RESUMEN
Objective: To compare the costs of dupilumab and omalizumab for treating severe allergic asthma patients from the perspective of the Brazilian private healthcare system. Methods: Using clinical and demographic inputs from the literature, we simulated a cohort of 5,000 severe allergic asthma patients and estimated the treatment cost with omalizumab. Results: In the simulated cohort, 81.3% were female, the mean body weight was 75.1 kg (SD 13.1), and the mean serum IgE was 532 IU/mL (SD 688). All patients were eligible for treatment with dupilumab, but 830 (16.6%) were ineligible for treatment with omalizumab due to serum IgE level and/or body weight combinations, according to the product label. Over four weeks, the mean dose of omalizumab was 537 mg (SD 285). The annual mean per-patient cost for treatment with omalizumab was BRL 110,783.89 (SD 58,385.81), ranging from BRL 31,797.49 to BRL 246,643.15. The treatment cost with dupilumab is BRL 111,724.21 for the first year and BRL 107,599.91 for subsequent years. Conclusions: We observed slightly lower mean treatment costs with dupilumab than with omalizumab. However, while the treatment cost with dupilumab is fixed and predictable, the treatment cost with omalizumab is highly variable, depending on patients' characteristics. Health managers should consider these findings for reimbursement and clinical protocol development decisions.
Objetivo: Comparar os custos de dupilumabe e omalizumabe para o tratamento de pacientes com asma alérgica grave na perspectiva do sistema de saúde privado brasileiro. Métodos: Utilizando parâmetros clínicos e demográficos a partir de dados da literatura, simulamos uma coorte com 5.000 pacientes com asma alérgica grave e estimamos o custo de tratamento com o omalizumabe. Resultados: Na coorte simulada, 81,3% eram do sexo feminino, com peso médio de 75,1 kg (DP 13,1) e IgE sérica de 532 IU/mL (DP 688). Todos os pacientes eram elegíveis para o tratamento com dupilumabe, porém 830 (16,6%) não eram elegíveis para o tratamento com omalizumabe devido a combinações específicas de IgE sérica e/ou peso corporal, de acordo com a bula do produto. Para o período de 4 semanas, a dose média de omalizumabe foi de 537 mg (DP 285). O custo médio anual por paciente do tratamento com omalizumabe foi de R$ 110.783,89 (DP 58.385,81), variando de R$ 31.797,49 a R$ 246.643,15. O custo do tratamento com dupilumabe é de R$ 111.724,21 no primeiro ano e R$ 107.599,91 nos anos seguintes. Conclusões: Foi observado que o custo médio do tratamento com dupilumabe é ligeiramente menor que o custo com omalizumabe. Todavia, enquanto o custo do tratamento com dupilumabe é fixo e previsível, o custo do tratamento com omalizumabe é altamente variável, dependendo de características dos pacientes. Esses achados devem ser considerados pelos gestores de saúde para decisões sobre reembolso e desenvolvimento de protocolos clínicos.
Asunto(s)
Asma , Costos y Análisis de Costo , OmalizumabRESUMEN
Objetivo: O estudo tem por objetivo entender as características demográficas e a utilização de recursos para o tratamento da dermatite atópica (DA) no Sistema Único de Saúde (SUS). Métodos: Estudo observacional retrospectivo de dados disponibilizados pelo Departamento de Informática do SUS (Datasus). Os pacientes de interesse foram selecionados por meio do CID-10 L20 (DA). Os dados de interesse foram extraídos do Sistema de Informações Hospitalares (SIH) e Ambulatoriais (SIA) do SUS. Foram extraídos dados de janeiro de 2015 a junho de 2020. Resultados: Foram identificados 27.813 pacientes que realizaram algum procedimento (ambulatorial ou hospitalar) relacionado diretamente com o CID-10 L20. A maior prevalência dos pacientes encontra-se no estado de SP, com 28,6% do total. Foram identificados 116 pacientes que utilizaram alguma das terapias sistêmicas utilizadas no tratamento da DA, sendo a ciclosporina o medicamento mais utilizado (53%). Todas as dispensações estão vinculadas a CIDs de doenças diferentes da DA, porém, pelas premissas adotadas nesse estudo, assumimos que os medicamentos utilizados foram para tratamento da DA, com exceção daqueles relacionados a transplante. Foram realizados 49.245 procedimentos/atendimentos. Identificaram-se 5.006 internações, realizadas por 4.616 pacientes. Foi observado um repasse total de R$ 2.007.757,13 para atendimentos; 77% desse total representam gastos com hospitalizações. Conclusões: Entender o perfil da população afetada pela DA no Brasil e o padrão de uso de recursos pode ajudar a compreender a carga da doença para o sistema público de saúde e auxiliar no desenvolvimento de protocolos clínicos e diretrizes terapêuticas para o tratamento da doença
Objective: The study aims to understand the demographic characteristics and use of resources related to atopic dermatitis (AD) treatment in the Brazilian Unified National Health System (SUS). Methods: Retrospective observational study of data obtained from Brazilian Health Informatics Department (Datasus). Patients of interest were selected using the ICD-10 L20 (AD). The data of interest were extracted from the Hospital (SIH) and the Outpatient Information System (SIA). Data were extracted from January 2015 to June 2020. Results: We identified 27,813 patients who underwent some procedure (outpatient or hospital) directly related to ICD-10 L20. The highest prevalence of patients is in the state of SP, with 28,6% of the total. We identified 116 patients who used some of the systemic therapies used in the treatment of AD, and cyclosporine was the most used drug (53%). However, all dispensations are linked to ICDs of diseases other than AD, but due to the premises adopted in this study, we assumed that the use of the drugs were for the treatment of AD, except for those related to transplantation. 49,245 procedures/visits were performed. A total of 5,006 hospitalizations were identified by 4,616 patients. A total transfer of 2,007,757.13 BRL was observed for health care, and 77% of this total represent hospitalization expenses. Conclusions: Understanding the profile of the population affected by AD in Brazil and the pattern of resource use can help to understand the burden of the disease on the public health system and assist in the development of clinical protocols and therapeutic guidelines for the treatment of the disease
Asunto(s)
Sistema Único de Salud , Dermatitis Atópica , Estudios Observacionales como AsuntoRESUMEN
The Dictyostelium protein kinase YakA is required for the growth-to-development transition. During growth YakA controls the cell cycle, regulating the intervals between cell divisions. When starved for nutrients Dictyostelium cells arrest growth and undergo changes in gene expression, decreasing vegetative mRNAs and inducing the expression of pkaC. YakA is an effector of these changes, being necessary for the decrease of vegetative mRNA expression and the increase of protein kinase A (PKA) activity that will ultimately regulate expression of adenylyl cyclase, cAMP synthesis, and the induction of development. We report a role for this kinase in the response to nitrosoative or oxidative stress of Dictyostelium cells. Hydrogen peroxide and sodium nitroprusside arrest the growth of cells and trigger cAMP synthesis and activation of PKA in a manner similar to the well-established response to nutrient starvation. We have found that yakA null cells are hypersensitive to nitrosoative/oxidative stress and that a second-site mutation in pkaC suppresses this sensitivity. The response to different stresses has been investigated and YakA, cAMP, and PKA have been identified as components of the pathway that regulate the growth arrest that follows treatment with compounds that generate reactive oxygen species. The effect of different types of stress was evaluated in Dictyostelium and the YakA/PKA pathway was also implicated in the response to heat stress.
