Estimated Loss of Productivity Attributed to Cardiovascular Diseases in South America. / Estimativa de Produtividade Perdida Atribuída a Doenças Cardiovasculares na América do Sul.

BACKGROUND: Cardiovascular diseases (CVD) have significant health and economic burdens. In South America, the loss of productivity related to these diseases has not yet been well explored. OBJECTIVE: Estimate the potentially productive years of life lost (PPYLL) and loss of productivity related to premature mortality associated with CVD in South America, in 2019. METHODS: Mortality data available from the 2019 Global Burden of Disease Study were used to estimate the burden of disease attributable to CVD. For monetary calculations of productivity loss, a proxy of the human capital approach was used. Data were stratified by sex, in working age groups. RESULTS: The total number of deaths due to CVD in South America in 2019 was 754,324, and the total number of PPYLL was 2,040,973. The total permanent loss of productivity was approximately US$ 3.7 billion and US$ 7.8 billion in purchasing power parity, equivalent to 0.11% of the gross domestic product. The cost per death was US$ 22,904, and the ratio between men and women for the cost per death was 1.45. The variation in scenarios indicates that the estimates are robust, even with important differences between countries. CONCLUSIONS: CVD impose a significant economic burden on countries in South America. The characterization of this burden can support governments in the allocation of resources for the planning and execution of health policies and interventions in promotion, prevention, and recovery.

FUNDAMENTO: As doenças cardiovasculares (DCV) têm ônus sanitário e econômico significativos. Na América do Sul (AS), a perda de produtividade relacionada a estas enfermidades ainda não foi bem explorada. OBJETIVO: Estimar os anos de vida produtiva perdidos (AVPP) e a perda de produtividade relacionados a mortalidade prematura associada as DCV na AS, em 2019. MÉTODOS: Empregou-se dados de mortalidade disponíveis no Global Burden of Disease Study 2019 na estimativa da carga de doença atribuível a DCV. Para os cálculos monetários da perda da produtividade usou-se uma proxy da abordagem de capital humano. Estratificou-se por sexo, nas faixas etárias de trabalho. RESULTADOS: O número total de mortes por DCV na AS no ano de 2019 foi de 754.324 e os AVPP foram 2.040.973. A perda permanente de produtividade total foi de aproximadamente US$ 3,7 bilhões e US$ 7,8 bilhões em paridade do poder de compra, equivalente a 0,11% do produto interno bruto. O custo por morte foi de US$ 22.904, e a razão desse custo por óbito, entre homens e mulheres foi 1,45. A variação dos cenários aponta robustez nas estimativas, mesmo com diferenças importantes entre os países. CONCLUSÕES: As DCV impõem um ônus econômico significativo a este bloco de países. A caracterização deste fardo pode amparar os governos na alocação de recursos destinados ao planejamento e execução de políticas e intervenções sanitárias, sejam de promoção, prevenção ou recuperação.

Cost-effectiveness analysis and budgetary impact of anidulafungin treatment for patients with candidemia and other forms of invasive candidiasis in Brazil.

Candidemia and other forms of invasive candidiasis (C/IC) are serious conditions, especially for immunosuppressed individuals with prolonged hospitalization in intensive care units (ICU). This study analyzed the incremental cost-effectiveness and budgetary impact (BI) of treatment for IC with anidulafungin compared to amphotericin B lipid complex (ABLC) and amphotericin B deoxycholate (ABD) or conventional amphotericin B (CAB), in the Brazilian Unified Health System (SUS). A decision model was conducted with a time horizon of two weeks from the perspective of SUS. The primary effectiveness endpoints were survival and treatment response rate. All patients were followed up until successful therapy or death. BI analysis was performed based on the measured demand method. A five-year time horizon was adopted based on the number of hospitalizations (per 1,000 hospitalizations). For effectiveness measured in the successful response rate (SRR), anidulafungin dominated the ABLC and ABD formulations. In the results of the analysis with the effectiveness measured according to survival, anidulafungin had a better cost-effectiveness ratio (R$988.26/survival) compared to ABD (R$16,359.50/survival). The BI estimate related to the incorporation of anidulafungin suggests savings of approximately 148 million reais in 5 years when comparing it to ABD. The economic evaluation of anidulafungin and its comparators found it to be cost-effective. The consensus of international scientific societies recommends it as a first-line drug for IC, and its incorporation by SUS would be important.

Perda de Produtividade Atribuída a Neoplasias na América do Sul / Lost Productivity Attributed to Neoplasms in South America / Pérdida de Productividad Atribuida a Neoplasias en América del Sur

Introdução: A carga da doença tem sido empregada em estimativas do impacto das neoplasias, mas a perda de produtividade em razão dessas enfermidades ainda não foi tão explorada. Objetivo: Estimar os anos de vida produtiva perdidos (AVPP) e a perda de produtividade por conta da mortalidade prematura relacionada ao câncer em países da América do Sul em 2019. Método: Dados de mortalidade disponíveis no Global Burden of Disease (GBD) Study 2019 foram usados para estimar a carga de doença atribuível a neoplasias. A perda de produtividade em termos monetários foi calculada usando um proxy da abordagem do capital humano (ACH). Os cálculos foram realizados por sexo, nas faixas etárias de trabalho. Resultados: O total de óbitos foi de 192.240 e o de AVPP, 2.463.155. A perda total de produtividade permanente foi de US$ 4,4 bilhões e US$ 9,4 bilhões em purchasing power parity (PPP) ­ 0,13% do produto interno bruto (PIB) da região. O custo total por morte foi de US$ 23.617. Houve diferenças significativas entre os países, mas a variação dos cenários mostra robustez das estimativas. Conclusão: O câncer impõe um ônus econômico significativo à América do Sul tanto em termos de saúde quanto de produtividade. Sua caracterização pode subsidiar os governos na alocação de recursos destinados ao planejamento de políticas e execução de intervenções de saúde

Introduction: The burden of the disease has been utilized in estimates of the impact of neoplasms, but the loss of productivity due to these diseases has not yet been explored. Objective: To estimate the years of productivity life lost (YPLL) and lost productivity due to premature cancer-related mortality in South American countries in 2019. Method: Mortality data available from Global Burden of Disease (GBD) Study 2019 was analyzed to estimate the burden attributable to neoplasms. The productivity loss in monetary terms was estimated using a proxy of the human capital approach (HCA). Calculations were performed by sex, in working age groups. Results: The total deaths and YPLL reached 192,240 and 2.463.155, respectively. The total permanent productivity loss was around US$ 4.4 billion and US$ 9.4 billion in purchasing power parity (PPP) ­ 0.13% of the continent's gross domestic product (GDP). Total cost per death was US$23,617. There were significant differences among countries, but the variation of scenarios shows robustness of the estimates. Conclusion: Cancer imposes a significant economic burden on South American, both in terms of health and productivity. Its characterization can help governments to allocate resources for policies planning and health interventions.

Introducción: Se ha utilizado la carga de enfermedad en las estimaciones del impacto de las neoplasias, pero aún no se ha explorado la pérdida de productividad por estas enfermedades. Objetivo: Estimar los años de vida productiva perdidos (AVPP) y la pérdida de productividad debido a la mortalidad prematura relacionada con el cáncer en los países de la América del Sur en 2019. Método: Datos de mortalidad disponibles del Global Burden of Disease (GBD) Study 2019 fueron utilizado para estimar la carga de enfermedad atribuible a las neoplasias. La pérdida de productividad en términos monetarios se calculó utilizando un proxy de enfoque de capital humano (ACH). Los cálculos se realizaron por sexo, en los grupos de edad laboral. Resultados: El número total de muertes fue de 192.240 y de AVPP, 2.463.155. La pérdida total de productividad permanente fue del orden de US$ 4.400 millones y US$ 9.400 millones en purchasing power parity (PPP) ­ 0,13% del producto interior bruto (PIB) de la región. El costo total por muerte fue de $23,617. Hubo diferencias significativas entre países, pero la variación de escenarios muestra la robustez de las estimaciones. Conclusión: El cáncer impone una carga económica significativa a América del Sur, tanto en términos de salud como de productividad. Su caracterización puede apoyar a los gobiernos en la asignación de recursos para la planificación de políticas y ejecución de intervenciones en salud.

Using the analytic hierarchy process to elicit patient preference in the evaluation of first-line treatment of HER2-overexpressing metastatic breast cancer / Uso do processo analítico hierárquico para eleger a preferência do paciente na avaliação da primeira linha de tratamento do câncer de mama metastático her2 hiperexpresso

Abstract Background The many combinations of chemotherapeutic agents and biologicals available in the Brazilian National Health System for the treatment of metastatic breast cancer require analysis that contribute to decision making. Objective The study's primary aim was to evaluate the first-line treatment of HER2- overexpressing metastatic breast cancer from the Brazilian Unified Health System perspective using multicriteria decision analysis (MCDA). Method The treatment options evaluated were (a) pertuzumab combined with trastuzumab and docetaxel, and (b) trastuzumab in combination with docetaxel. Using the hierarchical analytical method, medical oncologists compared the relevance of five predefined criteria: overall survival, response to treatment, adverse events, cost- effectiveness, and budget impact. Results The therapeutic scheme considered more appropriate by the model was pertuzumab combined with trastuzumab and docetaxel. The most sensitive criteria were adverse events, cost-effectiveness, and budget impact. The results suggest that the classification has a close relationship with the perspective of healthcare professionals participating in the questionnaire. Conclusion Defining the treatment of an incurable disease associated with a short survival time and high-cost treatment options necessitates complex decision-making. MCDA allows the weighting of criteria and considering criteria that would be difficult to measure in other methods, such as cost-effectiveness. These aspects differ from economic models and contribute to a broader evaluation of health decision-making.

Resumo Introdução As diversas combinações de agentes quimioterápicos e biológicos disponíveis no Sistema Único de Saúde brasileiro para o tratamento do câncer de mama metastático requerem análises que contribuam para a tomada de decisões. Objetivo O objetivo principal deste estudo foi avaliar o tratamento de primeira linha para câncer de mama metastático HER2 hiperexpresso sob a perspectiva do Sistema Único de Saúde, utilizando a análise de decisão multicritérios (MCDA). Método As opções de tratamento avaliadas foram: (a) pertuzumabe em combinação com trastuzumabe e docetaxel, e (b) trastuzumabe em combinação com docetaxel. Usando o método analítico hierárquico, médicos oncologistas compararam a relevância dos cinco critérios predefinidos: sobrevida global, resposta ao tratamento, eventos adversos, custo-efetividade e impacto orçamentário. Resultados O esquema terapêutico considerado mais apropriado pelo modelo foi pertuzumabe em combinação com trastuzumabe e docetaxel. Os critérios mais sensíveis foram eventos adversos, custo-efetividade e impacto orçamentário. Os resultados sugerem que a classificação está associada à perspectiva do profissional de saúde participante do questionário. Conclusão Definir o tratamento de uma doença incurável associada a um tempo de sobrevida curto e opções de tratamento de alto custo requer uma tomada de decisão complexa. O MCDA permite ponderar e considerar critérios que seriam difíceis de medir em outros modelos de decisão. Esses aspectos contribuem para uma avaliação mais ampla da tomada de decisões em saúde.

Cost-effectiveness analysis and budgetary impact of anidulafungin treatment for patients with candidemia and other forms of invasive candidiasis in Brazil

ABSTRACT Candidemia and other forms of invasive candidiasis (C/IC) are serious conditions, especially for immunosuppressed individuals with prolonged hospitalization in intensive care units (ICU). This study analyzed the incremental cost-effectiveness and budgetary impact (BI) of treatment for IC with anidulafungin compared to amphotericin B lipid complex (ABLC) and amphotericin B deoxycholate (ABD) or conventional amphotericin B (CAB), in the Brazilian Unified Health System (SUS). A decision model was conducted with a time horizon of two weeks from the perspective of SUS. The primary effectiveness endpoints were survival and treatment response rate. All patients were followed up until successful therapy or death. BI analysis was performed based on the measured demand method. A five-year time horizon was adopted based on the number of hospitalizations (per 1,000 hospitalizations). For effectiveness measured in the successful response rate (SRR), anidulafungin dominated the ABLC and ABD formulations. In the results of the analysis with the effectiveness measured according to survival, anidulafungin had a better cost-effectiveness ratio (R$988.26/survival) compared to ABD (R$16,359.50/survival). The BI estimate related to the incorporation of anidulafungin suggests savings of approximately 148 million reais in 5 years when comparing it to ABD. The economic evaluation of anidulafungin and its comparators found it to be cost-effective. The consensus of international scientific societies recommends it as a first-line drug for IC, and its incorporation by SUS would be important.

Cost-Effectiveness Analysis of the Implementation of Cryptococcal Antigen Lateral Flow Assay for the Diagnosis of Cryptococcal Meningitis in Symptomatic People Living With Human Immunodeficiency Virus in Brazil.

OBJECTIVES: Cryptococcal meningitis constitutes a significant source of mortality in the developing world. Annually, approximately 625 000 deaths occur worldwide among patients with human immunodeficiency virus (HIV) infection. This study aims to assess the cost-effectiveness of implementing cryptococcal antigen lateral flow assay (CRAG-LFA) screening in Brazil compared with the current practice. METHODS: An economic evaluation using a Monte Carlo microsimulation was conducted, considering the perspective of the Brazilian Public Health System, to calculate the cost-effectiveness of 4 diagnosis tests: (1) CRAG-LFA, (2) the cryptococcal antigen latex agglutination (CRAG-LA) test, (3) India ink, and (4) nontracking as a baseline. The time horizon comprised 1 year for the intervention and 5 years for the budgetary impact analysis. Two primary effectiveness outcomes were considered: years of life and quality-adjusted life-years. RESULTS: CRAG-LFA has extended dominance vis à vis CRAG-LA and India ink. CRAG-LFA would cost $418.46 more than CRAG-LA for the treatment of each symptomatic patient living with HIV, with an incremental cost effectiveness ratio of $2478.75/quality-adjusted life year. The budgetary impact analysis estimated that the incorporation of CRAG-LFA would have an additional cost of $1 959 236.50 in 5 years. CONCLUSIONS: These findings suggest that, for patients living with HIV in the Brazilian Public Health System, the adoption of CRAG-LFA screening is cost-effective compared with the use of CRAG-LA and India ink. It represents an opportunity to prevent cryptococcal meningitis and its mortality in Brazil.

Cost-effectiveness analysis and budgetary impact of the Cryptococcal Antigen Lateral Flow Assay (CRAG-LFA) implementation for the screening and diagnosis of cryptococcosis in asymptomatic people living with HIV in Brazil.

Cryptococcal infection is a frequent cause of mortality in Brazilian HIV-infected patients. The present study aimed to evaluate the cost-effectiveness and budgetary impact of four cryptococcosis screening strategies in HIV-infected patients with CD4+ ≤ 200 cells/mm3, in Brazil. A Monte Carlo microsimulation was used to compare the following diagnostic tests: a systematic serum cryptococcal antigen (CRAG) screening with latex agglutination (CRAG-LA), a lateral flow immunochromatographic test (CRAG-LFA), India ink staining and no intervention. The rationale was that of the Unified Health System (SUS), and the time horizon was of one year for the intervention and of five years for the budgetary impact analysis (BIA). The effectiveness outcomes were years of life and years of life adjusted for quality (QALY). The cost-effectiveness analysis showed that the two cryptococcal antigen tests were cost-effective, presenting with superior results in comparison with India ink and no screening. CRAG-LFA, compared to CRAG-LA, has an incremental cost of US$0.25 and an incremental cost-effectiveness ratio of US$73.36 (considering the US dollar equal to 5 reais, the Brazilian current money). The probabilistic sensitivity analysis between CRAG-LFA and CRAG-LA, despite showing a high agreement between the two tests, indicated the superiority of CRAG-LFA. The BIA estimated that the incorporation of CRAG-LFA would have an additional cost of approximately U$S 10.4 million dollars in five years. These findings suggest that, for the group of studied patients, the adoption of CRAG-LFA and CRAG-LA are cost-effective, while the India ink test and no intervention are less effective strategies. The BIA showed that using the CRAG-LFA test for people living with HIV (PLHIV) with CD4+ ≤ 200 cells/mm3 could reduce costs for the Brazilian Unified Health System (SUS).

Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars.

BACKGROUND: The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. METHODS: We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies' databases. The pricing between countries was based on purchasing power parity (PPP). RESULTS: The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain's price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. CONCLUSION: The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.

Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars

Abstract Background: The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods: We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies' databases. The pricing between countries was based on purchasing power parity (PPP). Results: The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain's price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusions: The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.(AU)

Cost-effectiveness analysis and budgetary impact of antipsychotics available in the Brazilian Unified Health System / Análise de custo-efetividade e impacto orçamentário dos antipsicóticos disponíveis no Sistema Único de Saúde brasileiro

Objective: To carry out a cost-effectiveness and budget impact analysis of antipsychotic use in adults to treat schizophrenia from the perspective of the Unified Health System (SUS). Methods: A Markov model simulated the treatment of schizophrenic patients with an initial average age of 25 years and a lifetime horizon. The possibility of combining drugs resulted in 20 pharmacotherapeutic strategies. Results: The lowest-cost strategy, risperidone/olanzapine, obtained values of $45,092.77 with effectiveness of 15.97 QALY. The incremental cost-effectiveness ratio in dollars/QALY of olanzapine/risperidone was 2,470.24, and risperidone/ziprasidone was 352,671.90, compared to the first option. All other therapeutic combinations were dominated. The budgetary impact assessment indicated that the most cost-effective choice could generate savings of US$ 1,555.00 on average, per patient, over five years. Conclusion: The therapeutic proposal with the lowest cost per patient was risperidone combined with olanzapine, revealing these two drugs as a strategy with lower budgetary impact and better cost-effectiveness.

Objetivo: Realizar uma análise de custo-efetividade e impacto orçamentário do uso de antipsicóticos em adultos para o tratamento da esquizofrenia, na perspectiva do Sistema Único de Saúde (SUS). Métodos: Um modelo de Markov simulou o tratamento de pacientes com esquizofrenia, com idade média inicial de 25 anos e horizonte lifetime. Analisaram-se 20 estratégias farmacoterapêuticas. Resultados: A estratégia de menor custo ­ risperidona/olanzapina ­ obteve valores de US$ 45.092,77, eficácia de 15,97 QALY. A relação custo-efetividade incremental em dólares/QALY da olanzapina/risperidona foi de 2.470,24, e de 352.671,90 para risperidona/ziprasidona, em comparação com a primeira opção. Todas as outras combinações terapêuticas foram dominadas. A avaliação do impacto orçamentário indicou que a escolha mais econômica geraria economia de US$ 1.555,00 em média, por paciente, ao longo de cinco anos. Conclusão: A proposta terapêutica de menor custo por paciente foi a risperidona associada à olanzapina, estratégia de menor impacto orçamentário e melhor custo-efetividade.

PEG-asparaginase and native Escherichia coli L-asparaginase in acute lymphoblastic leukemia in children and adolescents: a systematic review

Abstract Introduction Acute lymphoblastic leukemia (ALL) is the cancer with the highest incidence in childhood and adolescence, and pharmacotherapy is the primary form of treatment. Objective and methods A systematic review of the efficacy and safety of polyethylene glycol (PEG)-asparaginase in acute lymphoblastic leukemia therapy in children and adolescents was conducted to compare it with native Escherichia coli L-asparaginase. PubMed, Web of Science, Science Direct, Cochrane Library, Scopus, LILACS (Latin American and Caribbean Health Sciences Literature) and EMBASE databases were selected. The following outcomes were analyzed: complete remission of the disease, event-free survival, overall survival, anti-asparaginase antibody level, hypersensitivity reactions, asparaginase and asparagine serum levels, number of postdiagnosis events, and overall mortality. Five randomized controlled trials were included. Analysis of the quality of evidence and risk of bias was performed using the Cochrane recommendation tool and the GRADE system. Results The assessment results suggest that the level of certainty on the technology addressed is relatively weak from a methodological point of view. Evidence is insufficient to assess the effects on health outcomes because of the limited number and power of studies and important flaws in their design or conduct in classifying PEG-asparaginase as a superior drug or not, in the pharmacotherapy of ALL in children and adolescents. PEG-asparaginase can be used as a substitute for native E. coli L-asparaginase, demonstrating similar efficacy and safety. Conclusion The study may help decision-makers in the public health system to offer a more in-depth judgment on the therapeutic alternatives used to treat this neoplasm in children and adolescents.

PEG-asparaginase and native Escherichia coli L-asparaginase in acute lymphoblastic leukemia in children and adolescents: a systematic review.

INTRODUCTION: Acute lymphoblastic leukemia (ALL) is the cancer with the highest incidence in childhood and adolescence, and pharmacotherapy is the primary form of treatment. OBJECTIVE AND METHODS: A systematic review of the efficacy and safety of polyethylene glycol (PEG)-asparaginase in acute lymphoblastic leukemia therapy in children and adolescents was conducted to compare it with native Escherichia coli L-asparaginase. PubMed, Web of Science, Science Direct, Cochrane Library, Scopus, LILACS (Latin American and Caribbean Health Sciences Literature) and EMBASE databases were selected. The following outcomes were analyzed: complete remission of the disease, event-free survival, overall survival, anti-asparaginase antibody level, hypersensitivity reactions, asparaginase and asparagine serum levels, number of postdiagnosis events, and overall mortality. Five randomized controlled trials were included. Analysis of the quality of evidence and risk of bias was performed using the Cochrane recommendation tool and the GRADE system. RESULTS: The assessment results suggest that the level of certainty on the technology addressed is relatively weak from a methodological point of view. Evidence is insufficient to assess the effects on health outcomes because of the limited number and power of studies and important flaws in their design or conduct in classifying PEG-asparaginase as a superior drug or not, in the pharmacotherapy of ALL in children and adolescents. PEG-asparaginase can be used as a substitute for native E. coli L-asparaginase, demonstrating similar efficacy and safety. CONCLUSION: The study may help decision-makers in the public health system to offer a more in-depth judgment on the therapeutic alternatives used to treat this neoplasm in children and adolescents.

Availability of biological cancer drugs under research: registration and price in Brazil, Colombia, and Mexico / Disponibilidade de medicamentos biológicos contra o câncer: registro e preço no Brasil, Colômbia e México

Abstract This study seeks to understand biological cancer drug availability through registration and prices of the biological agents used for cancer therapy and authorized for sale in the last 5 years in Brazil, Colombia, and Mexico, comparing the data to those for the United States of America (USA) and Spain. The regulatory agencies' websites were assessed for drugs registered between January 1, 2014, and February 20, 2019. Drug prices were sought in the clerical databases. Prices were also compared using purchasing power parity (PPP). The comparison between the purchasing power (PP) of the three Latin American countries is hampered by market heterogeneity and uncertainty in the data. There is no registration synchronization. The average difference between the launch time in the USA and in the other countries is 1.6 to 2.6 years. The USA has the lowest PPP values, compared to the Latin American countries studied, but higher prices. Differences in registration time reveal issues in drug access in the Latin American countries studied or a lack of equity between countries. The economic effort that these countries make to have access to these supplies is much higher than that of the USA and Spain.

Resumo Este estudo busca entender a disponibilidade de medicamentos contra o câncer biológico por meio do registro e preços dos agentes biológicos utilizados na terapia do câncer e autorizados para venda nos últimos cinco anos no Brasil, Colômbia e México, comparando os dados com os dos Estados Unidos da América (EUA) e Espanha. Os sites das agências reguladoras foram consultados para medicamentos registrados entre 1º de janeiro de 2014 e 20 de fevereiro de 2019. Os preços dos medicamentos foram procurados nas bases de dados administrativas. Os preços também foram comparados usando a paridade do poder de compra (PPP). A comparação entre o poder de compra (PP) dos três países da América Latina é dificultada pela heterogeneidade de mercado e incerteza nos dados. Não há sincronização de registro. A diferença média entre o tempo de lançamento nos EUA e nos outros países é de 1,6 a 2,6 anos. Os EUA têm os menores valores de PPP, em comparação com os países latino-americanos estudados, mas preços mais altos. As diferenças no tempo de registro revelam problemas no acesso a medicamentos nos países latino- americanos estudados ou falta de equidade entre os países. O esforço econômico que esses países fazem para ter acesso a esses suprimentos é muito maior do que o dos EUA e da Espanha.

[Regulations on expanded access and compassionate use of medicines in South AmericaRegulación de los programas de acceso ampliado y uso compasivo de medicamentos en América del Sur]. / Normatização de programas de acesso expandido e uso compassivo de medicamentos na América do Sul.

OBJECTIVE: To describe and compare the regulatory framework governing policies on rapid/alternative access to medicines (expanded access and compassionate use) in South American countries. METHOD: An exploratory descriptive study with analysis of documents was performed. In addition to a literature review, official rules issued by regulatory agencies were reviewed if available. Information was collected on how countries define the concepts of expanded access and compassionate use, clinical phase in which the medicine becomes available for these alternative uses, and role of physicians and sponsors. RESULTS: Argentina, Brazil, Chile, Peru, and Uruguay were included in the study. The information obtained revealed that the regulatory scenario is more structured in Argentina and Brazil than in the other countries. In Chile, rules on expanded access and compassionate use are available, however without an explicit definition of these concepts. In Peru and Uruguay, important definitions are missing regarding expanded access. The search did not reveal any databases with information on expanded access and compassionate use programs, supporting the notion that empirical data to evaluate the results of these policies are lacking. CONCLUSIONS: All the countries analyzed have a regulatory framework that contemplates rapid/alternative access to medicines by patients at risk. However, databases and transparent information are lacking, preventing a snapshot of the medicines covered and patients benefiting from alternative access programs and assessments of these policies in South America.

OBJETIVO: Describir y comparar los marcos regulatorios de las políticas de acceso rápido y alternativo a medicamentos (acceso ampliado y uso compasivo) en países de América del Sur. MÉTODOS: Se realizó un estudio exploratorio y descriptivo, con análisis documental. Además de revisión de la bibliografía científica sobre el tema, se obtuvo información sobre las normas oficiales, si estaba disponible en las páginas electrónicas de las autoridades regulatorias de medicamentos. Se recolectó información sobre la forma en que cada país define los conceptos de acceso ampliado y uso compasivo, la fase clínica en que se ofrece el medicamento para uso alternativo y las obligaciones de los médicos y patrocinadores. RESULTADOS: A partir de los criterios de inclusión, se seleccionaron para el estudio Argentina, Brasil, Chile, Perú y Uruguay. La información obtenida mostró que Argentina y Brasil presentan un escenario regulatorio más estructurado en comparación con los demás países del grupo citado. Chile presenta una norma sobre acceso ampliado y uso compasivo, pero sin definir explícitamente esos conceptos. En Perú y Uruguay, se constató la falta de definiciones importantes en cuanto al acceso ampliado. No se encontraron bases de datos con información sobre acceso ampliado y uso compasivo, lo cual corroboró la percepción sobre la escasez de datos empíricos para evaluar los resultados de esas políticas. CONCLUSIONES: Todos los países analizados cuentan con un marco regulatorio que permite el acceso rápido y alternativo a medicamentos de los pacientes en situación de riesgo. Sin embargo, no existen bancos de datos ni información transparente que permitan determinar qué medicamentos y pacientes se benefician de ese acceso alternativo y evaluar los resultados de esas políticas en América del Sur.

Normatização de programas de acesso expandido e uso compassivo de medicamentos na América do Sul

[RESUMO]. Objetivo. Descrever e comparar os marcos regulatórios das políticas de acesso rápido/alternativo a medicamentos (acesso expandido e uso compassivo) em países da América do Sul. Métodos. Realizou-se um estudo exploratório e descritivo, com análise documental. Além de revisão da literatura científica sobre o tema, foram levantadas informações e normas oficiais caso estivessem disponíveis nas páginas eletrônicas das autoridades reguladoras de medicamentos. Foram coletadas informações sobre a forma como cada país define os conceitos de acesso expandido e uso compassivo, fase clínica em que o medicamento fica disponível para esses usos alternativos e obrigações de médicos e patrocinadores. Resultados. A partir dos critérios de inclusão, foram selecionados para o estudo Argentina, Brasil, Chile, Peru e Uruguai. O levantamento de informações mostrou que Argentina e Brasil apresentam um cenário regulatório mais estruturado. O Chile apresenta uma norma sobre acesso expandido e uso compassivo, porém sem definir explicitamente esses conceitos. No Peru e Uruguai, foi constatada a ausência de definições importantes quanto ao acesso expandido. Não foram identificadas quaisquer bases de dados com informações sobre acesso expandido e uso compassivo, corroborando a percepção de escassez de dados empíricos para avaliar os resultados dessas políticas. Conclusões. Todos os países analisados contam com um marco regulatório que permite o acesso rápido/ alternativo a medicamentos por pacientes em situação de risco. Porém, não existem bancos de dados e transparência de informações que permitam caracterizar quais medicamentos e pacientes se beneficiam desse acesso alternativo e avaliar os resultados dessas políticas na América do Sul.

[ABSTRACT]. Objective. To describe and compare the regulatory framework governing policies on rapid/alternative access to medicines (expanded access and compassionate use) in South American countries. Method. An exploratory descriptive study with analysis of documents was performed. In addition to a literature review, official rules issued by regulatory agencies were reviewed if available. Information was collected on how countries define the concepts of expanded access and compassionate use, clinical phase in which the medicine becomes available for these alternative uses, and role of physicians and sponsors. Results. Argentina, Brazil, Chile, Peru, and Uruguay were included in the study. The information obtained revealed that the regulatory scenario is more structured in Argentina and Brazil than in the other countries. In Chile, rules on expanded access and compassionate use are available, however without an explicit definition of these concepts. In Peru and Uruguay, important definitions are missing regarding expanded access. The search did not reveal any databases with information on expanded access and compassionate use programs, supporting the notion that empirical data to evaluate the results of these policies are lacking. Conclusions. All the countries analyzed have a regulatory framework that contemplates rapid/alternative access to medicines by patients at risk. However, databases and transparent information are lacking, preventing a snapshot of the medicines covered and patients benefiting from alternative access programs and assessments of these policies in South America.

[RESUMEN]. Objetivo. Describir y comparar los marcos regulatorios de las políticas de acceso rápido y alternativo a medicamentos (acceso ampliado y uso compasivo) en países de América del Sur. Métodos. Se realizó un estudio exploratorio y descriptivo, con análisis documental. Además de revisión de la bibliografía científica sobre el tema, se obtuvo información sobre las normas oficiales, si estaba disponible en las páginas electrónicas de las autoridades regulatorias de medicamentos. Se recolectó información sobre la forma en que cada país define los conceptos de acceso ampliado y uso compasivo, la fase clínica en que se ofrece el medicamento para uso alternativo y las obligaciones de los médicos y patrocinadores. Resultados. A partir de los criterios de inclusión, se seleccionaron para el estudio Argentina, Brasil, Chile, Perú y Uruguay. La información obtenida mostró que Argentina y Brasil presentan un escenario regulatorio más estructurado en comparación con los demás países del grupo citado. Chile presenta una norma sobre acceso ampliado y uso compasivo, pero sin definir explícitamente esos conceptos. En Perú y Uruguay, se constató la falta de definiciones importantes en cuanto al acceso ampliado. No se encontraron bases de datos con información sobre acceso ampliado y uso compasivo, lo cual corroboró la percepción sobre la escasez de datos empíricos para evaluar los resultados de esas políticas. Conclusiones. Todos los países analizados cuentan con un marco regulatorio que permite el acceso rápido y alternativo a medicamentos de los pacientes en situación de riesgo. Sin embargo, no existen bancos de datos ni información transparente que permitan determinar qué medicamentos y pacientes se benefician de ese acceso alternativo y evaluar los resultados de esas políticas en América del Sur.

[Breast cancer screening: modeling improvement of access using mobile mammography unitsSeguimiento del cáncer de mama: modelo de mejora del acceso con el uso de mamógrafos móviles]. / Rastreamento do câncer de mama: modelo de melhoria do acesso pelo uso de mamógrafos móveis.

OBJECTIVE: To investigate the impact of combined use of fixed and mobile mammography units to rationalize the management of breast cancer screening programs and increase population coverage. METHODS: An observational study was performed using agents-based modeling. The model was used to simulate breast cancer screening coverage in a specific region in the state of Rio de Janeiro (região serrana) where 22 fixed mammography units are installed. The number and distribution of fixed and mobile units, as well as the required number of daily exams, were estimated considering a population coverage of 100% and 60% in the region for the 2015-2016 biennium. RESULTS: For the two-year period, a 60% population coverage could be reached with eight mammography units (five fixed and three mobile). Considering a scenario in which 100% of the eligible population would undergo screening, 11 units would be required (seven fixed and four mobile units). The actual coverage in the region for the 2015-2016 biennium was 36.4%, with 22 mammography units performing four exams daily. CONCLUSIONS: The present simulation showed that it would be possible to reduce by half the number of mammography units in the region, ensuring 100% coverage. Adding more mobile units would facilitate access by the population from cities without installed mammography units and from rural areas.

OBJETIVO: Investigar la repercusión del uso conjunto de mamógrafos fijos y móviles para racionalizar la gestión de los programas de seguimiento del cáncer de mama, con el objeto de ampliar la cobertura de la población. MÉTODOS: Se realizó un estudio de observación con un modelo computacional basado en agentes. El modelo se utilizó para simular la cobertura mediante el seguimiento del cáncer de mama en la región serrana del estado de Rio de Janeiro (Brasil), donde se han instalado 22 mamógrafos fijos. Se estimaron el número y la distribución de mamógrafos fijos y móviles y el número de exámenes por día necesarios para lograr una cobertura de un 100% y de un 60% de la población de la región serrana en el bienio 2015-2016. RESULTADOS: Se determinó que, en el bienio objeto de estudio, se alcanzaría una cobertura de un 60% de la población con ocho mamógrafos (cinco fijos y tres móviles). En un escenario en el cual se haría el examen a un 100% de la población seleccionada, se necesitaría un total de 11 mamógrafos (siete fijos y cuatro móviles) en la región serrana. En el bienio citado, la cobertura real de la mamografía en dicha región fue de 36,4%, con la realización de cuatro exámenes diarios con 22 mamógrafos. CONCLUSIONES: Esta simulación mostró que sería posible reducir a la mitad el número de equipos existentes en la región estudiada y garantizar un 100% de cobertura. El uso de un mayor número de mamógrafos móviles facilitaría el acceso de la población en los municipios carentes de ese equipo y en las zonas rurales.

Rastreamento do câncer de mama: modelo de melhoria do acesso pelo uso de mamógrafos móveis

[RESUMO]. Objetivo. Investigar o impacto do uso combinado de mamógrafos fixos e móveis para racionalizar a gestão dos programas de rastreamento do câncer de mama, a fim de ampliar a cobertura à população. Métodos. Realizou-se um estudo observacional utilizando um modelo computacional baseado em agentes. O modelo foi utilizado para simular a cobertura por rastreamento do câncer de mama na região serrana do Rio de Janeiro, Brasil, onde existem 22 mamógrafos fixos instalados. Foram estimados o número e a distribuição de mamógrafos fixos e móveis e o número de exames por dia necessário para alcançar uma cobertura de 100% e uma cobertura de 60% da população da região no biênio 2015-2016. Resultados. Para o período de 2 anos, determinou-se que a cobertura de 60% da população seria alcançada com oito mamógrafos, cinco fixos e três móveis. Para um cenário onde 100% da população elegível faria o exame, haveria necessidade de sete mamógrafos fixos e quatro mamógrafos móveis, totalizando 11 equipamentos na região serrana. A cobertura real de mamografia na região para o biênio 2015-2016 foi de 36,4%, com 22 mamógrafos realizando quatro exames por dia. Conclusões. A simulação mostrou que seria possível reduzir pela metade o número de equipamentos existentes na região estudada, garantindo 100% de cobertura. O uso de um maior número de mamógrafos móveis facilitaria o acesso da população nos municípios sem mamógrafos e em áreas rurais.

[ABSTRACT]. Objective. To investigate the impact of combined use of fixed and mobile mammography units to rationalize the management of breast cancer screening programs and increase population coverage. Methods. An observational study was performed using agents-based modeling. The model was used to simulate breast cancer screening coverage in a specific region in the state of Rio de Janeiro (região serrana) where 22 fixed mammography units are installed. The number and distribution of fixed and mobile units, as well as the required number of daily exams, were estimated considering a population coverage of 100% and 60% in the region for the 2015-2016 biennium. Results. For the two-year period, a 60% population coverage could be reached with eight mammography units (five fixed and three mobile). Considering a scenario in which 100% of the eligible population would undergo screening, 11 units would be required (seven fixed and four mobile units). The actual coverage in the region for the 2015-2016 biennium was 36.4%, with 22 mammography units performing four exams daily. Conclusions. The present simulation showed that it would be possible to reduce by half the number of mammography units in the region, ensuring 100% coverage. Adding more mobile units would facilitate access by the population from cities without installed mammography units and from rural areas.

[RESUMEN]. Objetivo. Investigar la repercusión del uso conjunto de mamógrafos fijos y móviles para racionalizar la gestión de los programas de seguimiento del cáncer de mama, con el objeto de ampliar la cobertura de la población. Métodos. Se realizó un estudio de observación con un modelo computacional basado en agentes. El modelo se utilizó para simular la cobertura mediante el seguimiento del cáncer de mama en la región serrana del estado de Rio de Janeiro (Brasil), donde se han instalado 22 mamógrafos fijos. Se estimaron el número y la distribución de mamógrafos fijos y móviles y el número de exámenes por día necesarios para lograr una cobertura de un 100% y de un 60% de la población de la región serrana en el bienio 2015-2016. Resultados. Se determinó que, en el bienio objeto de estudio, se alcanzaría una cobertura de un 60% de la población con ocho mamógrafos (cinco fijos y tres móviles). En un escenario en el cual se haría el examen a un 100% de la población seleccionada, se necesitaría un total de 11 mamógrafos (siete fijos y cuatro móviles) en la región serrana. En el bienio citado, la cobertura real de la mamografía en dicha región fue de 36,4%, con la realización de cuatro exámenes diarios con 22 mamógrafos. Conclusiones. Esta simulación mostró que sería posible reducir a la mitad el número de equipos existentes en la región estudiada y garantizar un 100% de cobertura. El uso de un mayor número de mamógrafos móviles facilitaría el acceso de la población en los municipios carentes de ese equipo y en las zonas rurales.

Skills and Core Competencies of Pharmacists in Humanitarian Assistance.

BACKGROUND: Pharmacists' participation in health care within multi-disciplinary teams in Humanitarian Assistance (HA) shall be encouraged. Limited literature exists on their role in the humanitarian context. The objective of this paper is to evidence the skill-specific, comprehensive core competencies that pharmacists must demonstrate working in humanitarian interventions. METHODS: The literature search laid the groundwork for the development of interview guides and further analysis of the data. Semi-structured interviews were conducted with expatriate pharmacists and medical coordinators, all of whom have worked in the field of HA. The interviews were recorded, transcribed, and analyzed using a content analysis methodology. RESULTS: Three pharmacists and three medical coordinators were interviewed, who had worked in a combined 32 humanitarian missions. The main functions of pharmacists were focused on stock management and supply of medicinal products. However, pharmacists in HA did not perform many functions related to the provision of effective medication therapy management (MTM). A core competency framework for pharmacists working in the humanitarian field was created, which reflects the personal and technical competencies that are essential to work in HA. CONCLUSION: Self-management in a pressured and changing environment, the ability to adapt to changing situations, and planning, prioritizing, and performing tasks well under pressure are the skills required for pharmacists and for any other humanitarian health worker. The results highlight great efforts being dedicated to pharmaceutical product supply and management by pharmacists working in HA. VardanyanH, MoseguiGBG, MirandaES. Skills and core competencies of pharmacists in humanitarian assistance. Prehosp Disaster Med. 2018;33(3):266-272.

Fuzzy Visa: um modelo de lógica fuzzy para a avaliação de risco da Vigilância Sanitária para inspeção de resíduos de serviços de saúde / Fuzzy Visa: a fuzzy logic model for risk assessment of Health Surveillance for health services waste inspection

Resumo A inspeção sanitária de Gerenciamento de Resíduos de Serviços de Saúde (GRSS) carece de metodologia de trabalho padronizada que proporcione bases seguras de avaliação de risco potencial (RP). O objetivo deste trabalho foi propor um instrumento baseado em lógica fuzzy capaz de padronizar a inspeção e gerar indicadores de controle sanitário. O modelo foi desenvolvido com 18 subsistemas relacionados ao GRSS, que resultaram da aglutinação de elementos identificados na inspeção, como aqueles que interferem na avaliação e permeiam todas as etapas do GRSS. A validação do modelo foi realizada em dez unidades de saúde no Rio de Janeiro, de maio a novembro de 2009. Os resultados obtidos no sistema seguiram os diagnósticos realizados pelos especialistas, mostrando a possibilidade de sistematização e racionalização das avaliações de RP. Esse sistema de apoio à decisão torna mais eficiente a gestão e o planejamento de ações na avaliação do RP.

Abstract The sanitary inspection of Health Services Waste Management (HSWM) lacks a standardized work methodology that provides a secure basis for evaluating potential risk (PR). This study aimed to propose an instrument based on fuzzy logic that could standardize inspection and generate indicators of sanitary control. The model was developed with 18 subsystems related to HSWM obtained from the assembly of elements identified in the inspection as those that interfere with the assessment and permeate all stages of HSWM. The validation of the model was conducted in 10 health establishments in Rio de Janeiro between May to November 2009. The results obtained by this model were consistent with the diagnoses made by experts and clearly indicated the possibility of the systematization and rationalization of PR assessments. This decision support system makes management and planning of actions more efficient in PR evaluation.

The link between industry and social interests in health in Brazil's National Health Innovation System: the experience of the Brazilian National Institute of Traumatology and Orthopedics (INTO).

This article has two parts. The first discusses the relationship between industry and health interests based on three different but non-mutually exclusive "logics": (a) independent; (b) divergent; and (c) convergent. The second part describes the experience at the Brazilian National Institute of Traumatology and Orthopedics (INTO) with a technology management model. The accumulated expertise in orthopedics at INTO can favor Brazil's domestic medical equipment industry without jeopardizing the country's social health needs. This means directing the production of feasible technologies adapted to the national reality, with a focus on safety and quality, without burdening the public coffers and by overcoming the country's dependency on imported products. The proposal is to promote socioeconomic development through a virtuous circle by attracting reserves and fomenting national competitiveness in domestic and foreign markets while improving social conditions and access to health. Resumo: Este artigo está dividido em duas partes. Na primeira, discute-se como se relacionam os interesses produtivos e a saúde a partir de três "lógicas" ou perspectivas diferentes que não são mutuamente excludentes: (a) independente; (b) divergente e (c) convergente. Na segunda, descreve-se a experiência do Instituto Nacional de Traumatologia e Ortopedia (INTO) na montagem de um modelo de gestão de tecnologia. O conhecimento internalizado em ortopedia do INTO pode favorecer a indústria nacional de equipamentos médicos sem abandonar as necessidades sociais brasileiras de saúde. Isto é, direcionar a produção de tecnologias viáveis e adaptadas à realidade nacional, com foco em segurança e qualidade, sem onerar os cofres públicos e abandonando a dependência de produtos importados. A proposta é a de promover um desenvolvimento socioeconômico que construa um ciclo virtuoso, por atrair divisas e fomentar a competitividade nacional em mercados internos e externos, melhorando as condições sociais e de acesso à saúde.