The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng por |
Título da fonte: | Revista de Saúde Pública |
Texto Completo: | https://www.revistas.usp.br/rsp/article/view/166635 |
Resumo: | OBJECTIVES: This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices. METHODS: Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis. RESULTS: All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices. CONCLUSION: Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands. |
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The case of eculizumab: litigation and purchases by the Brazilian Ministry of HealthO caso do eculizumabe: judicialização e compras pelo Ministério da SaúdeHemoglobinuria, Paroxysmal, drug therapyDrug CostsOrphan Drug Production, legislation & jurisprudenceHealth’s JudicializationPublic Expenditures on HealthNational Drug PolicyHemoglobinúria Paroxística, tratamento farmacológico.Custos de MedicamentosProdução de Droga sem Interesse Comercial, legislação & jurisprudênciaJudicialização da SaúdeGastos Públicos com SaúdePolítica Nacional de MedicamentosOBJECTIVES: This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices. METHODS: Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis. RESULTS: All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices. CONCLUSION: Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands.OBJETIVOS: O estudo examinou as aquisições de eculizumabe, um anticorpo monoclonal de alto custo utilizado no tratamento de doenças raras, pelos órgãos federais brasileiros, em termos das quantidades compradas, gastos e preços. MÉTODOS: Foram analisadas compras de eculizumabe realizadas entre março de 2007 e dezembro de 2018, por meio de dados secundários extraídos do sistema de compras do governo federal (Siasg). Foram examinados o número de compras, quantidades adquiridas, número de doses diárias definidas por 1.000 habitantes por ano, gastos anuais e preços praticados. Os preços foram corrigidos pelo índice nacional de preços ao consumidor amplo para dezembro de 2018. Regressão linear foi utilizada para análises de tendência. RESULTADOS: Todas as aquisições por órgãos federais foram realizadas pelo Ministério da Saúde. As compras se iniciaram em 2009, sendo efetuadas por dispensa de licitação e para atendimento de demanda judicial. Houve tendência crescente no número de compras e quantidades adquiridas ao longo do tempo. Foram realizadas 283 compras, totalizando 116.792 unidades adquiridas, 28,2% compradas em 2018. Os gastos totais contratados corrigidos somaram mais de R$ 2,44 bilhões. Após a aprovação do registro pela Agência Nacional de Vigilância Sanitária, o preço médio ponderado caiu aproximadamente 35%, para valores abaixo dos preços estabelecidos pela Câmara de Regulação do Mercado de Medicamentos. CONCLUSÃO: O eculizumabe representou gastos extremamente significativos para o Ministério da Saúde no período. Todas as compras foram feitas para atendimento de demandas judiciais, fora do ambiente competitivo. Seu registro promoveu queda importante nos preços praticados. O estudo aponta a relevância do registro sanitário e da necessidade de monitoramento e auditoria permanentes das compras de medicamentos para atendimento de demandas judiciaisUniversidade de São Paulo. Faculdade de Saúde Pública2020-02-13info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfapplication/xmlhttps://www.revistas.usp.br/rsp/article/view/16663510.11606/s1518-8787.2020054001693Revista de Saúde Pública; Vol. 54 (2020); 22Revista de Saúde Pública; Vol. 54 (2020); 22Revista de Saúde Pública; v. 54 (2020); 221518-87870034-8910reponame:Revista de Saúde Públicainstname:Universidade de São Paulo (USP)instacron:USPengporhttps://www.revistas.usp.br/rsp/article/view/166635/159336https://www.revistas.usp.br/rsp/article/view/166635/159337https://www.revistas.usp.br/rsp/article/view/166635/159338Copyright (c) 2020 Revista de Saúde Públicainfo:eu-repo/semantics/openAccessCaetano, RosângelaRodrigues, Paulo Henrique AlmeidaCorrêa, Marilena C VillelaVillardi, PedroOsorio-de-Castro, Claudia Garcia Serpa2020-03-24T20:14:27Zoai:revistas.usp.br:article/166635Revistahttps://www.revistas.usp.br/rsp/indexONGhttps://www.revistas.usp.br/rsp/oairevsp@org.usp.br||revsp1@usp.br1518-87870034-8910opendoar:2020-03-24T20:14:27Revista de Saúde Pública - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health O caso do eculizumabe: judicialização e compras pelo Ministério da Saúde |
title |
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health |
spellingShingle |
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health Caetano, Rosângela Hemoglobinuria, Paroxysmal, drug therapy Drug Costs Orphan Drug Production, legislation & jurisprudence Health’s Judicialization Public Expenditures on Health National Drug Policy Hemoglobinúria Paroxística, tratamento farmacológico. Custos de Medicamentos Produção de Droga sem Interesse Comercial, legislação & jurisprudência Judicialização da Saúde Gastos Públicos com Saúde Política Nacional de Medicamentos |
title_short |
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health |
title_full |
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health |
title_fullStr |
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health |
title_full_unstemmed |
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health |
title_sort |
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health |
author |
Caetano, Rosângela |
author_facet |
Caetano, Rosângela Rodrigues, Paulo Henrique Almeida Corrêa, Marilena C Villela Villardi, Pedro Osorio-de-Castro, Claudia Garcia Serpa |
author_role |
author |
author2 |
Rodrigues, Paulo Henrique Almeida Corrêa, Marilena C Villela Villardi, Pedro Osorio-de-Castro, Claudia Garcia Serpa |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Caetano, Rosângela Rodrigues, Paulo Henrique Almeida Corrêa, Marilena C Villela Villardi, Pedro Osorio-de-Castro, Claudia Garcia Serpa |
dc.subject.por.fl_str_mv |
Hemoglobinuria, Paroxysmal, drug therapy Drug Costs Orphan Drug Production, legislation & jurisprudence Health’s Judicialization Public Expenditures on Health National Drug Policy Hemoglobinúria Paroxística, tratamento farmacológico. Custos de Medicamentos Produção de Droga sem Interesse Comercial, legislação & jurisprudência Judicialização da Saúde Gastos Públicos com Saúde Política Nacional de Medicamentos |
topic |
Hemoglobinuria, Paroxysmal, drug therapy Drug Costs Orphan Drug Production, legislation & jurisprudence Health’s Judicialization Public Expenditures on Health National Drug Policy Hemoglobinúria Paroxística, tratamento farmacológico. Custos de Medicamentos Produção de Droga sem Interesse Comercial, legislação & jurisprudência Judicialização da Saúde Gastos Públicos com Saúde Política Nacional de Medicamentos |
description |
OBJECTIVES: This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices. METHODS: Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis. RESULTS: All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices. CONCLUSION: Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-02-13 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.revistas.usp.br/rsp/article/view/166635 10.11606/s1518-8787.2020054001693 |
url |
https://www.revistas.usp.br/rsp/article/view/166635 |
identifier_str_mv |
10.11606/s1518-8787.2020054001693 |
dc.language.iso.fl_str_mv |
eng por |
language |
eng por |
dc.relation.none.fl_str_mv |
https://www.revistas.usp.br/rsp/article/view/166635/159336 https://www.revistas.usp.br/rsp/article/view/166635/159337 https://www.revistas.usp.br/rsp/article/view/166635/159338 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2020 Revista de Saúde Pública info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2020 Revista de Saúde Pública |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf application/xml |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Saúde Pública |
publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Saúde Pública |
dc.source.none.fl_str_mv |
Revista de Saúde Pública; Vol. 54 (2020); 22 Revista de Saúde Pública; Vol. 54 (2020); 22 Revista de Saúde Pública; v. 54 (2020); 22 1518-8787 0034-8910 reponame:Revista de Saúde Pública instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Revista de Saúde Pública |
collection |
Revista de Saúde Pública |
repository.name.fl_str_mv |
Revista de Saúde Pública - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
revsp@org.usp.br||revsp1@usp.br |
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1800221801241903104 |