scholarly journals Social participation in the health technology incorporation process into Unified Health System

2019 ◽  
Vol 53 ◽  
pp. 109
Author(s):  
Aline Silveira Silva ◽  
Maria Sharmila Alina de Sousa ◽  
Emília Vitória da Silva ◽  
Dayani Galato
Keyword(s):  
Health System ◽  
Social Participation ◽  
Health Technology ◽  
Public Consultation ◽  
National Committee ◽  
Health Technologies ◽  
Unified Health System ◽  
Health Council ◽  
Public Hearings ◽  
Other Information

OBJECTIVE: To describe the current process of social participation in the incorporation of health technologies in Brazil, within the context of the Unified Health System (SUS). METHODS: A descriptive study was conducted based on the analysis of official records of the actions of the National Committee for Health Technology Incorporation into Unified Health System and its website, from the beginning of its activities in January 2012 until December 2017. RESULTS: The findings indicate that, in Brazil, there are legal instruments related to social participation in health, including the health technology assessment (HTA) field. However, its implementation is relatively recent and has been carried out gradually. In addition to the legal instruments (National Health Council representative, public consultation and public hearing forecast), other information and transparency strategies have been shown to be allied to social participation in the incorporation of health technologies. However, activities such as legally provided public hearings have not yet been carried out. CONCLUSIONS: Several actions to foster social participation were developed over the analyzed period, but they need to be evaluated in order to maintain or improve them. In addition, there is a need for more qualified social participation in the various existing spaces, including those prescribed by law.

OP133 Health Technology Assessment In Brazil: A 5-year Review Of Brazilian Health System (CONITEC) Activities

2017 ◽  
Vol 33 (S1) ◽  
pp. 62-62 ◽  
Author(s):  
Roberta Rabelo ◽  
Vania Canuto ◽  
Clarice Petramale ◽  
Tacila Mega
Keyword(s):  
Health Technology Assessment ◽  
Health System ◽  
Technology Assessment ◽  
Public Management ◽  
New Technologies ◽  
Health Technology ◽  
National Committee ◽  
Health Technologies ◽  
Health Council ◽  
Brazilian Health System

INTRODUCTION:Since the creation of the National Committee for Health Technology Incorporation in the Brazilian Health System (CONITEC), a new phase started in the public Brazilian Health System (SUS): a continuous updating of the system based on Health Technology Assessment (HTA). CONITEC was created by federal law in 2012 and is responsible for advising the Ministry of Health regarding the incorporation or disinvestment of health technologies. The whole process involves a strong interaction with society, including the composition of the committee, which has the participation of the National Health Council. The objective of this study was to describe the results of CONITEC in five years of operation.METHODS:This is a retrospective descriptive study, based on information from the database (period 2012–2016) and CONITEC's website.RESULTS:Since 2012, CONITEC assessed 541 technologies, including drugs (360), health products (71) and procedures (110); 303 assessment requests came from SUS agencies and institutions and the other 238 requests from pharmaceutical companies, medical societies, patient associations and the judiciary bodies. In this period, there were 190 public consultations, during which more than 24,000 feedback from society were received. The average time for evaluation was 146 days. The committee recommended the incorporation of 186 technologies into SUS, the disinvestment of 43 and was unfavorable to the incorporation of 88, generating a budgetary impact of approximately BRL2.5 billion (USD764 million).CONCLUSIONS:From 2012–2016, CONITEC tripled the average annual incorporation of new technologies compared to the period 2006–2011. In this process, it was necessary to assess efficacy, safety and cost-effectiveness of technologies, generating positive results for the expansion of access, health gains for patients and sustainability for the system. It should be considered that the use of evidence for decision making strengthens transparency in public management and the development of active processes of information, communication and social participation.

OP158 Overview Of Technology Assessment For Multiple Sclerosis In The Brazilian Public Health System

2018 ◽  
Vol 34 (S1) ◽  
pp. 57-58
Author(s):  
Kathiaja Souza ◽  
Flavia Salomon ◽  
Artur Felipe de Brito
Keyword(s):  
Public Health ◽  
Multiple Sclerosis ◽  
Clinical Practice ◽  
Health System ◽  
Clinical Practice Guideline ◽  
Practice Guideline ◽  
Public Health System ◽  
Health Technology ◽  
National Committee ◽  
Health Technologies

Introduction:The National Committee for Health Technology Incorporation (CONITEC) has a structured process for the incorporation, disinvestment, or alteration of different health technologies in the Brazilian public health system and provides technical support for the decision-making process. Since its creation, CONITEC has received several submissions for the incorporation of medicines and the update of clinical practice guidelines for multiple sclerosis (MS). Nowadays, more than twelve different therapies are currently available to treat MS and the Brazilian clinical practice guideline, which was last updated in 2015, offers six medicines to treat MS that are divided into first, second, and third line treatments. The purpose of this study was to describe CONITEC's assessments of applications for incorporation, disinvestment, or alteration of medicines for MS.Methods:A case study method was used to evaluate information, retrieved from CONITEC's database, about the health technology reports developed by CONITEC's Executive Secretariat in response to applications received in the period from 2012 to 2017.Results:Ten technical reports on health technologies for MS were produced by CONITEC during the study period. This number represented four percent of the external submissions for incorporation of technologies for several clinical conditions in the public health system. Six medicines were evaluated. The highest number of submissions were for incorporation (n = 6), followed by alteration of treatment lines (n = 3), and disinvestment (n = 1); fifty percent of the submissions were not recommended. The main reasons for rejection were low or unproven efficacy, high budget impact, and inadequacy of the proposal based on the evidence presented. CONITEC's favorable recommendations caused a profound change in the current clinical practice guideline and had a significant impact on the health system.Conclusions:MS is considered a rare disease in Brazil, but there is significant pressure from society to provide better treatment options that will impact the MS scenario in the health system. The recent CONITEC assessments have led to a revolution in the treatment of MS in Brazil, which is now in the process of being updated.

scholarly journals Social participation in the unified health system of Brazil: an exploratory study on the adequacy of health councils to resolution 453/2012

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rita de Cássia Costa da Silva ◽  
Maykon Anderson Pires de Novais ◽  
Paola Zucchi
Keyword(s):  
Health Policy ◽  
Health System ◽  
Board Of Directors ◽  
Monitoring System ◽  
Social Participation ◽  
Legal Regulation ◽  
Unified Health System ◽  
Health Council ◽  
Qualitative Variables ◽  
The Board Of Directors

Abstract Introduction Social participation is one of the guidelines of the Brazilian health system. Health councils are collegiate instances of participation established by Law 8.142/90. The most recent legal regulation for council organization and functioning was established through Resolution 453/2021. The institution of health councils has a permanent and deliberative nature to act in the formulation, deliberation and control of health policy implementation, including in economic and financial aspects. Objective To evaluate the compliance of health councils with the directives for the establishment, restructuring and operation of the councils from Brazil, based on Resolution 453/2012. Methods An exploratory, descriptive study that used the Health Council Monitoring System as a data source. Qualitative variables were selected to identify the characteristics related to the councils’ establishment (legal instruments for establishment), the strategies adopted for restructuring (budget allocation, existence of an executive secretariat, provision of a dedicated office) and the characteristics of the health councils’ operation (frequency of regular meetings, existence of a board of directors, the election of the board of directors). Results The study analyzed three groups of characteristics related to the constitution, strategies adopted for restructuring and the functioning of the councils. Regarding the constitution of the councils, the findings revealed that the vast majority was constituted in accordance with the legislation and, therefore, is in compliance with Resolution 453/2021. In the second group of characteristics that describe the restructuring of councils, the study found that less than half of registered councils are in compliance with the standard. And, finally, in the third group of characteristics, it was found that the boards have adopted different frequencies for regular meetings and approximately 50% of the boards studied have a board of directors. Conclusions The councils still do not meet the minimum conditions necessary to fulfil their role in the Unified Health System (SUS), as stipulated in Resolution 453/2021. This situation requires monitoring by public oversight agencies. Despite the increase in popular participation with the creation of the health councils, this study demonstrated that most councils still do not meet the minimum conditions for monitoring public health policy. The improvement of the Health Councils Monitoring System (SIACS) to become an instrument for monitoring the councils, with the definition of goals and results, may contribute to the organization of the councils and, therefore, to the realization of social participation in Brazil.

PD60 Public Consultations And Their Influence On Health Decisions

2018 ◽  
Vol 34 (S1) ◽  
pp. 151-152
Author(s):  
Tacila Mega ◽  
Roberta Rabelo ◽  
Aline Silva ◽  
Artur Felipe de Brito
Keyword(s):  
Decision Making ◽  
Scientific Information ◽  
Health Technology ◽  
Public Consultation ◽  
National Committee ◽  
Decision Making Process ◽  
The Public ◽  
Health Technologies ◽  
Public Consultations ◽  
Economic Studies

Introduction:Public consultation is one of the phases provided by the law that rules the health technology incorporation process in Brazilian Public Health System (SUS). In the Brazilian model, anyone can participate as long as he/she identifies her/himself. During the decision-making process these suggestions are analyzed by the National Committee for Health Technology Incorporation (CONITEC) and, sometimes, they are responsible for changing a preliminary recommendation for a technology. This study aims to identify the health technologies for which CONITEC revised the initial negative recommendations due to the contributions received during the public consultation.Methods:A descriptive study using as input data the information on coverage decisions available on the CONITEC website.Results:Since CONITEC's creation until October 2017, CONITEC enacted 241 public consultations. Fifteen cases of change to the preliminary negative recommendation were found and among these eight (53 percent) had the economic studies or proposed technology price reconsidered by the companies. In the other seven decisions, the Board also regarded as important the reasons for changing the initial recommendation: new evidence on efficacy and safety as well as the analysis of different outcomes previously unconsidered in the preliminary assessment.Conclusions:During the public consultations, besides technical-scientific information, personal experiences and opinion reports on each health technology analyzed, CONITEC received new price offers and economic studies from the applicants. This new material has allowed, in some cases, these technologies to become competitive and to be included as alternatives to those already available, provided there is no clinical impairment. This study reinforces the importance of the public consultation and social participation in the process of health technologies incorporation in Brazil, considering its capacity to add new information to the decision-making process.

OP103 CONITEC's Rapid Reports As Technical Support In The Litigation

2017 ◽  
Vol 33 (S1) ◽  
pp. 46-47
Author(s):  
Eliete Simabuku ◽  
Carla Biella ◽  
Izamara Catanheide ◽  
Sarah Silva ◽  
Vania Canuto
Keyword(s):  
Decision Making ◽  
Health System ◽  
Technical Assistance ◽  
Treatment Options ◽  
Technical Information ◽  
National Committee ◽  
Evidence Based ◽  
Health Technologies ◽  
Unified Health System ◽  
State Defense

INTRODUCTION:The Unified Health System (SUS) is based on the principle of health as a citizen's right and the state's duty, which must be guaranteed based on public policies. Although there are several legislations, lists of medicines and clinical guidelines, Brazilians who have been prescribed expensive technologies that are not part of the essential drug lists ask judges to issue court orders obliging public health managers to purchase these drugs or to provide elective medical procedures immediately. Due to the health technical inexperience from judges, prosecutors and public lawyers, a partnership has arisen for the National Committee for Health Technology Incorporation (CONITEC) to provide technical assistance to help their decision-making process. Thus the purpose of this study is to describe CONITEC's experiences in communicating with stakeholders in this process.METHODS:A case study method was used and information about the rapid reports developed by CONITEC's Executive Secretariat in response to the applicants in the period of 2012 to 2016, was retrieved from CONITEC database.RESULTS:Rapid reports (2,773) about health technologies incorporation such as medicines, procedures or medical devices were produced by CONITEC during this period. Most requests covering topics as treatments for diabetes, arterial hypertension, osteoporosis, oncology and epilepsy; diseases for which there are several treatment options in SUS. The data analysis indicated that CONITEC contributed to the evidence based decision-making. On one hand, the Prosecutor's Office has been increasingly requesting information before starting lawsuits and Judiciary Power has increasingly used evidence-based technical information before deciding on the concession of injunctions; on the other hand, from 2012 to 2016 the number of requests decreased for information to State defense in lawsuits that has been already established.CONCLUSIONS:There is a growing interest in technical knowledge for fair decision making that respects the current organization of the evidence-based health system.

scholarly journals Announcing the Canadian Journal of Health Technologies — A New Journal From CADTH

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Nicole Mittmann
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Health System ◽  
Canadian Journal ◽  
Health Technology ◽  
Health Care Decision ◽  
Health Technologies ◽  
Care Decision

The COVID-19 pandemic has put a spotlight on science and reaffirmed the value of evidence in health care decision-making. CADTH is a major Canadian publisher of evidence, advice, and recommendations regarding the assessment and management of health technologies. The Canadian Journal of Health Technologies will publish CADTH work in a single, PubMed-indexed, online location, making it easier for our health system partners to search and find CADTH work. Through the Canadian Journal of Health Technologies, CADTH will expand its reach and its collaborations with producers and users of health technology assessments.

OP316 Patients’ Testimonials In The National Committee For Health Technology Incorporation In Brazilian Public Health System (Conitec) Meetings

2021 ◽  
Vol 37 (S1) ◽  
pp. 12-13
Author(s):  
Clarice Portugal ◽  
Adriana Prates ◽  
Luiza Losco ◽  
Fabiana Floriano ◽  
Odete da Silva ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Patient Participation ◽  
Technology Assessment ◽  
Selection Process ◽  
Health Technology ◽  
Public Consultation ◽  
National Committee ◽  
The Public ◽  
Construction Of Knowledge ◽  
Main Representative

IntroductionThe Department of Management and Incorporation of Technologies and Innovation in Health (DGITIS) acts as Conitec's Executive Secretariat. Among its attributions, it promotes the public/patient involvement in the health technology assessment (HTA) process. Recently, Conitec has been working on the inclusion of patient's testimonials about their illness experience in the plenary sessions, that is, the monthly meeting where technologies are assessed.MethodsTo support the action of including patient reporting in Conitec's HTA process, DGITIS developed research on HTA agencies websites worldwide. The main criteria was the inclusion of patients’ reports in their Committee meetings. DGITIS contacted some of these agencies and requested a listserv question to the International Network of Agencies for Health Technology Assessment (INAHTA) members. These findings supported the DGITIS for the inclusion of patient participation in Conitec's meetings, from the selection process to the actual participation.ResultsFor the Conitec's HTA process, the patients’ participation should occur in the prior session to the public consultation, guaranteeing the inclusion of their perspective since the recommendation process beginning. Hence, every demand for incorporation to be discussed at Conitec's meeting should be preceded by a public call for patients with the clinical condition. The DGITIS will also hold preparatory meetings, which will serve as moments for shared construction of knowledge and literacy.ConclusionsThe nomination process, so far, has been grounded as a consensus among the patients. Thus, Conitec acts as a mediator, connecting the involved stakeholders, in a way that they can autonomously organize themselves and indicate the main representative and an alternate one. With the inclusion of the patient's perspective in the Conitec's meeting, another form of patient participation was opened in the HTA process. Therefore, the consolidation of this participation space is feasible and contributes to enrich the Brazilian HTA process.

VP214 Criteria That Influence The Brazilian Public Decision-Making

2017 ◽  
Vol 33 (S1) ◽  
pp. 248-248
Author(s):  
Andrea Brígida de Souza ◽  
Marisa Santos
Keyword(s):  
Public Health ◽  
Decision Making ◽  
Health System ◽  
Public Health System ◽  
Bipolar Affective Disorder ◽  
Health Technology ◽  
Multiple Criteria ◽  
Emission Computed Tomography ◽  
Hematopoietic Stem ◽  
Health Technologies

INTRODUCTION:In Brazil, the National Committee for Health Technology Incorporation in the public health system (CONITEC) advises the Ministry of Health about incorporation, exclusion and alteration of health technologies in Brazilian public health system (SUS). Decision making considers multiple criteria, included or not in legislation. This analysis was the first step for a multiple-criteria decision analysis (MCDA) building. This study aims to identify criteria that influence Health Technology Assessment (HTA) for SUS.METHODS:Five real cases of controversial recommendations of technology incorporation made by CONITEC were reviewed by listening to the plenary recordings and reviewing committee minutes. The choice was guided by convenience, with prioritization according to CONITEC's members, using a pre-defined standardized form. Weight in decision making was also raised and identified. Selected technologies judgments were: Trastuzumab for metastatic/advanced Breast Cancer; Fingolimod for Multiple Sclerosis; Clozapine, Lamotrigine, Olanzapine, Quetiapine and Risperidone for Bipolar Affective Disorder; Hematopoietic stem cell transplantation for Sickle Cell Disease; and Positron Emission Computed Tomography (PET-CT) for Lung Cancer and for hepatic metastasis from Colorectal Cancer.RESULTS:The choice of different technologies allowed verifying specific criteria used for the incorporation of each type of technology, as well as the similar criteria discussed and used by all these technology types. In addition, some identified criteria were specific to the Brazilian reality, such as: “Incorporation by other countries”, “Potential technologies without registration in Brazil” and “Off-label use”. These criteria were not previously identified in studies conducted in other countries. Some criteria have been identified in all decisions, such as: efficacy, disease severity, quality and confidence in the evidences, logistic challenges for implementation, unmet needs, budget impact and treatment costs. Relative impact of cost-effectiveness was considered low.CONCLUSIONS:CONITEC's recordings are an important source to understand the Brazilian decision-making process. To identify the important criteria can help to standardize and improve the HTA process.

OP113 Iramuteq Analysis Of Trastuzumab's Public Consultation In Brazil

2018 ◽  
Vol 34 (S1) ◽  
pp. 42-43
Author(s):  
Viviane Carvalho ◽  
Everton Silva ◽  
Maria-Sharmila Sousa ◽  
Ricardo Sampaio ◽  
Jorge Barreto
Keyword(s):  
Breast Cancer ◽  
Pharmaceutical Industry ◽  
Health Professionals ◽  
Public Involvement ◽  
Public Consultation ◽  
National Committee ◽  
Efficient Tool ◽  
Health Technologies ◽  
Class 1 ◽  
Public Consultations

Introduction:In Brazil, the “Sistema Unico de Saúde” (SUS) is a public health system that has universal coverage, comprehensive care, and principles like community participation. The incorporation, update or exclusion of new health technologies is done by the National Committee for Technology Incorporation (CONITEC), which issues reports on the incorporation of technologies and submits them to public consultations, which is the main mechanism of public involvement and an opportunity to influence the decision to access and coverage to new health technologies. Our study aimed to investigate a typology of social representations on the contributions from 2012 to the CONITEC's public consultations to the incorporation of Trastuzumab for the treatment of initial breast cancer in Brazil.Methods:Our study deployed a mixed-methods approach to semi-quantitatively analyze the social representativeness and corpus composition of all the public consultation contributions for the recommendation of the Trastuzumab's incorporation for treatment of initial breast cancer within SUS, as well as the authors' qualitative analysis of the IRAMUTEQ software as a potential effective and efficient tool to semi-qualitatively analyze such public consultations. All contributions were included (127 contributions, from several Brazilian states) and organized into a single corpus, which was submitted to 5 types of analyzes (classical lexical analysis, analysis of group specificities, descending hierarchical classification; similitude analysis and word cloud).Results:The general corpus consisted of 114 texts, separated into 685 text segments (TS), with use of 79.12 percent of total TS (684). The analyzed content was categorized into four classes: Class 1 – Patient Representations/ Advocacy (186 ST-34.3 percent); Class 2: Pharmaceutical Industry/ Advocacy (181 ST-33.4 percent); Class 3: Health Professionals (81 ST-14.9 percent); and Class 4: Individual Contributions (94 -17.3 percent). Class 1 corpus consisted mostly of contributions made from a breast cancer patient association/ advocacy report, which focused mainly on lay expertise terminology. We observed a proximity in corpus between Classes 2 and 3, showing a potential approximation between the pharmaceutical industry and health professionals' contributions, to whom the main word occurrences related to health technologies. Class 4 corpus focused on improvement and individual need, as well as in corpus referring to SUS.Conclusions:From our findings, we observed: (i) a potential similarity in contributions of health professionals and pharmaceutical industry; (ii) how lay expertise might affect the contributions of patients individually and within advocacy and patient organizations; and (iii) the uses and limitations of IRAMUTEQ as potentially effective and efficient tool to semi-qualitatively analyze health technology assessment public consultation contributions.

PP155 The Impact Of Lawsuits In The Brazilian Public Health System

2017 ◽  
Vol 33 (S1) ◽  
pp. 141-141
Author(s):  
Carla Biella ◽  
Viviane Pereira ◽  
Fabiana Raynal ◽  
Jorge Barreto ◽  
Vania Canuto ◽  
...  
Keyword(s):  
Public Health ◽  
Health Care ◽  
Health System ◽  
Public Health System ◽  
Scientific Evidence ◽  
Health Technology ◽  
Health Technologies ◽  
Access To Health ◽  
The Right ◽  
The Impact

INTRODUCTION:The increase of litigation in Brazil on the right to health, and the Brazilian Public Health System (SUS) targets of litigation, are phenomena that generate discussions both in the judiciary, and among researchers and managers of health. The lawsuits are based on the integrality that includes the right to any health technology. Our aim was to gather information on the use of scientific evidence by judges and other law professionals to support their decisions in lawsuits involving health care in Brazil.METHODS:A narrative review by literature search using key terms of legalization in specific databases was conducted.RESULTS:Twenty-five studies showed litigation matters relating to health care which were focused on legal claims about drugs. In general, law operators used the scientific evidences in a limited way when making decisions, by considering the medical report and medication label indications and disregarding therapeutic alternatives contemplated in the SUS list. The access to health technologies, by litigation, reveals that the gap between scientific knowledge and legal practice are similar to those found between science and decision-making in the formulation and implementation of health policies. The Health Technology Assessment studies have high potential for use by the judiciary as a reference source to support technical and scientific decisions in lawsuits on health care.CONCLUSIONS:For the judiciary to ensure not only access to health technologies, but also the efficacy and safety of technologies to system users, their decisions must be substantiated by scientific evidence. The National Committee for Health Technology Incorporation (CONITEC) in SUS has established actions in conjunction with law operators and society, such as a communication using e-mail, aiding the decision for the injunction and elaboration of technical reports and a policy brief, with the intention that the decisions are taken with the greatest possible knowledge about technologies provided by SUS, and based on scientific evidence.

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