technology that took place in Brazil between 2012 and 2021 based on technical reports and self-reported information collected from PC participants. A multiple logistic regression model identified factors associated with changes in Conitec’s recommendations following PC. Results: A total of 479 technical reports were published, of which 83% (n=400) were submitted to PC. Demands were made mainly by applicants from the state (n=262; 55%), regarding the adoption of medicines (n=367; 77%), in which conte...
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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... more
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%) recomenda...
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The reemergence of pertussis in the last two decades led to the introduction of adolescents and adults immunization strategies of tetanus-diphtheria-acellular pertussis vaccines (Tdap) in several countries. The health authorities must... more
The reemergence of pertussis in the last two decades led to the introduction of adolescents and adults immunization strategies of tetanus-diphtheria-acellular pertussis vaccines (Tdap) in several countries. The health authorities must consider economic aspects when deciding to recommend and fund new programs. Here we present a systematic review of worldwide full economic evaluations of pertussis vaccination targeting adolescents or adults published from 2000. Studies were identified by searching MEDLINE, Excerpta Medica, CRD, and Lilacs databases. Twenty-seven economic evaluations of different strategies with Tdap were identified. Booster vaccination for adolescents and adults were the most frequent, followed by cocooning and pregnant women vaccination. Strategies performance varied considerably among different studies. Assumptions regarding underreporting correction, herd protection and vaccine coverage were crucial to cost-effectiveness results. Understanding the model and the par...
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The aim of this study was to critically evaluate the quality of the models used in economic evaluations of screening strategies for cervical cancer prevention. We systematically searched multiple databases, selecting model-based full... more
The aim of this study was to critically evaluate the quality of the models used in economic evaluations of screening strategies for cervical cancer prevention. We systematically searched multiple databases, selecting model-based full economic evaluations (cost-effectiveness analyses, cost-utility analyses, and cost-benefit analyses) of cervical cancer screening strategies. Two independent reviewers screened articles for relevance and performed data extraction. Methodological assessment of the quality of the models utilized formal checklists, and a qualitative narrative synthesis was performed. Thirty-eight articles were reviewed. The majority of the studies were conducted in high-income countries (82%, n=31). The Pap test was the most used screening strategy investigated, which was present in 86% (n=33) of the studies. Half of the studies (n=19) used a previously published Markov model. The deterministic sensitivity analysis was performed in 92% (n=35) of the studies. The mean numbe...
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A significant increase in pertussis incidence occurred in Brazil, from 2011 to 2014, despite high coverage of childhood immunization with whole-cell-pertussis (wP) containing vaccines. This study presents pertussis surveillance data from... more
A significant increase in pertussis incidence occurred in Brazil, from 2011 to 2014, despite high coverage of childhood immunization with whole-cell-pertussis (wP) containing vaccines. This study presents pertussis surveillance data from São Paulo state and discusses the challenges to interpret them considering pertussis cyclic epidemic behavior, the introduction of new diagnostic techniques and new vaccination strategies, and enhanced disease awareness during epidemics. Observational study including pertussis cases reported to the Surveillance System in São Paulo state, from January 2001 to December 2015. Pertussis cases data were retrieved from the National Notifiable Diseases Information System (SINAN) website and from São Paulo state Epidemiological Surveillance Center (CVE/SP) database. Vaccination coverage and homogeneity data were collected from the Unified Health System Department of Informatics (DATASUS). We presented cases distribution by year, age group and diagnostic cri...
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To systematically review the economic evaluations of 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults aged ≥60 years to inform the development of local studies through the discussion of parameters and assumptions that... more
To systematically review the economic evaluations of 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults aged ≥60 years to inform the development of local studies through the discussion of parameters and assumptions that influence the results of the analyses. We searched the MEDLINE, Excerpta Medica, Cochrane Library, Latin-American and Caribbean Health Sciences Literature (LILACS), Brazilian Regional Library of Medicine, National Health Service Economic Evaluation, and Centre for Reviews and Dissemination-as well as the Scopus citation index and the Web of Science for full economic evaluations of PPV23 published up to March 2016. Two independent reviewers screened the articles for relevance and extracted the data. Main study characteristics and methods (clinical and epidemiological data, cost and incremental cost-effectiveness ratios (ICERs) were extracted and compared. Costs were updated to 2016 international dollars. Twenty-seven studies published from 1980 to 2016 we...
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Little is known about the quality and quantity of cost-utility analyses (CUAs) in Brazil. The objective of this study was to provide a systematic review of published CUAs of healthcare technologies in Brazil. We performed a systematic... more
Little is known about the quality and quantity of cost-utility analyses (CUAs) in Brazil. The objective of this study was to provide a systematic review of published CUAs of healthcare technologies in Brazil. We performed a systematic review of economic evaluations studies published in MEDLINE, EMBASE, LILACS (Latin American and Caribbean Health Sciences Literature), SciELO (Scientific Electronic Library Online), NHS EED (National Health Service Economic Evaluation Database), HTA (Health Technology Assessment) Database, Web of Science, Scopus, Bireme (Biblioteca Regional de Medicina), BVS ECOS (Health Economics database of the Brazilian Virtual Library of Health), and SISREBRATS (Sistema de Informação da Rede Brasileira de Avaliação de Tecnologias em Saúde [Brazilian Network for the Evaluation of Health Technologies]) from 1980 to 2013. Articles were included if they were CUAs according to the classification devised by Drummond et al. Two independent reviewers screened articles for ...
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Several countries require manufacturers to present a budget impact analysis (BIA), together with a cost-effectiveness analysis, to support national funding requests. However, guidelines for conducting BIA of vaccines are scarce. To... more
Several countries require manufacturers to present a budget impact analysis (BIA), together with a cost-effectiveness analysis, to support national funding requests. However, guidelines for conducting BIA of vaccines are scarce. To analyze the methodological approaches used in published budget impact analysis (BIA) of vaccines, discussing specific methodological issues related to vaccines. This systematic review of the literature on BIA of vaccines was carried out in accordance with the Centre for Reviews and Dissemination - CRD guidelines. We searched multiple databases: MedLine, Embase, Biblioteca Virtual de Saúde (BVS), Cochrane Library, DARE Database, NHS Economic Evaluation Database (NHS EED), HTA Database (via Centre for Reviews and Dissemination - CRD), and grey literature. Two researchers, working independently, selected the studies and extracted the data. The methodology quality of individual studies was assessed using the ISPOR 2012 Budget Impact Analysis Good Practice II ...
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Pertussis incidence has increased significantly in Brazil since 2011, despite high coverage of whole-cell pertussis containing vaccines in childhood. Infants <4 months are most affected. This study aimed to evaluate the... more
Pertussis incidence has increased significantly in Brazil since 2011, despite high coverage of whole-cell pertussis containing vaccines in childhood. Infants <4 months are most affected. This study aimed to evaluate the cost-effectiveness of introducing universal maternal vaccination with tetanus-diphtheria-acellular pertussis vaccine (Tdap) into the National Immunization Program in Brazil. Economic evaluation using a decision tree model comparing two strategies: (1) universal vaccination with one dose of Tdap in the third trimester of pregnancy and (2) current practice (no pertussis maternal vaccination), from the perspective of the health system and society. An annual cohort of newborns representing the number of vaccinated pregnant women were followed for one year. Vaccine efficacy were based on literature review. Epidemiological, healthcare resource utilization and cost estimates were based on local data retrieved from Brazilian Health Information Systems. Costs of epidemiolo...
Research Interests: Pediatrics, Brazil, Medicine, Biological Sciences, Pregnancy, and 15 moreHumans, Hospitalization, Female, New Economic Models, Infant, Immunization, Cost effectiveness, Vaccination, Cohort, Newborn Infant, Cost Benefit Analysis, Tetanus, Diphtheria, Immunization Programs, and Medical and Health Sciences
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OBJECTIVE To describe methods and challenges faced in the health impact assessment of vaccination programs, focusing on the pneumococcal conjugate and rotavirus vaccines in Latin America and the Caribbean. METHODS For this narrative... more
OBJECTIVE To describe methods and challenges faced in the health impact assessment of vaccination programs, focusing on the pneumococcal conjugate and rotavirus vaccines in Latin America and the Caribbean. METHODS For this narrative review, we searched for the terms "rotavirus", "pneumococcal", "conjugate vaccine", "vaccination", "program", and "impact" in the databases Medline and LILACS. The search was extended to the grey literature in Google Scholar. No limits were defined for publication year. Original articles on the health impact assessment of pneumococcal and rotavirus vaccination programs in Latin America and the Caribbean in English, Spanish or Portuguese were included. RESULTS We identified 207 articles. After removing duplicates and assessing eligibility, we reviewed 33 studies, 25 focusing on rotavirus and eight on pneumococcal vaccination programs. The most frequent studies were ecological, with time series an...
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Objectives: The aim of this study was to evaluate in relation to diagnosis and treatment for Rheumatoid Arthritis (RA) patients Brazilian population, and compare the management offered to patients who are followed up in the public and... more
Objectives: The aim of this study was to evaluate in relation to diagnosis and treatment for Rheumatoid Arthritis (RA) patients Brazilian population, and compare the management offered to patients who are followed up in the public and private sectors.Material and Methods: An electronic questionnaire was sent to 650 rheumatologists, members of the Brazilian Rheumatology Society (SBR) and who were attending adult RA patients in the public and/or private sector, who had a contact e-mail address available in the SBR register and agreed to take part in the survey.Results: The rheumatologists estimated that 51.7% of the patients had had their disease diagnosed and of these, 56.1% were undergoing treatment. It was also estimated that 53.9% of the RA patients that was under treatment were being followed up by rheumatologists. The mean time interval estimated by the rheumatologists, between the appearance of the first symptoms of RA and the diagnosis made by a doctor, was greater among the p...
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OBJECTIVE: To analyze the cost effectiveness of the diagnostic program for the germline mutation in BRCA1/2 genes and of preventative strategies for the relatives of patients diagnosed with ovarian cancer associated with this mutation.... more
OBJECTIVE: To analyze the cost effectiveness of the diagnostic program for the germline mutation in BRCA1/2 genes and of preventative strategies for the relatives of patients diagnosed with ovarian cancer associated with this mutation. METHODS: The study analyzed the cost effectiveness by developing an analysis of the Markov decision process from the perspective of the National Health System. The strategies compared reflect upon the adoption of genetic testing and preventative strategies for relatives or the usual care currently proposed. The incremental cost-effectiveness ratio was expressed in terms of cost per case avoided. The sensitivity analysis was performed in a univariate and deterministic manner. RESULTS: The study showed increments for effectiveness and for costs when performing genetic testing and adopting prophylactic measures for family members. The incremental cost-effectiveness ratio was estimated at R$908.58 per case of cancer avoided, a figure considered lower than...
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The youth of Health Technology Assessment (HTA), as an institutional policy at the national level, signals the need to reflect on how its implementation took place under the perspective of its insertion in health policy and the scientific... more
The youth of Health Technology Assessment (HTA), as an institutional policy at the national level, signals the need to reflect on how its implementation took place under the perspective of its insertion in health policy and the scientific field. At the end of its first decade, these questions arise: has HTA translated into a health policy informed by science? Has its scientific foundation been used in the service of politics? To understand this political process, we apply the multiple-streams framework formulated by John Kingdon. The use of science to inform policy and the political use of science present themselves in an unstable balance. The survival of this policy will depend not only on science but on the art of orchestrating the interests of various agents so that HTA becomes a health policy for strengthening and sustainability of SUS.
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Resumo O texto se propõe a discutir o problema das doenças raras e drogas órfãs no contexto da ciência e da prática médica, sobretudo no que se refere ao desenvolvimento tecnológico produzido nesse âmbito, e ao processo de avaliação e... more
Resumo O texto se propõe a discutir o problema das doenças raras e drogas órfãs no contexto da ciência e da prática médica, sobretudo no que se refere ao desenvolvimento tecnológico produzido nesse âmbito, e ao processo de avaliação e incorporação de tecnologias nos sistemas de saúde. Esses processos têm gerado impactos importantes sobre a teoria, prática e políticas da Avaliação de Tecnologias em Saúde (ATS). Desenvolveu-se um estudo teórico, baseado em revisão de literatura das áreas da Medicina, Sociologia da Medicina, Ciência e Tecnologia em Saúde e Saúde Coletiva, com o objetivo de discutir esta questão a partir de uma abordagem interdisciplinar. Entre as doenças raras, foram privilegiadas aquelas decorrentes de alterações genéticas, por constituírem casos paradigmáticos para a compreensão dos desafios implicados à Medicina. A partir dos anos 1970, ocorreram mudanças significativas nas formas de diagnosticar, classificar e conhecer essas doenças, nas perspectivas clínica, labor...
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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... more
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 ...
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Managed Flow C20 (MFC20) is an integrated care pathway (ICP) for rectal cancer implemented at a public teaching hospital. This study aims to quantify resource utilization and estimate direct costs and outcomes associated with the use of... more
Managed Flow C20 (MFC20) is an integrated care pathway (ICP) for rectal cancer implemented at a public teaching hospital. This study aims to quantify resource utilization and estimate direct costs and outcomes associated with the use of this ICP. We evaluated consecutive rectal cancer patients treated with neoadjuvant chemoradiotherapy (nCRT) followed by surgery, comparing the period before the ICP implementation (Pre-MFC20 group) and after (MFC20 group). We assessed times between treatment steps and quantified the resources utilized, as well as their costs. There were 112 patients in the Pre-MFC20 group and 218 in the MFC20 group. The mean treatment intervals were significantly shorter in the MFC20 group - from the first medical consultation to nCRT (48.3 vs. 87.5 days; P < 0.001); and from nCRT to surgery (14.8 vs. 23.0 weeks; P < 0.001) - as was the mean total treatment time (192.0 vs. 290.2 days; P < 0.001). Oncology consultations, computed tomography, MRI, and radiothe...
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SUMMARY Objective: Despite the progress in the implementation of health promotion programs in the workplace, there are no questionnaires in Brazil to assess the scope of health promotion interventions adopted and their scientific basis.... more
SUMMARY Objective: Despite the progress in the implementation of health promotion programs in the workplace, there are no questionnaires in Brazil to assess the scope of health promotion interventions adopted and their scientific basis. This study aimed to translate into Brazilian Portuguese and culturally adapt the CDC Worksite Health ScoreCard (HSC) questionnaire. Method: The HSC has 100 questions grouped into twelve domains. The steps are as follows: translation, reconciliation, back-translation, review by expert panel, pretesting, and final revision. The convenience sample included 27 individuals from health insurance providers and companies of various sizes, types and industries in São Paulo. Data were analyzed using descriptive statistics. Results: The average age of the sample was 38 years, most of the subjects were female (21 of 27), and were responsible for programs to promote health in these workplaces. Most questions were above the minimum value of understanding set at 90...
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Research Interests: Brazil, Health Policy, Adolescent, Medicine, Biological Sciences, and 15 moreHumans, Child, Female, Young Adult, Vaccine, Vaccination, Aged, Middle Aged, Adult, Cost Benefit Analysis, Statistical models, Immunization Programs, Papillomavirus Infections, Uterine Cervical Neoplasms, and Medical and Health Sciences
OBJECTIVE To analyze the costs of vaccination regimens for introducing inactivated polio vaccine in routine immunization in Brazil.METHODS A cost analysis was conducted for vaccines in five vaccination regimens, including inactivated... more
OBJECTIVE To analyze the costs of vaccination regimens for introducing inactivated polio vaccine in routine immunization in Brazil.METHODS A cost analysis was conducted for vaccines in five vaccination regimens, including inactivated polio vaccine, compared with the oral polio vaccine-only regimen. The costs of the vaccines were estimated for routine use and for the “National Immunization Days”, during when the oral polio vaccine is administered to children aged less than five years, independent of their vaccine status, and the strategic stock of inactivated polio vaccine. The presented estimated costs are of 2011.RESULTS The annual costs of the oral vaccine-only program (routine and two National Immunization Days) were estimated at US$19,873,170. The incremental costs of inclusion of the inactivated vaccine depended on the number of vaccine doses, presentation of the vaccine (bottles with single dose or ten doses), and number of “National Immunization Days” carried out. The cost of...
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Os objetivos deste artigo são apresentar e comparar os resultados do estudo de custo-efetividade da vacina antimeningocócica C conjugada, no qual inserimos novos dados de custos denominados de "gastos familiares" para tratamento... more
Os objetivos deste artigo são apresentar e comparar os resultados do estudo de custo-efetividade da vacina antimeningocócica C conjugada, no qual inserimos novos dados de custos denominados de "gastos familiares" para tratamento de sequelas, coletados por entrevistas diretas com famílias de pessoas nessa situação, em relação ao modelo de análise apresentado por De Soarez et al, (2011), resultante de um projeto de pesquisa feito para o PNI (Programa Nacional de Imunização) sobre a viabilidade da antimeningocócica C na rotina de vacinação. Mostra-se como resultado que a inserção de novos custos modificou a relação de custo-efetividade da vacina em questão, tornando-a mais efetiva.
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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... more
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 whi...
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The aim of this study was to present the contributions of the systematic review of economic evaluations to the development of a national study on childhood hepatitis A vaccination. A literature review was performed in EMBASE, MEDLINE,... more
The aim of this study was to present the contributions of the systematic review of economic evaluations to the development of a national study on childhood hepatitis A vaccination. A literature review was performed in EMBASE, MEDLINE, WOPEC, HealthSTAR, SciELO and LILACS from 1995 to 2010. Most of the studies (8 of 10) showed favorable cost-effectiveness results. Sensitivity analysis indicated that the most important parameters for the results were cost of the vaccine, hepatitis A incidence, and medical costs of the disease. Variability was observed in methodological characteristics and estimates of key variables among the 10 studies reviewed. It is not possible to generalize results or transfer epidemiological estimates of resource utilization and costs associated with hepatitis A to the local context. Systematic review of economic evaluation studies of hepatitis A vaccine demonstrated the need for a national analysis and provided input for the development of a new decision-making ...
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A maioria das avaliações econômicas que participam dos processos de decisão de incorporação e financiamento de tecnologias dos sistemas de saúde utiliza modelos de decisão para avaliar os custos e benefícios das estratégias comparadas.... more
A maioria das avaliações econômicas que participam dos processos de decisão de incorporação e financiamento de tecnologias dos sistemas de saúde utiliza modelos de decisão para avaliar os custos e benefícios das estratégias comparadas. Apesar do grande número de avaliações econômicas conduzidas no Brasil, há necessidade de aprofundamento metodológico sobre os tipos de modelos de decisão e sua aplicabilidade no nosso meio. O objetivo desta revisão de literatura é contribuir para o conhecimento e o uso de modelos de decisão nos contextos nacionais das avaliações econômicas de tecnologias em saúde. Este artigo apresenta definições gerais sobre modelos e preocupações com o seu uso; descreve os principais modelos: árvore de decisão, Markov, microssimulação, simulação de eventos discretos e dinâmicos; discute os elementos envolvidos na escolha do modelo; e exemplifica os modelos abordados com estudos de avaliação econômica nacionais de tecnologias preventivas e de programas de saúde, diag...
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CONTEXT AND OBJECTIVE:Data on the costs of outpatient follow-up after liver transplantation are scarce in Brazil. The purpose of the present study was to estimate the direct medical costs of the outpatient follow-up after liver... more
CONTEXT AND OBJECTIVE:Data on the costs of outpatient follow-up after liver transplantation are scarce in Brazil. The purpose of the present study was to estimate the direct medical costs of the outpatient follow-up after liver transplantation, from the first outpatient visit after transplantation to five years after transplantation.DESIGN AND SETTING:Cost description study conducted in a university hospital in São Paulo, Brazil.METHODS:Cost data were available for 20 adults who underwent liver transplantation due to acute liver failure (ALF) from 2005 to 2009. The data were retrospectively retrieved from medical records and the hospital accounting information system from December 2010 to January 2011.RESULTS:Mean cost per patient/year was R$ 13,569 (US$ 5,824). The first year of follow-up was the most expensive (R$ 32,546 or US$ 13,968), and medication was the main driver of total costs, accounting for 85% of the total costs over the five-year period and 71.9% of the first-year tot...