Cristina Mariano Ruas Brandão

Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil

OBJETIVO: Analisar o perfil dos requerentes e dos medicamentos pleiteados em acoes judiciais. METODOS: Estudo descritivo sobre 827 processos judiciais com 1.777 pedidos de medicamentos de 2005 a 2006 no Estado de Minas Gerais. Avaliaram-se os tipos de atendimento no sistema de saude e a representacao dos autores junto ao Poder Judiciario. Os medicamentos foram descritos segundo registro na Agencia Nacional de Vigilância Sanitaria, essencialidade, inclusao programatica no Sistema Unico de Saude e evidencias de eficacia. RESULTADOS: Mais de 70% dos autores foram atendidos no sistema privado de saude e 60,3% foram representados por advogados particulares. O diagnostico mais frequente foi o de artrite reumatoide (23,1%) e os imunossupressores foram os medicamentos mais solicitados (principalmente adalimumabe e etanercepte). Aproximadamente 5% dos medicamentos pleiteados nao eram registrados na Agencia, 19,6% estavam presentes na Relacao Nacional de Medicamentos Essenciais, 24,3% compunham o Programa de Medicamentos de Alto Custo e 53,9% apresentavam evidencia consistente de eficacia. Dentre os medicamentos nao disponiveis no sistema publico, 79,0% apresentavam alternativa terapeutica nos programas de assistencia farmaceutica. CONCLUSOES: O fenomeno da judicializacao na saude pode indicar falhas do sistema publico de saude, uma vez que ha solicitacoes de medicamentos constantes de suas listas. Todavia, constitui um obstaculo para a pratica do uso racional de medicamentos e para a consolidacao das premissas da Politica Nacional de Medicamentos, principalmente quando sao solicitados medicamentos sem comprovacao de eficacia e nao padronizados pelo Sistema Unico de Saude.OBJECTIVE To analyze the profile of claimants and medicines demanded in lawsuits. METHODS Descriptive study that examined 827 lawsuits with 1,777 demands of access to medicines in the period between July 2005 and June 2006 in the state of Minas Gerais, Southeastern Brazil. There were examined the type of health care provided to claimants and their attorneyship. The medicines were described based on the following: drug registration at the National Health Surveillance Agency (Anvisa); wheter they were essential medicines; supply in the Brazilian Health System programs; and evidence of drug efficacy. RESULTS More than 70% of the claimants were provided care in the private health system and 60.3% hired private lawyers. The most common diagnosis of claimants was rheumatoid arthritis (23.1%) and the immunosuppressant agents were the most frequent demand medicines (mainly adalimumab and etanercept). Approximately 5% of the medicines demanded were not registered at Anvisa, 19.6% were included in the Brazilian List of Essential Medicine, 24.3% were included in the High-Cost Drug Program and 53.9% showed consistent evidence of efficacy. Among the medicines that were not available in Brazilian Health System, 79.0% had therapeutic alternatives in drug programs. CONCLUSIONS The phenomenon of judicialization of health in Brazil can point out failures in the public health system as some medicines demanded are included in its lists. However, it is a barrier for rational drug use and application of the National Drug Policy guidelines, especially when there are demanded medicines with no evidence of efficacy and that are not included in Brazilian Health System standards.

Treatment of postmenopausal osteoporosis in women: a systematic review

Osteoporosis, a typical disease of the elderly, has become a frequent and relevant public health problem. Several drugs are available for treatment of osteoporosis, some of which are currently dispensed by the Brazilian Unified National Health System. The objective of this study was to present a systematic review of drugs for treatment of osteoporosis, focusing on the adequacy of clinical protocols based on existing evidence in the scientific literature. We conducted a search for randomized clinical trials in PubMed and LILACS that presented results for bone mineral density, incidence of vertebral fractures, and adverse effects. 32 articles met the reviews inclusion criteria. Bisphosphonates were reported to have consistently reduced the risk of vertebral fractures. Hormone replacement therapy showed positive outcomes, but its use has been found to increase the risk of cardiovascular disease and breast cancer. Teriparatide and monofluorophosphate also showed efficacy against osteoporosis. Calcium and vitamin D were given to patients as food supplements.

Análise farmacoeconômica das estratégias de tratamento da osteoporose em mulheres na pós-menopausa: uma revisão sistemática

Osteoporosis, especially in postmenopausal women, has a high socioeconomic impact on the individual and on the society. There are several drugs for its prevention and treatment; however, their effectiveness and costs vary considerably. Several economic assessments have been conducted in order to evaluate the most effective strategies. This study aimed at conducting a systematic review of complete economic assessments focusing on the treatment of postmenopausal osteoporosis performed in Brazil and worldwide. Articles about economic assessment of drugs for the treatment of postmenopausal osteoporosis were searched in the PubMed and LILACS databases. In general, bisphosphonates were the most frequently assessed strategies and had the best incremental cost-effectiveness ratios. Hormone therapy, vitamin D and calcium, strontium ranelate, raloxifene, teriparatide, and denosumab were assessed and showed variable results depending on the perspective of the country and the assumptions made for each study. None of the results could be extrapolated to the Brazilian population, which limits their use by decision makers.

Perfil demográfico e epidemiológico dos usuários de medicamentos de alto custo no Sistema Único de Saúde

The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministrys databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the programs users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministry’s databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the program’s users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.

The efficacy of adefovir dipivoxil, entecavir and telbivudine for chronic hepatitis B treatment: a systematic review

INTRODUCTION Chronic hepatitis B is one of the most frequent infectious disease in the world and represents a serious problem of public health METHODS A systematic review of randomized clinical trials was conducted to evaluate the efficacy of the nucleoside/nucleotide analogues (adefovir, entecavir and telbivudine) used for the treatment of chronic hepatitis B. The databases PubMed and LILACS were consulted, among others RESULTS Twenty nine articles published between January/1970 to December/2009 were selected CONCLUSIONS All nucleoside/nucleotide analogues demonstrate upper or similar efficacy to lamivudine. The entecavir can be appropriate for patients with chronic hepatitis B, HBeAg positive and negative treatment-naive as alternative to lamivudine, considering its low potential of viral resistance. The addition of adefovir to lamivudine presented good results in lamivudine resistant patients. The use of entecavir and telbivudine in those patients presents risk of crossed resistance. TBV is one of the most recent antivirals available, but antiviral resistance already documented represents limitation to its use as therapeutic option to LAM. Adverse events of nucleoside/nucleotide analogues were similar in characteristics, gravity and incidence when compared to the lamivudina and placebo.

Consumer Willingness to Pay for Dengue Vaccine (CYD-TDV, Dengvaxia®) in Brazil; Implications for Future Pricing Considerations

Introduction and Objective: Dengue virus is a serious global health problem with an estimated 3.97 billion people at risk for infection worldwide. In December 2015, the first vaccine (CYD-TDV) for dengue prevention was approved in Brazil, developed by Sanofi Pasteur. However, given that the vaccine will potentially be paid via the public health system, information is need regarding consumers’ willingness to pay for the dengue vaccine in the country as well as discussions related to the possible inclusion of this vaccine into the public health system. This was the objective of this research. Methods: We conducted a cross-sectional study with residents of Greater Belo Horizonte, Minas Gerais, about their willingness to pay for the CYD-TDV vaccine. Results: 507 individuals were interviewed. These were mostly female (62.4%) had completed high school (62.17%), were working (74.4%), had private health insurance (64.5%) and did not have dengue (67.4%). The maximum median value of consumers’ willingness to pay for CYD-TDV vaccine is US

Gastos publicos com medicamentos para o tratamento da osteoporose na pos-menopausa

33.61 (120.00BRL) for the complete schedule and US

Public spending on drugs for the treatment of osteoporosis in post-menopause

11.20 (40.00BRL) per dose. At the price determined by the Brazil’s regulatory chamber of pharmaceutical products market for the commercialization of Dengvaxia® for three doses, only 17% of the population expressed willingness to pay for this vaccine. Conclusion: Brazil is currently one of the largest markets for dengue vaccine and the price established is a key issue. We believe the manufacturer should asses the possibility of lower prices to reach a larger audience among the Brazilian population.

Cost-effectiveness of nucleoside/nucleotide analogues in chronic hepatitis B

OBJETIVO: Analizar los gastos con medicamentos para el tratamiento de la osteoporosis en la post-menopausia y los factores asociados al gasto promedio per capita. METODOS: Pareamiento probabilistico-deterministico a partir de las bases de las Autorizaciones de Procedimientos de Alta Complejidad con el Sistema de Informacion sobre Mortalidad, resultando en cohorte historica de pacientes que utilizaron medicamentos de alto costo para el tratamiento de la osteoporosis en la post-menopausia de 2000 a 2006. El gasto promedio mensual con medicamentos fue estratificado por grupos etarios y descrito de acuerdo con las caracteristicas demograficas, clinicas y tipo de medicamento usado. Se utilizo modelo de regresion linear para evaluar el impacto de las caracteristicas socio demograficas y clinicas sobre el gasto promedio mensual per capita con los medicamentos. RESULTADOS: Se identificaron 72.265 mujeres que recibieron medicamentos para el tratamiento de la osteoporosis en la post-menopausia. El gasto promedio mensual per capita en el primer ano de tratamiento fue de R

Custo-efetividade dos análogos de nucleosídeos/nucleotídeos para hepatite crônica B

90,00 (de R