THE IMPACT OF JUDICIALIZATION OF ECULIZUMAB ON THE BUDGET OF BRAZILIAN HEALTH SYSTEM

Author(s)

Simabuku EM1, Beutel JO1, Souza KM1, Biella Cd2, Rabelo RB3, Brito AF1
1Brazilian Ministry of Health, Brasilia, Brazil, 2Brazilian Ministry of Health, Brasília, Brazil, 3Department of Management and Incorporation of Health Technology, National Committee for Health Technology Incorporation (CONITEC), Brazilian Ministry of Health, Brasília, Brazil

OBJECTIVES: Identify the profile of plaintiffs in lawsuits, which obliged the Brazilian Ministry of Health (MoH) to target part of his budget to buy eculizumab, the most expensive drug requested by judicial proceeding from 2010-2016. METHODS: This is a cross-sectional descriptive study using as input data the information available in MoH management reports. RESULTS: eculizumab is used to treat the atypical hemolytic-uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH). Licensed in FDA and EMA since 2007, only recently the manufacturing company requested its license In Brazil. From 2010-2016, judicial decisions obliged the MoH to import the drug at high prices. In the period under review, we identified 514 lawsuits, of which 376 (73 percent) in the Federal District, 46 (9 percent) in the State of São Paulo, and the remainder from several other Brazilian states. It was found that a single law firm filed 361 lawsuits, representing 70 percent of the total. In 27.13 percent of the cases, there was no doctor's name. 32.4 percent of the prescriptions originated from private doctors and 31.2 percent from the Brazilian Public Health System (SUS). Eculizumab was registered at the Brazilian regulatory agency only in March 2017, and got the pricing by the Drug Market Regulation Chamber (CMED) in October 2017, allowing its commercialization. The approved price per 1 vial of 30ml was BRL 17,060 (USD 5,278), an annual treatment cost of up to BRL 1.8 million (USD 570,032) per patient. However, its incorporation into SUS has not yet been requested to the National Committee for Health Technology Incorporation (CONITEC). CONCLUSIONS: For years the commercial strategy was judicialization. There was no interest in licensing eculizumab in Brazil, since the acquisition by judicial proceedings was more lucrative, despite promoting the litigation and irrational prescription of drug and jeopardizes the public budget.

Conference/Value in Health Info

2018-05, ISPOR 2018, Baltimore, MD, USA

Value in Health, Vol. 21, S1 (May 2018)

Code

PSY32

Topic

Economic Evaluation

Topic Subcategory

Budget Impact Analysis

Disease

Rare and Orphan Diseases

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