Health Technology Assessment In Brazil Research Articles

HPR57 Health Technology Assessment and the Private Health Insurance Sector in Brazil: A Scoping Review

Health Technology Assessment (HTA) supports public policies in several countries. The institutionalization of HTA in Brazil began in 2000 at the Ministry of Health (MS) and had the participation of the National Regulatory Agency for Private Health Insurance (ANS). However, the public system and the private health insurance sector followed different paths in the consolidation of this policy. Different HTA processes in the country can generate rework, inefficiency and increase inequalities between the public and the private sector.

Expectations for the Development of Health Technology Assessment in Brazil.

The implementation of health technology assessment (HTA) in emerging countries depends on the characteristics of the health care system and the needs of public health care. The objective of this survey was to investigate experts’ expectations for the development of HTA in Brazil and to derive measures to strengthen the impact of HTA in Brazil on health care decisions. Based on a scoping literature review, a questionnaire was developed proposing eight theses for seven domains of HTA: (i) capacity building, (ii) public involvement, (iii) role of cost-effectiveness analysis (CEA), (iv) institutional framework, (v) scope of HTA studies, (vi) methodology of HTA, and (vii) HTA as the basis for jurisdiction. Thirty experts responded in full to the survey and agreed to five of the eight theses proposed. Experts suggested several measures to promote HTA within the scope of each domain, thus addressing capacity building related to HTA, availability, and reliability of population data, and legal endowment of the HTA system. Finally, HTA processes in Brazil should also address public health issues (e.g., appraisal of interventions directed at chronic diseases).

Public engagement in health technology assessment in Brazil: the case of the public consultation on National Clinical Guidelines for Care in Normal Birth

BackgroundThere is a growing body of literature that recognizes the importance of public engagement in health technology assessment. However, there is still uncertainty regarding how the results should be recorded, analyzed, and used by decision makers.ObjectiveSynthesize the contributions of the Brazilian public (women, health professionals, managers, educational institutions, and companies) about the implementation of the National Clinical Guidelines for Care in Normal Birth from the public consultation carried out in Brazil.MethodIRaMuTeQ software was used to organize and summarize the corpus based on three types of analysis: descriptive statistics; descending hierarchical classification; and specificities analysis. The public consultation was conducted in 2016 by the National Committee for Health Technology Incorporation (CONITEC) in the Brazilian public health system as part of the guideline development process.ResultsThe corpus consisted of 303 texts, separated into 1233 text segments, 1081 of which were used, corresponding to retention of 87.67%. Five classes emerged from our analyses: mandatory presence of an obstetrician during labor and delivery in hospital settings; barriers and facilitators for guideline implementation; use of evidence—based practices by health professionals; progression of labor and delivery and women’s rights; and mobilization to promote the guideline For each class, the most frequent words and sentences with the highest chi-squared scores were presented. Barriers were associated with lack of financial resources, training and professional motivation, and facilitators with training to change the practices of health professionals. Obstetric nurses emerged as an alternative for supervising normal births as well as the mandatory presence of an obstetrician during childbirth in hospital settings.ConclusionOur findings summarize the contributions provided by the Brazilian public and shed some light on the barriers and facilitators of clinical guidelines for care in normal birth. These topics are not typically explored by quantitative studies. Including this information in the decision-making process would not only increase public engagement, but provide greater evidence for implementing the clinical guidelines nationwide.

PNS68 Latin America HTA: Brazil and Argentina Report Card

Health Technology Assessment (HTA) bodies evaluate the clinical and/or economic impact of healthcare technologies to inform reimbursement policies. As global healthcare expenditure grows, many countries are instituting or expanding the roles of HTA to achieve more affordable and equitable healthcare. The National Committee for Health Technology Incorporation (CONITEC) is the national HTA in Brazil established 2011. In Argentina, plans to establish an official national HTA agency (Agency for Evaluation of Health Technologies; AGNET) have not yet been implemented; however, the Institute for Clinical Effectiveness and Health Policy (IECS, established 2003) issues HTA reports utilized by the interim national HTA agency (National Health Technology Assessment Commission; CONETEC). This research evaluates HTA reports by CONITEC and IECS. CONITEC and IECS HTA reports were identified from contitec.gov.br and www.iecs.org.ar (01/01/2018-31/12/2020) and key information extracted. 184 CONITEC HTA reports were identified (70 in 2018, 57 2019, and 56 2020). 47% of drug HTA report outcomes were to include in the Sistema Único de Saúde (SUS, Brazil’s publicly funded national healthcare system), 39% were not to be incorporated into the SUS, 9% were to expand the use of a medicine, 4% to not expand the use, and 4% were excluded/removed. 294 IECS reports were identified (125 in 2018, 70 in 2019, and 99 in 2020). 67% were HTA reports and 33% were individual patient requests. The most common indications assessed were in oncology (19%) and neurology (11%). CONITEC and IECS represent HTA bodies in two of the biggest Latin American pharmaceutical markets, both issuing an average of over 80 reports per year. CONITEC have been particularly impactful in Brazil, not recommending reimbursement of almost 40% of technologies assessed. The implementation of the new HTA body AGNET in Argentina and its impact on national access for medicines will be an important focus for future research.

Hospital-based health technology assessment in Brazil: current experiences and challenges

Abstract In Brazil, there is no consensus on the concept of hospital-based health technology assessment (HB-HTA). There is great variability in the existing models and difficulty in evaluating their results—whether in respect of clinical decisions, quality of care, and hospital policy and management or in respect of optimizing the use of resources. This study aims to discuss the experiences of HB-HTA, its integration into the regulatory system for the adoption of new technologies into the Brazilian public (SUS) (Unified Health System), and its main challenges. During a workshop, a panel of specialists in HTA and/or HB-HTA was formed, representative of four different perspectives: (i) Health services and health technology assessment units, (ii) Academia, (iii) Secretary of State for Health, and (iv) the Federal SUS sector. This was followed by discussion, a preliminary consensus, contributions from the audience, a plenary session, and a final consensus. HB-HTA is not institutionalized, nor is it part of the regulation system for the adoption of new technologies in the SUS. The main challenges are the difficulties in creating qualified teams, financial support, and sustainability. The work of these bodies in respect of the evaluation of new technologies deserves further studies analyzing the relationship between the pressure for adoption from the hospital team and industry professionals and legal rulings. It is necessary to strengthen HB-HTA culture and implement this policy in hospital management, making assessment bodies a part of managerial and decision-making processes in hospitals, and develop regional collaborative networks and a national network of HTA.

PP495 Addressing The Interactions Between Health Regulation And Health Technology Assessment In Brazil

IntroductionThe interaction of health technology assessment (HTA) and health regulatory agencies has been widespread, especially for decision-making in health system coverage. The objective of this paper is to report the HTA-regulatory interaction in Brazil.MethodsThis is a case study on the interaction between HTA and regulation in Brazil. Technical documents and Brazilian legislation on health regulation and HTA were analyzed. The study was conducted in July 2019.ResultsHTA-Regulatory Interaction in Brazil is still incipient. There is no responsible agency for interaction between agencies, as there is in Europe and Canada, for example. In the last 4 years, cooperation has started between the Brazilian Health Surveillance Agency (Anvisa) and the Oswaldo Cruz Foundation (Fiocruz) for post-registration monitoring of medicines. During this partnership, 170 post-marketing drug opinions were prepared, assisting the regulatory agency in decision-making.ConclusionsBrazil legislation guarantees essential medicines at low cost or free. The interaction between HTA and regulation has the potential to reduce the time taken to incorporate technology to the patient, in addition to ensuring greater safety for users of the Unified Health System. In this sense, it was observed that the interaction between health regulation and science and technology institutions has innovative potential in this approach.

Public engagement in health technology assessment in Brazil: the case of the Trastuzumab public consultation

BackgroundPublic engagement in health technology assessment (HTA) is increasing worldwide. There are several forms of public engagement and it is not always possible to determine which stakeholders participate in the HTA process and how they contribute. Our objective was to investigate which types of social representatives contributed to the public consultation on the incorporation of Trastuzumab for early-stage breast cancer treatment within the public health system in Brazil, held in 2012 by the National Committee for Health Technology Incorporation (CONITEC).MethodsA mixed methods approach was used to analyze social representativeness and the composition of the corpus from the public consultation, which consisted of 127 contributions. Three types of analysis were performed using IRaMuTeQ software: classic lexical analysis, descending hierarchical classification and specificities analysis. The contributions were clustered according to the main categories of discourse observed, into four social representation categories: 1) patient representation/advocacy; 2) pharmaceutical industry/advocacy; 3) healthcare professionals; and 4) individual contributions.ResultsCategory 1 contained words related to increased survival due to use of the drug and a low score for words pertaining to studies on Trastuzumab. The word “safety” obtained a positive score only in category 2, which was also the only category that exhibited a negative score for the word “risk”. Category 3 displayed the lowest scores for “diagnosis” and “safety”. The word “efficacy” had a negative score only in category 4.ConclusionsEach category exhibited different results for words related to health systems and to key concepts linked to HTA. Our analysis enabled the identification of the most prominent contributions for each category. Despite the promising results obtained, further research is needed to validate this software for use in analyzing public contributions.

PP100 Unraveling Hospital-Based Health Technology Assessment In Brazil

IntroductionIn Brazil, hospital-based health technology assessment (HB-HTA) units have been implemented countrywide since early 2000 to improve decision-making processes. Multiple-criteria decision analysis (MCDA) can provide a deeper understanding of a given subject. The present study used MCDA to evaluate capacity building among HB-HTA units in Brazil.MethodsThis study analyzed preliminary data from a survey developed and sent to all HB-HTA units in Brazil in 2018. The survey comprised 116 questions covering a wide range of aspects. Initially, an expert panel was organized, and 46 objective questions (out of 116) were selected by four experts. Next, these experts classified the selected questions by weighting them according to their relative importance. A Likert scale was used to identify the levels of importance, which were converted to weights ranging from zero to one. The experts then defined a final importance score threshold of 60 percent to classify units as fully operational. Grades below this threshold indicated the need for a more detailed evaluation. Of the 80 survey questionnaires, 23 were evaluated by the proposed method.ResultsImportance weights for each classification were defined as follows: personnel (25%); level of expertise (31%); work production (31%); and infrastructure (13%). The mean final importance score for the HB-HTA units was 68 percent. The maximum and minimum scores achieved were 95 percent and 15 percent, respectively. The HB-HTA units had been established for an average of 6 years, and ten of the 23 units were classified as fully operational.ConclusionsThe multicriteria method presented by this study simplified HB-HTA unit evaluation, reducing the subjectivity of results. Final importance scores for each unit's categories indicated which areas need improvement. Results from the study indicated that infrastructure and personnel could be greatly enhanced, even though the production profile was satisfactory.

The incorporation of nusinersen by the Brazilian Unified National Health System: critical thoughts on the institutionalization of health technology assessment in Brazil

In April 2019, a ruling was signed for the incorporation of the drug nusinersen by the Brazilian Unified National Health System (SUS). Nusinersen is the most expensive drug ever incorporated by the SUS and is used to treat type I 5q spinal muscular atrophy. The incorporation has been described as a milestone in decision-making on new technologies in the SUS, enabled through a risk-sharing agreement. The article discusses the process involved in the incorporation of nusinersen, highlighting the context, timing, and technical issues, in addition to possible consequences for the institutionalization of health technology assessment (HTA) in the SUS. The study used an exploratory method, reviewing public information produced by the Commission for Incorporation of Technologies in the SUS (CONITEC) and searches in government databanks on prices and purchases. A timeline was produced, describing the key points in the process of incorporation. There were two formal requests for the drug's incorporation. The first was submitted by the Division of Science, Technology, and Strategic Inputs (SCTIE) of the Brazilian Ministry of Health and was turned down unanimously in November 2018. This was followed by a petition by the head of the SCTIE to the Attorney General's Office (AGU) to overrule the recommendation by the CONITEC plenary. The AGU recommended a new submission, made by the drug's manufacturing company, which was approved unanimously in March 2019. The was no addition of new evidence or a price reduction to justify the change of decision. No elements were identified in the risk-sharing agreement. This suggests problems of transparency and accountability, as well as risks in the process of institutionalization of HTA that had been underway in the SUS.

OP124 Research Gaps In Health Technology Assessment In Brazil

Introduction:In 2017 the Brazilian Ministry of Health (BMH), through the Department of Science and Technology (DECIT) and in partnership with the Hospital Alemão Oswaldo Cruz (HAOC), financially supported research activities focused on health technology assessment (HTA) on topics deemed important by the BMH. The aim was to help resolve the priority health problems of the Brazilian population and to strengthen the management of the Unified Health System, within the scope of HTA.Methods:A survey of HTA research needs was carried out in all BMH sectors through internal meetings conducted by representatives from each of the sectors. The problems and needs were then discussed, prioritized, and transformed into research lines in a workshop sponsored jointly by DECIT and the HAOC. Following this, a specific public call was made to the HTA community to comment on the prioritized research lines. The submitted research projects were then judged and selected by a committee of experts in the field. The approved projects were contracted, and when the projects were completed the results were presented and discussed by the researchers in a final seminar for representatives of the BMH technical areas.Results:A total of 135 research gaps were identified, of which forty-two lines of research were included in the research call after the prioritization workshop and the search for evidence in the literature. The call involved an amount of BRL one million (USD 280,442), and seventeen research projects were financed, including two systematic reviews, seven rapid reviews, and eight economic evaluations.Conclusions:The promotion of research by the BMH has enabled the search for scientific evidence to support public policies and decision making in health services.

PP033 Patient And Public Involvement In Health Technology Assessment: The Brazilian Experience

INTRODUCTION:The National Committee for Health Technology Incorporation (CONITEC) (1) was created in 2011, when the participation of civil society in the Health Technology Assessment (HTA) process was formalized in Brazil. According to legislation, patient and public involvement (PPI) in HTA occurs through: public consultations (PC); representation of SUS (Brazilian Public Health System) users in the plenary of CONITEC and by public hearings in relevant cases. Due the incipient culture of social participation in Brazil, strategies involving better communication, direct participation and popular education were developed to broaden and qualify this participation.METHODS:•Case study about PPI strategies developed in 5 years of CONITEC•Analysis of documents and official records from the Brazilian Ministry of Health.RESULTS:Since its creation, the innovations of CONITEC regarding PPI were: creation of specific PC form to reproduce or represent the perspectives of patients and caregivers; summarized versions of technical reports written in a simplified language to improve users involvement; surveys prior to elaborating clinical guidelines, a bi-weekly educational program transmitted by streaming, and the recent launch of an HTA Users Guide and a mobile app.After the implementation of these strategies (which started in 2014), there was an increase of annual contributions, from 2,584 in 2014 to 13,619 in 2015. Most participants were patients, family members or caregivers. Surveys concerning clinical guidelines received about 3,000 contributions. There were thirty-seven published society reports until December 2016. The publication of the HTA Users Guide and other related actions increased the number of accesses to the CONITEC website and its subsection for social participation. The educational program had more than 800 online accesses in five months.CONCLUSIONS:These actions allowed expanding and qualifying PPI beyond what is legally defined, and it is possible to predict an increasingly favorable scenario regarding the patient and public participation in HTA in Brazil.

PHP59 - Health Technology Assessment In Brazil: Metrics From The Reports Of The National Commission For Incorporation Of Technologies (Conitec)

PHP59 - Health Technology Assessment In Brazil: Metrics From The Reports Of The National Commission For Incorporation Of Technologies (Conitec)

Health technology assessment (HTA) organizations: dimensions of the institutional and political framework.

Health technology assessment (HTA) is consolidated as a scientific and technological practice. The aim of this study is to identify HTA organizations from different settings and analyze their relevant dimensions in terms of effectiveness/impact, in order to address the challenges they face in Brazil. Narrative literature review based on data and websites of HTA organizations. There are well-established activity development processes in all organizations. These activities have specific features in their profile, in the process of technology assessment, decision and implementation of technologies that influence their potential impact on health systems. Agencies share in common the challenges of ranking the technologies to be assessed, and the implementation of their recommendations. Technical and political strengthening of the institutionalization of HTA in Brazil may foster scientific, technological and innovation policies, effectively impacting health policies. Resumo: A avaliação de tecnologias em saúde (ATS) está consolidada enquanto prática científica e tecnológica. O objetivo do estudo é identificar organizações de ATS de diferentes contextos e analisá-las de acordo com dimensões relevantes na avaliação de sua efetividade/impacto, buscando contribuir com os desafios enfrentados no contexto nacional. Revisão narrativa da literatura, realizada em bases de dados e web sites de organizações de ATS. Existem processos de desenvolvimento das atividades bem estabelecidos em todas as organizações. Elas apresentam particularidades no seu perfil, nos processos de avaliação, decisão e implementação das tecnologias que influenciam o seu impacto potencial sobre os sistemas de saúde. As agências compartilham os desafios de priorização das tecnologias a serem avaliadas e implementação das suas recomendações. O fortalecimento técnico e político do processo de institucionalização da ATS no contexto nacional poderá contribuir com as políticas científicas, tecnológicas e de inovação, impactando de forma efetiva as políticas de saúde.

A Perspective on the use of Health Technology Assessment in Brazil and Mexico

A Perspective on the use of Health Technology Assessment in Brazil and Mexico

Processo de Incorporação dos Inibidores de Protease para Hepatite C Crônica em Sistemas Públicos de Saúde: estudo de caso comparativo entre Brasil, Austrália, Canadá e Inglaterra.

Os estudos de Avaliação em Tecnologias em Saúde (ATS) subsidiam decisões quanto ao uso racional das tecnologias em saúde. Encontrar um equilíbrio entre a sustentabilidade dos sistemas de saúde, e o adequado acesso e utilização das tecnologias, representa um desafio e pressupõe o uso de ferramentas consistentes. Foram analisadas neste trabalho as características gerais das agências ou instituições responsáveis pela ATS, bem como o processo de avaliação e a incorporação dos inibidores de protease, telaprevir e boceprevir, para o tratamento da hepatite C crônica por meio de um estudo de caso comparativo de Brasil, Austrália, Canadá e Inglaterra. Trata-se de estudo de caso. Foi realizada pesquisa nos relatórios publicados sobre telaprevir e boceprevir, em 2013, nos endereços eletrônicos dos órgãos avaliadores dos países escolhidos. Observou-se, comparativamente a outras agências, que a Comissão brasileira (CONITEC), diferentemente das demais, aceitou a submissão e publicou no mesmo relatório a avaliação de medicamentos diferentes; sua composição tem perfil diverso das demais agências, cujos membros são indicados por sua expertise em ATS; o modelo de ATS é homogêneo entre os países; Houve divergências nos critérios de elegibilidade da população-alvo, mesmo com aprovação do medicamento; o preço praticado no Brasil foi o menor; a Comissão Brasileira definiu no relatório de avaliação da incorporação do telaprevir e boceprevir também as regras de organização da rede assistencial, a elaboração de protocolos clínicos e diretrizes terapêuticas.

PHP87 - Health Technology Assessment In Brazil: A Technical Analysis

The objective of this study was to evaluate the decisions provided by the National Commission for Health Technology Incorporation (CONITEC) from the Brazilian public health care system (SUS) submitted from January 2011 until September 2013. All the submissions to CONITEC were evaluated based on the data available at the Ministry of Health website. The submissions were categorized by the type of submission (inclusion or exclusion), type of applicant (public body or external) and type of technology (drug, health product or procedure). The status of each submission requesting the incorporation of a new technology was analyzed and the success rate of the submissions was calculated as the number of incorporations divided by the number of submissions. A total of 276 submissions were done to CONITEC and 261 of those (95%) required the incorporation of a new health technology. Among the incorporation submissions, 64% were related to drugs, 20% to procedures and 16% to health products. Forty six per cent of those submissions were done by public bodies. The status of the submissions in September 2013 was: 56 positive decisions for incorporation (22%), 39 negative decisions (15%), 99 submissions under evaluation (38%), 55 submissions denied for failure to comply with CONITEC requirements (21%), 5 submissions terminated at the request of the company (1.9%), 6 submissions considered outside the scope of CONITEC (2.3%) and 1 technology already incorporated by SUS (0.4%). The success rate of the submissions done by public bodies was 33% and 11% for external submissions. The rate of technologies incorporated by CONITEC was higher than the rate of negative decisions but the success rate is still limited. Most submissions are still under evaluation and the rate of submissions considered incompliant was high, showing that there’s a learning process to comply with the new CONITEC requirements.

Guardians of opportunity: emerging health technology assessment in Brazil, South Korea and Taiwan

When considering their health technology assessment (HTA) submission strategy, pharmaceutical manufacturers have traditionally focused on catering to the demands of agencies in developed markets: the requirements of the National Institute for Health and Care Excellence (NICE) in the UK, Common Drug Review (CDR) in Canada and Pharmaceutical Benefits Advisory Committee (PBAC) in Australia are familiar to many. However, in strategically important emerging markets such as Brazil, South Korea and Taiwan manufacturers' HTA submissions are becoming increasingly critical pivots for determining access to the presumed commercial opportunity inherent in these markets. Often, these markets serve as regional bellwethers, blueprinting consequences of a local negative HTA decision for high-opportunity neighbouring markets. What types of evidence are required by these ‘guardians of opportunity’ and how can manufacturers achieve their successful recommendation? How can HTA submissions to the Health Insurance Review Agency (HIRA; South Korea), Comissao Nacional de Incorporacao de Tecnologias no Sistema Unico de Saude (CONITEC; Brazil) and Centre for Drug Evaluation (CDE)/Bureau for National Health Insurance (BNHI; Taiwan) be optimised in the context of a global HTA strategy?

Institutionalizing Health Technology Assessment in Brazil: Challenges Ahead

The evolving process of institutionalizing health technology assessment (HTA) in low- and middle-income countries is not yet fully understood. The present article aims to provide an analysis of some of the most recent changes in the development of HTA in Brazil, as well as the main challenges and potential barriers that may determine the process of institutionalizing HTA in the country vis-à-vis the recent approval of its federal HTA law at the end of 2011. Based on the authors’ experience in HTA from an academic research perspective as well as from national and regional/local policymaking implementations, this article also proposes some measures to foster the institutionalization of HTA, for which Brazil would have to overcome three fundamental challenges for decision making: 1) Brazil has to complete an unfinished agenda regarding the implementation of its national Unified Health System (SUS), 2) the complex governance of the SUS has to be thoroughly reassessed, and 3) HTA institutionalization is to be promoted to strengthen decision making. The recent creation of a Brazilian national HTA body represents an important step not only in terms of the development of HTA in the country but also regarding the consolidation of the universal access to health care that is guaranteed by the Brazilian Federal Constitution since the creation of SUS in 1988. There is an urgent need to promote broader approaches to assess the complexity of the governance of the SUS, thus strengthening the process of HTA within the decision-making process.

Health technology assessment in Brazil: what do healthcare system players think about it?

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. Observational cross-sectional study at the 2006 and 2008 International Health Economics Symposia, in São Paulo. 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. 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. 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.

Avaliação de tecnologia em saúde: II. A análise de custo-efetividade

New health technologies have made an impact in clinical and economic outcomes. Therefore, research methodologies that allow to evaluate the efficiency of these new technologies such as cost-effectiveness analysis are necessary. Cost-effectiveness analysis assess the value of health care interventions or drugs, the technology. Cost-effectiveness analysis is also deemed a determinant of modern health care practice, because the therapeutic options available at public (SUS) or private health care system must go through a formal health technology assessment in Brazil; thus, both the health care system and the health care professionals have to reevaluate the clinical consequences and costs of their actions to assure that the most efficient technologies are the one used in the practice. In this second article about health technology assessment we review the concepts of cost-effectiveness analysis, the steps involved in performing such analysis, and the criteria most frequently used to critically review the results.