Risk Sharing Agreement: a pilot project in the Brazilian Unified Health System

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.

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.

Cobertura de aseguramiento en salud: el caso peruano desde la Ley de Aseguramiento Universal / Health insurance coverage: the peruvian case since the universal insurance act

RESUMEN Objetivo. Describir la evolución de la cobertura de aseguramiento en salud (CAS) en Perú para el periodo 2009-2017 y evaluar los principales factores demográficos, sociales y económicos asociados. Materiales y métodos. Realizamos un análisis secundario de la Encuesta Nacional de Hogares. Para cada año estimamos la CAS global, del Seguro Integral de Salud (SIS) y del Seguro Social en Salud (EsSalud), y realizamos pruebas de tendencias anuales. Para los años 2009 (Ley de Aseguramiento Universal en Salud), 2013 (reforma del sector salud) y 2017, construimos una variable politómica del tipo de aseguramiento (SIS/EsSalud/No asegurado) y estimamos razones relativas de prevalencia (RRP) con intervalos de confianza (IC) al 95% mediante modelos logísticos multinomiales para muestras complejas. Resultados. Observamos un incremento en la CAS global (2009: 60,5%; 2013: 65,5%; 2017: 76,4%), en el SIS (2009: 34%; 2013: 35,4%; 2017: 47%) y en EsSalud (2009: 22,8%; 2013: 26,4%; 2017: 26,3%). Observamos que ser mujer aumentó la posibilidad de afiliación al SIS (RRP=2009: 1,64 y 2017: 1,53), mientras que tener entre 18 y 39 años, residir Lima Metropolitana y ser no pobre redujeron esa posibilidad (RRP=2009: 0,16 y 2017: 0,31; 2009: 0,17 y 2017: 0,37; 2009: 0,51 y 2017: 0,53; respectivamente). Por su parte, ser mujer, tener más de 65 años, ser del ámbito urbano, residir en Lima Metropolitana y ser no pobre aumentó la probabilidad de estar afiliados a EsSalud (RRP=2013: 1,12 y 2017: 1,24; 2013: 1,32 y 2017: 1,34; 2009: 2,18 y 2017: 2,08; 2009: 2,14 y 2017: 2,54; 2009: 3,57 y 2017: 2,53; respectivamente). Conclusiones. La CAS ha incrementado durante el periodo 2009-2017. No obstante, las características de la población asegurada difieren de acuerdo con el tipo de seguro.

ABSTRACT Objective. To describe the trends in health insurance coverage (HIC) in Peru during the period 2009-2017 and evaluate associations with demographic, social and economic factors. Materials and Methods. We carried out a secondary data-analysis from the Peruvian National Household Survey. For each year, we estimated the global HIC, for the Integral Health Insurance (SIS) and the Social Security system (EsSalud). In addition, we performed a trend analysis. For 2009 (Universal Health Insurance Act), 2013 (health care reform act) and 2017, we used a polytomous variable for the insurance type (SIS/EsSalud/Non-affiliated). We performed logistic multinomial regressions to estimate relative prevalence ratios (RPR) and their 95% CI with correction for complex sampling. Results. We observed an increasing trend in the global HIC (2009:60.5%; 2013:65.5%; 2017:76.4%), SIS coverage (2009:34%; 2013:35.4%; 2017:47%) and EsSalud coverage (2009:22.8%; 2013:26.4%; 2017:26.3%). Multinomial logistic regressions showed that being a woman increased the likelihood to be affiliated to the SIS (RPR= 2009:1.64 and 2017:1.53), while people between 18 and 39 years old, living in Lima Metropolitan area under non-poverty conditions reduced the likelihood to be affiliated to the SIS (RPR= 2009:0.16 and 2017:0.31; 2009:0.17 and 2017:0.37; 2009:0.51 and 2017:0.53; respectively). Furthermore, being a woman, 65 years old or over, living in urban Lima, and under non-poverty conditions increased the likelihood of being affiliated with the EsSalud (RPR= 2013:1.12 and 2017:1.24; 2013:1.32 and 2017:1.34; 2009:2.18 and 2017:2.08; 2009:2.14 and 2017:2.54; 2009:3.57 and 2017:2.53; respectively). Conclusions. HIC has increased during the period 2009-2017. However, the characteristics of those affiliated are different between the various types of health insurance.

Regresión logística y redes neuronales como herramientas para realizar un modelo Scoring / Logistic regression and neural networks as tools to perform a Scoring model / Regressão logística e redes neuronais como ferramentas para realizar Scoring

Resumen Introducción. El propósito de esta investigación es analizar el riesgo crediticio de una institución financiera no vigilada por la Superintendencia Financiera de Colombia en torno a un modelo scoring que permita determinar el incumplimiento de los clientes correspondiente a su cartera de consumo. Objetivo. Confrontar el poder de pronosticación de dos modelos scoring obtenidos a través de regresión logística y red neuronal. Materiales y métodos. Los modelos se desarrollan con base en una muestra de 43.086 obligaciones correspondiente a una cartera de consumo, utilizando las técnicas estadísticas de regresión logística y red neuronal. La primera está enmarcada en el grupo de los modelos lineales generalizados, los cuales utilizan una función logit y son útiles para modelar probabilidades referentes a un evento en función de otras variables, mientras que la segunda son modelos computacionales cuyo objetivo es resolver problemas utilizando relaciones ya estipuladas y para ello utiliza una muestra base del proceso que se ampara en el éxito del autoaprendizaje producto del entrenamiento. Resultados. Para ambos modelos se logra una precisión del 71% en la base de entrenamiento y del 72 % en la base de comprobación, sin embargo, a pesar de obtener resultados similares, la regresión logística arrojó la menor tasa de malos en la zona de aceptación. Conclusión. Las dos técnicas utilizadas son adecuadas para el estudio y predicción de la probabilidad de incumplimiento de un cliente correspondiente a una cartera de consumo, lo anterior, respaldado por el alto índice de eficacia predictiva en ambos modelos.

Abstract Introduction. The purpose of this research is to analyze the credit risk of a financial institution not supervised by the Financial Superintendence of Colombia around a scoring model that allows determining the default of clients corresponding to their consumer portfolio. Objective. Confront the forecasting power of two scoring models obtained through logistic regression and neural network. Materials and methods. The models are developed based on a sample of 43,086 obligations corresponding to a consumer portfolio, using the statistical techniques of logistic regression and neural network. The first is framed in the group of generalized linear models, which use a logit function and are useful for modeling probabilities related to an event based on other variables; while the second consists in computational models whose objective is to solve problems using relationships already stipulated, employing for this purpose a base sample of the process that is based on the success of the self-learning resulting from training. Results. For both models, an accuracy of 71 % in the training base and 72 % in the testing base is achieved. However, despite obtaining similar results, the logistic regression yielded the lowest rate of bad in the acceptance zone. Conclusion. The two techniques used are suitable for the study and prediction of the probability of default of a client corresponding to a consumer portfolio; the foregoing is supported by the high index of predictive effectiveness in both models.

Resumo Introdução. O propósito de esta pesquisa é analisar o risco creditício de uma instituição financeira não vigilada pela Superintendência Financeira da Colômbia em torno de um modelo scoring que permita determinar o incumprimento dos clientes correspondentes à sua carteira de consumidores. Objetivo. Confrontar o poder de previsão de dois modelos scoring obtidos através de regressão logística e rede neuronal. Materiais e métodos. Os modelos desenvolvam-se com base em uma amostra de 43.086 obrigações correspondentes à una carteira de consumidores, utilizando as técnicas estatísticas de regressão logística e rede neuronal. A primeira está enquadrada no grupo dos modelos lineais generalizados, os quais utilizam uma função logit e são úteis para modelar probabilidades referentes à um evento em função de outras variáveis, em quanto que, a segunda são modelos computacionais cujo objetivo é resolver problemas utilizando relações já estipuladas e para isso utiliza-se uma amostra base do processo que ampara-se no sucesso do autoaprendizagem produto do treinamento. Resultados. Para ambos os modelos se consegue uma precisão do 71% na base do treinamento e do 72% na base da comprovação, mas, não obstante isso, a pesar de obterem resultados semelhantes, a regressão logística mostrou a menor taxa ruim na zona de aceitação. Conclusão. As duas técnicas utilizadas são adequadas para o estudo e previsão da probabilidade do incumprimento de um cliente correspondente à una carteira de consumidores, o que precede, respaldado pelo alto índice de eficiência preditiva em ambos os modelos.

Equity in health benefit utilization and financial risk protection in outpatient and inpatient care: Baseline survey of two socioeconomic groups of a pilot primary care benefits scheme in the catchment areas of a university-based health facility

Background@#Health inequities in the Philippines are driven by health workforce maldistribution and health system fragmentation. These can be addressed by strengthening primary care through central social health insurance (PhilHealth) coverage. However, high reported PhilHealth population coverage and health provider accreditation have not necessarily increased health benefit utilization or financial risk protection.@*Objective@#This study aims to examine the impact of an enhanced, comprehensive primary care benefits package at a university-based health facility. This paper reports baseline utilization of health services and health benefits, and out-of-pocket health spending in two socioeconomic strata of the catchment population, for outpatient and inpatient services.@*Methods@#A questionnaire-guided survey was done among randomly selected faculty (higher income group) and non-faculty (lower income group) employees to determine the frequencies and costs of using outpatient and inpatient health services, and amounts paid out-of-pocket.@*Results@#Annually, both groups had approximately 1 consultation/patient and about 15 hospitalizations per 100 families annually. For hospitalizations, non-faculty inpatients utilized health insurance more frequently than faculty inpatients (75.7% vs. 66.7%), but paid higher out-of-pocket proportions (73.3% or Php 92,479/hospitalization vs. 57.4% or Php 16,273/hospitalization). For outpatient care, health benefit utilization rates were higher among non-faculty (12.4% vs 2.1% of consultations) although low overall, with similar total (Php 2,319 vs Php 1,741) and out-of-pocket expenses (100%).@*Conclusion@#These findings confirm inequities in accessing outpatient and inpatient health services and utilizing health insurance benefits in the target population.

A incorporação do nusinersena no Sistema Único de Saúde: uma reflexão crítica sobre a institucionalização da avaliação de tecnologias em saúde no Brasil / The incorporation of nusinersen by the Brazilian Unified National Health System: critical thoughts on the institutionalization of health technology assessment in Brazil / La incorporación del nusinersén al Sistema Único de Salud: una reflexión crítica sobre la institucionalización de la evaluación de tecnologías en salud en Brasil

Resumo: Em abril de 2019, foi assinada a portaria de incorporação do medicamento nusinersena no Sistema Único de Saúde (SUS). É o medicamento mais caro já incorporado ao SUS, para uso no tratamento de atrofia muscular espinhal 5q tipo I. A incorporação é referida como um marco na tomada de decisão sobre novas tecnologias no SUS, a ser viabilizada por meio de acordo de partilha de risco. O trabalho discute o processo de incorporação do nusinersena, destacando aspectos contextuais, temporais e técnicos, além de possíveis consequências para a institucionalização da avaliação de tecnologias em saúde (ATS) no SUS. Seguiu método exploratório, com revisão de informações públicas produzidas pela Comissão de Incorporação de Tecnologias no SUS (CONITEC) e busca em bancos de dados governamentais de preços e compras. Foi produzida linha temporal descrevendo os pontos-chave do processo de incorporação. Houve dois pedidos de incorporação do medicamento. O primeiro, submetido pela Secretaria de Ciência, Tecnologia e Insumos Estratégicos (SCTIE) do Ministério da Saúde, negado por unanimidade, em novembro de 2018. Seguiu-se o pedido do Secretário da SCTIE à Advocacia-Geral da União (AGU), para que pudesse decidir de forma contrária à recomendação do plenário da CONITEC. A AGU recomendou uma nova submissão, feita pela empresa produtora e aprovada por unanimidade, em março de 2019. Não houve acréscimo de novas evidências ou redução de preço que justificassem a mudança de decisão. Não foram identificados os elementos constituintes do acordo de partilha de risco. São sinalizados problemas de transparência e accountability, bem como riscos ao processo de institucionalização da ATS que vinha em curso no SUS.

Abstract: In April 2019, a ruling was signed for the incorporation of the drug nusinersen by the Brazilian Unified National Health System (SUS). Nusinersen is the most expensive drug ever incorporated by the SUS and is used to treat type I 5q spinal muscular atrophy. The incorporation has been described as a milestone in decision-making on new technologies in the SUS, enabled through a risk-sharing agreement. The article discusses the process involved in the incorporation of nusinersen, highlighting the context, timing, and technical issues, in addition to possible consequences for the institutionalization of health technology assessment (HTA) in the SUS. The study used an exploratory method, reviewing public information produced by the Commission for Incorporation of Technologies in the SUS (CONITEC) and searches in government databanks on prices and purchases. A timeline was produced, describing the key points in the process of incorporation. There were two formal requests for the drug's incorporation. The first was submitted by the Division of Science, Technology, and Strategic Inputs (SCTIE) of the Brazilian Ministry of Health and was turned down unanimously in November 2018. This was followed by a petition by the head of the SCTIE to the Attorney General's Office (AGU) to overrule the recommendation by the CONITEC plenary. The AGU recommended a new submission, made by the drug's manufacturing company, which was approved unanimously in March 2019. The was no addition of new evidence or a price reduction to justify the change of decision. No elements were identified in the risk-sharing agreement. This suggests problems of transparency and accountability, as well as risks in the process of institutionalization of HTA that had been underway in the SUS.

Resumen: En abril de 2019, se firmó el decreto de incorporación del medicamento nusinersén en el Sistema Único de Salud brasileño (SUS). Es el medicamento más caro que se ha incorporado al SUS para su uso en el tratamiento de la atrofia muscular espinal 5q tipo I. La incorporación del mismo está considerada como un marco de referencia en la toma de decisiones sobre nuevas tecnologías en el SUS, que puede ser viable mediante el acuerdo de distribución de riesgo. El trabajo discute el proceso de incorporación del nusinersén, destacando aspectos contextuales, temporales y técnicos, además de posibles consecuencias para la institucionalización de la evaluación de tecnologías en salud (ETS) en el SUS. El trabajo siguió el método exploratorio, con una revisión de la información pública, generada por la Comisión de Incorporación de Tecnologías en el SUS (CONITEC) y la búsqueda en bancos de datos gubernamentales de precios y compras. Se creó una línea temporal, describiendo los puntos-clave del proceso de incorporación. Hubo dos peticiones de incorporación del medicamento. La primera, sometida a la Secretaría de Ciencia, Tecnología e Insumos Estratégicos (SCTIE) del Ministerio de Salud, rechazada por unanimidad, en noviembre de 2018. A lo que le siguió la petición del Secretario de la SCTIE a la Abogacía-General de la Unión (AGU), para que pudiese decidir en otro sentido respecto a la recomendación del pleno de la CONITEC. La AGU recomendó una nueva remisión, realizada por la empresa productora y aprobada por unanimidad, en marzo de 2019. No se produjo un incremento de nuevas evidencias o una reducción del precio que justificasen el cambio de decisión. No se identificaron los elementos constituyentes del acuerdo de distribución de riesgo. Se señalaron los problemas de transparencia y rendición de cuentas, así como riesgos para el proceso de institucionalización de la ETS que estaba en curso en el SUS.

Valoraciones entorno al riesgo financiero en las medianas empresas de la Provincia de Manabí / Assessments about financial risk in the medium-sized companies of Manabí / Valorações meio ao risco financeiro nas médias empresas da Província de Manabí

Resumen Introducción: El riesgo financiero en las empresas es uno de los problemas científicos de relevancia, que preocupan a: empresarios, gerentes, emprendedores, entre otros. La sostenibilidad y eficiencia de las empresas, en especial de las medianas empresas, depende, en gran medida, del sistema financiero que adopten. Evaluar la probabilidad de riesgo, adquiere una gran relevancia. La presente investigación realizada en la provincia de Manabí, tiene como objetivo analizar la necesidad de la introducción del análisis del riesgo en el financiamiento de las medianas empresas (Me). Para el desarrollo de la investigación se utilizaron materiales y métodos, entre los que se puede mencionar: el análisis de documentos, el método hipotético deductivo, el método comparativo, la abstracción científica, el análisis de documentos y el método hermenéutico. En calidad de resultados fundamentales de la investigación se pueden citar: la determinación de las fuentes de financiamientos para la Me, el perfeccionamiento de la definición de riesgo financiero y las sugerencias para un uso racional de los recursos financieros y para obtención de crédito. Conclusión. Se caracterizó la mediana empresa de la provincia, determinando así las vías de financiamientos para las mismas.

Abstract Introduction: Financial risk in companies is one of the relevant scientific problems, which concern: entrepreneurs, managers, entrepreneurs, among others. The sustainability and efficiency of companies, especially medium-sized companies, depends to a large extent on the financial system they adopt. Assess the probability of risk, acquires great relevance. The present investigation carried out in the province of Manabí, has like objective analyze the necessity of the introduction of the analysis of the risk in the financing of the medium companies (Me). For the development of the research materials and methods were used, among which we can mention: the analysis of documents, the deductive hypothetical method, the comparative method, scientific abstraction, the analysis of documents and the hermeneutical method. The following are fundamental results of the research: the identification of financing sources for the Me, the improvement of the definition of financial risk and the suggestions for a rational use of financial resources and for obtaining credit. Conclusion. The medium-sized company of the province was characterized, thus determining the means of financing for them.

Resumo Introdução: O risco financeiro nas empresas é um dos problemas científicos relevantes, que dizem respeito a: empresários, gestores, empresários, entre outros. A sustentabilidade e a eficiência das empresas, especialmente as médias empresas, dependem em grande medida do sistema financeiro que adotam. Avalie a probabilidade de risco, adquira grande relevância. A presente investigação realizada na província de Manabí, tem como objetivo analisar a necessidade da introdução da análise do risco no financiamento das médias empresas (Me). Para o desenvolvimento dos materiais e métodos de pesquisa foram utilizados, dentre os quais podemos citar: a análise de documentos, o método hipotético-dedutivo, o método comparativo, a abstração científica, a análise de documentos e o método hermenêutico. A seguir, são apresentados os resultados fundamentais da pesquisa: a identificação de fontes de financiamento para o eu, o aprimoramento da definição de risco financeiro e as sugestões para o uso racional dos recursos financeiros e para obtenção de crédito. Conclusão A empresa de tamanho médio da província foi caracterizada, determinando assim os meios de financiamento para eles.

Assessment of financial risk exposure of county-level public hospitals reform pilots in Inner Mongolia Autonomous Region / 中华医院管理杂志

Objective To establish an assessment model of financial risk exposure for the county-levelpublic hospitals in Inner Mongolia Autonomous Region,which can be used to assess the risk exposure of the hospital in question,and as decision making reference for their financial management and risk prevention and control.Methods Using indicators standardized methods and entropy method to process 1 5 financial indicators (quantitative indicators and qualitative indicators )for the 20 public hospitals,and using the gray clustering method to assess financial risk exposure.Results 70% of the county-level public hospitals are faced with less financial risks,while four of them need to pay close attention,and two have large loopholes pending solution.Conclusions Entropy-Gray clustering methods can complement each other,as found in the study.This study proves its significance,and health authorities should establish their long-term financial risk control mechanisms.

The need for better evidence to evaluate the health & economic benefits of India’s Rashtriya Swasthya Bima Yojana.

In this review the existing evidence on the impact of Rashtriya Swasthya Bima Yojana (RSBY) is discussed in the context of international literature available on health insurance. We describe potential pathways through which health insurance can affect health and economic outcomes, discuss evidence from other developing countries, and identify potential biases and inconsistencies in existing studies on RSBY impact. Given the relatively recent introduction of RSBY, lack of quality, verifiable data on utilization patterns, and the absence of reliable evaluation studies, there is a need to exercise caution while assessing the merits of the programme. Considering the enormous potential and cost of the programme, we emphasize the need for a rigorous impact evaluation of RSBY. It will not only help capture the real impact of the scheme, but may also be able to estimate the extent of systemic inefficiencies at the level of the consumer.

The Bottleneck Problem and Countermeasures of TCM Overseas Education in China / 浙江中医药大学学报

Objective] Aiming at the problem of a slower growth in overseas TCM students in China, to find out the causes of the problem and put forward countermeasure to promote the further development of TCM overseas education in China. [Method] The article, from the aspects of nearby schooling, the financial crisis and tuition costs, analyzed the causes for the slower growth in overseas TCM students in China, and put forward the corresponding countermeasures.[Results] Through the analysis about the present situation of TCM overseas education in China, it points out that the scale growth delay is the bottleneck problem of current TCM overseas education in China, and needs a series measures to cope with such as collaborating with overseas TCM schools, promoting teaching quality, and setting up the TCM overseas education brand in China, etc. [Conclusion] TCM overseas education in China should conform to the trend, turn the emphasis to the connotation construction from enlarging the scale and promote its the further development.

THINKING ABOUT THE INDEBTEDNESS OF THE LARGE PUBLIC HOSPITAL / 现代医院

Public hospital is a public medical institutions , but at the present, the government's financial abil-ity is limited, which input for the hospital is symbolic .In fact, in order to survive and develop , the hospital debts be-come the main means of financing of public hospital .The liabilities of hospital mainly include two aspects : one is the current liabilities, such as the credit payment which is formed by the drug ; the other is the long term liabilities, such as the borrowing from financial institutions , which is used to construct the fixed asset of the hospital .Now, the man-agement of the debts has become an important means for the development of hospital , although, the hospital can solve the problem of the shortage of the funds to expand the scale of development and the power of competing , but inevita-bly, which will accompany by some risks , at the same time of indebtedness .So, hospital should carry on the scientif-ic decision, and make the early warning and management about the necessary financial risk .

Universal access to medicines: evidence from Rajasthan, India

India has outlined its commitment to achieving universal health coverage and several states in India are rolling out strategies to support this aim. In 2011, Rajasthan implemented an ambitious universal access to medicines programme based on a centralized procurement and decentralized distribution model. In terms of the three dimensions of universal health coverage, the scheme has made significant positive strides within a short period of implementation. The key objectives of this paper are to assess the likely implications of providing universal access to essential medicines in Rajasthan, which has a population of 70 million. Primary field-level data were obtained from 112 public health-care facilities using multistage random sampling. National Sample Survey Organization data and health system data were also analysed. The per capita health expenditure during the pre-reform period was estimated to be `5.7 and is now close to `50. Availability of essential medicines was encouraging and utilization of public facilities had increased. With additional per capita annual investment of `43, the scheme has brought about several improvements in the delivery of essential services and increased utilization of public facilities in the state and, as a result, enhanced efficiency of the system. Although there was an attempt to convert the scheme into a targeted one with the change in government, strong resistance from the civil society resulted in such efforts being defeated and the universality of the scheme has been retained.