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PP152 Options To Approach Health Litigation In Brazil: A Policy Brief
- Carla Biella, Fabiana Raynal, Viviane Pereira, Laura Boeira, Marcel Carvalho, Vania Canuto Santos, Clarice Petramale, Artur Felipe de Brito, Jorge Barreto
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 126-127
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Introduction:
In Brazil, health is a constitutional right and the government is responsible for its guarantee. The Brazilian health system is characterized by universality, equality, and integrality, but citizens still strive to guarantee their rights through litigation. This work aimed to develop an evidence brief to support the decision-making process of judges with respect to health technologies, based on scientific evidence.
Methods:Support tools from the Evidence-Informed Policy Network (EVIPNet) were used to develop the evidence brief. After defining and describing the problem, a comprehensive search was conducted in PubMed, Health Systems Evidence, The Campbell Library, The Cochrane Library, Rx for Change, and PDQ-Evidence for systematic reviews published from 2010 to 2016. Nine systematic reviews were found. Review selection and quality appraisal were conducted independently by two reviewers. Three strategies for addressing the health litigation were defined. Evidence was summarized on benefits, harms, resource use, cost-effectiveness, uncertainties, and implementation. Implementation barriers and facilitators were also described.
Results:Three strategies were found: (i) Rapid response services to support evidence-informed decision making in health technology decisions—educational activities and materials were described as an effective way to involve different stakeholders and inform decision making, even when financial reallocation is needed; (ii) Continuing education programs focused on developing health technology assessment knowledge among law workers—continued education and educational outreach may be effective in knowledge and ability acquisition and retention, changing professional practices. Eventual lack of interest from or availability of the professionals can be addressed by involving leaders and opinion makers, as well as offering multimedia educational materials and activities adapted for the public; and (iii) Restorative justice conferencing (RJC) focused on the litigation of health technologies—the use of RJC through face-to-face meetings or social councils involves citizens in the decision-making process, including resource management. There are multiple barriers to this option (e.g. a lack of understanding among the public, conflicts of interest, a lack of professionals capable of conducting RJCs, and the need for legal reformulation) because of its unprecedented use in the healthcare setting. Opinion leaders should be invited to facilitate communication and the decision-making process among citizens, government, and the law.
Conclusions:This evidence brief will be debated among interested parties and presented to the health minister and state secretaries in order to implement the strategy options, once regional specificities are taken into account.
PD65 The Acquisition Of Eculizumab By Judicial Proceeding In Brazil
- Flavia Salomon, Eliete Simabuku, Jose Beutel, Eduardo De Oliveira, Roberta Rabelo, Clarice Petramale, Artur Felipe de Brito, Kathiaja Miranda Souza
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 153-154
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Introduction:
Eculizumab is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) or with atypical hemolytic uremic syndrome (aHUS). In Brazil in recent years eculizumab was the most expensive drug requested through court orders, obliging public health managers to import it from the USA. From 2012 to 2016, approximately BRL 424 million (USD 112 million) was spent on eculizumab. The purpose of this study was to assess the regulatory situation and the scientific evidence on the safety and efficacy of eculizumab.
Methods:A literature search was conducted in PubMed, The Cochrane Library, and the Centre for Reviews and Dissemination databases on September 2017. The websites of regulatory agencies were also searched.
Results:In 2007, the use of eculizumab was approved by the United States Food and Drug Administration and the European Medicines Agency. In Brazil, despite the provision of eculizumab through judicial proceedings since 2009, the manufacturer of eculizumab only requested a licence for it in 2017, after several meetings with the government when the company agreed to provide the drug at approximately half the price of the imported product. The efficacy of eculizumab in PNH patients was assessed in one randomized, placebo controlled study, one single arm study, and one long-term extension study. The drug reduced hemolysis and the need for transfusion, although the studies had methodological problems. The efficacy of eculizumab in the treatment of aHUS was assessed in four prospective, controlled open-label studies, two long-term extension studies, and one retrospective study. Eculizumab normalized platelet counts and reduced the need for plasmapheresis, although the studies had no control group. Eculizumab was well tolerated, with no meningococcal infections occurring after patients were immunized.
Conclusions:Some companies have no interest in licensing their products in Brazil because their provision by judicial proceedings is more lucrative. This situation promotes litigation and irrational prescription of drugs, and also obligates the Brazilian government to import expensive health products.
PP109 Horizon Scanning For Information Providing In Brazil
- Pollyanna Gomes, Avila Vidal, Andrea Brígida de Souza, Vania Canuto, Clarice Petramale
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 123-124
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INTRODUCTION:
The last five years represented an advanced season for the establishment and reinforcement of the Brazilian Ministry of Health's Horizon Scanning System. The recognition of Horizon Scanning (HS) as a tool for evidence- based decision making has been reflected in the requests for information directed to the Horizon Scanning's team. These requests for information about new and emerging technologies come from cabinets offices and thematic departments of the Ministry of Health. The methodology of Horizon Scanning assessments described in EuroScan's toolkit1 has been applied to guarantee that the information reach stakeholders at the right time. The National Committee for Health Technology Incorporation (CONITEC) was accepted as a member of EuroScan (1) in 2016, and this represented another important step of Brazil's HS System.
METHODS:In order to provide the specific information requested, the assessments of the technologies are done. So, databases on ongoing clinical trials, commercial pharmaceutical database, registration and licensing sites, proceedings and abstracts of scientific conferences and scientific databases are checked to collect the information. The extent and depth of the assessments depends on the stakeholders needs and time available to complete them. However, information as how the technology works, the clinical burden of disease, if there are available technologies in the Brazilian Public Health System to treat the disease, safety and effectiveness data, the regulatory status in the world as well costs, social, ethical and legal concerns are commonly given.
RESULTS:The information provided using the HS methodology is used by stakeholders for several purposes as to defend the Ministry of Health in the Courts in the typical Latin American phenomena called “judicialization of health;” in assistance of the decision making of incorporation of technologies by the Brazilian Public Health and to support the definition of which medicines would be more strategic for establishment of Public-private partnerships for development of medicines, the named “Productive Development Partnerships (PDPs)”.
CONCLUSIONS:The assessment of the technologies and the prediction of its potential for impact has helped the health policy making process in Brazil.
OP40 First Case Of Disinvestment Using Real-World Evidence In Brazil
- Livia Pires de Lemos, Augusto Guerra, Ramon Pereira, Rosangela Gomes, Isabella Godói, Isabela Diniz, Ivan Zimmermann, Marisa Santos, Marion Bennie, Brian Godman, Vania Canuto, Clarice Petramale, Francisco Acurcio
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 18-19
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INTRODUCTION:
Beta-interferons are used as first-line therapy for relapsing-remitting multiple sclerosis in Brazil. In order to evaluate the possible inferiority of one of the beta-interferons available and support a guideline update, we conducted an eleven-year (January 2000 to December 2010) nationwide real-world performance assessment using the Unified Health System (SUS) databases.
METHODS:We assessed whether patients using subcutaneous beta-interferon switched treatment, relapsed or died (composite event) earlier than patients using intramuscular beta-interferons. Patients without a dispensing registry longer than three months were censored. We used the Kaplan-Meier method to estimate the cumulative probability of persistence on initial treatment, and compared groups with the Log-rank test. The influence of the drug on the occurrence of event was assessed with Cox proportional hazards analysis.
RESULTS:The number of patients included was 12,154, and the majority started treatment with subcutaneous beta-interferon-1a (45.7 percent), followed by subcutaneous beta-interferon-1b (27.7 percent) and by intramuscular beta-interferon (26.6 percent). Women represented 73.1 percent and the mean age was 38.93±11.34 years old. The group of patients who used intramuscular beta-interferon switched treatment, relapsed or died earlier (median 47 months; 95 percent Confidence Interval, CI 44–52) than patients using the subcutaneous beta-interferons, (69 months (95 percent CI 64–76) for beta- interferon 1a and 73 (95 percent CI 66–84) months for beta-interferon 1b) (p< .0001 for both comparisons). Accordingly, the use of intramuscular beta-interferon was associated with a higher probability of event (Hazard ratio, HR 1.38; 95 percent CI 1.29-1.48), while the use of the other beta-interferons had a protective effect (1a: HR .86; 95 percent CI .81-.92; 1b: HR .89; 95 percent CI .83-.95).
CONCLUSIONS:The inferiority of intramuscular beta-interferon found in the real-world corroborates findings from head-to-head studies and systematic reviews conducted by Cochrane and the National Commission for Technology Incorporation in SUS (CONITEC/Brazil). This result led to disinvestment in intramuscular beta-interferon and was the first case of clinical guideline update using real-world evidence in Brazil.
PP086 Horizon Scanning In Multiple Sclerosis Decisions In Brazil
- Andrea Brígida de Souza, Avila Vidal, Pollyanna Gomes, Vania Canuto, Clarice Petramale
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 111
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INTRODUCTION:
In Brazil, the pharmaceutical sector has requested an individual incorporation in the Brazilian public health system (SUS) for each new drug for multiple sclerosis that receives sanitary authorization for marketing. Horizon Scanning within Brazilian Ministry of Health has played a key role in the recommendations made by the National Committee for Health Technology Incorporation (CONITEC). Horizon Scanning seeks to predict which technologies have potential to impact health care in SUS, before their formal request. This study aims to present the impact of horizon scanning in two assessments made by CONITEC on drugs to treat Multiple Sclerosis.
METHODS:Grey literature was searched to find new and emerging drugs for multiple sclerosis treatment. Regulatory agencies were also searched: European Medicines Agency (EMA), Food and Drug Administration (FDA) and Brazilian Regulation and Health Surveillance Agency (Anvisa). A pre-defined standardized form was used. Information extracted about each drug was identified as: drugs name, mechanism of action, indication, administration route, finished phases of clinical trial and registration in other countries.
RESULTS:In 2014, horizon scanning identified seven drugs while CONITEC was assessing Fingolimod for multiple sclerosis. In this case, the drug's administration route was a differential, as only three new drugs identified were also orally administrated. Thus, Fingolimod received a positive recommendation for incorporation. In 2016, horizon scanning identified fourteen drugs while Teriflunomide was under assessment. At this moment, the orally administrated Fingolimod was already available and it was identified other eight new drugs with the same route. Therefore, the initial recommendation was against its incorporation.
CONCLUSIONS:Horizon scanning has proved to be of major importance for assisting recommendation-making process of the committee. In the two cases presented, horizon scanning information could predict which technologies were being developed and could be registered in Brazil. These new technologies had influenced the recommendations made by CONITEC's members. As a result, a horizon scanning section in all CONITEC's reports became mandatory.
PP125 Evidence-based Policy Making – Bottom-Up Heuristic Engagement Process
- Evelinda Trindade, Anna Maria Buehler, Clarice Petramale, Luiz Augusto Carneiro D'Albuquerque, David Uip, Lorena Pozzo
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 130-131
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INTRODUCTION:
Solid organ and hematopoietic cell transplantation are some of the more expensive procedures universally paid by the public Brazilian Unified Healthcare System (SUS). Transplanted patients depend on maintenance immunosuppression to prevent death or graft loss. A bottom-up heuristic process proposed new immunosuppression drugs for incorporation into the SUS.
METHODS:Systematic evidence synthesis and Brazilian transplantation registries base-cases, Kaplan-Myer survival and economic assessments were presented in specialized national congresses with open public Delphi sessions to build professional Clinical and Therapeutic Protocols (PCDT) by consensus. Five consensus transplantation PCDTs with a SUS perspective budget impact and sensitivity analysis were submitted to the Health Ministry SUS Technology Incorporation National Commission (CONITEC) plenary for a decision. PCDTs were publicized in CONITEC Internet and Diário Oficial da União, an, official periodic publication, as well as undergoing widespread dissemination through mailings for Public Consultation. Public contributions were added to PCDTs to support Health Ministry policy making.
RESULTS:The São Paulo State Health Secretariat coordinated the synthesis and economic assessments made by 115 experienced transplantation specialists and health technology evaluators over ten years. Heart, lung, liver, pancreas and hematopoietic cells transplantation PCDTs (with tacrolimus, sirolimus and everolimus alternative immunosuppression) can significantly prevent 27.8 percent, 28.1 percent, 7.2 percent, 11.1 percent and 4.3 percent graft loss or graft versus host disease and death, respectively, for refractory transplantees rescue during the first year post-transplantation, saving healthcare resources. Ten-year follow-up data demonstrated partial benefits were sustained. Analysis demonstrated +USD689,655.17, +USD501,567.40, -USD377,802.51, +USD221.289,42 and +USD50.734,08 budget impact, respectively, resulting in an overall USD1,085,443.55 for 2,146 transplantees. The 5 PCDTs were favorably voted by CONITEC plenary members, 155 public contributions were added by patients and stakeholders, and the Brazilian Health Ministry decided to adopt the SUS reimbursement listing.
CONCLUSIONS:Democratic participation gave PCDTs real-world basis adjustments, SUS innovation and improved compliance.
PP033 Patient And Public Involvement In Health Technology Assessment: The Brazilian Experience
- Tacila Mega, Aline Silva, Clarice Petramale, Roberta Rabelo
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 86
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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.
OP133 Health Technology Assessment In Brazil: A 5-year Review Of Brazilian Health System (CONITEC) Activities
- Roberta Rabelo, Vania Canuto, Clarice Petramale, Tacila Mega
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 62
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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.
PP155 The Impact Of Lawsuits In The Brazilian Public Health System
- Carla Biella, Viviane Pereira, Fabiana Raynal, Jorge Barreto, Vania Canuto, Clarice Petramale
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 141
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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.
HEALTH TECHNOLOGY PERFORMANCE ASSESSMENT: REAL-WORLD EVIDENCE FOR PUBLIC HEALTHCARE SUSTAINABILITY
- Augusto Afonso Guerra-Júnior, Lívia Lovato Pires de Lemos, Brian Godman, Marion Bennie, Cláudia Garcia Serpa Osorio-de-Castro, Juliana Alvares, Aine Heaney, Carlos Alberto Vassallo, Björn Wettermark, Gaizka Benguria-Arrate, Iñaki Gutierrez-Ibarluzea, Vania Cristina Canuto Santos, Clarice Alegre Petramale, Fransciso de Assis Acurcio
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue 2 / 2017
- Published online by Cambridge University Press:
- 23 June 2017, pp. 279-287
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Objectives: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health.
Methods: Our methods used include extensive literature review, refinement with experts across countries, and public consultation.
Results: A comprehensive guideline was developed, which has been adopted by the Brazilian government.
Conclusion: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.