Improving Waiting Time for Chemotherapy with Ahead-of-Time Drug Preparation.

Waiting time for chemotherapy infusion is a fundamental factor to measure quality of care. It has been shown that a prolonged waiting time is related to a higher incidence of anticipatory nausea and poor patient adherence to scheduled appointments and recommended oncology treatment programs. Some chemotherapy regimens can be prepared hours ahead-of-time, due to long stability. We aimed to study the effect of an informatic-led workflow redesign intervention, facilitating workflow changes in the Oncology Pharmacy, on patient waiting time. This intervention included changes on EHR processes and the chemotherapy CPOE. Their main effect was allowing ahead-of-time preparation of selected chemotherapy regimes. We conducted a cross sectional study, comparing waiting times pre and post intervention periods. A total of 4600 programmed chemotherapy episodes were included. We found a 26.5 % decrease in the mean wait time in the post intervention period (p > 0.02). We were able to show a decrease in waiting time and a measurable impact of the intervention. This evaluation produced valuable and actionable data for Oncology units and adds a valuable, Latin American experience to the literature.

Study of the Spanish Society of Medical Oncology (SEOM) on the access to oncology drugs and predictive biomarkers in Spain.

PURPOSE: The Spanish Society of Medical Oncology (SEOM) has carried out a study to analyse the conditions of access to oncology drugs in clinical practice in Spain. For the first time, the access of predictive biomarkers has also been analyzed. METHODS: A questionnaire was sent to 146 hospitals in Spain to collect information on the process of approval of 11 oncology drugs of an unquestionable clinical benefit and five predictive biomarkers of mandatory determination for specific treatments. RESULTS: Results highlight the still existing differences in the access of oncology drugs, as well as the newly identified differences in the access to predictive biomarkers between Autonomous Communities (AACC) in Spain, as well as between different hospitals within the same Autonomous Community. Conclusions The SEOM considers it necessary to reduce the differences identified, increase homogeneity, and improve conditions of access to oncology drugs and biomarkers, and makes proposals to address these issues.

Availability, prices, and affordability of selected essential cancer medicines in a middle-income country - the case of Mexico.

BACKGROUND: More alternatives have become available for the diagnosis and treatment of cancer in low- and middle-income countries. Because of increasing demands, governments are now facing a problem of limited affordability and availability of essential cancer medicines. Yet, precise information about the access to these medicines is limited, and the methodology is not very well developed. We assessed the availability and affordability of essential cancer medicines in Mexico, and compared their prices against those in other countries of the region. METHODS: We surveyed 21 public hospitals and 19 private pharmacies in 8 states of Mexico. Data were collected on the availability and prices of 49 essential cancer medicines. Prices were compared against those in Chile, Peru, Brazil, Colombia and PAHO's Strategic Fund. RESULTS: Of the various medicines, mean availability in public and private sector outlets was 61.2 and 67.5%, respectively. In the public sector, medicines covered by the public health insurance "People's Health Insurance" were more available. Only seven (public sector) and five (private sector) out of the 49 medicines were considered affordable. Public sector procurement prices were 41% lower than in other countries of the region. CONCLUSIONS: The availability of essential cancer medicines, in the public and private sector, falls below World Health Organization's 80% target. The affordability remains suboptimal as well. A national health insurance scheme could serve as a mechanism to improve access to cancer medicines in the public sector. Comprehensive pricing policies are warranted to improve the affordability of cancer medicines in the private sector.

A judicialização no Sistema Único de Saúde e o caso da fosfoetanolamina sintética / Health litigation in the Unified Health System and the case of the synthetic phosphoethanolamine

A judicialização do direito à saúde, que de acordo com a Carta Magna de 1988 também constitui dever do Estado ­ evoca uma discussão sobre o impacto na equidade e integralidade no Sistema Único de Saúde (SUS), que constitui um bem comum e cujo compartilhamento é coletivo. A judicialização se torna complexa no contexto da Oncologia, em virtude da carga da doença, estrutura do segmento de mercado para Oncologia e da intensa relação do câncer com a inovação. O Caso da Fosfofetanolamina Sintética (FOS-S) compreendeu o litígio por acesso a substância, atingindo um volume de cerca de 15 mil ações em dois anos, acompanhado de intensa discussão social, a partir da suspensão do fornecimento da FOS-S pelo Instituto de Química de São Carlos da Universidade de São Paulo (IQSC/USP), onde foi pesquisada, desenvolvida e distribuída desde 1990 ainda sem comprovação de indicação como medicamento e sem registro sanitário no Brasil., para o tratamento de neoplasias malignas, A Defensoria Pública da União (DPU) por meio de Ação Civil Pública motivou o Poder Executivo a instaurar providências para atendimento da demanda social. A Lei N° 1.3269 de abril /2016 liberou a distribuição da substância. Esta Lei teve sua eficácia suspensa em maio /2016. Este estudo teve como objetivo principal analisar o processo de judicialização na assistência oncológica no SUS considerando o contexto do Caso FOS-S. Como objetivos específicos foram considerados a reconstrução da trajetória do processo de judicialização para o acesso a FOS-S para o tratamento de neoplasias malignas no SUS; a contextualização do processo regulatório para concessão de registro sanitário de insumos farmacêuticos ativos, medicamentos e a incorporação de tecnologias em saúde no SUS; a análise da judicialização na assistência oncológica no SUS no contexto do Caso FOS-S. A estrutura metodológica compreendeu um estudo de caso único tendo como unidade de análise o caso da FOS-S, utilizando análise documental complementada por revisão da literatura nas principais bases de dados eletrônicas sobre o tema. O horizonte temporal compreendeu o período entre 2014 e 2016. O estudo confirmou como primeiro tensor da judicialização em Oncologia distorções gerenciais, envolvendo descompassos entre políticas públicas e o processo de Pesquisa e Desenvolvimento (P&D) de novas moléculas para Oncologia no SUS, e ainda ausência de integração no fluxo de incorporação tecnológica e as listas de medicamentos. O segundo tensor reflete distorções na participação da sociedade na arena política, favorecendo a ausência de formação de grupos de pressão pelo SUS, e ainda na falta de solidariedade no SUS. O estudo concluiu que o fortalecimento das redes de pesquisa em Oncologia pode favorecer a implementação de políticas públicas e de P&D nacional. A revisão do tratamento dados aos antineoplásicos nas listas de medicamentos e na política de reembolso do SUS seria uma prioridade para amenizar a judicialização. A necessidade de discussão social sobre a tomada de decisões sob escassez e ainda sobre a solidariedade no compartilhamento considerando o SUS como bem comum e atuação de grupos de interesse pelo SUS poderiam reduzir o litígio e fortalecer o SUS

Health litigation of the right to health, which according to the Constitution of 1988 is also a duty of the State ­ introduces a discussion on the impact on equity and integrality on the Unified Health System (SUS), which is a common good shared by all citizens in Brazil. Health litigation becomes complex in the context of Oncology due to the burden of disease, the structure of the market segment for Oncology and the intense relationship between cancer and innovation. The Case of Synthetic Phosphoethanolamine (FOS-S) comprised the litigation for access to the substance, reaching a volume of about 15 thousand lawsuits in two years, accompanied by intense social discussion, from the suspension of supply of FOS-S by São Carlos Chemistry Institute of São Paulo State University (IQSC / USP), where it was researched, developed and distributed as a antineoplastic drug since 1990, although still not indicated as medicine and without sanitary registration in Brazil. The Public Defender's Office of the Government (DPU) through a Public Civil Action motivated the Executive Branch to establish measures to meet social demand. Law No. 1.3269 of April / 2016 released the distribution of the substance. This Law was effectively suspended in May / 2016. This study had as main objective to analyze the process of health litigation in Oncology in the SUS considering the context of the FOS-S Case. As specific objectives were considered the reconstruction of the trajectory of the process of health litigation for access to FOS-S for the treatment of malignant neoplasms in the SUS; the contextualization of the regulatory process for granting sanitary registration of active pharmaceutical ingredient and medicines and the incorporation of health technologies in SUS; the analysis of the health litigation in Oncology in the SUS in the context of the FOS-S Case. The methodological structure comprised a single-case study having the FOS-S case as the unit of analysis, using documentary analysis complemented by literature review in the main electronic databases on the subject. The time horizon comprised the period between 2014 and 2016. The study confirmed as the first tensor of the judicialization in Oncology managerial distortions, involving mismatches between public policies and the process of Research and Development (R & D) of new molecules for Oncology in SUS, and still absence of integration in the technological incorporation flow and the lists of medicines. The second tensor reflects distortions in the participation of society in the political arena, favoring the absence of formation of pressure groups by the SUS, also in the lack of solidarity in the SUS. The study concluded that the strengthening of research networks in Oncology can favor the implementation of public policies and national R & D. Reviewing the treatment given to antineoplastics in the lists of medicines and the SUS reimbursement policy would be a priority to ease the judicialization. The need for social discussion about decision making under scarcity and about sharing solidarity considering the SUS as a common good and political lobbism for the SUS could reduce litigation and strengthen the health system

Concern over cost of and access to cancer treatments: A meta-narrative review of nivolumab and pembrolizumab studies.

BACKGROUND: A better understanding of the modulation of the immune system has resulted in the development of new classes of antitumor agents such as nivolumab and pembrolizumab. Despite the proven effectiveness and tolerability of these new drugs for specific types of cancer, the high cost of treatment has affected their accessibility. OBJECTIVE: The aim of this study is to conduct a meta-narrative review of studies that have addressed the concerns that have been voiced regarding the cost of and access to nivolumab and pembrolizumab in oncology health care. This meta-narrative review attempts to answer the following questions: (1) which papers have considered this broad topic area?; (2) what are the main empirical/theoretical findings?; and (3) what insights can be drawn by combining and comparing findings from different papers? METHODS AND DATA SOURCE: A meta-narrative review has been conducted in 5 research databases (Web of Science, Science Direct, Scopus, Embase and Pubmed) without time limitations up to January of 2017 to address concerns related to the cost of and access to nivolumab and pembrolizumab in oncology health care. From each research base, articles were selected that had a key word related to the theme of pharmacoeconomics and nivolumab or pembrolizumab in any field of scientific work. The research questions were analyzed through the application of a meta-narrative review approach and the use of a convergence-coding matrix to summarize similarities and differences directly related to the research topic between the different papers. KEY FINDINGS: The first contribution of this meta-narrative review is that it summarizes economic-based works on the use of nivolumab and pembrolizumab, particularly for three therapeutic indications: melanoma, NSCLC and RCC. In general, despite the clinical benefit of nivolumab and pembrolizumab being well accepted and proven by scientific works, the published studies show that there are contradictory results with regard to the cost-effectiveness of these anti-PD-1s. The regulatory, economic and epidemiological variations mean that healthcare costs for cancer patients vary greatly from country to country and according to the type of tumor. The second contribution has to do with the recommendations for the development of high quality process for pharmacoeconomic analyses, especially in the new field of immuno-oncology. Finally, the third contribution is with regard to recommendations for the sustainable use of immunotherapies. CONCLUSIONS: Given the revolution in cancer therapy in recent years, the efficient allocation of existing resources is essential for healthcare systems to meet the evolving needs of populations and remain sustainable in the long term. The application of high quality information that stems from scientific evidence and economic modeling can help considerably to make the healthcare system sustainable over time mainly due to a higher number of therapeutic indications or more countries giving regulatory approval for the use of new and expensive cancer drugs.

The lawsuits to antineoplastic drugs: the tip of an iceberg? / Demandas judiciais por medicamentos antineoplásicos: a ponta de um iceberg?

The lawsuits with antineoplastic drugs generate high costs for governments and require careful analysis to ensure efficient and adequate health results. This study analyzed cases conducted by federal entities to a reference institute for the treatment of cancer for technical opinion. Data were collected from copies of the cases examined from July 1 to December 31, 2013. It was analyzed: therapeutic subgroups, presence in essential drug list, drug registry, off-label use, indications of clinical practice guidelines, drug incorporation in Brazilian Health System and estimated value of court cases. 158 cases were examined, with a total of 164 requests of 35 antineoplastic drugs. Most of the medications were protein kinase inhibitors (31.4%), ten (28.6%) were included in the essential drugs list, three did not contain sanitary registration, ten had indication of off-label use, 56.7% were described in clinical practice guidelines and four drugs were recommended for incorporation. The total estimated amount of the court cases was R$ 18,110,504.89. It was identified that the technical and sanitary instruments currently available to support the decisions seem to be insufficient and that there is need to establish strategies to minimize inconsistencies that compromise the comprehensiveness of care.

Demandas judiciais por medicamentos antineoplásicos: a ponta de um iceberg? / The lawsuits to antineoplastic drugs: the tip of an iceberg?

Resumo Ações judiciais com medicamentos antineoplásicos geram custos elevados aos governos e demandam análises criteriosas para garantir resultados eficientes e adequados em saúde. Este trabalho analisou processos enviados por entes federados a um instituto referência no tratamento de câncer para emissão de parecer técnico. Coletou-se dados das cópias dos processos analisados entre julho e dezembro/2013 e avaliou-se: subgrupos terapêuticos, presença em lista de medicamentos essenciais, registro sanitário, indicação off label, indicações constantes em diretrizes clínicas, incorporação do medicamento no sistema público de saúde e valor estimado das causas. Foram examinados 158 processos, com 164 solicitações de 35 antineoplásicos. A maioria dos medicamentos eram inibidores da tirosinoquinase, dez figuravam em lista de medicamentos essenciais, três não continham registro sanitário, dez tinham indicação de uso off label, 56,7% estavam descritas em diretrizes clínicas, quatro tinham recomendação para incorporação e o valor estimado das causas foi de R$ 18.110.504,89. Identificou-se que os instrumentos técnico-sanitários disponíveis para subsidiar as decisões parecem ser insuficientes e que há a necessidade de se estabelecer estratégias para minimizar o comprometimento da integralidade do cuidado.

Abstract The lawsuits with antineoplastic drugs generate high costs for governments and require careful analysis to ensure efficient and adequate health results. This study analyzed cases conducted by federal entities to a reference institute for the treatment of cancer for technical opinion. Data were collected from copies of the cases examined from July 1 to December 31, 2013. It was analyzed: therapeutic subgroups, presence in essential drug list, drug registry, off-label use, indications of clinical practice guidelines, drug incorporation in Brazilian Health System and estimated value of court cases. 158 cases were examined, with a total of 164 requests of 35 antineoplastic drugs. Most of the medications were protein kinase inhibitors (31.4%), ten (28.6%) were included in the essential drugs list, three did not contain sanitary registration, ten had indication of off-label use, 56.7% were described in clinical practice guidelines and four drugs were recommended for incorporation. The total estimated amount of the court cases was R$ 18,110,504.89. It was identified that the technical and sanitary instruments currently available to support the decisions seem to be insufficient and that there is need to establish strategies to minimize inconsistencies that compromise the comprehensiveness of care.

Real world patterns of care in HER2-overexpressing breast cancer: Results of a survey of TEACH clinical trial investigators in 2011.

BACKGROUND: HER2-overexpressing breast cancer (BC) is common among young patients and poses a public health burden. Adjuvant anti-HER2/neu therapy with trastuzumab reduces the risk of recurrence and improves survival. METHODS: A web-based survey was sent to 386 physicians of the "TEACH" trial in 2011 to determine access to HER2/neu testing and treatment patterns for HER2-overexpressing BC. RESULTS: There were 151 responders (39%) from 28 countries. Ninety-seven percent reported HER2/neu expression is routinely measured in their institutions by immunohistochemistry (85%), FISH (80%) and other methods (16%). Twenty percent of responders from Asia reported that the test was not routinely available. Forty-eight percent of participants reported instances when adjuvant HER2-directed therapy was recommended to a patient who eventually did not receive it. Reasons for not receiving trastuzumab was cost (73%, p < 0.0001) in low- and middle-income countries and co-morbidities in high-income countries (43%, p = 0.003). CONCLUSIONS: This survey reflects the availability of HER2/neu testing and anti-HER2/neu therapy among physicians who participated in TEACH. A high proportion of women with HER2-overexpressing BC may not receive standard adjuvant therapy due to unavailability of the test and cost of therapy. Despite having some limitations, such as a possible selection bias of participating physicians, variable definitions of access to healthcare among respondents, and changes in trastuzumab availability since 2011, our results demonstrate that access to care and region of practice impact the implementation of cancer treatments.

[Strategies by civil society organizations for access to breast cancer drugs in the Brazilian Unified National Health System]. / Estratégias de instituições da sociedade civil no acesso a medicamentos para câncer de mama no SUS.

This study aims to identify and analyze strategies by civil society organizations working with breast cancer (CSOs) on access to drugs in Brazilian Unified National Health System (SUS) and the main social actors. A qualitative approach used the snowball technique, semi-structured interviews, and participant observation. Thematic analysis was based on the following categories: access to drugs for breast cancer treatment, relationship between CSOs and government, relationship between CSOs and the pharmaceutical industry, and other strategies used by CSOs. The results showed that civil society organizations have influenced access to drugs for breast cancer in the SUS and that their main strategies have focused on pressuring government at all levels. Meanwhile, the pharmaceutical industry sponsors some CSOs in order to strengthen them and expand its own market. The main difficulties in access to such drugs involve insufficient services, unequal treatment, and inclusion of technology in the SUS.

Estratégias de instituições da sociedade civil no acesso a medicamentos para câncer de mama no SUS / Strategies by civil society organizations for access to breast cancer drugs in the Brazilian Unified National Health System / Estrategias de las instituciones de la sociedad civil sobre el acceso a medicamentos para el cáncer de mama en el Sistema Único de Salud brasileño

Esta pesquisa objetiva identificar e analisar as estratégias de instituições da sociedade civil dedicadas ao câncer de mama (ISC-CM) no acesso a medicamentos no SUS e seus principais atores sociais. Utilizou-se a abordagem qualitativa, empregando-se os métodos de análise de redes sociais e bola-de-neve e as técnicas de observação participante e entrevistas semiestruturadas. A análise temática baseou-se nas categorias: acesso a medicamentos para tratamento de câncer de mama; relacionamento das ISC-CM com o Estado; relacionamento das ISC-CM com a indústria farmacêutica; e outras estratégias utilizadas por ISC-CM no acesso a medicamentos. Os resultados mostraram que as ISC-CM têm influenciado o acesso a medicamentos para câncer de mama no SUS e sua principal estratégia é a pressão sobre o Estado. A indústria farmacêutica patrocina algumas dessas instituições para fortalecê-las com o intuito de ampliar seu mercado. As principais dificuldades no acesso a medicamentos se referem à deficiência de serviços, à iniquidade dos tratamentos oferecidos, e à inclusão de tecnologias no SUS.

This study aims to identify and analyze strategies by civil society organizations working with breast cancer (CSOs) on access to drugs in Brazilian Unified National Health System (SUS) and the main social actors. A qualitative approach used the snowball technique, semi-structured interviews, and participant observation. Thematic analysis was based on the following categories: access to drugs for breast cancer treatment, relationship between CSOs and government, relationship between CSOs and the pharmaceutical industry, and other strategies used by CSOs. The results showed that civil society organizations have influenced access to drugs for breast cancer in the SUS and that their main strategies have focused on pressuring government at all levels. Meanwhile, the pharmaceutical industry sponsors some CSOs in order to strengthen them and expand its own market. The main difficulties in access to such drugs involve insufficient services, unequal treatment, and inclusion of technology in the SUS.

Esta investigación tiene como objetivo identificar y analizar las estrategias de las instituciones de la sociedad civil, dedicadas al cáncer de mama (ISC-CM), sobre el acceso a los medicamentos en el Sistema Único de Salud (SUS) y sus actores sociales. Se utilizó un enfoque cualitativo, mediante entrevistas semi-estructuradas, de bola de nieve, y observación participante. El análisis temático se basó en las categorías: acceso a los medicamentos para el tratamiento del cáncer de mama; relación de ISC-CM con el Estado; relación de ISC-CM con la industria farmacéutica; y otras estrategias usadas por el ISC-CM. Los resultados mostraron que el ISC-CM ha influido en el acceso a los medicamentos para el cáncer de mama en el SUS y sus principales estrategias se han centrado en la presión sobre el Estado. Por otro lado, la industria farmacéutica patrocina algunos ISC-CM para fortalecerlos a fin de ampliar su mercado. Las principales dificultades en el acceso a los medicamentos se refieren a los servicios de discapacidad, la falta de equidad de los tratamientos que se ofrecen y la inclusión de la tecnología en el SUS.

Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil.

OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17% of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million. CONCLUSIONS: The results reinforce the need for technical expertise in dealing with legal suits and for capacity-building of health professionals in approaching the scientific literature, in order to appropriately select drugs and to ensure the best therapeutic decision for each clinical condition, and thus guarantee access to safe and effective health technologies and, therefore, to enhance the quality of the Brazilian pharmaceutical services model in oncology.

Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo / Uso racional de medicamentos antineoplásicos y acciones judiciales en el estado de Sao Paulo, Sureste de Brasil / Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, southeastern Brazil

OBJETIVO: Avaliar a racionalidade das ações judiciais e pedidos administrativos recebidos pela Secretaria de Estado da Saúde de São Paulo segundo evidências científicas de eficácia e segurança. MÉTODOS: Estudo descritivo, transversal, baseado em informações da Secretaria de Saúde sobre os medicamentos antineoplásicos solicitados por via judicial, com maior impacto financeiro para o Sistema Único de Saúde em 2006 e 2007. Os fármacos foram avaliados quanto às evidências clínicas de eficácia e segurança, com base na classificação do Micromedex®, em metanálises e revisões sistemáticas. As indicações foram confrontadas com aquelas aprovadas em agências reguladoras. RESULTADOS: Os medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe e temozolomida geraram gastos superiores a R$ 40 milhões para atender 1.220 solicitações, com custo médio de R$ 33,5 mil por paciente. Os estudos selecionados não recomendam parte das indicações dos medicamentos prescritos. Cerca de 17 por cento dos pedidos não tinham evidência para a indicação mencionada no pleito, o que equivale a um gasto inadequado de, no mínimo, R$ 6,8 milhões...

OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17 percent of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million...

OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo según evidencias científicas de eficacia y seguridad. MÉTODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplásicos solicitados por vía judicial, con mayor impacto financiero para el Sistema Único de Salud en 2006 y 2007. Los fármacos fueron evaluados considerando las evidencias clínicas de eficacia y seguridad, con base en la clasificación de Micromedx®, metanálisis y revisiones sistemáticas. Las indicaciones fueron confrontadas con las aprobadas en agencias reguladoras. RESULTADOS: Los medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe y temozolomida generaron gastos superiores a R$ 40 millones para atender 1.220 solicitudes, con costo promedio de R$ 33,5 mil por paciente. Los estudios seleccionados no recomiendan parte de las indicaciones de los medicamentos prescritos. Cerca de 17 por ciento de los pedidos no tenían evidencia para la indicación mencionada en el pleito, lo que equivale a un gasto inadecuado de, mínimo, R$ 6,8 millones...

Los medicamentos antineoplásicos y sus perspectivas en los países del tercer mundo / The antineoplastic drugs and their perspectives in the Third World countries

El cáncer es la segunda causa de muerte de la población en la mayoría de los países del mundo, incluyendo en éstos a algunos países subdesarrollados. Sin embargo, los países desarrollados tienen acceso a la mayoría de los medicamentos antineoplásicos en comparación con el que tienen los países del Tercer Mundo; donde existe una gran diferencia en el nivel de consumo por enfermo. Para que se tenga una magnitud de esta problemática, se realiza una evaluación económica estimada de los casos de cáncer en el Tercer Mundo y los costos promedio de los tratamientos quimioterapéuticos; también se realizan una comparación entre los niveles estimados del consumo actual y el consumo necesario para satisfacer las necesidades prioritarias de los países pobres en materia de medicamentos antineoplásicos. Sobre la base de este panorama, los países subdesarrollados sólo tienen una alternativa que es el autoabastecimiento de sus necesidades a partir de la producción nacional de fármacos para el cáncer. Esto no es más, que la adquisición de una planta productora de formas terminadas de medicamentos a partir de la materia prima importada(AU)