Overview of managed entry agreements : an integrative review towards policy making in Brazil

Resuminho (60 palavras): In order to provide legal and scientific embasement for policy making in Brazil, the aim of this study was to provide a panorama of Managed Entry Agreements around the world. A systematic review was conducted and the information about the agreements were summarized. It was included 25 studies, which described 446 agreements performed in 29 countries. Introduction (100 palavras): Managed Entry Agreements (MEA) are a reality in many countries. They are used as a tool to reduce the impact of uncertainty and the high cost of new drugs by providing access to new technologies under pre-established conditions. In Brazil, the Ministry of Health approved a high-cost technology under performance evaluation, being the first experience in the country. The aim of this study was to conduct a review to identify MEA performed worldwide to provide embasement to inform public health policy making in Brazil, as well as critical considerations surrounding the implementation of performance based agreements. Methods (75 palavras): A review of MEA for health technologies was conducted, using the question ‘What are the health technology managed entry agreements that have being performed around the world?’. The searches were conducted in april 2019, through PUBMED, EMBASE, LILACS and Cochrane Library databases, as well as manual search and gray literature. The selection of studies was performed by two independent reviewers and, in cases of disagreement, solved by a third reviewer. Results (75 palavras): A total of 25 studies were included, describing 446 agreements in 29 countries, being Australia (122), Italy (96), the United States (48) and Scotland (42) more frequent. Financial risk-sharing agreements were the most prevalent (43%). About 95% of the agreements involved medicines - more than half antineoplastic agents. The outcomes assessed and the impact of the agreements were not addressed in most studies, which may be due to the confidentiality character of them. Conclusions (100 palavras): We are likely to see a growth in MEA in the future with the continual launch of new high priced and complex treatments, coupled with increasing demands on available resources. They are an important tool to improve access to innovative and high cost medicines to achieve universal health coverage, although there are critical issues to consider. Besides the embedded confidentiality of most of the agreements, learning from already stablished knowledge, experiences and practices across countries can be a crucial strategy to guide Brazil’s initial experiences in this area

Access to medicines by patients of the primary health care in the Brazilian Unified Health System

OBJETIVO: Avaliar o acesso aos medicamentos na Atenção Primária em Saúde do Sistema Único de Saúde na perspectiva do usuário. MÉTODOS: Estudo transversal que utilizou dados da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional no Brasil – Serviços, 2015, realizado por meio de entrevistas com 8.591 usuários em municípios das cinco regiões do Brasil. A avaliação do acesso aos medicamentos utilizou conceitos propostos por Penshansky e Thomas (1981), segundo as dimensões: disponibilidade, acessibilidade geográfica, adequação, aceitabilidade e capacidade aquisitiva. Cada uma das dimensões foi avaliada por meio de indicadores próprios. RESULTADOS: Para dimensão disponibilidade, 59,8% dos usuários declararam ter acesso total aos medicamentos, sem diferença significante entre regiões. Para acessibilidade geográfica, 60% dos usuários declararam que a unidade básica de saúde não ficava longe de sua residência, 83% afirmaram ser muito fácil/fácil chegar até a unidade e a maioria dos usuários relatou caminhar (64,5%). Para adequação, a unidade foi avaliada como muito bom/bom para os itens conforto (74,2%) e limpeza (90,9%), e 70,8% dos usuários relataram não ter de esperar para retirar seus medicamentos, embora o tempo médio de espera tenha sido 32,9 minutos. Para aceitabilidade: 93,1% dos usuários relataram ser atendidos com respeito e cortesia pelos funcionários das unidades dispensadoras e 90,5% declararam ser muito bom/bom o atendimento das unidades. Para capacidade aquisitiva 13% dos usuários relataram ter deixado de comprar algo importante para cobrir gastos com problemas de saúde, 41,8% dos participantes apontaram a despesa com medicamentos. CONCLUSÕES: Os resultados mostram 70%–90% de conformidade, compatível com países desenvolvidos. No entanto, o acesso aos medicamentos continua sendo um desafio pois ainda é fortemente comprometido pela baixa disponibilidade de medicamentos essenciais em unidades públicas de saúde, demonstrando que não ocorre de forma universal, equânime e resolutiva à populaçãoOBJECTIVE: To evaluate the access to medicines in primary health care of the Brazilian Unified Health System (SUS), from the patients’ perspective. METHODS: This is a cross-sectional study that used data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Services, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), conducted by interviews with 8,591 patients in cities of the five regions of Brazil. Evaluation of access to medicines used concepts proposed by Penshansky and Thomas (1981), according to the dimensions: availability, accessibility, accommodation, acceptability, and affordability. Each dimension was evaluated by its own indicators. RESULTS: For the “availability” dimension, 59.8% of patients reported having full access to medicines, without significant difference between regions. For “accessibility,” 60% of patients declared that the basic health unit (UBS) was not far from their house, 83% said it was very easy/easy to get to the UBS, and most patients reported that they go walking (64.5%). For “accommodation,” UBS was evaluated as very good/good for the items “comfort” (74.2%) and “cleanliness” (90.9%), and 70.8% of patients reported that they do not wait to receive their medicines, although the average waiting time was 32.9 minutes. For “acceptability,” 93.1% of patients reported to be served with respect and courtesy by the staff of the dispensing units and 90.5% declared that the units’ service was very good/good. For “affordability,” 13% of patients reported not being able to buy something important to cover expenses with health problems, and 41.8% of participants pointed out the expense with medicines. CONCLUSIONS: Results show 70%–90% compliance, which is compatible with developed countries. However, access to medicines remains a challenge, because it is still heavily compromised by the low availability of essential medicines in public health units, showing that it does not occur universally, equally, and decisively to the populatio

Integrative review of managed entry agreements : chances and limitations

Introduction: Managed Entry Agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. Methods: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was ‘What are the health technology MEAs that have been applied around the world?’ This review was supplemented with studies not retrieved in the search known to the senior level co-authors including key South American markets. Afterall, involved senior level decision makers and advisers providing guidance on potential advantages and disadvantages of MEAs and ways forward. Results: 25 studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%), and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. Conclusion: We are likely to see a growth in MEAs with the continual launch of new high priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome based MEAs could be an important tool to improve access to new innovative medicines there are critical issues to address. Comparing knowledge, experiences and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs

Adverse events of COVID-19 vaccines in pregnant and postpartum women in Brazil: A cross-sectional study.

BackgroundBy the fact that pregnant and postpartum women are currently using COVID-19 vaccines, ensure their safety is critical. So, more safety evidence is crucial to include this new technology to their vaccine's calendar and to develop public policies regarding the support and training of Health Care Personnel. This study aims to describe the adverse events (AE) of COVID-19 vaccines in pregnant and postpartum women in the early stage of vaccination campaign in Brazil.MethodsAn observational cross-sectional study using data from the Brazilian surveillance information system to characterize the AE of COVID-19 vaccines (Sinovac/Butantan, Pfizer/BioNTech, AstraZeneca and Janssen) in Brazilian pregnant and postpartum women from April to August 2021. Frequency and incidence rate of AE for COVID-19 vaccines were assessed.Results3,333 AE following immunization were reported for the study population. AE incidence was 309.4/100,000 doses (95% CI 297.23, 321.51). Within the vaccines available, Sinovac/Butantan had the lowest incidence (74.08/100,000 doses; 95% CI 63.47, 84.69). Systemic events were the most frequent notified (82.07%), followed by local (11.93%) and maternal (4.74%), being most of them classified as non-severe (90.65%).ConclusionOur results corroborate the recommendation of vaccination for these groups. Even though, further studies appraising a longer observation time are still needed to provide a broader safety aspect for the vaccines currently under use for this population

Trends in Pneumococcal and Bacterial Meningitis in Brazil from 2007 to 2019

The pneumococcal conjugate vaccination (PCV) was introduced into the Brazilian Childhood National Immunization Program in 2010; however, universal pneumococcal vaccination for older adults has not been implemented yet. Our aim is to evaluate the trends in pneumococcal meningitis incidence and case fatality rate (CFR) across all age groups from 2007 to 2019 using data from the National Surveillance System. The pre-PCV (2007–2009) and post-PCV (2011–2019) periods were compared; changes in incidence and CFR were assessed by joinpoint regression. Additional analyses of bacterial meningitis were performed to compare the patterns and trends. Over the 13-year period, 81,203 and 13,837 cases were classified as bacterial and pneumococcal meningitis, respectively. S. pneumoniae was the main etiological agent of bacterial meningitis in adults aged ≥50 years and the most lethal in all age groups. In the post-PCV period, a 56.5% reduction in the average incidence was seen in pneumococcal meningitis in the pediatric population. In contrast, there was an increasing trend among adults. The CFR for pneumococcal and bacterial meningitis remained stable in most age groups during the study period. These findings highlight the value of expanding pneumococcal vaccination policies, including vaccines that provide better indirect protection from children to adults and broadening vaccination to older adults

Acesso aos medicamentos pelos usuários da atenção primária no Sistema Único de Saúde

Objetivo: avaliar o acesso aos medicamentos na Atenção Primária em Saúde do Sistema Único de Saúde na perspectiva do usuário. Métodos: estudo transversal que utilizou dados da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional no Brasil – Serviços, 2015, realizado por meio de entrevistas com 8.591 usuários em municípios das cinco regiões do Brasil. A avaliação do acesso aos medicamentos utilizou conceitos propostos por Penshansky e Thomas (1981), segundo as dimensões: disponibilidade, acessibilidade geográfica, adequação, aceitabilidade e capacidade aquisitiva. Cada uma das dimensões foi avaliada por meio de indicadores próprios. Resultados: para dimensão disponibilidade, 59,8% dos usuários declararam ter acesso total aos medicamentos, sem diferença significante entre regiões. Para acessibilidade geográfica, 60% dos usuários declararam que a unidade básica de saúde não ficava longe de sua residência, 83% afirmaram ser muito fácil/fácil chegar até a unidade e a maioria dos usuários relatou caminhar (64,5%). Para adequação, a unidade foi avaliada como muito bom/bom para os itens conforto (74,2%) e limpeza (90,9%), e 70,8% dos usuários relataram não ter de esperar para retirar seus medicamentos, embora o tempo médio de espera tenha sido 32,9 minutos. Para aceitabilidade: 93,1% dos usuários relataram ser atendidos com respeito e cortesia pelos funcionários das unidades dispensadoras e 90,5% declararam ser muito bom/bom o atendimento das unidades. Para capacidade aquisitiva 13% dos usuários relataram ter deixado de comprar algo importante para cobrir gastos com problemas de saúde, 41,8% dos participantes apontaram a despesa com medicamentos. Conclusões: os resultados mostram 70%–90% de conformidade, compatível com países desenvolvidos. No entanto, o acesso aos medicamentos continua sendo um desafio pois ainda é fortemente comprometido pela baixa disponibilidade de medicamentos essenciais em unidades públicas de saúde, demonstrando que não ocorre de forma universal, equânime e resolutiva à população.Objetive: to evaluate the access to medicines in primary health care of the Brazilian Unified Health System (SUS), from the patients’ perspective. Methods: this is a cross-sectional study that used data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Services, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), conducted by interviews with 8,591 patients in cities of the five regions of Brazil. Evaluation of access to medicines used concepts proposed by Penshansky and Thomas (1981), according to the dimensions: availability, accessibility, accommodation, acceptability, and affordability. Each dimension was evaluated by its own indicators. Results: for the “availability” dimension, 59.8% of patients reported having full access to medicines, without significant difference between regions. For “accessibility,” 60% of patients declared that the basic health unit (UBS) was not far from their house, 83% said it was very easy/easy to get to the UBS, and most patients reported that they go walking (64.5%). For “accommodation,” UBS was evaluated as very good/good for the items “comfort” (74.2%) and “cleanliness” (90.9%), and 70.8% of patients reported that they do not wait to receive their medicines, although the average waiting time was 32.9 minutes. For “acceptability,” 93.1% of patients reported to be served with respect and courtesy by the staff of the dispensing units and 90.5% declared that the units’ service was very good/good. For “affordability,” 13% of patients reported not being able to buy something important to cover expenses with health problems, and 41.8% of participants pointed out the expense with medicines. Conclusions: results show 70%–90% compliance, which is compatible with developed countries. However, access to medicines remains a challenge, because it is still heavily compromised by the low availability of essential medicines in public health units, showing that it does not occur universally, equally, and decisively to the population

Evidence-based public policy making for medicines across countries; findings and implications for the future

Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Extensive narrative review of published papers and contextualizing the findings to provide future guidance. New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Multiple measures will be needed to attain and retain universal healthcare

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications

Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems. Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines. Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments