Validação externa da análise de impacto orçamentário do medicamento fingolimode no tratamento da esclerose múltipla sob a perspectiva do SUS
Validação externa da análise de impacto orçamentário do medicamento fingolimode no tratamento da esclerose múltipla sob a perspectiva do SUS
Data
2022
Autores
Campello, Cesar Ricardo Simioni
Journal Title
Journal ISSN
Volume Title
Publisher
Instituto Nacional de Cardiologia
Resumo
Introdução: O tratamento da esclerose múltipla contempla diferentes tipos de medicamentos que tem como objetivo controlar a atividade autoimune responsável pelo quadro clínico. O fingolimode foi a primeira opção via oral de tratamento incorporada ao SUS. Desde sua incorporação, em 2017, vários outros medicamentos foram acrescentados e modificadas as suas linhas de prescrição nos protocolos clínicos de diretrizes terapêuticas.
Objetivos: Realizar a validação externa da análise do impacto orçamentário do medicamento Fingolimode, após a sua incorporação pelo SUS, comparando os gastos reais oriundos de sua incorporação para o tratamento da esclerose múltipla remitente recorrente com as estimativas apresentadas no relatório 257 da CONITEC de 2017.
Método: Levantamento da população alvo validada por demanda aferida por meio da dispensação dos medicamentos no SUS de pacientes portadores de esclerose múltipla, validação dos custos unitários dos medicamentos por meio das compras realizadas pelo Departamento de Logística do Ministério da Saúde, estimativa do market share pela prescrição dos medicamentos utilizados no horizonte temporal definido, estimativa dos custos diretos relacionados à administração e monitoramento dos medicamentos e comparação dos valores calculados com o valor total publicado no relatório 257 da CONITEC 2017.
Resultados: Foram identificadas divergências entre os dados coletados de vida real com relação a população definida do estudo, o valor de compra dos medicamentos pelo Departamento de Logística em Saúde do Ministério da Saúde e principalmente no market share que apresentou divergências importantes em todos os medicamentos utilizados para o tratamento da esclerose múltipla. O impacto orçamentário calculado na validação para o horizonte temporal de quatro anos do estudo foi de R$ 851.495.043,00.
Conclusões: A validação da análise do impacto orçamentário ressalta a importância da utilização de dados que sejam os mais próximos da realidade da condição em questão, e a avaliação de aspectos como variação de preços e inserção de novos medicamentos ao mercado, o que por sua vez trará menor discrepância e maior previsibilidade dos dados publicados. A análise resultou em uma economia de R$ -532.435.571,00 em relação ao estimado no relatório de incorporação
Palavras-chave: Fingolimode; Impacto orçamentário; Validação; Esclerose múltipla
Introduction: The treatment of multiple sclerosis includes different types of drugs that aim to control the autoimmune activity responsible for the clinical condition. Fingolimod was the first oral treatment option incorporated in SUS. Since its incorporation in 2017, several other drugs have been added and modified to their prescription lines in clinical protocols of therapeutic guidelines. Objectives: To carry out the external validation of the budget impact analysis of the drug Fingolimod, after its incorporation by the SUS, comparing the actual expenses arising from its incorporation for the treatment of relapsing-remitting multiple sclerosis with the estimates presented in the CONITEC 2017 report 257 for incorporation of the drug. Method: Survey of the target population validated by demand measured through the dispensing of medicines in the SUS of patients with multiple sclerosis, validation of unit costs of medicines through purchases made by the Department of Health Logistics of the Ministry of Health, estimation of the market share by the prescription of medicines used in the defined time horizon, estimation of direct costs related to the administration and monitoring of medicines and comparison of the calculated values with the total value published in the CONITEC 2017 report 257. Results: Differences were identified between the data collected from real life in relation to the defined population of the study, the purchase price of medicines by the Department of Health Logistics of the Ministry of Health and especially in the market share that showed important differences in all medicines used for the treatment of multiple sclerosis. The budget impact calculated in the validation for the four-year time horizon of the study was BRL 851,495,043.00. Conclusions: The validation of the budget impact analysis highlights the importance of using data that are closest to the reality of the condition in question, and the evaluation of aspects such as price variation and insertion of new drugs on the market, which in turn will bring less discrepancy and greater predictability of published data. The analysis resulted in savings of BRL -532,435,571.00 in relation to what was estimated in the incorporation report Keywords: Fingolimod; Budget impact; Validation; Multiple sclerosis
Introduction: The treatment of multiple sclerosis includes different types of drugs that aim to control the autoimmune activity responsible for the clinical condition. Fingolimod was the first oral treatment option incorporated in SUS. Since its incorporation in 2017, several other drugs have been added and modified to their prescription lines in clinical protocols of therapeutic guidelines. Objectives: To carry out the external validation of the budget impact analysis of the drug Fingolimod, after its incorporation by the SUS, comparing the actual expenses arising from its incorporation for the treatment of relapsing-remitting multiple sclerosis with the estimates presented in the CONITEC 2017 report 257 for incorporation of the drug. Method: Survey of the target population validated by demand measured through the dispensing of medicines in the SUS of patients with multiple sclerosis, validation of unit costs of medicines through purchases made by the Department of Health Logistics of the Ministry of Health, estimation of the market share by the prescription of medicines used in the defined time horizon, estimation of direct costs related to the administration and monitoring of medicines and comparison of the calculated values with the total value published in the CONITEC 2017 report 257. Results: Differences were identified between the data collected from real life in relation to the defined population of the study, the purchase price of medicines by the Department of Health Logistics of the Ministry of Health and especially in the market share that showed important differences in all medicines used for the treatment of multiple sclerosis. The budget impact calculated in the validation for the four-year time horizon of the study was BRL 851,495,043.00. Conclusions: The validation of the budget impact analysis highlights the importance of using data that are closest to the reality of the condition in question, and the evaluation of aspects such as price variation and insertion of new drugs on the market, which in turn will bring less discrepancy and greater predictability of published data. The analysis resulted in savings of BRL -532,435,571.00 in relation to what was estimated in the incorporation report Keywords: Fingolimod; Budget impact; Validation; Multiple sclerosis
Description
Palavras-chave
Fingolimode, Impacto orçamentário, Validação, Esclerose múltipla, Fingolimod, Budget impact, Validation, Multiple sclerosis
Citação
CAMPELLO CRS. Validação externa da análise de impacto orçamentário do medicamento fingolimode no tratamento da esclerose múltipla sob a perspectiva do SUS. Dissertação [Mestrado Profissional em Avaliação de Tecnologias em Saúde]. Instituto Nacional de Cardiologia; 2022.