Adoption of new therapies in the treatment of Hepatitis: a verification of the accuracy of budget impact analysis to guide investment decisions.

OBJECTIVES: While there are good Budget Impact Analysis (BIA) guidelines, studies still register potential bias. To do this, we compared the results between theoretical and real-world evidence (RWE) expenditures for medicines for Hepatitis C: boceprevir (BOC) and telaprevir (TVR). While both are not currently recommended in treatment guidelines following recent developments, this is an emblematic case because for 4 years these medicines consumed considerable resources. METHODS: Theoretical results and RWE expenditures were compared regarding the incorporation of BOC and TVR in 2013-2014 into the Brazilian Public Health System. Theoretical values were extracted from Commission for Technology Incorporation Report and RWE expenditures were extracted from the administrative data records using deterministic-probabilistic linkage. RESULTS: The estimated number of patients treated (BOC+TVR) was 13,012 versus 7,641 (real). The estimated purchase price for BOC was US$6.20 versus US$11.07 (real) and for TVR was US$42.21 versus US$84.09 (average/real). The estimated budget impact was US$285.16 million versus US$128.58 million (real). CONCLUSION: This study demonstrates appreciable divergence (US$156.58 million) between the theoretical budget impact and RWE expenditures due to underestimated purchase prices and overestimated populations. The greater the degree of accuracy the more reliable and usable BIAs become for decision-making.

Budget impact analysis of medicines: estimated values versus real-world evidence and the implications.

OBJECTIVES: Budget Impact Analyses (BIA) of medicines helps managers in promoting health systems' sustainability when assessing the role and value of new medicines. However, it is not clear whether BIAs typically underestimate or overestimate the impact on real-world budgets. This retroactive analysis seeks to compare estimated values obtained by a BIA and Real-World Evidence (RWE) to guide discussions. METHODS: The estimated values were obtained through a BIA concerning the incorporation of adalimumab for the treatment of Rheumatoid Arthritis into the Brazilian Unified Health System (SUS) carried out retroactively and per international guidelines. RWE data was extracted from SUS computerized systems. We subsequently compared the number of treatments, costs, and Incremental Budget Impact (IBI). RESULTS: - The total number of treatments was underestimated by 10% (6,243) and the total expenditure was overestimated by 463% (US$ 4.7 billion). In five years, the total difference between the estimated values and real IBI reached US$ 1.1 billion. A current expenditure of US$ 1.0 was observed for every US$ 5.60 of estimated expenditure. CONCLUSION: - The higher estimates from the BIA might cause decision makers to be more cautious with the introduction of a new medicine to reduce the opportunity costs for other interventions.

Balances of federal transfers in SUS: what we have and what to expect from the COVID-19 increment. / Saldos dos repasses federais no SUS: o que temos e o que esperar do incremento para a COVID-19.

We analyzed the balances from the transfers from the Ministry of Health (MH) to subnational entities, to finance the Unified Health System (SUS), including for COVID-19. We verified the representativeness of these in relation to the transfers from the MH to public health actions and services, between 2019and 2020. We analyzed the MH ordinances that gave rise to the COVID-19 transfers, classifying them as: quantity; object; apportionment criterion; amount of installments; execution linked to MH strategies; value. More than 70.000 current accounts were accounted for, and some subnational entities had more than 100. In 2019, balances reached R$16.29 billion (annual increase of 10.2%), representing 19.9% ​​of the total transferred. In 2020, they reached R$23.83 billion (an increase of 46.3%), representing 21.1% of all transfers, with a monthly trend of continued growth. More than 616 ordinances, with 28 different objectives, transferred R$32.30 billion to COVID-19. The resource, originally freely available, had R$11.88 billion (36.8%) linked to the strategies of the MH: R$1.36 billion (99.9%) linked to the Structuring Block, and R$10.52 billion (34.0%) linked to the Maintenance Block. There are several causes that give rise to the accumulation of balances, however the quality, quantity and complexity of the SUS normative framework strongly contribute to an execution of resources that is not very fast, effective, efficient and useful.

Analisamos os saldos provenientes dos repasses do Ministério da Saúde (MS) aos entes subnacionais, destinados ao financiamento do Sistema Único de Saúde (SUS), inclusive para COVID-19. Verificamos a representatividade destes frente aos repasses do MS destinados às ações e serviços públicos de saúde, entre 2019 e 2020. Analisamos as portarias do MS que deram origem aos repasses COVID-19, classificando-as em: quantidade, objeto, critério de rateio, quantidade de parcelas, execução vinculada a estratégias do MS, valor. Mais de 70 mil contas-correntes foram contabilizadas, alguns entes subnacionais tinham mais de cem. Em 2019, saldos atingiram R$16,29 bilhões (aumento anual de 10,2%), representando 19,9% do total repassado. Em 2020, R$23,83 bilhões (aumento de 46,3%), representando 21,1% do repassado, com tendência de crescimento. Mais de 616 portarias, com 28 diferentes objetivos, repassaram R$32,30 bilhões à COVID-19. O recurso, antes de livre utilização, teve R$11,88 bilhões (36,8%) vinculados às estratégias do MS: R$1,36 bilhão (99,9%) Bloco Estruturação e R$10,52 bilhões (34,0%) Bloco Manutenção. Várias podem ser as causas que dão origem ao acúmulo de saldos, todavia qualidade, quantidade e complexidade do arcabouço normativo do SUS contribuem fortemente para uma execução dos recursos pouco célere, efetiva, eficiente e eficaz.

Saldos dos repasses federais no SUS: o que temos e o que esperar do incremento para a COVID-19 / Balances of federal transfers in SUS: what we have and what to expect from the COVID-19 increment

Resumo Analisamos os saldos provenientes dos repasses do Ministério da Saúde (MS) aos entes subnacionais, destinados ao financiamento do Sistema Único de Saúde (SUS), inclusive para COVID-19. Verificamos a representatividade destes frente aos repasses do MS destinados às ações e serviços públicos de saúde, entre 2019 e 2020. Analisamos as portarias do MS que deram origem aos repasses COVID-19, classificando-as em: quantidade, objeto, critério de rateio, quantidade de parcelas, execução vinculada a estratégias do MS, valor. Mais de 70 mil contas-correntes foram contabilizadas, alguns entes subnacionais tinham mais de cem. Em 2019, saldos atingiram R$16,29 bilhões (aumento anual de 10,2%), representando 19,9% do total repassado. Em 2020, R$23,83 bilhões (aumento de 46,3%), representando 21,1% do repassado, com tendência de crescimento. Mais de 616 portarias, com 28 diferentes objetivos, repassaram R$32,30 bilhões à COVID-19. O recurso, antes de livre utilização, teve R$11,88 bilhões (36,8%) vinculados às estratégias do MS: R$1,36 bilhão (99,9%) Bloco Estruturação e R$10,52 bilhões (34,0%) Bloco Manutenção. Várias podem ser as causas que dão origem ao acúmulo de saldos, todavia qualidade, quantidade e complexidade do arcabouço normativo do SUS contribuem fortemente para uma execução dos recursos pouco célere, efetiva, eficiente e eficaz.

Abstract We analyzed the balances from the transfers from the Ministry of Health (MH) to subnational entities, to finance the Unified Health System (SUS), including for COVID-19. We verified the representativeness of these in relation to the transfers from the MH to public health actions and services, between 2019and 2020. We analyzed the MH ordinances that gave rise to the COVID-19 transfers, classifying them as: quantity; object; apportionment criterion; amount of installments; execution linked to MH strategies; value. More than 70.000 current accounts were accounted for, and some subnational entities had more than 100. In 2019, balances reached R$16.29 billion (annual increase of 10.2%), representing 19.9% ​​of the total transferred. In 2020, they reached R$23.83 billion (an increase of 46.3%), representing 21.1% of all transfers, with a monthly trend of continued growth. More than 616 ordinances, with 28 different objectives, transferred R$32.30 billion to COVID-19. The resource, originally freely available, had R$11.88 billion (36.8%) linked to the strategies of the MH: R$1.36 billion (99.9%) linked to the Structuring Block, and R$10.52 billion (34.0%) linked to the Maintenance Block. There are several causes that give rise to the accumulation of balances, however the quality, quantity and complexity of the SUS normative framework strongly contribute to an execution of resources that is not very fast, effective, efficient and useful.

Ordinance 3992/2017: challenges and advances for resource management in the Brazilian Unified Health System (SUS).

To advance in order to overcome the challenge of enabling greater autonomy in the use of financial resources in the Unified Health System (SUS), system managers agreed that transfers from the Union to other federated entities will be carried out through a financial investment account and a costing account. Over the past few years, states and municipalities managed more than 34,000 bank accounts dedicated to the Union's on-lendings, in which balance exceeded R$8 billion. However, from 2018, Ordinance 3,992/2017 unequivocally separated the budget flow from the financial flow, and the fund-to-fund transfers started to be carried out in only 11,190 bank accounts. Since then, managers have had financial autonomy in the management of financial resources received from the Union, if in accordance with the parameters established in their respective budget items at the end of each fiscal year.

Ordinance 3992/2017: challenges and advances for resource management in the Brazilian Unified Health System (SUS) / Portaria 3992/2017: desafios e avanços para gestão dos recursos no Sistema Único de Saúde

ABSTRACT To advance in order to overcome the challenge of enabling greater autonomy in the use of financial resources in the Unified Health System (SUS), system managers agreed that transfers from the Union to other federated entities will be carried out through a financial investment account and a costing account. Over the past few years, states and municipalities managed more than 34,000 bank accounts dedicated to the Union's on-lendings, in which balance exceeded R$8 billion. However, from 2018, Ordinance 3,992/2017 unequivocally separated the budget flow from the financial flow, and the fund-to-fund transfers started to be carried out in only 11,190 bank accounts. Since then, managers have had financial autonomy in the management of financial resources received from the Union, if in accordance with the parameters established in their respective budget items at the end of each fiscal year.

RESUMO A fim de avançar na superação do desafio de viabilizar maior autonomia na utilização dos recursos financeiros no Sistema Único de Saúde, os gestores do sistema pactuaram que as transferências da União aos demais entes federados passam a ser realizadas por meio de uma conta financeira de investimento e uma conta de custeio. Ao longo dos últimos anos, estados e municípios chegaram a gerenciar mais de 34 mil contas bancárias dedicadas somente aos repasses da União, nas quais foram acumulados saldos acima de R$8 bilhões. Entretanto, a partir de 2018, a Portaria 3.992/2017 separou de forma inequívoca o fluxo orçamentário do fluxo financeiro e as transferências fundo a fundo passaram a ser realizadas em apenas 11.190 contas bancárias. Desde então, os gestores passaram a ter autonomia financeira na gestão dos recursos financeiros recebidos da União, desde que obedecidos os parâmetros estabelecidos em suas respectivas peças orçamentárias ao final de cada exercício.

Financing of Pharmaceutical Services in the municipal management of the Brazilian Unified Health System.

OBJECTIVE: To discuss factors related to the financing of the Basic Component of Pharmaceutical Services within the municipal management of the Brazilian Unified Health System. METHODS: The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil - Serviços (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services) is a cross-sectional, exploratory, and evaluative study that performed an information survey in a representative sample, stratified by Brazilian regions It considered different study populations in the sampling plan, which represent primary health care services in the cities. Data were collected in 2015 by two methods: in person, by applying direct observation scripts and interviews with users, physicians, and professionals responsible for the dispensing of medicines in primary care services; by telephone interviews with municipal health managers and municipal professionals responsible for Pharmaceutical Services. The results were extracted from the questionnaires applied by telephone. RESULTS: Of the sample of 600 eligible cities, we collected 369 interviews (61.5%) with secretaries and 507 (84.5%) with pharmaceutical services managers. 70.8% of the cities have a computerized management system; and 11.9% have qualification/training of professionals. More than half (51.3%) of the cities received funds for the structuring of pharmaceutical services, and almost 60% of these cities performed this type of spending. In 35.4% of cases, municipal secretaries of health said that they use resources of medicines from the Componente Básico da Assistência Farmacêutica (CBAF - Basic Component of Pharmaceutical Services) to cover demands of other medicines, but only 9.7% believed that these funds were sufficient to cover the demands. The existence of a permanent bidding committee exclusively for acquiring medicines was reported in 40.0% of the cities. CONCLUSIONS: We found serious deficiencies in the public financing of medicines, as well as little concern about the formality in the use of public resources, expenses that meet individual demands to the detriment of the community, insufficient resources allocated to the Basic Component of Pharmaceutical Services, and exhaustion of the financing model.

Financing of Pharmaceutical Services in the municipal management of the Brazilian Unified Health System / Financiamento da assistência farmacêutica na gestão municipal do Sistema Único de Saúde

ABSTRACT OBJECTIVE To discuss factors related to the financing of the Basic Component of Pharmaceutical Services within the municipal management of the Brazilian Unified Health System. METHODS The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil - Serviços (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services) is a cross-sectional, exploratory, and evaluative study that performed an information survey in a representative sample, stratified by Brazilian regions It considered different study populations in the sampling plan, which represent primary health care services in the cities. Data were collected in 2015 by two methods: in person, by applying direct observation scripts and interviews with users, physicians, and professionals responsible for the dispensing of medicines in primary care services; by telephone interviews with municipal health managers and municipal professionals responsible for Pharmaceutical Services. The results were extracted from the questionnaires applied by telephone. RESULTS Of the sample of 600 eligible cities, we collected 369 interviews (61.5%) with secretaries and 507 (84.5%) with pharmaceutical services managers. 70.8% of the cities have a computerized management system; and 11.9% have qualification/training of professionals. More than half (51.3%) of the cities received funds for the structuring of pharmaceutical services, and almost 60% of these cities performed this type of spending. In 35.4% of cases, municipal secretaries of health said that they use resources of medicines from the Componente Básico da Assistência Farmacêutica (CBAF - Basic Component of Pharmaceutical Services) to cover demands of other medicines, but only 9.7% believed that these funds were sufficient to cover the demands. The existence of a permanent bidding committee exclusively for acquiring medicines was reported in 40.0% of the cities. CONCLUSIONS We found serious deficiencies in the public financing of medicines, as well as little concern about the formality in the use of public resources, expenses that meet individual demands to the detriment of the community, insufficient resources allocated to the Basic Component of Pharmaceutical Services, and exhaustion of the financing model.

RESUMO OBJETIVO Discutir fatores relacionados ao financiamento do Componente Básico da Assistência Farmacêutica no âmbito da gestão municipal do Sistema Único de Saúde. MÉTODOS A Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil - Serviços é um estudo transversal, exploratório, de natureza avaliativa, que realizou levantamento de dados em amostra estratificada pelas regiões brasileiras, consideradas diferentes populações de estudo no plano de amostragem representativa de serviços de atenção primária em municípios. Os dados foram coletados em 2015, na forma presencial mediante a aplicação de roteiros de observação direta, entrevistas com usuários, médicos e responsáveis pela entrega dos medicamentos nos serviços de atenção primária e entrevistas telefônicas com gestores municipais de saúde e responsáveis municipais pela assistência farmacêutica. Os resultados foram extraídos dos questionários aplicados por telefone. RESULTADOS Da amostra de 600 municípios elegíveis, foram coletadas 369 entrevistas (61,5%) com secretários e 507 (84,5%) com responsáveis pela assistência farmacêutica. Em 70,8% dos municípios existe sistema informatizado de gestão; e em 11,9% qualificação/capacitação dos profissionais. Mais da metade (51,3%) dos municípios receberam recursos destinados à estruturação da assistência farmacêutica, quase 60% desses municípios realizou este tipo de gastos. Em 35,4% dos casos, secretários municipais de saúde afirmaram utilizar recursos de medicamentos do Componente Básico da Assistência Farmacêutica para cobrir demandas de outros medicamentos, mas apenas 9,7% acreditam que esses recursos são suficientes para atender à demanda. A existência de comissão permanente de licitação exclusiva para a aquisição de medicamentos foi registrada em 40,0% dos municípios. CONCLUSÕES São graves as deficiências, a pouca preocupação com a formalidade na execução dos recursos públicos, os gastos ocorridos para atendimento de demandas individuais em detrimento da coletividade, a insuficiência de recursos destinados ao Componente Básico da Assistência Farmacêutica e a exaustão do modelo de financiamento.

Budget impact analysis of medicines: updated systematic review and implications.

This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001-2015 on 'budget impact analysis' with 'drug' interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.

Perfil demográfico e epidemiológico dos usuários de medicamentos de alto custo no Sistema Único de Saúde

O artigo descreve o perfil demográfico e epidemiológico dos pacientes atendidos pelo programa, para isso realizou-se um relacionamento probabilístico-determinístico de dados provenientes de registros do Datasus: Autorizações de Procedimentos de Alta Complexidade/Alto Custo e Sistema de Informação sobre Mortalidade.

Pesquisa e produção científica em economia da saúde no Brasil

Este artigo elabora um diagnóstico sobre a área de economia da saúde (ES) no Brasil, a partir de inquérito enfocando os grupos de pesquisa em ES cadastrados no Conselho Nacional de Desenvolvimento Científico e Tecnológico e de um levantamento da produção científica brasileira em ES disponibilizado na Biblioteca Virtual em Saúde Bireme.

[Expenses of the Brazilian Ministry of Health for high-cost drugs: a demographic and clinical analysis]. / Gastos do Ministério da Saúde do Brasil com medicamentos de alto custo: uma análise centrada no paciente.

OBJECTIVE: To describe the expenses of the Ministry of Health of Brazil with users of High-Cost Drug Program that began treatment between 2000-2004, according to their demographic and clinical characteristics. METHODS: We made a probabilistic-deterministic linkage of national databases of drugs and mortality, resulting in a historical cohort of patients using high-cost medications in 2000-2004. The per capita spending on medicines were stratified by a follow-up period and described according to demographic, clinical and type of drug used. RESULTS: The total population atended by the program was 611,419, being 63.5% female, average age 46 years. 41.9% of patients living in the Southeast and 29.7% in the Northeast of Brazil. 24.5% of patients began treatment in 2000, 12.4% in 2001, with increasing trend until 2004. The most prevalent diagnosis referred to the genitourinary system diseases and the most common use of chemical groups were antianemic preparations. 40,941 deaths were detected (6.7% of total). The total expenditure per capita was R$4.794,34. Higher spending per capita was observed in males, aged 47, who lived in the Southeast of Brazil and began treatment in 2000, had diagnoses of infectious and parasitic diseases and used blood substitutes and perfusions solutions. CONCLUSION: The understanding of the expenses involved subsidizes restructuring actions and scheduling drug programs, also provides information for therapeutic groups which are priorities for analysis.

Gastos do Ministério da Saúde do Brasil com medicamentos de alto Custo: uma análise centrada no paciente / Expenses of the Brazilian Ministry of Health for high-cost drugs: a demographic and clinical analysis

Objective:To describe the expenses of the Ministry of Health of Brazil with users of High-Cost Drug Program that began treatment between2000 –2004, according to their demographic and clinical characteristics.Methods:We made a probabilistic-deterministic linkage of nationaldata bases of drugs and mortality, resulting in a historical cohort ofpatients using high-cost medications in 2000 –2004. The per capitas pending on medicines were stratified by a follow-up period and de-scribed according to demographic, clinical and type of drug used. Results: The total population atended by the program was 611,419, being 63.5% female, average age 46 years. 41.9% of patients living in the Southeast and 29.7% in the North east of Brazil. 24.5% of patients began treatment in 2000, 12.4% in 2001, with increasing trend until 2004. The most prevalent diagnosis referred to the genitourinary system diseases and the most common use of chemical groups were antianemic prep-arations. 40,941 deaths were detected (6.7% of total). The total expen-diture per capita was R$4.794,34. Higher spending per capita was observed in males, aged 47, who lived in the Southeast of Brazil and began treatment in 2000, had diagnoses of infectious and parasitic diseases and used blood substitutes and perfusions solutions. Conclusion: Theunder standing of the expenses involved subsidizes restructuring actions and scheduling drug programs, also provides information for therapeutic groups which are priorities for analysis.

Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil

O artigo analisa o perfil dos requerentes e dos medicamentos pleiteados em ações judiciais, com base no estudo descritivo sobre 827 processos judiciais com 1.777 pedidos de medicamentos de 2005 a 2006 no Estado de Minas Gerais.

Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil / Judicialization of access to medicines in Minas Gerais state, Southeastern Brazil / Judicialización del acceso a medicamentos en el Estado de Minas Gerais, Sureste de Brasil

OBJETIVO: Analisar o perfil dos requerentes e dos medicamentos pleiteados em ações judiciais. MÉTODOS: Estudo descritivo sobre 827 processos judiciais com 1.777 pedidos de medicamentos de 2005 a 2006 no Estado de Minas Gerais. Avaliaram-se os tipos de atendimento no sistema de saúde e a representação dos autores junto ao Poder Judiciário. Os medicamentos foram descritos segundo registro na Agência Nacional de Vigilância Sanitária, essencialidade, inclusão programática no Sistema Único de Saúde e evidências de eficácia. RESULTADOS: Mais de 70 por cento dos autores foram atendidos no sistema privado de saúde e 60,3 por cento foram representados por advogados particulares. O diagnóstico mais freqüente foi o de artrite reumatóide (23,1 por cento) e os imunossupressores foram os medicamentos mais solicitados (principalmente adalimumabe e etanercepte). Aproximadamente 5 por cento dos medicamentos pleiteados não eram registrados na Agência, 19,6 por cento estavam presentes na Relação Nacional de Medicamentos Essenciais, 24,3 por cento compunham o Programa de Medicamentos de Alto Custo e 53,9 por cento apresentavam evidência consistente de eficácia. Dentre os medicamentos não disponíveis no sistema público, 79,0 por cento apresentavam alternativa terapêutica nos programas de assistência farmacêutica. CONCLUSÕES: O fenômeno da judicialização na saúde pode indicar falhas do sistema público de saúde, uma vez que há solicitações de medicamentos constantes de suas listas. Todavia, constitui um obstáculo para a prática do uso racional de medicamentos e para a consolidação das premissas da Política Nacional de Medicamentos, principalmente quando são solicitados medicamentos sem comprovação de eficácia e não padronizados pelo Sistema Único de Saúde.

OBJECTIVE: To analyze the profile of claimants and medicines demanded in lawsuits. METHODS: Descriptive study that examined 827 lawsuits with 1,777 demands of access to medicines in the period between July 2005 and June 2006 in the state of Minas Gerais, Southeastern Brazil. There were examined the type of health care provided to claimants and their attorneyship. The medicines were described based on the following: drug registration at the National Health Surveillance Agency (Anvisa); wheter they were essential medicines; supply in the Brazilian Health System programs; and evidence of drug efficacy. RESULTS: More than 70 percent of the claimants were provided care in the private health system and 60.3 percent hired private lawyers. The most common diagnosis of claimants was rheumatoid arthritis (23.1 percent) and the immunosuppressant agents were the most frequent demand medicines (mainly adalimumab and etanercept). Approximately 5 percent of the medicines demanded were not registered at Anvisa, 19.6 percent were included in the Brazilian List of Essential Medicine, 24.3 percent were included in the High-Cost Drug Program and 53.9 percent showed consistent evidence of efficacy. Among the medicines that were not available in Brazilian Health System, 79.0 percent had therapeutic alternatives in drug programs. CONCLUSIONS: The phenomenon of judicialization of health in Brazil can point out failures in the public health system as some medicines demanded are included in its lists. However, it is a barrier for rational drug use and application of the National Drug Policy guidelines, especially when there are demanded medicines with no evidence of efficacy and that are not included in Brazilian Health System standards.

OBJETIVO: Analizar el perfil de los requirentes y de los medicamentos pleiteados en acciones judiciales. MÉTODOS: Estudio descriptivo sobre 827 procesos judiciales con 1.777 pedidos de medicamentos de 2005 a 2006 en el Estado de Minas Gerais, Sureste de Brasil. Se evaluaron los tipos de asistencia en el sistema de salud y la representación de los autores junto al Poder Judicial. Los medicamentos fueron descritos según registro en la Agencia Nacional de Vigilancia Sanitaria, esencialidad, inclusión programática en el Sistema Único de Salud y evidencias de eficiencia. RESULTADOS: Más de 70 por ciento de los autores fueron atendidos en el sistema privado de salud y 60,3 por ciento fueron representados por abogados particulares. El diagnóstico más frecuente fue el de artritis reumatoidea (23,1 por ciento) y los inmunosupresores fueron los más solicitados (principalmente adalimumabe y etanercepte). Aproximadamente 5 por ciento de los medicamentos pleiteados no eran registrados en la Agencia, 19,6 por ciento estaban presentes en la Relación Nacional de Medicamentos Esenciales, 24,3 por ciento componían el Programa de Medicamentos de Alto Costo y 53,9 por ciento presentaban evidencia consistente de eficiencia. Entre los medicamentos no disponibles en el sistema público, 79,0 por ciento presentaban alternativa terapéutica en los programas de asistencia farmacéutica. CONCLUSIONES: El fenómeno de la judicialización en la salud puede indicar fallas del sistema público de salud, dado que hay solicitudes de medicamentos constantes de sus listas. Aún constituye un obstáculo para la práctica del uso racional de medicamentos y para la consolidación de las premisas de la Política Nacional de Medicamentos, principalmente cuando son solicitados medicamentos sin comprobación de eficiencia y no estandarizados por el Sistema Único de Salud.

Judicialization of access to medicines in Minas Gerais state, Southeastern Brazil.

OBJECTIVE: To analyze the profile of claimants and medicines demanded in lawsuits. METHODS: Descriptive study that examined 827 lawsuits with 1,777 demands of access to medicines in the period between July 2005 and June 2006 in the state of Minas Gerais, Southeastern Brazil. There were examined the type of health care provided to claimants and their attorneyship. The medicines were described based on the following: drug registration at the National Health Surveillance Agency (Anvisa); wheter they were essential medicines; supply in the Brazilian Health System programs; and evidence of drug efficacy. RESULTS: More than 70% of the claimants were provided care in the private health system and 60.3% hired private lawyers. The most common diagnosis of claimants was rheumatoid arthritis (23.1%) and the immunosuppressant agents were the most frequent demand medicines (mainly adalimumab and etanercept). Approximately 5% of the medicines demanded were not registered at Anvisa, 19.6% were included in the Brazilian List of Essential Medicine, 24.3% were included in the High-Cost Drug Program and 53.9% showed consistent evidence of efficacy. Among the medicines that were not available in Brazilian Health System, 79.0% had therapeutic alternatives in drug programs. CONCLUSIONS: The phenomenon of judicialization of health in Brazil can point out failures in the public health system as some medicines demanded are included in its lists. However, it is a barrier for rational drug use and application of the National Drug Policy guidelines, especially when there are demanded medicines with no evidence of efficacy and that are not included in Brazilian Health System standards.

Perfil demográfico e epidemiológico dos usuários de medicamentos de alto custo no Sistema Único de Saúde / Perfil demográfico y epidemiológico de los usuarios de medicamentos de costo elevado en el Sistema Único de Salud / Epidemiological profile of high cost medicines users in the Brazilian Health System

O Programa de Medicamentos Excepcionais, do Ministério da Saúde, provê, ao tratamento de doenças, medicamentos de alto valor unitário, ou que, em caso de uso crônico ou prolongado, configurem um tratamento de custo elevado. Com o objetivo de descrever o perfil demográfico e epidemiológico dos pacientes atendidos pelo programa, realizou-se um relacionamento probabilístico-determinístico de dados provenientes de registros do Datasus: Autorizações de Procedimentos de Alta Complexidade/Alto Custo (Apac/SIA) e Sistema de Informação sobre Mortalidade (SIM). A coorte formada pelo pareamento das bases de dados identificou 611.419 indivíduos que iniciaram o tratamento no período de 2000-2004. As análises foram desagregadas por sexo, região de residência, diagnósticos e medicamentos mais utilizados. A construção desta coorte histórica propiciou a descrição das características demográficas, epidemiológicas e de utilização de medicamentos dos usuários do programa. Além disso, o banco de dados gerado viabiliza uma série de análises específicas por doenças, que podem contribuir para avaliações de efetividade e eficiência de alternativas terapêuticas constantes nos protocolos clínicos, com o objetivo de fornecer subsídios aos tomadores de decisão no que tange ao planejamento das ações e oferta de medicamentos de alto custo pelo SUS.

El Programa de Medicamentos Excepcionales del Ministerio de Salud tiene como objetivo satisfacer la demanda de medicamentos de alto valor unitario, o de aquellos empleados en enfermedades crónicas que impliquen un tratamiento de costo elevado. Con el objetivo de describir el perfil demográfico y epidemiológico de los pacientes incluidos en el programa, se realizó una vinculación probabilística-determinística de datos provenientes de registros del DATASUS (Banco de Datos del Sistema Único de Salud): Autorizaciones de Procedimientos de Alta Complejidad/Alto Costo (Apac/SIA) y Sistema de Información sobre Mortalidad (SIM). La cohorte formada a partir de la vinculación de las bases de datos identificó a 611.419 individuos que comenzaron el tratamiento en el período 2000-2004. Los análisis se han separado por sexo, región de residencia, diagnóstico y medicamentos más utilizados. La construcción de esta cohorte histórica permitió la descripción de las características demográficas, epidemiológicas y de utilización de medicamentos de los usuarios del programa. Además, el banco de datos generado hace posible la realización de una serie de análisis específicos para determinación de enfermedades, que pueden contribuir a evaluaciones de eficacia y eficiencia de las alternativas terapéuticas incluidas en los protocolos clínicos, con el objetivo de proporcionar subsidios a quienes toman decisiones con respecto a la planificación de las acciones y la oferta de medicamentos de alto costo por parte del SUS.

The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministry's databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the program's users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.

A judicialização da saúde e a política nacional de assistência farmacêutica no Brasil: gestão da clínica e medicalização da justiça / The judicialization of healthcare and the pharmaceutic care national policy in Brazil: the clinic management and the medicalization of the justice

Ainda são raras as referências de estudos publicados no país que tenham como objeto o fenômeno denominado “judicialização da saúde” (demandas judiciais para acesso a serviços e insumos de saúde). A complexidade do fenômeno, por suscitar a interface entre Judiciário e Executivo, confrontados no desafio constitucional de garantir os direitos dos cidadãos à atenção integral à saúde, repercute no constrangimento dos gestores do sistema de saúde pública, frente aos mecanismos jurídicos que visam a garantir aos pacientes/usuários a assistência médica recomendada. Esse fenômeno apresenta correlação com eventos similares ocorridos em países que possuem sistemas universais de saúde e mesmo naqueles onde há predominância de seguros privados. Percebe-se que os sistemas de saúde, sempre sob contingenciamento orçamentário, são mais ou menos permeáveis às pressões externas de grupos de interesses e à ação das lideranças políticas. Porém, em todos os sistemas, são os profissionais de saúde quem mais influenciam o setor, supostamente sob o imperativo tecnológico da medicalização. Para se investigar tal fenômeno na assistência farmacêutica, como instrumento de garantia do acesso e/ou de incorporação de novas tecnologias ao sistema público de saúde no Brasil, é necessário o desenvolvimento de um marco conceitual. Neste trabalho, a partir de revisão da literatura, são apresentadas as bases conceituais para a discussão da judicialização da saúde no Brasil.