Evidence map›Paper›PMID 32130309›Full record

ArticleRevista de saude publica2020

The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health.

Rosângela Caetano, Paulo Henrique Almeida Rodrigues, Marilena C Villela Corrêa, Pedro Villardi, Claudia Garcia Serpa Osorio-de-Castro

Open access · goldAbstract read
In one paragraph

Article in Revista de saude publica, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Rosângela CaetanoUniversidade do Estado do Rio de Janeiro. Instituto de Medicina Social. Departamento de Política, Planejamento e Administração em Saúde. Rio de Janeiro,RJ, Brasil.ORCID http://orcid.org/0000-0003-1480-2453
Paulo Henrique Almeida RodriguesUniversidade do Estado do Rio de Janeiro. Instituto de Medicina Social. Departamento de Política, Planejamento e Administração em Saúde. Rio de Janeiro,RJ, Brasil.ORCID http://orcid.org/0000-0002-3159-6711
Marilena C Villela CorrêaUniversidade do Estado do Rio de Janeiro. Instituto de Medicina Social. Departamento de Políticas e Instituições de Saúde. Rio de Janeiro, RJ, Brasil.ORCID http://orcid.org/0000-0003-1742-8639
Pedro VillardiUniversidade do Estado do Rio de Janeiro. Instituto de Medicina Social. Departamento de Políticas e Instituições de Saúde. Rio de Janeiro, RJ, Brasil.ORCID http://orcid.org/0000-0001-7788-6055
Claudia Garcia Serpa Osorio-de-CastroFundação Oswaldo Cruz, Escola Nacional de Saúde Pública Sergio Arouca. Departamento de Política de Medicamentos e Assistência Farmacêutica. Rio de Janeiro, RJ, Brasil.ORCID http://orcid.org/0000-0003-4875-7216
Universidade do Estado do Rio de Janeiro · BREscola Nacional de Saúde Pública · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis 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.

methodsEculizumab 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.

resultsAll 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.

conclusionEculizumab 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.

Indexed as

Federal GovernmentHealth ExpendituresAntibodies, Monoclonal, HumanizedBrazilComplement Inactivating AgentsDrug and Narcotic ControlGovernment AgenciesHumansAntibodies, Monoclonal, HumanizedComplement Inactivating Agentseculizumab

Identifiers

PMID32130309
PMCPMC7017980
OpenAlexW3006081591

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.