Academic Journal
The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health ; O caso do eculizumabe: judicialização e compras pelo Ministério da Saúde
| العنوان: | The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health ; O caso do eculizumabe: judicialização e compras pelo Ministério da Saúde |
|---|---|
| المؤلفون: | Caetano, Rosângela, Rodrigues, Paulo Henrique Almeida, Corrêa, Marilena C Villela, Villardi, Pedro, Osorio-de-Castro, Claudia Garcia Serpa |
| المصدر: | Revista de Saúde Pública; Vol. 54 (2020); 22 ; Revista de Saúde Pública; v. 54 (2020); 22 ; 1518-8787 ; 0034-8910 |
| بيانات النشر: | Universidade de São Paulo. Faculdade de Saúde Pública |
| سنة النشر: | 2020 |
| المجموعة: | Universidade de São Paulo: Portal de Revistas da USP |
| مصطلحات موضوعية: | 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 |
| الوصف: | 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. ; 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf; application/xml |
| اللغة: | English Portuguese |
| Relation: | 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; https://www.revistas.usp.br/rsp/article/view/166635 |
| الاتاحة: | https://www.revistas.usp.br/rsp/article/view/166635 |
| Rights: | Copyright (c) 2020 Revista de Saúde Pública |
| رقم الانضمام: | edsbas.62BDCED4 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |