Legal demands of the tiotropium bromide for treatment of chronic obstructive pulmonary disease and their financial impact for the State of Paraná, Brazil / Demandas judiciais do uso de brometo tiotrópio para o tratamento da doença pulmonar obstrutiva crônica e o impacto financeiro para o Estado do Paraná, Brasil

ABSTRACT Objective To analyze the legal demands of tiotropium bromide to treat chronic obstructive pulmonary disease. Methods We included secondary data from the pharmaceutical care management systems made available by the Paraná State Drug Center. Results Public interest civil action and ordinary procedures, among others, were the most common used by the patients to obtain the medicine. Two Health Centers in Paraná (Londrina and Umuarama) concentrated more than 50% of the actions. The most common specialty of physicians who prescribed (33.8%) was pulmonology. There is a small financial impact of tiotropium bromide on general costs with medicines of the Paraná State Drug Center. However, a significant individual financial impact was observed because one unit of the medicine represents 38% of the Brazilian minimum wage. Conclusion Our study highlights the need of incorporating this medicine in the class of long-acting anticholinergic bronchodilator in the Brazilian public health system.

RESUMO Objetivo Analisar as demandas judiciais do brometo de tiotrópio para tratar a doença pulmonar obstrutiva crônica. Métodos Foram considerados dados secundários dos sistemas gerenciais de assistência farmacêutica, disponibilizados pelo Centro de Medicamentos do Paraná. Resultados Ações civis públicas e ações ordinárias, de procedimento comum, entre outras, foram as mais praticadas pelos pacientes para obter o medicamento. Duas Regionais de Saúde do Paraná (Londrina e Umuarama) concentraram mais de 50% das ações. Quanto à especialidade dos médicos prescritores, 33,8% eram pneumologistas. Verificou-se discreto impacto financeiro do brometo de tiotrópio nos gastos gerais com medicamentos pelo Centro de Medicamentos do Paraná. Entretanto, também houve relevante impacto financeiro individual, pois uma unidade do medicamento consome 38% do salário mínimo. Conclusão O estudo aponta para a necessidade de incorporação deste medicamento da classe broncodilatadores anticolinérgicos de longa duração, no Sistema Único de Saúde.

Costo efectividad y análisis de impacto presupuestario del óxido nítrico inhalatorio neonatal en un hospital, desde la perspectiva del sistema público de salud / Cost effectiveness and budget impact analysis of inhaled nitric oxide in a neonatal unit from the perspective of the public health system

El óxido nítrico inhalatorio (ONi) es actualmente la terapia de primera línea en la insuficiencia respiratoria hipoxémica grave del recién nacido; la mayor parte de los centros neonatales de regiones en Chile no cuentan con esta alternativa terapéutica. Objetivo: Determinar el costo-efectividad del ONi en el tratamiento de la insuficiencia respiratoria asociada a hipertensión pulmonar del recién nacido, comparado con el cuidado habitual y el traslado a un centro de mayor complejidad. Pacientes y método: Se modeló un árbol de decisiones clínicas desde la perspectiva del sistema de salud público chileno, se calcularon razones de costo-efectividad incremental (ICER), se realizó análisis de sensibilidad determinístico y probabilístico, se estimó el impacto presupuestario, software: TreeAge Health Care Pro 2014. Resultados: La alternativa ONi produce un aumento promedio en los costos de 11,7 millones de pesos por paciente tratado, con una razón de costo-efectividad incremental comparado con el cuidado habitual de 23 millones de pesos por muerte o caso de oxigenación extracorpórea evitada. Al sensibilizar los resultados por incidencia, encontramos que a partir de 7 casos tratados al año resulta menos costoso el óxido nítrico que el traslado a un centro de mayor complejidad. Conclusiones: Desde la perspectiva de un hospital regional chileno incorporar ONi en el manejo de la insuficiencia respiratoria neonatal resulta la alternativa óptima en la mayoría de los escenarios posibles.

Inhaled nitric oxide (iNO) is currently the first-line therapy in severe hypoxaemic respiratory failure of the newborn. Most of regional neonatal centres in Chile do not have this therapeutic alternative. Objective: To determine the cost effectiveness of inhaled nitric oxide in the treatment of respiratory failure associated with pulmonary hypertension of the newborn compared to the usual care, including the transfer to a more complex unit. Patients and method: A clinical decision tree was designed from the perspective of Chilean Public Health Service. Incremental cost effectiveness rates (ICER) were calculated, deterministic sensitivity analysis was performed, and probabilistic budget impact was estimated using: TreeAge Pro Healthcare 2014 software. Results: The iNO option leads to an increase in mean cost of $ 11.7 million Chilean pesos (€ 15,000) per patient treated, with an ICER compared with the usual care of $ 23 million pesos (€ 30,000) in case of death or ECMO avoided. By sensitising the results by incidence, it was found that from 7 cases and upwards treated annually, inhaled nitric oxide is less costly than the transfer to a more complex unit. Conclusions: From the perspective of a Chilean regional hospital, incorporating inhaled nitric oxide into the management of neonatal respiratory failure is the optimal alternative in most scenarios.