Política de medicamentos de alto costo en un hospital público pediátrico: Análisis de utilización y costos / High-cost medication policy at a public pediatric hospital: utilization and cost analysis

Objetivos. Analizar el circuito de utilización de los medicamentos de alto costo (MAC) y los resultados clínicos obtenidos en un hospital de pediatría público de alta complejidad de Argentina y presentar una estrategia de selección replicable para otras instituciones de similares características de la región. Métodos: Estudio prospectivo, descriptivo, aleatorizado, conducido en el Hospital de Pediatría Juan P. Garrahan de la Ciudad Autónoma de Buenos Aires en el período entre el 1 de setiembre de 2018 y el 31 de marzo de 2019. Se evaluaron dos unidades de estudio, la unidad paciente y la unidad MAC. Resultados: Los MAC consumen 7.921.200 dólares estadounidenses (USD) anuales y representan el 41% del costo de los medicamentos del hospital de alta complejidad. El 50% del costo de los MAC estuvo representado por la gammaglobulina (medicamento utilizado en diferentes enfermedades). Los pacientes proceden de toda la Argentina y otros países y un 44% tiene cobertura de salud. Los diagnósticos para los que se prescribieron MAC con mayor frecuencia fueron los relacionados con patología oncológica (leucemia linfoide aguda, leucemia mieloblástica aguda). El 54% de los pacientes presentó mejoría atribuible directamente a la administración de los MAC, 39% no presentó cambios y el 7% empeoró. Conclusiones: La efectividad en los resultados clínicos y el análisis de los circuitos de aprobación indican que, además de la aprobación por las entidades nacional e internacionales, la evaluación responsable por parte de las instituciones efectoras, mediante la discusión interdisciplinaria basada en la mejor evidencia, contribuye a optimizar la utilización de los MAC y la seguridad de los pacientes (AU)

Objectives. To analyze the utilization circuit of high-cost medications (HCM) and the clinical results obtained in a tertiarycare public pediatric hospital in Argentina and to present a selection strategy that may be disseminated to other institutions of similar characteristics in the region. Methods: A prospective, descriptive, randomized study was conducted at Hospital de Pediatría Juan P. Garrahan in Buenos Aires between September 1, 2018 and March 31, 2019. Two study units were evaluated, the patient and the HCM. Results: HCMs account for 7,921,200 US dollars (USD) per year and represent 41% of the cost of drugs in this tertiary-care hospital. Gamma globulin (a drug used for different diseases) accounted for 50% of the cost of HCMs. Patients came from Argentina and other countries and 44% had a health insurance. Cancer (acute lymphoid leukemia, acute myeloblastic leukemia) was the diagnosis for which HCMs were most frequently prescribed. Fifty-four percent of patients showed improvement directly attributable to the administration of HCMs, 39% showed no change, and 7% worsened. Conclusions: The effectiveness in clinical outcomes and the analysis of approval circuits show that, in addition to approval by national and international entities, responsible evaluation by the effector institutions through interdisciplinary discussion based on the best evidence contributes to optimizing the use of HCMs and patient safety (AU)

Variabilidad de costos de antipsicóticos según establecimientos farmacéuticos en Lima, Perú / Cost variability of antipsychotics according to pharmaceutical establishments in Lima, Peru

RESUMEN Los objetivos del estudio fueron determinar la variabilidad de costos de antipsicóticos en establecimien tos farmacéuticos públicos (hospitales) y privados (farmacias y clínicas), calcular la variabilidad de cos tos de antipsicóticos entre establecimientos y estimar el costo de tratamiento mensual de mantenimiento con antipsicóticos. Se realizó un estudio de análisis de costos, los costos unitarios de los antipsicóticos se obtuvieron del Observatorio Peruano de Productos Farmacéuticos. Los resultados muestran que la va riabilidad de costos de los antipsicóticos fue mayor en farmacias y clínicas que en hospitales, y el análisis de variabilidad de costos entre establecimientos farmacéuticos mostró que el costo de un antipsicótico en una farmacia y clínica fue 1,3 a 140 veces y de 2,8 a 124 veces, respectivamente, el costo que tuvo el fármaco en un hospital. El costo de tratamiento mensual de mantenimiento varió de S/ 3 a S/ 2130 según el fármaco y establecimiento farmacéutico.

ABSTRACT The objectives of the study were to determine the cost variability of antipsychotics in public (hospi tals) and private pharmaceutical establishments (pharmacies and clinics), calculate the cost variability of antipsychotics between establishments and estimate the cost of monthly maintenance treatment with antipsychotics. A cost analysis study was performed, unit costs of antipsychotics were obtained from the Peruvian Pharmaceutical Products Observatory. The results show that the cost variability of antipsycho tics was greater in pharmacies and clinics than in hospitals, and the analysis of cost variability between pharmaceutical establishments showed that the cost of an antipsychotic in a pharmacy and clinic was 1.3 to 140 times and 2.8 to 124 times, respectively, the cost of the drug in a hospital. The cost of monthly maintenance treatment varied from S/3 to S/2130 according to the drug and pharmaceutical establish ment.

Cost-effectiveness of Anti-VEGF treatments for age-related macular degeneration: a Brazilian perspective / Estudo de custo-efetividade de tratamentos para a degeneração macular relacionada à idade: uma perspectiva brasileira

ABSTRACT Purpose: To study the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration. Methods: We used a decision tree model to analyze the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration, from the Brazilian Public Health System (SUS) perspective. Ranibizumab and bevacizumab were administered to patients with the same treatment procedure, and the difference in treatment costs was calculated based on the cost of the drugs. Direct costs were estimated using the information provided by the Brazilian SUS. Effectiveness in terms of quality-adjusted life years (QALYs) was calculated based on the utility values for visual impairment. Incremental cost-effectiveness ratio was calculated by comparing both treatments. The analytical horizon was one year. Results: The decision tree analysis showed that the difference in treatment effectiveness was 0.01 QALY. Incremental cost-effectiveness ratio showed that ranibizumab treatment required an incremental annual cost of more than R$ 2 million to generate 1 additional QALY, as compared to bevacizumab. Conclusions: From the Brazilian SUS perspective, bevacizumab is more cost-effective than ranibizumab for the treatment of neovascular age-related macular degeneration. Its use could allow potential annual savings in health budget.

RESUMO Objetivo: Estudar o custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade neovascular. Métodos: Utilizamos um modelo de árvore de decisão para analisar a relação custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade, sob a perspectiva do Sistema Único de Saúde. O ranibizumabe e bevacizumabe foram administrados a pacientes com o mesmo procedimento de tratamento, e a diferença nos custos do tratamernto foi calculada com base no custo dos medicamentos. Os custos diretos foram estimados utilizando as informações fornecidas pelo SUS. A efetividade foi determinada em anos de vida ajustados pela qualidade (QALY) baseados em valores de utilidade em deficiênciavisual. A razãoincremental custo-efetividadefoicalculada comparando os dois tratamentos. O horizonte analítico foi de um ano. Resultados: A análise da árvore de decisão mostrou que a diferença na efetividade do tratamento foi de 0,01 QALY. A razão incremental de custo-efetividade mostrou que o tratamento com ranibizumabe exigiu um custo anual incremental de R$ 2 milhões para gerar um QALY adicional, em comparação ao bevacizumabe. Conclusões: Do ponto de vista do SUS, o bevacizumabe é mais custo-efetivo que o ranibizumabe no tratamento da degeneração macular relacionada à idade neovascular. O seu uso poderia gerar uma grande economia anual para o orçamento em saúde.

Gasto privado com medicamentos entre idosos e o comprometimento da renda familiar em município de médio porte no estado de São Paulo / Medicines' private costs among elderly and the impairment of family income in a medium-sized municipality in the state of São Paulo

RESUMO: Introdução: A aquisição de medicamentos responde por proporção importante dos gastos privados em saúde. O objetivo deste trabalho foi analisar o gasto privado com a compra de medicamentos e o comprometimento da renda familiar por idosos. Métodos: Inquérito populacional realizado em Praia Grande, São Paulo, 2013. O gasto mensal e o comprometimento da renda familiar per capita com a compra de medicamentos foram calculados com base nas informações obtidas nas entrevistas. As variáveis foram descritas em frequências absolutas e relativas, e os testes de hipótese utilizados foram o χ2 de Pearson, o t de Student e a análise de variância (Anova), com nível de significância de 5%. Resultados: A prevalência de utilização de medicamentos foi de 61,2%, e o gasto médio mensal per capita, de R$ 34,59, sendo significativamente maior o comprometimento da renda para os indivíduos com maior escolaridade, sem doenças crônicas e beneficiários de planos de saúde. Conclusão: A prevalência de utilização de medicamentos foi baixa. O custo gerado pela aquisição de medicamentos é uma das formas pelas quais pode se manifestar a desigualdade na sociedade. A ampliação da provisão gratuita de medicamentos seria necessária para expandir o acesso e evitar gastos, sobretudo àqueles que possuem planos de saúde privados, mas que não conseguem arcar com as despesas de tratamento medicamentoso.

ABSTRACT: Introduction: The acquisition of medicines accounts for a significant proportion of private health expenditures. The objective of this study was to analyse the private spending with the purchase of medicines and the commitment of the family income, by the elderly. Methods: Population survey conducted in Praia Grande, São Paulo, Brazil. The monthly expenditure and the per capita family income commitment with the purchase of medicines were calculated from the information obtained in the interviews. The variables were described in absolute and relative frequencies and the hypothesis test was Pearson's χ2, Student's t and Anova, with a significance level of 5%. Results: The prevalence of drug use was 61.2%. The average monthly expenditure per capita was R$ 34.59, with significantly higher income impairment for individuals with higher levels of education, without chronic diseases and health plan beneficiaries. Conclusion: The prevalence of drug use was low. The cost generated by the purchase of medicines is one of the ways in which inequality can manifest in society. The expansion of free drug provision would be necessary to expand access and avoid spending, especially those who have private health plans but cannot afford drug treatment.

The Relationship between Lifestyle and Costs Related to Medicine Use in Adults / Relação entre Estilo de Vida e Custos Relacionados ao Uso de Medicamentos em Adultos

Abstract Background: The unhealthy lifestyle is growing and this can have repercussions on health status demanding actions on the occurrence of diseases and leads to increased expenses. Objective: To examine the interrelationship between the costs of medicine use and lifestyle behaviors. Methods: A cohort study with 118 participants, age around 51.7 ± 7.1 years old. It was collected personal and anthropometric data and information about medicine of continuous use to calculate the costs. Lifestyle variables included habitual physical activity (PA) assessed by pedometer, sedentary behavior by Baecke questionnaire, sleep quality by mini sleep questionnaire and self-report of smoke and alcohol consumption. Statistical analyses were performed by BioEstat (version 5.2) and the significance level set at p-value < 0.05. Results: In 12 months, 62 subjects bought 172 medicines, representing an overall cost of US$ 3,087.01. Expenditures with drugs were negatively related to PA (r = -0.194, p-value = 0.035 and r = -0.281, p-value = 0.002), but positively related with sleep quality (r = 0.299, p-value=0.001 and r = 0.315, p-value = 0.001) and age (r = 0.274, p-value = 0.003). Four multivariate models were executed considering lifestyle behaviors in different moments of cohort and medicine costs, and all these models identify important relationship between lifestyle behaviors with expenditures with drugs. Conclusion: Worse sleep quality seems to increase the costs related to medicine use in adults, while obesity and ageing play a relevant role in this phenomenon and alcohol consumption seems a variable with relevant economic impact.

Resumo Fundamento: O estilo de vida pouco saudável está se expandindo e isso pode ter repercussões no estado de saúde, exigindo ações contra a ocorrência de doenças e levando ao aumento de gastos. Objetivo: Examinar a interrelação entre os custos do uso de medicamentos e comportamentos de estilo de vida. Métodos: Estudo de coorte com 118 participantes com idade de 51,7 ± 7,1 anos. Foram coletados dados pessoais e antropométricos e informações sobre medicamentos de uso contínuo para calcular os custos. As variáveis de estilo de vida incluíram: atividade física (AF) habitual, avaliada por pedômetro; comportamento sedentário, pelo questionário de Baecke; qualidade do sono, através do Mini Questionário do Sono, e autorrelato de tabagismo e consumo de álcool. As análises estatísticas foram realizadas no programa BioEstat (versão 5.2), e o nível de significância estabelecido como p < 0,05. Resultados: Em 12 meses, 62 indivíduos compraram 172 medicamentos, representando um custo total de US$ 3.087,01. Gastos com medicamentos foram negativamente relacionados à AF (r = -0,194, p-valor = 0,035 e r = -0,281, p-valor = 0,002), mas relacionaram-se positivamente com a qualidade do sono (r = 0,299, p-valor=0,001 e r=0,315, p-valor = 0,001) e idade (r = 0,274, p-valor = 0,003). Quatro modelos multivariados foram executados, considerando os comportamentos de estilo de vida em diferentes momentos da coorte e custos dos medicamentos, e todos esses modelos identificam relações importantes entre comportamentos de estilo de vida e gastos com medicamentos. Conclusão: A pior qualidade do sono parece aumentar os custos relacionados ao uso de medicamentos em adultos, enquanto a obesidade e o envelhecimento desempenham um papel relevante nesse fenômeno, e o consumo de álcool parece ser uma variável com impacto econômico significativo.

Valor terapéutico y precio de los nuevos fármacos comercializados en Argentina: ¿valen lo que cuestan? / Therapeutic value and price of the new pharmaceuticals commercialized in Argentina: Are they worth what they cost?

RESUMEN En Argentina, los nuevos medicamentos pueden ser autorizados presentando el certificado de aprobación en al menos uno de los 15 países considerados de alta vigilancia sanitaria, sin necesidad de realizar una evaluación propia de eficacia, seguridad o valor terapéutico agregado por el nuevo producto. En este artículo, evaluamos los nuevos medicamentos comercializados en Argentina en el año 2016, utilizando diferentes enfoques: su aprobación por otras agencias reguladoras, demostración de eficacia en ensayos clínicos aleatorizados, tipo de desenlaces estudiados, calificación del valor terapéutico agregado por medio de dos escalas reconocidas y el precio de venta al público. Se concluye que, como reflejo de lo que ocurre en los países desarrollados, los nuevos medicamentos ingresan con precios exorbitantes, pero la mayoría no representa un avance terapéutico significativo. El resultado es un aumento de riesgos para los pacientes y una sobrecarga para los sistemas de financiación públicos y privados.

ABSTRACT In Argentina, new drugs can be authorized by presenting the drug's certificate of approval in at least one of 15 countries considered to have rigorous health surveillance, without needing to carry out a local evaluation of the efficacy, safety or added therapeutic value of the new product. In this article, we evaluate the new drugs commercialized in Argentina in 2016 using different approaches: their approval by other regulatory agencies, the demonstration of their efficacy in randomized clinical trials, types of outcomes studied, rating of their added therapeutic value using two widely recognized scales, and their sale price to the public. It is concluded that, as a reflection of what occurs in developed countries, new drugs enter the market at exorbitant prices, but the majority do not represent a significant therapeutic advancements. The result is increased risks to patients and an overburdening of the public and private funding systems.

Chagas disease: review of needs, neglect, and obstacles to treatment access in Latin America

Abstract After more than one century since its discovery, Chagas disease is still extremely prevalent in 21 Latin American countries. Chagas disease is one of the most concerning public health problems in Latin America; the overall cost of CD treatment is approximately 7 billion United States dollars per year and it has a strong social impact on populations. Little progress has been made regarding the access to diagnosis and treatment at the primary health care level, calling into question the current policies to ensure the right to health and access to essential medications. In this article, diverse dimensions of access to treatment for Chagas disease are reviewed, illustrating the present state of benznidazole medication in relation to global production capacity, costs, and needs. The findings are based on an investigation requested by Médecins Sans Frontières Brazil through a consultancy in 2015, aiming to estimate the current costs of benznidazole production.

Análise do gasto com judicialização de medicamentos no Distrito Federal, Brasil / Analysis of drug expenditure with judicialization in the Federal District, Brazil / Análisis del gasto con la judicialización de medicamentos en el Districto Federal, Brasil

A judicialização como fenômeno de garantia do direito social à saúde é uma questão com discussão crescente no Brasil, devido à definição constitucional de saúde no país, que contempla a integralidade. Objetivo: Analisar o perfil do gasto da saúde pública no Distrito Federal com medicamentos não-padronizados, a fim de compreender quais as circunstâncias em que a judicialização de medicamentos ocorre nesse local. Métodos: Análise jurisprudencial nos processos judiciais sobre medicamentos. Foram utilizados registros administrativos de distribuição dos medicamentos no período de setembro/2014 a agosto/2016. O gasto apurado foi classificado por item e por grupo de doença conforme CID-10. Resultados: O gasto total apurado foi de R$ 43,7 milhões. Dentre os medicamentos com maior gasto, observou-se o fator IX recombinante, utilizado para tratamento de hemofilia, como maior responsável (22,53%), seguido da alfaglicosidase (9,74%), do fingolimode (8,44%) e da abiraterona (6,63%). As doenças com maior demanda de atendimento via judicial foram as doenças do sangue que incluem as hemofilias (26,6%), as neoplasias (24,9%) e as doenças metabólicas (17,5%). Conclusão: Os resultados obtidos permitiram verificar um padrão de demandas particular do DF, com uma participação importante no orçamento destinado à compra de medicamentos.

Judicialization as a phenomenon for right to health guarantee is an issue of increasing discussion in Brazil due to the constitutional definition of health in the country, which opens scenario for integrality. Objective: The way the lawsuits come impacting on public health policies in the three government levels puts this item as pressing point in the discussion of an agenda for the health system. Methods:This study analyzed the profile of public health expenditure in the Federal District with non-protocol drugs in order to understand in which circumstances the lawsuits of drugs ocurr in that territory. Administrative records of drug distribution were collected from September / 2014 to August / 2016. Results: The recorded expenditure was classified by item and by disease group as ICD-10. It was found that the total calculated expense was R$ 43.7 million, with recombinant factor IX, used to treat hemophilia, as most responsible (22.53%), followed by alpha-glucosidase (9.74%), of fingolimod (8.44%) and abiraterone (6.63%). Diseases with increased demand for judicial services were blood diseases that include hemophilia (26.6%), cancer (24.9%) and metabolic disorders (17.5%). Conclusión: The results obtained showed a pattern of particular demands of the Federal District, with an important role in drug purchasing budget.

La judicialización como un fenómeno de garantizar el derecho social à la salud es un tema de creciente debate en Brasil debido a la definición constitucional de la salud en el país, que se abre el escenario para la integridad. Objetivo: La forma en que las demandas vienen impactando sobre las políticas de salud pública en los tres niveles de gestión pone este material como punto de discusión urgente de una agenda para el sistema de salud. Métodos: En este estudio se analizó el perfil del gasto en la salud pública en el Distrito Federal con medicamentos no estándar con el fin de entender cuáles son las circunstancias en que la judicialización se pasa en esto local. Fueron usados archivos administrativos de la distribución de medicamentos a partir de septiembre / 2014 a agosto / 2016. Resultados: El gasto registrado fue clasificado por tema y por grupo de enfermedades como la CIE-10. Se encontró que el gasto total calculado fue de R$ 43,7 millones de dólares. Entre los fármacos con un mayor gasto, se observó el factor IX recombinante, que se utiliza para tratar la hemofilia, como mayor responsable (22,53%), seguido de la alfa-glucosidasa (9,74%), del fingolimod (8,44%) y de la abiraterona (6,63%). Las enfermedades con mayor demanda de servicios judiciales fueron enfermedades de la sangre que incluyen la hemofilia (26,6%), el cáncer (24,9%) y los trastornos metabólicos (17,5%). Conclusión: Los resultados obtenidos mostraron un estándar de demandas judiciales peculiar del Distrito Federal, con una parte importante del presupuesto para la compra de medicamentos.

Economic evaluation of the new oral anticoagulants for the prevention of thromboembolic events: a cost-minimization analysis / Avaliação econômica dos novos anticoagulantes para a prevenção de eventos tromboembólicos: análise de custo-minimização

ABSTRACT CONTEXT AND OBJECTIVE: Randomized clinical trials have shown that the new oral anticoagulants have at least similar impact regarding reduction of thromboembolic events, compared with warfarin, with similar or improved safety profiles. There is little data on real costs within clinical practice. Our aim here was to perform economic analysis on these strategies from the perspective of Brazilian society and the public healthcare system. DESIGN AND SETTING: Cost-minimization analysis; anticoagulation clinic of Hospital Municipal Odilon Behrens, Belo Horizonte, MG, Brazil. METHODS: Patients at the anticoagulation clinic were recruited between August and October 2011, with minimum follow-up of four weeks. Operational and non-operational costs were calculated and corrected to 2015. RESULTS: This study included 633 patients (59% women) of median age 62 years (interquartile range ­49-73). The mean length of follow-up was 64 ± 28 days. The average cost per patient per month was $ 54.26 (US dollars). Direct costs accounted for 32.5% of the total cost. Of these, 69.5% were related to healthcare professionals. With regards to indirect costs, 52.4% were related to absence from work and 47.6% to transportation. Apixaban, dabigatran and rivaroxaban were being sold to Brazilian public institutions, on average, for $ 49.87, $ 51.40 and $ 52.16 per patient per month, respectively, which was lower than the costs relating to warfarin treatment. CONCLUSION: In the Brazilian context, from the perspective of society and the public healthcare system, the cumulative costs per patient using warfarin with follow-up in anticoagulation clinics is currently higher than the strategy of prescribing the new oral anticoagulants.

RESUMO CONTEXTO E OBJETIVO: Estudos clínicos randomizados demonstraram que novos anticoagulantes orais têm pelo menos impacto semelhante em reduzir eventos tromboembólicos quando comparados à varfarina, com perfil de segurança similar ou superior. Há pouca evidência acerca de custos reais na prática clínica. Nosso objetivo é realizar análise econômica dessas estratégias, na perspectiva do sistema de saúde pública e da sociedade brasileiros. TIPO DE ESTUDO E LOCAL: Análise de custo-minimização; Clínica de Anticoagulação do Hospital Municipal Odilon Behrens, Belo Horizonte, MG, Brasil. MÉTODOS: Os pacientes da clínica de anticoagulação foram recrutados de agosto a outubro de 2011, com tempo mínimo de acompanhamento de quatro semanas. Custos operacionais e não operacionais foram computados e corrigidos para 2015. RESULTADOS: Este estudo incluiu 633 pacientes, com idade mediana de 62 (intervalo interquartil 49-73) anos, sendo 59% mulheres. O tempo médio de acompanhamento foi de 64 ± 28 dias. O custo médio por paciente por mês foi de $ 54.26 (dólares). Custos diretos foram responsáveis por 32,5% do custo total. Destes, 69,5% foram relacionados aos profissionais de saúde. Em relação aos custos indiretos, 52,4% estavam relacionados ao absenteísmo ao trabalho e 47,6% ao transporte. Apixaban, dabigatran e rivaroxaban são vendidos a órgãos públicos brasileiros, respectivamente, a um preço médio mensal de $ 49.87, $ 51.40 e $ 52.26 por paciente por mês, valores inferiores aos custos relacionados ao tratamento com varfarina. CONCLUSÃO: No contexto brasileiro, na perspectiva do sistema de saúde pública e da sociedade, os custos cumulativos por paciente em uso de varfarina acompanhados em clínica de anticoagulação são atualmente superiores à estratégia de prescrever novos anticoagulantes orais.

Cost-utility analysis of methylphenidate treatment for children and adolescents with ADHD in Brazil

Objective: To perform a cost-utility analysis on the treatment of attention deficit hyperactivity disorder (ADHD) with methylphenidate immediate-release (MPH-IR) in children and adolescents from Brazil. Method: A Markov model was constructed to compare MPH-IR vs. no treatment. A 24-week naturalistic study was conducted to collect transition probabilities and utility data. Effectiveness was expressed as quality-adjusted life-years (QALY), and costs reported in 2014 international dollars (I$). The perspective was the Brazilian Unified Health System as payer, and the time horizon was 6 years. Results: Of 171 patients, 73 provided information at baseline, and 56 at week 24. Considering the MPH-IR monthly cost of I$ 38, the incremental cost-effectiveness ratio (ICER) of treatment was I$ 9,103/QALY for children and I$ 11,883/QALY for adolescents. In two-way sensitivity analysis, considering one Gross National Product per capita (I$ 11,530) as willingness-to-pay, a cost of no-treatment lower than I$ 45/month would render MPH-IR a cost-saving strategy. Discussion: MPH-IR treatment of children and adolescents is cost-effective for ADHD patients from the Brazilian public health system perspective. Both patients and the healthcare system might benefit from such a strategy. Trial registration number: NCT01705613.

Judicialização do direito à saúde: o impacto orçamentário das ações judiciais sobre medicamentos no município de Vitória da Conquista – BA (2010-2014) / Legalization of the right to health: the budgetary impact of lawsuits on drugs in Vitoria da Conquista city - BA (2010-2014)

A crescente judicialização do sistema de saúde tem gerado impacto no orçamento de municípios. As ações judiciais impetradas contra a Secretaria de Saúde de Vitória da Conquista geram impacto no orçamento. Esta pesquisa tem como objetivo central analisar a evolução no tempo do impacto orçamentário das demandas judiciais por medicamentos no Município de Vitória da Conquista no período de 2010 a 2014. Para tanto, foram coletados dados na Secretaria de Saúde do município de Vitória da Conquista. A abordagem metodológica utilizada foi a quali-quantitativa. Os dados foram organizados em tabelas e gráficos. Verificamos um crescente aumento de ações judiciais no período estudado 2010-2014. O gasto com atendimento a liminares faz com que o orçamento da Secretaria de Saúde de Conquista seja impactado pelo aumento de despesa com ações que atendem casos individuais e específicos.

The increasing judicialization of the health system has generated impact on the budget of municipalities. The lawsuits filed against the Department of Health of Vitoria da Conquista generate impact on the budget. This research was aimed to analyze the evolution of the budgetary impact time of the legal demands for drugs in Vitória da Conquista Municipality in the period 2010 to 2014. Therefore, data were collected in the Health Department of the city of Vitória da Conquista. The methodological approach used was qualitative and quantitative. Data were organized in tables and graphs. We found a growing number of lawsuits in the study period 2010-2014. Spending on care for injunctions makes the budget of Conquest Health Department is impacted by expense increase with actions that meet individual and specific cases.

Access to medicines in Brazil based on monetary and non-monetary acquisition data obtained from the 2008/2009 Household Budget Survey

ABSTRACT OBJECTIVE To investigate the access to medicines by Brazilian families by monetary and non-monetary acquisition data. METHODS This is a cross-sectional study based on data obtained from the 2008/2009 Brazilian Household Budget Survey. The units of assessment were households that participated in the survey and the data on the acquisition of medicines over the 30 days prior to the interviews. The medicines were classified according to the Anatomical Therapeutic Chemical classification system. RESULTS Acquisition of medicines was reported by 82.9% of Brazilian households, with 2.38 medicines/household, and 0.72 medicine/individual. In the South and Southeast regions, the average acquisition was slightly greater than the national average (2.53 and 2.49, respectively). In 22.3% of Brazilian households, it was reported that a medicine was not acquired due to lack of financial resources, mainly in the North and Northeastern regions, and in rural areas. Approximately 15.0% of medicines were obtained with no costs, 90.1% of them by the Brazilian Unified Health System. The medicines most acquired were those acting on the nervous system (28.8% of Brazilian households), on the cardiovascular system (15.7%), on the digestive tract and metabolism (14.3%), and on the respiratory system (12.1%). Overall, the quantity of medicines acquired was greater in higher socioeconomic classes of the population, with the exception of antiparasitic products, most likely because of the precarious sanitary conditions faced by less privileged social classes. CONCLUSIONS The acquisition of medicines is a common practice in Brazil, being reported by over 80.0% of the Brazilian households in 2008/2009. Although the data obtained from the Brazilian Household Budget Survey have some limitations, the information obtained in this study can help health authorities to design national and regional policies to guarantee access to these products while promoting their rational use.

Iniciativas de enfrentamento da barreira patentária e a relação com o preço de medicamentos adquiridos pelo Sistema Único de Saúde / Iniciativas para enfrentarse a la barrera patentaria y su relación con el precio de medicamentos adquiridos por el Sistema Único de Salud / Initiatives to challenge patent barriers and their relationship with the price of medicines procured by the Brazilian Unified National Health System

Resumo: Desde 1996, com a consolidação da oferta do tratamento antirretroviral (ARV) às pessoas vivendo com HIV no Brasil, o governo tem como desafio assegurar a sustentabilidade desta oferta num contexto de incorporação de medicamentos patenteados. O artigo teve como objetivo analisar a série histórica do preço do lopinavir/ritonavir (LPV/r) no Brasil e no mercado internacional à luz de iniciativas de enfrentamento da barreira patentária no período de 2001 a 2012. A metodologia consistiu em mapeamento de iniciativas de enfrentamento da barreira patentária para o LPV/r e análise da série histórica do preço no Brasil e no mercado internacional. Os resultados encontrados apontam que, entre 2001 e 2003, identificaram-se esforços de ameaça de licença compulsória. De 2005 a 2007, identificaram-se iniciativas por diferentes atores: declaração de interesse público, subsídios ao exame e ação civil pública. De 2006 e 2008, iniciativas internacionais de licença compulsória resultaram na redução do preço no Brasil. Entre 2009 e 2012, observa-se uma redução do preço de aquisição pelo Brasil de 30%.

Resumen: Desde 1996, con la consolidación de la oferta de tratamiento antirretroviral (ARV) para las personas viviendo con VIH, el Gobierno de Brasil tiene el desafío de asegurar la sostenibilidad de dicha oferta en un contexto de incorporación de medicamentos patentados. El objetivo de este artículo es analizar la serie histórica del precio del lopinavir/ritonavir (LPV/r) en Brasil y en el mercado internacional, a la luz de iniciativas para enfrentar la barrera patentaria durante el período de 2001 a 2012. La metodología consistió en un mapeo de iniciativas para hacer frente a la barrera patentaria del LPV/r y el análisis de la serie histórica de sus precios de adquisición por el SUS y en el mercado internacional. Entre 2001 y 2003 se identificaron esfuerzos por obtener reducciones de precio de LPV/r, mediante la amenaza de expedición de licencia obligatoria. De 2005 a 2007, se identificaron varias iniciativas de diferentes actores, tales como, la expedición de declaración de interés público, preseentación de subsidios para el examen de solicitudes de patente de este medicamento y la interpesición de acción civil pública. Entre 2006 y 2008, la expedición de licencias obligatorias en el marco de iniciativas internacionales, propiciaron reducciones de precio de LPV/r en Brasil. La reducción promedio del precio de adquisición por parte SUS fue de 30% entre 2009 y 2012.

Abstract: Since 1996, when antiretroviral (ARV) treatments started being guaranteed to people living with HIV in Brazil, the government has faced the challenge of ensuring sustainability of this policy within a context of incorporating patented medicines. This article sought to analyze the historical series of the price of lopinavir/ritonavir (LPV/r) in Brazil and in the international market also considering the initiatives to challenge patent barriers between 2001 and 2012. The methods used were mapping initiatives to challenge LPV/r patent barriers and the analysis of historical series of its price in Brazil and in the international market. Results show that, between 2001 and 2003, there were efforts to use compulsory licensing as a threat. From 2005 to 2007, initiatives by different satkeholders were identified: declaration of public interest, pre-grant opposition ("support to examination") and civil action. From 2006 to 2008, compulsory licensing initiatives in other countries resulted in a price reduction in Brazil. Between 2009 and 2012, there was a 30% reduction in the Brazilian purchasing price.

Cost-effectiveness analysis of ticagrelor compared to clopidogrel for the treatment of patients with acute coronary syndrome in Colombia / Análisis de costo-efectividad del ticagrelor en comparación con el clopidogrel para el tratamiento de pacientes con síndrome coronario agudo en Colombia

Introduction: Acute coronary syndrome is one of the most frequent medical emergencies in developing countries. Objective: To determine, from the perspective of the Colombian health system, the cost-effectiveness of ticagrelor compared to clopidogrel for the treatment of patients with acute coronary syndrome. Materials and methods: We conducted a cost-effectiveness analysis from the perspective of the Colombian health system comparing ticagrelor and clopidogrel for the treatment of patients with acute coronary syndrome. To estimate the expected costs and outcomes, a Markov model was constructed in which patients could remain stable without experiencing new cardiovascular events, suffer from a new event, or die. For the baseline case, a 10-year time horizon and a discount ratio of 3% for costs and benefits were adopted. The transition probabilities were extracted from the PLATO (Platelet Inhibition and Patient Outcomes) clinical trial. Vital statistics were drawn from the Departmento Administrativo Nacional de Estadística (DANE) and additional information from Colombian patients included in the Access registry. To identify and measure resource use, a standard case was built by consulting guidelines and protocols. Unit costs were obtained from Colombian rate lists. A probabilistic sensitivity analysis was conducted in which costs were represented by a triangular distribution, and the effectiveness through a beta distribution. Results: In the base case, the additional cost per quality-adjusted life-year gained with ticagrelor was COP$ 28,411,503. The results were sensitive to changes in the time horizon and the unit cost of clopidogrel. For a willingness-to-pay equivalent to three times the Colombian per capita gross domestic product, the probability of ticagrelor being cost-effective was 75%. Conclusions: Ticagrelor is a cost-effective strategy for the treatment of patients with acute coronary syndrome in Colombia.

Introducción. El síndrome coronario agudo es una de las emergencias médicas más frecuentes en los países en desarrollo. Objetivo. Determinar, desde la perspectiva del sistema de salud colombiano, la relación de costo-efectividad del ticagrelor comparado con el clopidogrel para el tratamiento de pacientes con síndrome coronario agudo. Materiales y métodos. Se hizo un análisis de costo-efectividad desde la perspectiva del sistema de salud colombiano, comparando el ticagrelor y el clopidogrel para el tratamiento de pacientes con síndrome coronario agudo. Para estimar los costos y resultados esperados de las dos alternativas, se construyó un modelo de Markov en el cual los pacientes podían permanecer estables sin experimentar nuevos eventos cardiovasculares, sufrir de un nuevo evento coronario o morir. Para el caso de base, se adoptó un horizonte temporal de 10 años y una tasa de descuento de 3 % para los costos y beneficios. Las probabilidades de transición se extrajeron del estudio Platelet Inhibition and Patient Outcomes , PLATO. Las estadísticas vitales se consultaron en informes del Departamento Administrativo Nacional de Estadística (DANE) y los parámetros adicionales del modelo se basaron en la información de los pacientes colombianos incluidos en el registro en Access. Para identificar y medir el uso de recursos, se construyó un caso estándar a partir de guías y protocolos. Los costos unitarios se obtuvieron de manuales tarifarios colombianos. Se hizo un análisis de sensibilidad probabilístico en el que los costos se representaron por una distribución triangular y, las probabilidades de transición, mediante una distribución beta. Resultados. En el caso de base, el costo adicional por años de vida ajustados por calidad ganados con el ticagrelor fue de COP$ 28´411.503. Los resultados fueron sensibles a los cambios en el horizonte temporal y al costo unitario del clopidogrel. Para un umbral de costo-efectividad equivalente a tres veces el producto interno bruto per cápita de Colombia, la probabilidad de que el ticagrelor fuera costo-efectivo fue de 75 %. Conclusiones. El ticagrelor es una estrategia costo-efectiva para el tratamiento de los pacientes con síndrome coronario agudo en Colombia.

Reverse Auction: A Potential Strategy for Reduction of Pharmacological Therapy Cost / Pregão: Estratégia para Redução do Custo da Terapia Farmacológica em Insuficiência Cardíaca e Transplante Cardíaco

Background:Polypharmacy is a significant economic burden.Objective:We tested whether using reverse auction (RA) as compared with commercial pharmacy (CP) to purchase medicine results in lower pharmaceutical costs for heart failure (HF) and heart transplantation (HT) outpatients.Methods:We compared the costs via RA versus CP in 808 HF and 147 HT patients followed from 2009 through 2011, and evaluated the influence of clinical and demographic variables on cost.Results:The monthly cost per patient for HF drugs acquired via RA was $10.15 (IQ 3.51-40.22) versus $161.76 (IQ 86.05‑340.15) via CP; for HT, those costs were $393.08 (IQ 124.74-774.76) and $1,207.70 (IQ 604.48-2,499.97), respectively.Conclusion:RA may reduce the cost of prescription drugs for HF and HT, potentially making HF treatment more accessible. Clinical characteristics can influence the cost and benefits of RA. RA may be a new health policy strategy to reduce costs of prescribed medications for HF and HT patients, reducing the economic burden of treatment.

Fundamento:A polifarmácia tem um significativo peso econômico.Objetivo:Testar se o uso de pregão em comparação ao de farmácias comerciais (FC) para a compra de medicamentos reduz o custo do tratamento de pacientes ambulatoriais de insuficiência cardíaca (IC) e transplante cardíaco (TC).Métodos:Comparação dos custos do tratamento através de pregão versus FC em pacientes de IC (808) e TC (147) acompanhados de 2009 a 2011, avaliando-se a influência de variáveis clínicas e demográficas no custo.Resultados:Os custos mensais por paciente para medicamentos de IC adquiridos através de pregão e através de FC foram $10,15 (IQ 3,51-40,22) e $161,76 (IQ 86,05-340,15), respectivamente. Para TC, aqueles custos foram $393,08 (IQ 124,74-774,76) e $1.207,70 (IQ 604,48-2.499,97), respectivamente.Conclusão:O pregão pode reduzir o custo dos medicamentos prescritos para IC e TC, podendo tornar o tratamento de IC mais acessível. As características clínicas podem influenciar o custo e os benefícios do pregão, que pode ser uma nova estratégia de política de saúde para baixar os custos dos medicamentos prescritos para IC e TC, diminuindo o peso econômico do tratamento. (Arq Bras Cardiol. 2015; [online].ahead print, PP.0-0).

Análisis comparativo de insulina glargina frente a la insulina detemir: un modelo de minimización de costos aplicable en Colombia / Comparative analysis of insulin glargine vs. insulin detemir: A cost-minimization study applicable to Colombia

Introducción. Más del 90 % de los individuos diagnosticados con diabetes mellitus presentan el tipo 2, cuya resistencia periférica a la acción de la insulina es conocida. Objetivo. Desarrollar un modelo de minimización de costos del tratamiento con insulina glargina una vez al día o con insulina detemir, una o dos veces al día, en pacientes con diabetes mellitus de tipo 2 que requieren insulina, desde la perspectiva del tercer pagador en Colombia. Materiales y métodos. Se hizo una búsqueda sistemática de estudios clínicos comparativos de la administración de insulina glargina e insulina detemir en pacientes con diabetes mellitus de tipo 2 que requieren insulina, con el fin de extraer los datos sobre su uso y efectividad, y sobre la frecuencia de eventos secundarios. La meta establecida de control glucémico fue de HbA1c=7 %. Los costos de la insulina se tomaron del Sistema Integrado de Precios de Medicamentos, 2012, del Ministerio de Salud y Protección Social, y los precios por tableta se basaron en el promedio móvil de doce meses en diciembre de 2012 según el IMS Consulting Group. Los análisis de sensibilidad se hicieron con simulaciones de Montecarlo para las dosis y los costos de la insulina. Resultados. Cinco publicaciones cumplieron con los criterios de inclusión. El rango de la diferencia entre dosis de insulina fue de 3,2 a 33 UI. El porcentaje de pacientes que requirieron dos dosis de insulina detemir estuvo entre 12,6 y 100 %. No hubo diferencias significativas en los eventos hipoglucémicos. Tanto para el canal de compra al por menor como para el de compras institucionales, la diferencia de costos entre la insulin glargina y la detemir favoreció a la primera en cuatro y cinco estudios, respectivamente. Solo un estudio mostró lo contrario en lo concerniente a la venta al por menor. Conclusiones. La diferencia en cuanto a la dosis promedio entre la insulina ganglir y la detemir, genera costos anuales que favorecen el uso de la insulina ganglir, lo que la convierte en una alternativa costo-efectiva frente a la determir.

Introduction: More than 90% of subjects diagnosed with diabetes mellitus present with type 2, which is recognized for peripheral insulin resistance. Objective: To determine the costs of achieving glycemic target with the use of basal insulin analogs, insulin glargine (IG) once a day vs. insulin detemir (ID) once or twice a day, with a cost minimization model built from a third-party payer perspective in Colombia. Materials and methods: A systematic review of comparative clinical trials between IG and ID in patients with insulin-resistant type 2 diabetes was performed to determine data of use, effectiveness and frequency of and adverse events. The goal of glycemic control (effectiveness measure) was defined as HbA1c=7%. The costs of insulin were extracted from the Integrated System of Medication Prices 2012 (Ministerio de Salud y Protección Social de Colombia) and the IMS Consulting Group mobile average cost for the past year as of December, 2012. Sensitivity analyses were performed via Montecarlo simulations for dose and medication costs (insulin). Results: Five publications met inclusion criteria. The range of the difference between insulin doses was 3.2 IU to 33 IU. The percentage of patients requiring two ID doses was 12.6-100%. There were no significant differences in hypoglycemic events. For both retail and institutional channels, there was a higher differential cost between IG vs. ID favoring IG in 4 and 5 studies, respectively. For the retail channel only one study showed the opposite results. Conclusions: As only medication costs are considered, differences in insulin units between IG and ID result in a differential cost in favor of IG that makes it a cost/effective alternative.

Impacto de la infección nosocomial en un hospital de Bogotá (Colombia): efectos en mortalidad y costos / Nosocomial infections impact in a hospital in Bogota (Colombia): effects on mortality and hospital costs

Background: Nosocomial infections (NI) are events associated with high impact on hospital costs and mortality. Aim: To evaluate from the health provider's perspective the costs and mortality attributable to NI. Methods: We selected a sample of patients with and without NI matched by age and diagnosis at admission. Costs were calculated and converted from Colombian pesos to US dollars using the average exchange rate of 2008. We evaluated the mortality rate in both groups. Results: We collected data on 187 patients with NI and 276 without NI. Median total hospitalization cost was US$ 6,329 (95% CI US$5,527-7,934) in NI patients, while in non-infected patients this median was US$1,207 (95% CI US$ 974-1,495). Mortality was higher in the NI group (31.6% versus 5.1%). Patients with NI had longer hospital stays (median 21 days, 95% CI 18-24 days) than non-infected patients (median 5 days, 95% CI 5-6 days). Mortality was also markedly higher in the NI group than in the non-infected group (31.6% versus 5.1%). Conclusion: NI are adverse and costly events related to patient attention that affect adversely the quality of attention.

Introducción: Las infecciones asociadas a la atención en salud (IAAS) están relacionadas con un incremento en los costos de hospitalización y un mayor riesgo de mortalidad. Objetivo: Establecer los costos y la mortalidad asociados a la presentación IAAS en una institución de cuarto nivel. Métodos: Se hizo una selección pareada de pacientes con IAAS y sin IAAS para calcular el costo por medio de costeo directo y emparejamiento. Los costos fueron calculados en pesos colombianos y convertidos a dólares estadounidenses según la tasa de cambio de 2008. Resultados: Se incluyeron 187 pacientes con IAAS y 276 pacientes sin IAAS. La tasa de IAAS fue de 1,8% La mediana del costo de hospitalización en los pacientes con IAAS fue US$ 6.329 (95% CI US$ 5.527-7.934) y en los no infectados de US$1,207 (95% CI US$ 974-1.495). Los pacientes con IAAS presentaron mayor tiempo de estancia hospitalaria, con una diferencia de 16 días respecto a los no infectados (21 días (IC 95% 18-24) vs 5 días (IC 95% 5-6)). Se encontró una mortalidad atribuible de 26,4%. Conclusiones: Las IAAS son eventos adversos a la atención, que se asocian con mayor mortalidad y generación de costos extra.

Avaliação socioeconômica do tratamento medicamentoso de pacientes geriátricos em ambulatório especializado / Socio-economic evaluation from drug treatment of geriatric patients in specialized clinics

Em estudo realizado com 167 pacientes ambulatoriais idosos atendidos em serviço especializado de geriatria em centro de saúde escola, localizado no bairro da Consolação, no município de São Paulo (SP), foi avaliado o perfil farmacoepidemiológico, investigado se as listas de medicamentos padronizados coincidem com as prescrições e estimados os custos da medicação utilizada. Para este estudo, foram utilizadas informações extraídas dos prontuários médicos e obtidas através de entrevistas com os pacientes ou seus acompanhantes responsáveis. A maioria foi do sexo feminino (74,4%), a média de idade foi 80,4 anos, sendo 71 pacientes entre 60 e 79 anos e 96 entre 80 e 96 anos. Os participantes apresentaram condições socioeconômicas acima da média da população brasileira na faixa etária estudada. O perfil de morbidade, entre os pacientes entrevistados, mostrou média de 6,3 (± 2,5) diagnósticos. O número de medicamentos prescritos a cada paciente foi em média 6,1 (± 2,7). Não houve correlação significativa entre as variáveis pessoais pesquisadas e o número de doenças ou medicamentos registrados. No total foram 1.018 medicamentos prescritos, a maioria (82,9%) de padronizados e distribuídos gratuitamente pelo serviço público. A estimativa de gasto mensal pelo governo com a aquisição desses medicamentos foi de R$ 4.100,55, R$ 24,55/paciente/mês, equivalentes a US$ 11,92/paciente/mês (US$ 0,40/dia). Para 100 pacientes foi registrado pelo menos um medicamento não padronizado, observando-se alguns fármacos indisponíveis na padronização com prevalência relativamente alta de prescrição (memantina, mirtazapina, zolpidem, domperidona). É sugerido um estudo para revisão da padronização de medicamentos para o tratamento de pacientes idosos

In study carried out with 167 elderly outpatients attended in specialized geriatric service in Centro de Saúde Escola, located in Consolação district, in the municipality of São Paulo, was evaluated the pharmacoepidemiological profile, investigating if the standardized medicament lists match with the prescriptions and estimated the costs from the utilized medication. For this study it was used information extracted from the medical handbooks and obtained through interviews with the patients or their accompanying charge. The majority was female (74,4%), average age of 80,4 years old, being 71 patients between 60 and 79 years old, and 96 between 80 and 96 years old. The participants presented socio-economic conditions above the Brazilian average in the age group studied. The morbidity profile, between the interviewed patients, shown an average of 6,3 (± 2,5) diagnostics. The number of medicaments prescribed to each patient had an average of 6,1 (± 2,7). There were no significantly correlation between the personal variables researched and the number of diseases or medicaments registered. In total 1.018 medicaments were prescribed, the majority (82,9 %) of standardized and freely distributed by the public service. The estimative of monthly cost by the government with the acquisition of these medicaments was R$ 4.100,55, R$ 24,55 by patient a month, equivalent to US$ 11,92 a month (US$ 0,40 a day). For 100 patients was registered at least one non standardized medicament, observing some unavailable drugs on the standardization with relatively high prescription prevalence (memantine, mirtazapine, zolpidem, domperidone). It's suggested a revision study from the standardization of medicaments for treatment of elderly patients