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)

Access to high-cost medications for psoriatic arthritis in the National Health System in Brazil: the long path up to dispensation

Abstract Background: Pharmaceutical Assistance (PA) is a dynamic and multidisciplinary process that aims to supply health systems, programs or services with quality medicines, enabling access and health care, in an efficient and timely manner. The objective of the study was to evaluate the profile of administrative processes for the treatment of PsA, identify the time elapsed in the flow of processes and its associated factors. Methods: A cross-sectional study of medication requests for the treatment of PsA was carried out between November 2014 and December 2016. Linear regression was used to verify the factors associated with time to delivery. Results: A total of 218 cases containing 250 drugs were analyzed. The median time between the medical appointment and the first dispensation was 66 days (interquartile range, 44-90). The State proceedings, which includes requesting the drug until the authorization of treatment, was the stage that most contributed to the total time spent. The factors associated with the longer time to delivery of medications were prescriptions coming from clinics and specialty centers, from dermatologists, non-authorized processes and non-persistent patients in the treatment in 12 months. Conclusion: The median time to receive medicines for the PsA treatment in Belo Horizonte health region after a medical prescription was higher than 2 months. The time between the solicitation of the medicines and the authorization of the treatment in the SUS (State administrative procedure) was the main component of the total time spent.

Perfil de gastos com o tratamento da Artrite Reumatoide para pacientes do Sistema Único de Saúde em Minas Gerais, Brasil, de 2008 a 2013 / Profile of spending on the treatment of rheumatoid arthritis for patients of the Unified Health System in the state of Minas Gerais - 2008-2013

Resumo A artrite reumatoide (AR) é uma doença crônica que afeta cerca de 1% da população adulta. No estudo de coorte histórica de pacientes de Minas Gerais, registrados no Sistema de Informações Ambulatoriais (SIA), em 2008-2013, foram identificados 11.573 indivíduos. A perspectiva foi a do financiador público e os valores observados como gastos do Sistema Único de Saúde (SUS) foram ajustados pelo Índice Nacional de Preços ao Consumidor Amplo (IPCA), de dezembro de 2015. O Etanercept foi o tratamento mais caro. A análise múltipla mostrou uma relação negativa entre o aumento das despesas e idade, sexo feminino e diagnóstico de entrada na coorte, e relação positiva para as variáveis Índice de Desenvolvimento Humano Municipal (IDH-M) e o uso de medicamentos bloqueadores do fator de necrose tumoral (ANTI-TNF). Este estudo identificou os fatores que têm impacto sobre o gasto com o tratamento medicamentoso da AR. Também apontou que métodos que permitem extrair dados demográficos e de gastos de sistemas de informação administrativos podem ser ferramentas importantes na construção de estudos econômicos capazes de subsidiar as avaliações econômicas de saúde, especialmente do ponto de vista da gestão.

Abstract Rheumatoid arthritis (RA) is a chronic condition that affects about 1% of the adult population. In a historical cohort of Minas Gerais State, 11,573 RA patients registered in the Outpatient Information System (SIA) between 2008 and 2013 were identified. For this study we adopted the public funding body's perspective and the values were adjusted by the national inflation index (IPCA) of December 2015. Etanercept was the most expensive treatment. The mean cohort age was 52 years old and most of the patients were women. Multiple regression analysis indicated a negative association between higher expenditure and age, female sex, and diagnosis at entry in the cohort and positive association between high expenditure and the Human Development Index (HDI) of the municipality and use of tumor necrosis factor agents. This study identified the factors that have an impact on RA drug treatment expenditure. Also, we showed that methods that enable extracting demographic and expenditure data of administrative information systems may represent important tools in the construction of economic studies to subsidize economic health evaluations, especially from the standpoint of the managers.

Impact of rheumatoid arthritis in the public health system in Santa Catarina, Brazil: a descriptive and temporal trend analysis from 1996 to 2009 / Impacto da artrite reumatoide no sistema público de saúde em Santa Catarina, Brasil: análise descritiva e de tendência temporal de 1996 a 2009

ABSTRACT Introduction: There are few studies that carried out a descriptive and trend analysis based on available data from the Unified Health System (SUS) between pre- and post-free dispensing of pharmacological treatment of rheumatoid arthritis (RA) from the perspective of the public health system, in terms of the direct cost of the disease among adults and elderly residents of the State of Santa Catarina, Brazil. This study aims to characterize the direct cost of medical and surgical procedures before and after the dispensing of drugs in this state. Methods: This is a time series-type study with a cross-sectional survey of data from the Hospital (SIH) and Outpatient (SIA) Information System of SUS during the period from 1996 to 2009. Results: Between 1996 and 2009, the total expenditure for hospital- and outpatient pharmacological treatment of rheumatoid arthritis was R$ 26,659,127.20. After the dispensing of drug treatment by SUS a decrease of 36% in the number of hospital admissions was observed; however, an increase of 19% in clinical procedures was noted. Conclusion: During the observed period, a reduction in the number of hospital admissions for both clinical and orthopedic surgical procedures related to this disease was observed. Nevertheless, there was an increase in the cost of medical admissions.

RESUMO Introdução: Poucos estudos fizeram uma análise descritiva e de tendência dos dados disponíveis do Sistema Único de Saúde (SUS) entre os períodos pré e pós-dispensação gratuita do tratamento medicamentoso da artrite reumatoide (AR) sob a perspectiva do sistema público de saúde em termos de custo direto da doença entre adultos e idosos moradores do Estado de Santa Catarina, Brasil. O presente trabalho tem o objetivo de caracterizar o custo direto de procedimentos clínicos e cirúrgicos antes e após o fornecimento de medicamentos no estado. Métodos: Estudo do tipo série temporal com levantamentos transversais entre 1996 e 2009 dos dados do Sistema de Informação Hospitalar (SIH) e Ambulatorial (SIA) do SUS. Resultados: Entre 1996 a 2009, o gasto total para o tratamento hospitalar e medicamentoso ambulatorial da artrite reumatoide foi de R$ 26.659.127,20. Após a dispensação do tratamento medicamentoso pelo SUS observou-se queda de 36% do número de internações hospitalares. Entretanto notou-se um aumento de 19% nos procedimentos clínicos. Conclusão: No período observado notou-se uma redução do número de internações hospitalares tanto para procedimentos clínicos quanto cirúrgicos ortopédicos relacionadas a essa doença. Apesar disso, ocorreu um aumento do custo das internações clínicas.