Health Technology Incorporation Research Articles

Application of natural language processing to predict final recommendation of Brazilian health technology assessment reports.

Health technology assessment (HTA) plays a vital role in healthcare decision-making globally, necessitating the identification of key factors impacting evaluation outcomes due to the significant workload faced by HTA agencies. The aim of this study was to predict the approval status of evaluations conducted by the Brazilian Committee for Health Technology Incorporation (CONITEC) using natural language processing (NLP). Data encompassing CONITEC's official report summaries from 2012 to 2022. Textual data was tokenized for NLP analysis. Least Absolute Shrinkage and Selection Operator, logistic regression, support vector machine, random forest, neural network, and extreme gradient boosting (XGBoost), were evaluated for accuracy, area under the receiver operating characteristic curve (ROC AUC) score, precision, and recall. Cluster analysis using the k-modes algorithm categorized entries into two clusters (approved, rejected). The neural network model exhibited the highest accuracy metrics (precision at 0.815, accuracy at 0.769, ROC AUC at 0.871, and recall at 0.746), followed by XGBoost model. The lexical analysis uncovered linguistic markers, like references to international HTA agencies' experiences and government as demandant, potentially influencing CONITEC's decisions. Cluster and XGBoost analyses emphasized that approved evaluations mainly concerned drug assessments, often government-initiated, while non-approved ones frequently evaluated drugs, with the industry as the requester. NLP model can predict health technology incorporation outcomes, opening avenues for future research using HTA reports from other agencies. This model has the potential to enhance HTA system efficiency by offering initial insights and decision-making criteria, thereby benefiting healthcare experts.

OP07 Eleven Years Of Conitec: Advances And Challenges Of Patient And Public Involvement In The Brazilian Health Technology Assessment Process

IntroductionPatient and public involvement (PPI) is a core element of the health technology assessment (HTA) process. Since its creation in 2011, the National Committee for Health Technology Incorporation (Conitec) has promoted initiatives to include stakeholders in HTA for the Brazilian Public Health System (SUS). This work aimed to present a report on the advances and challenges related to PPI in 11 years of Conitec.MethodsA retrospective analysis of PPI actions carried out at Conitec was conducted, based on an analysis of minutes and records of meetings and discussions held internally and documents published on Conitec´s website.ResultsEvents and meetings were held over the years with different actors interested in the HTA process. Since 2015, a plain-language version of the technical report has been made available to the public during public consultations for each HTA topic. Recently, a register of patients, specialists, and SUS managers was created to form a database and establish a network with the stakeholders. Since 2020, SUS users have been allocated time to speak at Conitec´s meetings. Qualitative analysis of public consultation documents started in 2021 and a pilot qualitative evidence synthesis was carried out in 2022. These initiatives, although not directly focused on PPI, increase the consideration of the perspectives of patients, family members, and caregivers in the HTA process.ConclusionsPPI actions implemented at Conitec have significantly promoted inclusiveness and exchanges among stakeholders, contributing to a greater transparency regarding Conitec’s actions. Nonetheless, we have important challenges on our horizon, such as strengthening connections with primary healthcare managers and professionals and social movements. It is also strategic to expand the technical and scientific discussion on PPI and qualitative approaches with HTA researchers and the voting members of Conitec. Finally, another aim is to improve knowledge of HTA and public health policy among law professionals and the pharmaceutical industry in Brazil.

OP54 Experiences With Out-Of-Hospital Drug Treatment For Systemic Lupus Erythematosus: A Thematic Synthesis

IntroductionSystemic 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.

PP19 Health Technology Assessment Reports In Brazilian Unified Health System: Number Of Potential Beneficiaries in 2022

IntroductionUniversal access to health public services was established in Brazil 32 years ago. However, health technology assessment (HTA) as a requirement for the decision-making process in the Unified Health System (SUS) was defined only in 2011 with the National Committee for Health Technology Incorporation of the SUS (Conitec), which advises the Ministry of Health on the decision to incorporate health technologies into the SUS. All of Conitec’s recommendations are based on the best available scientific evidence regarding efficacy, effectiveness, and safety of a technology, but also include economic evaluation studies of these technologies, developed from the perspective of the SUS. Considering this an estimate of the population eligible for use of the technology under evaluation, if it is incorporated into the SUS, it is considered in the decision-making process.MethodsThis descriptive study, based on open access data from Conitec’s website, aimed at identifying the estimated number of patients potentially benefitting by the recommendations published in 2022, from January to November. Since each report includes an estimate for the first five years of incorporation of the technologies, all data were collected to check whether population growth was considered.ResultsFinally, 38 recommendation reports were identified, with 28 reports on incorporation and 10 reports for expansion of technology use. Among them, they related to 31 medicines and seven procedures or products. In the first year after incorporating the listed technologies, a total of 7,767,321 potential beneficiary patients were estimated, while over five years the total number would increase to approximately 7,967,874 patients. There were recommended drugs for rare diseases whose benefited population did not exceed the estimate of 10 patients per year; as an example is cerliponase alfa for treating neuronal ceroid lipofuscinosis. In another example, an estimate of 4,494,539 women would benefit by incorporated contraceptives into the SUS.ConclusionsThis study describes how accessible public health is becoming, meeting more health policies, showing potential to benefit more patients every day and showing what trends can be expected in the future.

OP165 Changing Decision Criteria: An Analysis Of Health Technology Assessment Reports To The Brazilian Unified Health System

IntroductionIn Brazil, the National Committee for Health Technology Incorporation of the Brazilian Public Health System (Conitec) defines the criteria for incorporating technologies into the public health system. However, all recommendations are submitted to public consultations to ensure transparency and public participation.Contributions from the public consultation are analyzed and entered into Conitec’s final report and sometimes change the preliminary recommendation.MethodsThis descriptive, retrospective exploratory study aimed to gather qualitative and quantitative data on criteria considered by healthcare decision makers from Conitec and to identify which criteria most changed after reports were submitted to public consultation. Data from 2012 to November 2022 were collected from the Conitec website, entered into a specific extraction form, and analyzed using descriptive statistics.ResultsMedicines (77%) were the most frequently evaluated type of technology, followed by procedures (15%), and products (8%). A total of 763 recommendations were analyzed. Of these, 70 percent did not change the decision criteria from the preliminary to the final published report, 9 percent did change, and 20 percent were simplified analyses of technologies of relevant public interest that were of low cost and low budget impact (these were not submitted to public consultation or public hearing). As pharmaceutical companies usually propose cost reductions or discounts during the Conitec public consultations, most of the recommendations (45%) were modified in the final report, with incremental budgetary reduction being the main criterion. This study identified that most of the changes occurred in neurology and were related to the high incremental budgetary impact of technologies for the care of rare diseases like spinal muscular atrophy.ConclusionsAlthough different criteria are considered for Conitec recommendations, some of these are regarded as crucial for decision-making. Unfortunately, as there is no definition for the weight of each of these criteria, it is difficult to understand their influence on the recommendations made. Therefore, it is crucial to establish standardized criteria for proper decision-making.

PP42 Insights Of Health Technology Assessment In Brazilian Health Unified System: Areas Of Interests In Health

IntroductionThe National Committee for Health Technology Incorporation of the Brazilian Public Health System’ s (Conitec) principle is to advise the Ministry of Health (MS) in the tasks related to incorporation, exclusion or modification of any health technologies into the Unified Health System (SUS). Moreover, this also involves alteration of clinical protocols or therapeutic guidelines. All of the recommendations consider the international classification of diseases (CID) as a common language that allows health professionals and managers to understand standardized information, to identify trends and benefits of recommendations in each therapeutic area.MethodsThis exploratory, descriptive and retrospective study aims to provide qualitative and quantitative data from the technologies evaluated by the Conitec in the period June 2012 to November 2022. Data were extracted in Conitec’s website.ResultsThe searches resulted in 763 recommendations in total. Among them, the most evaluated therapeutic area was Infectology with 126 technologies (16.5%). In this field the highlighted diseases and conditions were Hepatitis 42 (33.3%); HIV 23 (18.3%) and COVID-19 11 (8.7%). In Oncology, 113 recommended technologies (14.8%) were identified, in order of prominence for the diseases: Breast Cancer 21 (18.6%); Colorectal Cancer 11 (9.7%); Leukemias 17 (15.0%). In the Respiratory Diseases area, 89 technologies (11.7%) were recommended, among them: Chronic obstructive pulmonary disease (COPD) 17 (19.1%); Asthma 15 (16.9%) and COVID-19 11 (12.4%). These results clarify which diseases are most needing new technologies to be treated.ConclusionsThe results show what conditions and fields in health needs to be prioritized for public policies and prevention measures. This study demonstrates how important is to make accessible the public health information, improving public knowledge and social actions in SUS.

OP167 An Analysis Of Medication Exclusion Reports In The Health Technology Assessment Process For The Brazilian Unified Health System

IntroductionThe National Committee for Health Technology Incorporation of the Brazilian Public Health System (Conitec), which was created in 2011 by federal law, defines the criteria for incorporating and excluding health technologies in the Brazilian health system. For technology evaluation proposals a recommendation report is carried out, which finds the best scientific evidence about the efficacy, accuracy, effectiveness, and safety of the technology being analyzed. The report also provides a comparative economic evaluation of the technologies already in the health system to promote and protect public health, achieve the best allocation of resources, and reduce regional inequalities.MethodsThis exploratory, descriptive, and retrospective study aimed to identify the criteria considered for the exclusion of medicines within the Brazilian health system from 2012 to November 2022. Data were extracted from Conitec’s website into a specific extraction form and analyzed using descriptive statistics.ResultsDuring the evaluation period, 763 technology recommendations by Conitec were identified, of which 75 (10%) related to the exclusion of medicines. Several criteria were identified among the exclusion recommendations, including protocol updates, expiry or lack of registration in the National Health Surveillance Agency, and drugs whose clinical indication was not included in the list of drugs registered for treatments in the health system.ConclusionsAlthough there is no standardization of criteria in Conitec for recommendations on the exclusion of health technologies, this study contributes to a better understanding of these technologies. Disinvestment of technologies positively impacted the population because it resulted in better allocation of resources in the health system, and some of the excluded technologies presented a greater risk of interactions and undesirable adverse reactions.

PP17 Rare Diseases: An Analysis Of Assessments Carried Out By The National Committee For Health Technology Incorporation In Brazilian Public Health System (Conitec)

IntroductionThe treatment of rare diseases has been a challenge for the Brazilian Unified Health System. In addition to the high costs of treatments, the characteristics inherent to this type of disease bring weaknesses to the scientific evidence of efficacy and safety. The National Committee for Health Technology Incorporation In Brazilian Public Health System (Conitec) is formed by a plenary of experts who monthly assess demands for incorporation into the public health system.MethodsThis exploratory, descriptive, and retrospective study aims to gather qualitative and quantitative data on criteria considered by healthcare decision-makers from Conitec and analyzes which rare diseases were benefited by the commission recommendations. Data from June 2012 to November 2022 were collected from the Conitec website to a specific extraction form and analyzed using descriptive statistics.ResultsA total of 763 technologies were evaluated from June 2012 to November 2022, with 158 being drugs for rare diseases. Among these, those with the highest number of diseases benefited were multiple sclerosis 13.3 percent (n=21), cystic fibrosis 6.3 percent (n=10) and pulmonary hypertension 5.7 percent (n=9). About 70 (44.3%) technologies were incorporated into the Unified Health System to treat rare diseases. In these incorporations, 25 technologies initially had an unfavorable recommendation, and only after the public consultation they were recommended for incorporation. Reasons that contributed to this change in recommendation were the new scientific evidence presented (64%), new negotiation of the drug price (28%), and new budgetary impact by revising the calculation of the target population (8%).ConclusionsThe criteria for evaluating technologies for rare diseases are similar to those adopted for other clinical conditions. However, it is important to adopt specific criteria in analysis of drugs targeted at diseases considered rare for the population. Negotiating prices with industry is an important factor that was highlighted, potentially favoring access to new treatments that can modify the progress of these diseases.

OP29 Impact Of New Drug Indications After Initial Registration By The Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil

IntroductionMost drugs have data only from clinical trials focused on a specific population at the time of first registration, so their indications for use are restricted to this population. In Brazil, the prices of new drugs for clinical conditions with no therapeutic alternatives are relatively high. When these drugs expand to other indications their prices are not reviewed, which can have a major financial impact. This study aimed to evaluate the financial impact of expanding the indication for trastuzumab deruxtecan.MethodsWe calculated the annual cost to treat all Brazilian patients with the indications listed for trastuzumab deruxtecan at first registration, and then all additional indications. Populations were estimated from epidemiological data from National Committee for Health Technology Incorporation reimbursement documents and a clinical trial comparing trastuzumab deruxtecan with trastuzumab emtansine. Costs were calculated using the ANVISA Câmara de Regulação do Mercado de Medicamentos price value and a patient weight of 70 kg.ResultsIn January 2022, trastuzumab deruxtecan was introduced in Brazil for patients with human epidermal growth factor receptor (HER2) positive metastatic or unresectable breast cancer who had received two or more anti-HER2 treatment regimens. In June 2022, the indication was expanded to patients with HER2-positive metastatic or unresectable breast cancer who had received one anti-HER2 treatment regimen. In November 2022, the indication was further expanded to patients with metastatic or unresectable low-expression HER2 breast cancer who had received prior systemic therapy. The number of patients estimated to be eligible for the drug increased from 383 to 23,000, with an increased total cost from BRL467,970,786 (USD90,621,763) to BRL26,048,234,160 (USD5,044,197,164).ConclusionsThe expansion of indications for trastuzumab deruxtecan may substantially increase its financial impact and compromise the sustainability of health systems. In Brazil, the lack of monitoring of drug prices means that the only change in prices occurs due to regulated annual inflation adjustments. Regulation is needed to reduce drug prices according to new indications, changes in therapeutic options for the same condition, and obsolescence.

OP152 Use of Real-world Evidence By The Brazilian Health Technology Assessment Committee (Conitec) For Monitoring Of Health Technologies

IntroductionIn Brazil, the incorporation or disinvestment of health technologies into the Unified Health System (SUS) are advised by the National Committee for Health Technology Incorporation (Conitec). Despite the thorough evaluation carried out by Conitec, the results measured after implementation do not always reflect the economic and clinical impact expected from the incorporation. Thus, real-world evidence (RWE) is essential for monitoring health technologies. The aim of this study was to report how Brazil is using the RWE to obtain additional information about the incorporated technologies.MethodsActions related to the use of RWE for monitoring of technologies incorporated into the SUS were described. The period evaluated was between 2012 and 2022.ResultsThe first Conitec recommendation in which the use of real-life data in the decision-making process was evidenced occurred in 2016. Administrative data from a cohort of patients identified that beta-interferons for Multiple Sclerosis were less effective than the other drugs used in the Brazilian public system. A further eight reports have been published assessing the performance of technologies using administrative data.Another strategy for RWE generation was through the funding of primary studies, highlighting a study with 21 rare diseases and another one to evaluate Zolgensma gene therapy, acquired through court for Spinal Muscular Atrophy. Both studies are ongoing and aim to evaluate the effectiveness, safety, adherence, and cost of medications in the evaluated diseases. Conitec is also following studies in RWE financed by pharmaceutical companies to evaluate effectiveness for incorporated technologies subject to reassessment. Additionally, managed access arrangements have been promoted for generating RWE when there is uncertainty about outcomes.ConclusionsReal-world evidence from administrative data and clinical research allows monitoring after the implementation of technologies in the Unified Health System in Brazil. This makes it possible to reallocate resources in health and contribute for the system sustainability, in addition to generating data that reduce the uncertainties assumed at the time of incorporation.

Does patient and public involvement impact public health decision-making? A 10 year retrospective analysis of public consultation in Brazil

Background The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health Technology Incorporation in the Unified Health System (Conitec) of Brazil, and to identify factors associated with changes in Conitec’s recommendations following these PC.Methods This cross-sectional study analysed all processes related to the adoption of technologies that took place in Brazil between 2012 and 2021 based on technical reports and self-reported information collected from PC participants. A multiple logistic regression model identified factors associated with changes in Conitec’s recommendations following PC.Results A total of 479 technical reports were published, of which 83% (n = 400) were submitted to PC. Demands were made mainly by applicants from the government (n = 262; 55%), regarding the adoption of medicines (n = 366; 76%), in which context neoplasms and infectious diseases were the most frequent indications (n = 66; 14% for each). A total of 264 (55%) processes resulted in a final recommendation in favour of introducing the technology. Over the period of 10 years, 196 483 contributions were received in response to PC. The largest volume of contributions was made by patients and their families or representatives (n = 99 082; 50%), females (122 895; 67%), white individuals (129 165; 71%) and individuals between the ages of 25 and 59 years (145 364; 80%). Alteration of the preliminary recommendation occurred in 13% (n = 53) of the PC, with a higher proportion of recommendations being altered from 2017 onwards. Increased participation by patients had a significant impact on the alteration of the preliminary recommendation (odds ratio 3.87, 95% CI 1.33–13.35, p = 0.02).ConclusionsIncreased engagement of patients and their families and caregivers in PC was associated with changing the preliminary recommendation of Conitec about the adoption of technologies into the public health system in Brazil.

RWD132 A Real-World Evidence Study on the Chronic Obstructive Pulmonary Disease Treatments Submitted to the Brazilian National Committee for Health Technology Incorporation

To analyze the chronic obstructive pulmonary disease (COPD) treatments submitted to the Brazilian National Committee for Health Technology Incorporation (CONITEC) by comparing the main points of CONITEC analysis in order to classify each one as a strong or weak point for each treatment.

Exploring the COVID-19 Pandemic’s Impact on the Health Technology Assessment Process of the National Commission for the Incorporation of Technologies Into the Brazilian Health System

ObjectivesThis study aimed to evaluate the impact of the COVID-19 pandemic on Brazilian health technology assessment processes based on public reports from the National Committee for Health Technology Incorporation (CONITEC). MethodsThis descriptive study analyzed CONITEC’s official reports on Brazil available on its website between 2018 and 2021 that aimed to propose recommendations for technologies to be incorporated into its public healthcare system. We used descriptive statistics covering the number of technologies and number of reports about drugs per year, objective, type of technology, demanding sector, and outcome before 2018 to 2019 and during the COVID-19 pandemic (2020-2021). Furthermore, we used logistic regression to explore any association between the final decision labeled as “incorporated” and the emergence of the COVID-19 pandemic. ResultsA total of 278 reports were analyzed. Approximately 85% (136 of 278), 79% (220 of 278), and 45% of the reports (125 of 278) were about drugs, for incorporation, and requested by the government, respectively. Moreover, 74 of 130 (57%) and 56 of 148 decisions (38%) were “incorporated” before and during the pandemic, respectively. No significant association was noted between incorporated decisions and the arrival of the COVID-19 pandemic for all technologies (odds ratio 1.43; 95% CI 0.84-2.46; P = .192) and for drugs (odds ratio 1.43; 95% confidence interval 0.81-2.53; P = .223) while adjusting for the type of technology and demandant. ConclusionsThe COVID-19 pandemic has brought many challenges, but it does not seem to have had a significant impact on the health technology assessment approval decisions of CONITEC in Brazil.

Da recomendação à reversão: análise das razões de alteração do posicionamento da Comissão Nacional de Incorporação de Tecnologia a partir das consultas públicas

Abstract This study analyzes the reasons for changes to the initial recommendations of opinions issued by the National Committee for Health Technology Incorporation (Conitec) after public consultations. Through exploratory, documentary research, 45 public consultations conducted by the Committee in 2020 were analyzed. Of these 45 consultations, seven had their initial understanding changed based on the recommendations received during public consultations. Results show that the economic aspects of the analyzed technologies, along with safety and effectiveness criteria, were the main arguments considered to modify preliminary recommendations. Public consultation is a democratic mechanism with the potential to generate progress in the development of a more equitable Brazilian National Health System (SUS) that meets the real interests of society.

OP62 Patients’ Opinion On Health Technology Assessment Reports: An Analysis Of Brazilian Health Technology Assessment In 2021

IntroductionThe Brazilian health technology assessment (HTA) process includes calls for public consultations, in which society can give its opinion on reports emitted by the National Committee for Health Technology Incorporation (CONITEC). Open and closed queries for public consultation are performed by official formularies and can be accessed online at CONITEC webpage. Queries are divided into two categories of reports: clinical protocols and guidelines, and incorporation/exclusion demands. Incorporation/exclusion queries are subdivided in two additional categories: opinion and experience, or technical. In this study we analyze the weight of patients’ participation in opinion and experience queries and their opinion (pro or con) on inclusion/exclusion of health technologies.MethodsFormularies concerning concluded public consultations on health technology incorporation/exclusion reports were extracted from CONITEC website from 1 January to 26 November 2021. Entries on the opinion and experience formularies included amongst others, a close-ended question about the opinion of participants on health technology incorporation/exclusion reports (“favorable”/“against”/“neither”). In this study, we analyzed patients’ opinion contained within concluded public consultations on incorporation/exclusion of health technologies.ResultsA total of 63 health technology incorporation/exclusion queries were performed in the analyzed period, of which there were only four exclusions. A total of 32,209 contributions were registered. “Patients”, “Health professionals”, “Family or caregivers”, “Interest on the theme”, accounted for 99.4 percent (13.5, 16.7, 32.3, 36.7%, respectively). Patient participation accounted for 4,367 (13.5%) entries. The total number of opinions in favor of the presented documents by the “Patients” was 4,268 (97.7%), 59 (1.4%) disagreed and 40 (0.9%) had no opinion.ConclusionsPublic consultation of official HTA reports is a very useful tool to legitimize decisions through social participation. Although patient participation is not numerically the most important category to contribute on public consultation queries, patients are, if not the most influential stakeholder, the main recipient of decisions concerning health technologies incorporations. Further analyses shall investigate experience narratives included in public consultation queries.

PD52 The Role Of Public Consultation In CONITEC Recommendations Between 2012 And 2020: An Introductory Analysis

IntroductionPublic 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.

PP95 Health Professionals’ Participation On Health Technology Assessment (HTA) Public Consultation: A Distribution Analysis Of Brazilian HTA In 2021

IntroductionThe Brazilian HTA process includes calls for public consultations, in which society can give its opinion on reports emitted by the National Committee for Health Technology Incorporation (CONITEC). Open and closed queries for public consultation are performed by official formularies and are available online at CONITEC webpage. There are two categories of queries: clinical protocols and guidelines, and incorporation/exclusion demands. Incorporation/exclusion queries are subdivided in two additional categories: opinion and experience, or technical. In this study we analyze health professionals’ technical contributions and their opinion (pro or con) on the inclusion or exclusion of health technologies.MethodsOn November 26th, 2021, formularies concerning concluded public consultations on health technology incorporation/exclusion reports were extracted from CONITEC website for the period, January 1, 2021 to November 26, 2021. Entries on the technical contributions formularies included a close-ended question about the opinion of participants on health technology incorporation/exclusion reports (“favorable”/“against”/“neither”).ResultsA total of 63 health technology incorporation/exclusion queries were carried out during the study period, of which only 4 were exclusions. A total of 7783 contributions were registered. “Patients”, “Family or caregivers”, “Interest on the theme”, and “Health professionals”, accounted for 96.4% (10.9, 15.2, 17.1 and 53% respectively). Health professionals’ participation alone accounted for 4130 entries. Concerning the category “health professionals”, the total number of favorable opinions on the presented documents was 2740 (66.3%), 1306 (31.6%) disagreed, and 84 (2%) had no opinion.ConclusionsHealth professionals can be considered one of the main stakeholders considering HTA for technology incorporation in public health systems. Brazilian HTA reports are submitted to public consultation through queries, which are available open access at the Brazilian National Committee for Health Technology Incorporation website.

PP43 Impact Of The COVID-19 Pandemic In The Brazilian National Committee for Health Technology Incorporation (Conitec) Recommendation Process

IntroductionHealth Technology Assessment (HTA) Process assists decision-making in health policies. The COVID-19 pandemic caused a high demand on protocol or guideline updates and incorporation of new drugs or therapies, overwhelming local agencies. A recent study reported that major HTA bodies in England, Scotland, Germany, and Canada reduced their number of drug recommendations in 2020, due to reprioritization of resources and COVID-related challenges. The present study aimed to evaluate the impact of the COVID-19 pandemic at the Brazilian National Committee for Health Technology Incorporation (Conitec) recommendation process.MethodsThis descriptive study evaluated all official recommendation reports available on the Government website in 2020 and 2021, extracting the data of disease category, technology type, the aim of the report, Public Involvement, and final result for the recommendation. The results were presented in tabular and graphical form using the machine learning, through the software R studio and excel.ResultsA total of 168 documents were evaluated, including guidelines and recommendation reports, with no reduction in the number of evaluations considering 2019. In 2020, there was a more significant evaluation of guidelines, and in 2021, a report on the non-incorporation of technologies. There were four specific documents about COVID 19, including vaccines and hospital care guidelines. The most incorporated and non-incorporated technologies were medication, targeting rare and highly prevalent diseases in balance. The Brazilian government was the main proposer. These results are part of the study “A Survey about the core methods of the recommendation reports for Brazilian Ministry of Health carried out by Brazilian Health Technology Assessment Centers”, which will characterize and analyze the core methods of the recommendation reports conducted by the Brazilian HTA Centers.ConclusionsThe pandemic had a low impact on demands in the routine of the Conitec. Establish indicators and technological norms applicable to health services, contribute to the identification of possible new practices, methods or criteria.

OP97 Stakeholders’ Involvement In Brazilian Health Technology Assessment Incorporation In 2021: A Statistical Description Of Demands To The Brazilian National Committee For Health Technology Incorporation

IntroductionThe demands for incorporating or excluding health technologies within the Brazilian Public Health System (SUS) can be requested by different stakeholders, including public administration, pharmaceutical companies, specialists’ and patients’ organizations/associations. The Brazilian National Committee for Health Technology Incorporation (CONITEC), part of the Ministry of Health, is the responsible organ to evaluate these demands and emit recommendations. The aim of this study is to show an overview of stakeholders according to the type of technology under request.MethodsOn 26 November 2021, a search was performed at CONITEC website. Health Technology Assessment (HTA) incorporation reports from 1 January to 26 November 2021 were extracted. From these reports, data regarding the demanded technology (e.g., medications, diagnostic tests, etc.), demand (technology incorporation, exclusion, or alteration), pharmacological classification according with the Anatomical Therapeutic Chemical (ATC), and requester’ categorization (e.g., pharmaceutical companies, official administration organs, etc.).ResultsPreliminary results showed a total of 77 health technologies, in 63 HTA incorporation submissions, of which 87 percent (n = 67) were medications, and 9 percent (n = 6) were new medical procedures. Only one medical device, one vaccine and two diagnostic tests were requested. Technology incorporation accounted for 94.8 percent of the demands (73), and 4 demands of exclusion. Seventy-one percent of the requested medications were classified, according to first ATC coding level, within groups L (Antineoplastic and immunomodulating agents), N group (Nervous system), A group (Alimentary tract and metabolism), and R group (Respiratory system), accounting 28.3, 17.9, 8.9 and 8.9 percent, respectively. Regarding stakeholders, the Brazilian Ministry of Health and its associated departments were responsible for 57.1 percent of the demands, while pharmaceutical companies requested 37.6 percent of incorporations. Other requesters included the Federal Justice Department, patients’, and specialists’ organizations, summing up with only four demands.ConclusionsThese results present the numerical weight of stakeholders in the Brazilian HTA incorporation system, with special attention to Brazilian bureaucracy and pharmaceutical companies. Further analysis regarding association between demand and other variables such as budgetary impact, costs, and ICD-10, shall deepen our understanding of different stakeholders’ role in Brazilian HTAi.

PD51 Patient Perspective: A Preliminary Analysis Of The First Year Of The Patient Involvement in CONITEC Meetings

IntroductionThe 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.