Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos : métodos

A Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM) – componente Serviços teve por objetivo caracterizar a organização dos serviços de assistência farmacêutica na Atenção Básica do Sistema Único Saúde. A PNAUM – Serviços foi um estudo transversal, avaliativo, com amostra planejada de 600 municípios, realizado entre 2014 e 2015, composto por uma fase remota, com entrevistas telefônicas com gestores. Desses 600 municípios foram selecionados 300 para um inquérito em serviços de saúde. Foram selecionadas as 27 capitais, 0,5% dos maiores municípios de cada região e realizado um sorteio dos demais municípios. O cálculo do tamanho da amostra representativa nacional considerou três níveis: municípios, serviços de dispensação de medicamentos e usuários. As entrevistas foram realizadas com a utilização de um questionário estruturado específico para: secretário municipal de saúde, responsável pela assistência farmacêutica no município, responsável pela entrega de medicamentos, médico e usuário. Os dados secundários foram obtidos em bases oficiais, na data mais recente de atualização. A PNAUM – Serviços foi a primeira pesquisa de âmbito nacional visando a avaliação e obtenção de indicadores nacionais e regionais acerca de acesso a medicamentos, bem como utilização e uso racional, sob a ótica de variados atores sociais.The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos –Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) aimed to characterize the organization of pharmaceutical services in the Primary Health Care of the Brazilian Unified Health System (SUS). PNAUM – Services is a cross-sectional and evaluative study, with planned sample of 600 cities, held between 2014 and 2015, composed of a remote phase, with telephone interviews with health managers. Of these 600 cities, 300 were selected for a survey on health services. We selected the 27 capitals, the 0.5% largest cities of each region, and the remaining cities were drawn. The estimate of the representative national sample size considered three levels: cities, medicine dispensing services, and patients. The interviews were carried out with a structured questionnaire specific for: municipal secretaries of health, professionals responsible for pharmaceutical services in the city, professionals responsible for the dispensing of medicines, physicians, and patients. The secondary data were obtained in official databases, in the latest update date. PNAUM – Services was the first nationwide research aimed at the assessment and acquisition of national and regional indicators on access to medicines, as well as use and rational use, from the perspective of various social subjects

The budget impact of monoclonal antibodies used to treat metastatic colorectal cancer in Minas Gerais, Brazil

Introduction: Biological medicines have increased the cost of cancer treatments, which also raises concerns about sustainability. In Brazil, three monoclonal antibodies (mAbs)—bevacizumab, cetuximab, and panitumumab—are indicated for the treatment of metastatic colorectal cancer (mCRC) but not currently funded by the Unified Health System (SUS). However, successful litigation has led to funding in some cases. Objective: Our objective was to evaluate the budgetary impact of including the mAbs bevacizumab, cetuximab, and panitumumab in standard chemotherapy for the treatment of mCRC within the SUS of Minas Gerais (MG), Brazil. Method: A budget impact analysis of incorporating mAbs as first-line treatment of mCRC in MG was explored. The perspective taken was that of the Brazilian SUS, and a 5-year time horizon was applied. Data were collected from lawsuits undertaken between January 2009 and December 2016, and the model was populated with data from national databases and published sources. Costs are expressed in $US. Results: In total, 351 lawsuits resulted in funding for first-line treatment with mAbs for mCRC. The three alternative scenarios analyzed resulted in cost increases of 348–395$US103,360,980 compared with the reference scenario over a 5-year time horizon, and bevacizumab and cetuximab had budgetary impacts of $US111,334,890 and 113,772,870, respectively. The use of the anti-epidermal growth factor receptor (EGFR) mAbs (cetuximab and panitumumab) is restricted to the approximately 41$US106 million. Conclusion: These results highlight the appreciable costs for incorporating bevacizumab, cetuximab, and panitumumab into the SUS. Appreciable discounts are likely to be necessary before incorporation of these mAbs is approved

Terapia antiangiogênica para edema macular diabético: impacto orçamentário no sus e influência dos acordos mercadológicos

Exportado OPUSMade available in DSpace on 2019-08-12T20:33:28Z (GMT). No. of bitstreams: 1 disserta__o_jans_final.pdf: 2055822 bytes, checksum: 8770716cc7e9cce73864638ec48331ef (MD5) Previous issue date: 6Introdução: Análises de Impacto Orçamentário (AIO) são, de maneira geral, os últimos estudos realizados antes da incorporação de tecnologias de saúde em um determinado sistema de saúde. O perfil de judicialização de um determinado sistema pode apontar vazios terapêuticos e nortear estudos de incorporação de tecnologias, bem como AIO. Métodos: Realizou-se AIO, por meio do método de planilhas determinísticas, para avaliar a possibilidade de incorporação de terapia antiangiogência de aplicação intravítrea como tratamento de segunda linha do Edema Macular Diabético no Sistema Único de Saúde (SUS) do Estado de Minas Gerais, alternativa indisponível atualmente e frequente alvo de ações judiciais. Foram incluídos na análise os medicamentos Bevacizumabe, Ranibizumabe e Aflibercepte, todos com evidências científicas de efetividade e segurança, sendo o uso do primeiro off-label. Resultados: O impacto orçamentário incremental destas incorporações, num horizonte temporal de cinco anos, é de R$473.226.278,78 para Bevacizumabe; R$ 2.378.732.103,09 para Ranibizumabe e R$3.703.524.490,16 para Aflibercepte, considerando a estimativa epidemiológica de número de pacientes. Segundo estimativa por demanda aferida, os valores são de R$ 69.493.906,95 para Bevacizumabe, R$349.319.965,60 para Ranibizumabe e R$ 543.867.485,47 para Aflibercepte, de modo que Bevacizumabe se mostrou a alternativa financeiramente mais viável. Discussão: Como a incorporação em questão geraria um incremento de cerca de 3% do orçamento destinado pelo fundo estadual de saúde para a compra de medicamentos, segundo estimativa de demanda aferida, avalia-se que a mesma é viável para o SUS-MG, porém dependendo de avaliação criteriosa de prioridades do gestor. A discrepância de preços entre os produtos demonstra a atuação das forças e acordos de mercado. Para o caso em tela percebemos que, além de um acordo comercial que envolve o não-registro de um medicamento efetivo para uma determinada condição, ainda foi envolvido o Poder Judiciário de modo a se modular uma política pública não norteada apenas pelas necessidades de saúde da população. Tal pratica aparentemente é executada mundialmente. Existe um acordão judicial europeu, proveniente de processo originado na Itália, que aplicou multas à Roche e à Novartis nos valores de 90,6 e 92 milhões de euros, respectivamente. Tais multas foram justificadas pelo fato de que as duas empresas celebraram acordo, relativo ao período avaliado entre 1º de junho de 2011 e 27 de fevereiro de 2014, que visava obter uma diferenciação artificial entre os medicamentos Avastin® (Bevacizumabe) e Lucentis® (Ranibizumabe), manipulando a percepção dos riscos da utilização do Avastin® em oftalmologia. No cerne desta disputa, podemos exemplificar um caso no qual que o SUS, no Brasil, está sendo obstaculizado pelos interesses ditados pela exploração capitalista da saúde, que em um contexto de agenda neoliberal. Toda esta trama nos leva a uma discussão importantíssima acerca da inovação em saúde, do atual sistema de patentes, do financiamento dos sistemas de saúde e dos lucros quando a saúde é colocada sob a ótica de mercado.Budget Impact Analysis (BIA) are very often the last studies before the of health technologies incorporation in a health system, and the litigation of health rights profile might expose therapeutic vacuums and guide the path of studies, as well as BIA. Using this assumption, BIA was performed by the deterministic planning method to evaluate the incorporation of anti-angiogenic therapy of intravitreal application for the second-line treatment of Diabetic Macular Edema in the Unified Health System (SUS) of the State of Minas Gerais, a current inexistent alternative and often target of lawsuits. We included in the analysis the medicines Bevacizumab, Ranibizumab and Alfibercept, all of them with known evidences of effectiveness and safety, however being the first used off-label in Brazil. The incremental budgetary impact of the medicines represents, over a five-year horizon, R$473,226,278.78 for Bevacizumab; R$ 2,378,732,103.09 for Ranibizumab and R$3,703,524,490.16 for Aflibercept, according to the epidemiological approach. According to measured demand estimate, the amounts are R$ 69,493,906.95 for Bevacizumab, R$349,319,965.60 for Ranibizumab and R$ 543,867,485.47 for Aflibercept, so that Bevacizumabe proved to be the more viable alternative as it has lower costs. A Bevacizumab incorporation would generate an increase of around 3% of the State of Minas Gerais budget for procurement of medicines, according to measured demand estimate. It is considered that it is feasible within the Minas Gerais State SUS, depending on the careful evaluation and opinion of the manager's priorities. The price discrepancy between products demonstrates the performance of forces and market agreements. For the present case we realize that in addition to a commercial agreement that involves not registering an effective drug for a given condition, the courts were even used in order to modulate a kind of public policy not only based by the health needs of the population. This especific procedure seems to be executed worldwide, proof of this is that there is an novel European judicial agreement arising from a procedure originated in italian court, which imposed a fine on Roche and Novartis of EUR 90.6 million and EUR 92 million respectively. This fine was justified by the fact that the two companies entered into an agreement, for the period evaluated between June 1, 2011 and February 27, 2014, which "aimed at obtaining an artificial differentiation between Avastin (Bevacizumab) and Lucentis (Ranibizumab), manipulating the perception of the risks of using Avastin in ophthalmology ". At the core of this struggle, we can exemplify this as a case in which SUS, is being hampered by the interests dictated by the capitalist exploitation of health, that in a context of neoliberal agenda. This whole plot leads us to a very important discussion about health innovation, the current patent system, the financing of health systems and profits when health is placed under the market's perspective

National Survey on Access, Use and Promotion of Rational Use of Medicines: methods

<div><p>ABSTRACT The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos –Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) aimed to characterize the organization of pharmaceutical services in the Primary Health Care of the Brazilian Unified Health System (SUS). PNAUM – Services is a cross-sectional and evaluative study, with planned sample of 600 cities, held between 2014 and 2015, composed of a remote phase, with telephone interviews with health managers. Of these 600 cities, 300 were selected for a survey on health services. We selected the 27 capitals, the 0.5% largest cities of each region, and the remaining cities were drawn. The estimate of the representative national sample size considered three levels: cities, medicine dispensing services, and patients. The interviews were carried out with a structured questionnaire specific for: municipal secretaries of health, professionals responsible for pharmaceutical services in the city, professionals responsible for the dispensing of medicines, physicians, and patients. The secondary data were obtained in official databases, in the latest update date. PNAUM – Services was the first nationwide research aimed at the assessment and acquisition of national and regional indicators on access to medicines, as well as use and rational use, from the perspective of various social subjects.</p></div