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OP54 Experiences With Out-Of-Hospital Drug Treatment For Systemic Lupus Erythematosus: A Thematic Synthesis
- Clarice Portugal, Adriana Sacramento, Andrea Brigida de Souza, Andrija Almeida, Luiza Losco, Mariana Fonseca, Melina Barros, Vania Canuto
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- International Journal of Technology Assessment in Health Care / Volume 39 / Issue S1 / December 2023
- Published online by Cambridge University Press:
- 14 December 2023, p. S14
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Introduction
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects quality of life and sometimes requires the use of multiple drugs. Therefore, it is relevant to address the experiences of patients, family members, and caregivers in relation to out-of-hospital SLE drug treatment. This paper presents the results of a pilot project of a Qualitative Evidence Synthesis (QES) conducted by the National Committee for Health Technology Incorporation (Conitec) in the Brazilian public health system.
MethodsFor this thematic synthesis, a structured search was conducted in the MEDLINE, CINAHL, and LILACS databases. Seventeen articles were included, and their quality was evaluated using the Critical Appraisal Skills Program criteria. Article content, which was extracted into a spreadsheet adapted from JBI SUMARI, underwent thematic content analysis. Confidence in the findings was evaluated using the GRADE Confidence in the Evidence from Reviews of Qualitative Research tool.
ResultsFifteen findings related to three central themes: self-image and appearance; SLE as a chronic disease (disease oscillation, recurrence of symptoms, fear of organ damage, expectation of cure or modification of the disease course, and frequency of medical appointments); and experience with drug therapy (belief in the need for drugs, skepticism, chronicity of treatment, financial difficulty, adverse effects as obstacles to adherence and a source of suffering, efficacy/effectiveness, large quantity and frequency of drugs, and multiple therapeutic attempts).
ConclusionsThe findings suggest that patients, family members, and caregivers have an ambivalent relationship with drug treatment. Even though they believe in the effectiveness of the drugs, they also distrust the need to keep using them, especially when SLE is controlled. The improvement of cosmetic manifestations and adverse effects also seem to be important outcomes. Furthermore, the high occurrence of adverse effects and the daily use of many drugs can make treatment adherence harder. In any case, there is an expectation of cure or more significant impact on the course of the disease through pharmacotherapy.
PD52 The Role Of Public Consultation In CONITEC Recommendations Between 2012 And 2020: An Introductory Analysis
- Andrea Brigida Souza, Clarice Portugal, Adriana Prates, Andrija Almeida, Bruna Cabral de Pina Viana, Luiza Losco, Vania Canuto
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S110
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Introduction
Public consultation is a strategy for patient and public involvement (PPI) assured by the National Committee for Health Technology Incorporation in Brazilian Public Health System (CONITEC)´s normative framework. It aims to obtain society’s views on the matters under evaluation. It is made available after CONITEC issues an initial recommendation, which will be reviewed in light of society contributions. This paper examines the cases where the final recommendations differed from the initial ones in technology assessments carried out between 2012 and 2020, taking into account the arguments used by the CONITEC Plenary to support the modification.
MethodsFrom a total of 361 public consultations referring to the assessment of health technologies carried out by CONITEC between 2012 and 2020, 40 final reports of health technology assessment (HTA) processes that had changes from the initial to the final recommendation were examined. Then, analytical categories were built so that justifications for the change were investigated and the interpretations produced. The empirical approach excluded public consultations regarding clinical protocols and therapeutic guidelines.
ResultsIt was observed that, in 39 cases, the change occurred from an unfavorable position to a favorable position for the technology incorporation. The main reasons for changing the plenary’s decision were proposals to renegotiate the prices of technologies (that generate changes in the results of economic evaluation and budget impact analysis), the receipt of new evidence and experience, and opinion arguments sent mainly by health professionals.
ConclusionsThe analyzed data has shown that the changes in recommendations are mostly based on the content of contributions which led to changes in the assessment of clinical evidence, economic evaluation and budget impact. Thus, it appears that public consultation has been consolidated as a relevant instrument to inform the deliberative process in HTA in Brazilian Public Health System.
PD51 Patient Perspective: A Preliminary Analysis Of The First Year Of The Patient Involvement in CONITEC Meetings
- Clarice Portugal, Andrea Brigida de Souza, Adriana Prates, Andrija Almeida, Bruna Cabral de Pina Viana, Luiza Losco, Vania Canuto
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S109
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Introduction
The Patient Perspective is an initiative to include the testimonials of patients or their representatives at the time of the initial recommendation of health technology assessment (HTA) processes developed by the National Committee for Health Technology Incorporation in the Brazilian Public Health System (CONITEC). It allows these actors to be involved prior to the public consultation. This action is articulated with a framework of strategies to encourage patient and public involvement (PPI) in HTA in Brazilian Public Health System (SUS). This paper aims to analyze the first year of its implementation.
MethodsThis is a descriptive study, based on document analysis (minutes of meetings, technical and society reports, videos of CONITEC meetings, tables for internal control, etc.) and systematic observation of the activities related to the initiative. Field notes were taken and their contents were coded, following content analysis criteria.
ResultsFrom December 2020 to November 2021, 1,052 subscribers were registered in 75 public calls, which resulted in the participation of 42 people. The testimonials presented information about the illness experience, its impact on quality of life, use of technologies, and difficulties of accessing and adherence to treatment. The patient perspective has been useful to give visibility to specific dimensions of experiences regarding not only the health conditions but SUS as well. Furthermore, some testimonials produced tensions and repercussions about HTA processes, such as the consideration of aspects or technologies not covered in the clinical studies and thus the HTA, as well as the need of reviewing some results of the technical report.
ConclusionsThe patient perspective has had the support of the target audience. Additionally, it has been successful in including various types of participants and different aspects of the experience with the health condition and/or the technologies under evaluation. In general, it has been possible to observe the diversification of modes of PPI and institutional learning towards the improvement of HTA in SUS.
PP105 Applying Horizon Scanning To Decision Making: The Case of Tafamidis
- Pollyanna Teresa Cirilo Gomes, Andrea Brígida de Souza, Artur Felipe de Brito
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- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 105-106
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Introduction:
Horizon scanning (HS) is an important tool for guiding health policy formulation and the decision-making process in Brazil. In 2016, the Ministry of Health started to draft Brazilian clinical practice guidelines for transthyretin familial amyloid polyneuropathy (TTR-FAP), which is a rare disease caused by a mutation of the transthyretin gene. An initial HS report was conducted that provided information about new and emerging technologies for TTR-FAP. The HS identified five drugs that were based on two mechanisms of action: transthyretin stabilization (diflunisal, tafamidis, and tolcapone) and gene silencing (ALN-TTR02 and ISIS-TTR-Rx). At that time in Brazil there were no drugs registered for the treatment of TTR-FAP. However, a few months later tafamidis was licensed in Brazil. In early 2017 the manufacturer submitted an application to the National Committee for Health Technology Incorporation (CONITEC), with the aim of incorporating tafamidis into the Brazilian health system. As a result the HS report was updated to support the assessment by CONITEC. This study aims to show how HS is being used to support CONITEC in this issue.
Methods:As per the EuroScan toolkit, we performed a reassessment of the technologies included in the initial HS report. We searched clinical trial registers, the websites of pharmaceutical companies, conference proceedings, scientific journals, HS databases, and regulatory websites for further information. The data were synthesized and a reformulated landscape of the technological environment for TTR-FAP therapy was presented to the CONITEC Plenary.
Results:The main difference between the initial and final HS output was that tafamidis was approved for use in Brazil, making it the only registered drug for TTR-FAP. Another difference was related to the start of a new clinical trial with diflunisal for TTR-FAP, indicating that this drug could be a potential competitor for tafamidis. It was also possible to add published positive results from a clinical trial with ISIS-TTR-Rx, which were unavailable when the first report was written. Beyond that, it appears that there are two promising gene silencers on the horizon that could represent potential competitors for tafamidis.
Conclusions:The analysis of tafamidis for incorporation into the Brazilian health system is ongoing, but HS was able to deliver strategic information that could affect the final recommendation of CONITEC.
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.
VP214 Criteria That Influence The Brazilian Public Decision-Making
- Andrea Brígida de Souza, Marisa Santos
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- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 248
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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.
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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- 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.