Acordo de Compartilhamento de Risco: projeto-piloto no Sistema Único de Saúde / Risk Sharing Agreement: a pilot project in the Brazilian Unified Health System

O Acordo de Compartilhamento de Risco é definido como um acordo no qual o Estado concorda em oferecer acesso temporário a um novo medicamento, enquanto a indústria farmacêutica aceita receber pelo produto conforme o desempenho do medicamento em reais condições de uso. A partilha de risco depende, necessariamente, da coleta de evidências adicionais, que podem se referir aos benefícios terapêuticos ou ao volume de pacientes, conforme avaliação de seu uso na prática. Os autores descreveram a experiência do projeto-piloto de Acordo de Compartilhamento de Risco no Sistema Único de Saúde.

Risk Sharing Agreement is defined as an agreement in which the State agrees to offer temporary access to a new drug, while the pharmaceutical industry accepts to receive the product according to the performance of the drug in real conditions of use. Risk sharing necessarily depends on the collection of additional evidence that may refer to the therapeutic benefits or the volume of patients, according to the assessment of its use in practice. The authors described the experience of the pilot project of a Risk Sharing Agreement in the Unified Health System.

Linha de cuidados no tratamento da asma: informações úteis para o gestor / Comprehensive care in asthma treatment: useful information for the health-care manager

Realizou-se, no dia 29 de agosto de 2020, um encontro virtual com gestores, representantes de associações de pacientes e médicos prescritores envolvidos no tratamento da asma, com o objetivo de discutir a necessidade e a viabilidade da incorporação de novas tecnologias para o tratamento dessa patologia. A asma é uma enfermidade caracterizada pela inflamação crônica das vias aéreas. É a principal causa de absenteísmo escolar e laboral e estima-se que seja responsável por até cinco mortes diárias em nosso país. Em pesquisa efetuada em operadora de autogestão, com vidas espalhadas por todo o país, observou-se que essa patologia (associada à doença pulmonar obstrutiva crônica ­ DPOC) acomete quase 7% dos seus segurados e que a utilização do plano foi, nesse grupo, 1,9x maior para consultas, 1,6x maior para exames, 2,5x maior para terapias e 2,9x maior para internações, resultando em um aumento de 25,5% nos gastos assistenciais. Observou-se que é de elevada importância que o gestor tenha um profundo conhecimento de sua carteira e que priorize toda a linha de cuidado do paciente. Dessa maneira, atuando diretamente no controle da severidade da patologia, terão os melhores resultados de qualidade de vida e restringirão os doentes que necessitarão de medicações mais modernas e, também, mais caras, com resultado óbvio no controle de custos. A asma ainda não tem, em geral, para os gestores de operadoras de saúde privadas, no Brasil, uma importância tão grande na sinistralidade das suas carteiras. Os novos imunobiológicos são úteis e efetivos e alguma contrapartida por parte do fabricante, como, por exemplo, o compartilhamento de riscos, pode ser necessária para uma incorporação desse arsenal no Rol de produtos que serão disponibilizados para os pacientes que deles necessitarem

On August 29 (2020), a virtual meeting was held with managers, representatives of patient associations and physicians involved in the treatment of asthma, in order to discuss the need and the feasibility of incorporating new technologies for the treatment of this disease. Asthma is a condition characterized by chronic inflammation of the airways. It is the main cause of school and work absenteeism and it is estimated that it is the cause of up to 5 daily deaths in our country, annually. In a survey carried out at a Health Care Plan, with patients spread across the country, it was observed that this pathology (associated with COPD) affects almost 7% of its insured persons and that the use of the plan was, in this group, 1.9x higher for consultations, 1.6x higher for exams, 2.5x higher for therapies and 2.9x higher for hospitalizations, resulting in a 25.5% increase in the global health care expenses. It was observed that it is highly important that managers have a deep knowledge of his portfolio and that they prioritize the entire process of patient care. In this way, acting directly in the control of the severity of the pathology, they will have the best quality of life results and will restrict the number of patients who will need more modern and also more expensive medications, with obvious impact on costs. Asthma still does not have, for the manager of a Private Health Operator, in Brazil, such importance in the expenses of his portfolio. The new immunobiologicals are useful, effective and some counterpart on the part of the manufacturer, such as, for example, the risk-share agreements, may be necessary for the incorporation of this into the arsenal of products that will be made available to patients that need them

Potential life years not saved due to lack of access to anti-EGFR tyrosine kinase inhibitors for lung cancer treatment in the Brazilian public healthcare system: Budget impact and strategies to improve access. A pharmacoeconomic study

ABSTRACT BACKGROUND: Lung cancer is the fourth most common cancer in Brazil. In the 2000s, better understanding of molecular pathways led to development of epidermal growth factor receptor (EGFR)-targeted treatments that have improved outcomes. However, these treatments are unavailable in most Brazilian public healthcare services (Sistema Único de Saúde, SUS). OBJECTIVE: To assess the potential number of years of life not saved, the budget impact of the treatment and strategies to improve access. DESIGN AND SETTING: Pharmacoeconomic study assessing the potential societal and economic impact of adopting EGFR-targeted therapy within SUS. METHODS: We estimated the number of cases eligible for treatment, using epidemiological data from the National Cancer Institute. We used data from a single meta-analysis and from the Lung Cancer Mutation Consortium (LCMC) study as the basis for assessing differences in patients' survival between use of targeted therapy and use of chemotherapy. The costs of targeted treatment were based on the national reference and were compared with the amount reimbursed for chemotherapy through SUS. RESULTS: There was no life-year gain with EGFR-targeted therapy in the single meta-analysis (hazard ratio, HR, 1.01). The LCMC showed that 1,556 potential life-years were not saved annually. We estimated that the annual budget impact was 125 million Brazilian reais (BRL) with erlotinib, 48 million BRL with gefitinib and 52 million BRL with afatinib. Their incremental costs over chemotherapy per life-year saved were 80,329 BRL, 31,011 BRL and 33,225 BRL, respectively. A drug acquisition discount may decrease the budget impact by 30% (with a 20% discount). A fixed cost of 1,000 BRL may decrease the budget impact by 95%. CONCLUSION: Reducing drug acquisition costs may improve access to EGFR-targeted therapy for lung cancer.

Potential life years not saved due to lack of access to anti-EGFR tyrosine kinase inhibitors for lung cancer treatment in the Brazilian public healthcare system: Budget impact and strategies to improve access. A pharmacoeconomic study.

BACKGROUND: Lung cancer is the fourth most common cancer in Brazil. In the 2000s, better understanding of molecular pathways led to development of epidermal growth factor receptor (EGFR)-targeted treatments that have improved outcomes. However, these treatments are unavailable in most Brazilian public healthcare services (Sistema Único de Saúde, SUS). OBJECTIVE: To assess the potential number of years of life not saved, the budget impact of the treatment and strategies to improve access. DESIGN AND SETTING: Pharmacoeconomic study assessing the potential societal and economic impact of adopting EGFR-targeted therapy within SUS. METHODS: We estimated the number of cases eligible for treatment, using epidemiological data from the National Cancer Institute. We used data from a single meta-analysis and from the Lung Cancer Mutation Consortium (LCMC) study as the basis for assessing differences in patients' survival between use of targeted therapy and use of chemotherapy. The costs of targeted treatment were based on the national reference and were compared with the amount reimbursed for chemotherapy through SUS. RESULTS: There was no life-year gain with EGFR-targeted therapy in the single meta-analysis (hazard ratio, HR, 1.01). The LCMC showed that 1,556 potential life-years were not saved annually. We estimated that the annual budget impact was 125 million Brazilian reais (BRL) with erlotinib, 48 million BRL with gefitinib and 52 million BRL with afatinib. Their incremental costs over chemotherapy per life-year saved were 80,329 BRL, 31,011 BRL and 33,225 BRL, respectively. A drug acquisition discount may decrease the budget impact by 30% (with a 20% discount). A fixed cost of 1,000 BRL may decrease the budget impact by 95%. CONCLUSION: Reducing drug acquisition costs may improve access to EGFR-targeted therapy for lung cancer.

Promoting universal financial protection: evidence from seven low- and middle-income countries on factors facilitating or hindering progress.

Although universal health coverage (UHC) is a global health policy priority, there remains limited evidence on UHC reforms in low- and middle-income countries (LMICs). This paper provides an overview of key insights from case studies in this thematic series, undertaken in seven LMICs (Costa Rica, Georgia, India, Malawi, Nigeria, Tanzania, and Thailand) at very different stages in the transition to UHC.These studies highlight the importance of increasing pre-payment funding through tax funding and sometimes mandatory insurance contributions when trying to improve financial protection by reducing out-of-pocket payments. Increased tax funding is particularly important if efforts are being made to extend financial protection to those outside formal-sector employment, raising questions about the value of pursuing contributory insurance schemes for this group. The prioritisation of insurance scheme coverage for civil servants in the first instance in some LMICs also raises questions about the most appropriate use of limited government funds.The diverse reforms in these countries provide some insights into experiences with policies targeted at the poor compared with universalist reform approaches. Countries that have made the greatest progress to UHC, such as Costa Rica and Thailand, made an explicit commitment to ensuring financial protection and access to needed care for the entire population as soon as possible, while this was not necessarily the case in countries adopting targeted reforms. There also tends to be less fragmentation in funding pools in countries adopting a universalist rather than targeting approach. Apart from limiting cross-subsidies, fragmentation of pools has contributed to differential benefit packages, leading to inequities in access to needed care and financial protection across population groups; once such differentials are entrenched, they are difficult to overcome. Capacity constraints, particularly in purchasing organisations, are a pervasive problem in LMICs. The case studies also highlighted the critical role of high-level political leadership in pursuing UHC policies and citizen support in sustaining these policies.This series demonstrates the value of promoting greater sharing of experiences on UHC reforms across LMICs. It also identifies key areas of future research on health care financing in LMICs that would support progress towards UHC.

Mercado de valores, otra alternativa de financiamiento

El presente trabajo intenta demostrar que el mercado de valoares podria constituirse en una alternativa de financiamiento para las empresas en relación al financiamiento ofertado por el sistema bancario. En este sentido, se reviso el marco técnico sobre el financiamiento y su importancia para las empresas en sus planes de largo y corto plazo; se mostro la composición del sistema financiero económico de cuatro empresas, antes y despueés de que emitieran bonos atraves de la Bolsa de Valores S.A con el objeto de demostrar que financiarse mediante mercado de valores constituye reducir los costos financieros, mejorar el plazo del préstamo y que la presentación de garantía quirografaria no obstaculiza las decisiones de inversión

Portabilidade em planos de saúde no Brasil / Portability health plan in Brazil

Este estudo pretende revisar alguns fundamentos da composição do sistema de atenção à saúde no Brasil. Os benefícios advindos da regulação padronizaram e garantiram a prestação de serviços, porém levaram a aumento dos custos e diminuição da capacidade competitiva do mercado. O ônus decorrente da troca de plano de saúde expressa por perda de direitos adquiridos de cumprimento de prazos de carência e direito a atendimento de doenças preexistentes limita o poder de mercado do consumidor por tender a mantê-lo no mesmo plano de saúde mesmo quando não satisfeito com os serviços recebidos. O direito a troca de plano de saúde sem perda de direitos a portabilidade, restabeleceria o poder do consumidor e a competição do mercado ao permitir a troca de plano de saúde quando concorrentes oferecessem melhores condições de preço ou qualidade de serviços. A regulamentação da portabilidade é considerada, neste estudo, como a obrigatoriedade de cobertura de mais um procedimento, sendo, portanto geradora de custos para operadoras de planos de saúde. Estes custos estão relacionados a fatores atuariais e a fatores de difícil quantificação decorrentes de conduta não ética de beneficiários e operadoras. Algumas estratégias de contornar estas dificuldades são discutidas. A legislação em vigor também é revista procurando determinar situações onde a legislação pode ser aperfeiçoada para evitar a perda de direito de atendimento em planos de saúde após a perda de vínculo empregatício. O estudo conclui com a proposta de criação de uma taxa de portabilidade capaz de favorecer a mobilidade dos beneficiários e a competitividade do mercado sem concentrar todos os riscos sobre as operadoras.

[Mortality risk measure inequalities among workers in Southeast Brazil]. / Desigualdade de indicadores de mortalidade no Sudeste do Brasil.

INTRODUCTION: The main causes of illness and death in Brazil have been migrating backwards into the younger population during the last few years, increasing especially in the more productive age groups. Given the relationship between work and health/disease process, the hypothesis to be considered is that this phenomenon is partially due to the deterioration of workplace conditions. To contribute to investigating this hypothesis, this study estimates mortality risk indicators for the population of Botucatu, in the Southeast region of Brazil, classified according to their occupation. METHODS: Standardized mortality coefficient, standardized risk ratio, and years of potential life lost were calculated for the inhabitants of Botucatu who died after their 10th birthday, between January 1997 and March 1998, and classified according to their occupation and main cause of death. Occupational and medical information was obtained by interviewing families of the deceased and their doctors, and checking medical files. RESULTS: The standardized mortality coefficient ranged from 0.6 to 39.9 deaths/1000 workers in different occupations. The years of potential life lost ranged form 33 to 334 years/1000 workers. The ranking of causes of death varied according to occupation and the mortality risk considered. CONCLUSION: The risk measures analyzed showed a high heterogeneity when associated to occupation and causes of death, which reflects the great social inequality existing in the studied population.