Added therapeutic value of new drugs approved in Brazil from 2004 to 2016

Abstract: This study aimed to assess the level of therapeutic innovation of new drugs approved in Brazil over 13 years and whether they met public health needs. Comparative descriptive analysis of therapeutic value assessments performed by the Brazilian Chamber of Drug Market Regulation (CMED) and t...

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Main Authors: Rogério Hoefler, Teresa Leonardo Alves, Hubertus G. Leufkens, Janeth de Oliveira Silva Naves
Format: Article
Language:English
Published: Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz 2019-05-01
Series:Cadernos de Saúde Pública
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2019000605006&lng=en&tlng=en
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author Rogério Hoefler
Teresa Leonardo Alves
Hubertus G. Leufkens
Janeth de Oliveira Silva Naves
author_facet Rogério Hoefler
Teresa Leonardo Alves
Hubertus G. Leufkens
Janeth de Oliveira Silva Naves
author_sort Rogério Hoefler
collection DOAJ
description Abstract: This study aimed to assess the level of therapeutic innovation of new drugs approved in Brazil over 13 years and whether they met public health needs. Comparative descriptive analysis of therapeutic value assessments performed by the Brazilian Chamber of Drug Market Regulation (CMED) and the French drug bulletin Prescrire for new drugs licensed in Brazil, from January 1st 2004 to December 31st 2016. The extent to which new drugs met public health needs was examined by: checking inclusions into government-funded drug lists and/or clinical guidelines; comparing Anatomical Therapeutic Chemical Classification (ATC) codes and drug indications with the list of conditions contributing the most to the national disease burden; and assessing new medicines aimed to treat neglected diseases. 253 new drugs were approved. Antineoplastics, immunossupressants, antidiabetics and antivirals were the most frequent. Thirty-three (14%) out of 236 drugs assessed by the Brazilian chamber and sixteen (8.2%) out of 195 assessed by the French bulletin Prescrire were considered innovative. Thirty-six drugs (14.2%) were selected for coverage by the Brazilian Unified National Health System (SUS), seven of which were therapeutically innovative, and none were aimed to treat neglected disease. About 1/3 of the drugs approved aimed to treat conditions among the top contributors to Brazil’s disease burden. Few therapeutically innovative drugs entered the Brazilian market, from which only a small proportion was approved to be covered by the SUS. Our findings suggest a divergence between public health needs, research & development (R&D) and drug licensing procedures.
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spelling doaj.art-ef92de75aa9244a791c187e1266cc6602022-12-22T00:45:37ZengEscola Nacional de Saúde Pública, Fundação Oswaldo CruzCadernos de Saúde Pública1678-44642019-05-0135510.1590/0102-311x00070018S0102-311X2019000605006Added therapeutic value of new drugs approved in Brazil from 2004 to 2016Rogério HoeflerTeresa Leonardo AlvesHubertus G. LeufkensJaneth de Oliveira Silva NavesAbstract: This study aimed to assess the level of therapeutic innovation of new drugs approved in Brazil over 13 years and whether they met public health needs. Comparative descriptive analysis of therapeutic value assessments performed by the Brazilian Chamber of Drug Market Regulation (CMED) and the French drug bulletin Prescrire for new drugs licensed in Brazil, from January 1st 2004 to December 31st 2016. The extent to which new drugs met public health needs was examined by: checking inclusions into government-funded drug lists and/or clinical guidelines; comparing Anatomical Therapeutic Chemical Classification (ATC) codes and drug indications with the list of conditions contributing the most to the national disease burden; and assessing new medicines aimed to treat neglected diseases. 253 new drugs were approved. Antineoplastics, immunossupressants, antidiabetics and antivirals were the most frequent. Thirty-three (14%) out of 236 drugs assessed by the Brazilian chamber and sixteen (8.2%) out of 195 assessed by the French bulletin Prescrire were considered innovative. Thirty-six drugs (14.2%) were selected for coverage by the Brazilian Unified National Health System (SUS), seven of which were therapeutically innovative, and none were aimed to treat neglected disease. About 1/3 of the drugs approved aimed to treat conditions among the top contributors to Brazil’s disease burden. Few therapeutically innovative drugs entered the Brazilian market, from which only a small proportion was approved to be covered by the SUS. Our findings suggest a divergence between public health needs, research & development (R&D) and drug licensing procedures.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2019000605006&lng=en&tlng=enDrug EvaluationDrug IndustryProducts RegistrationDiffusion of InnovationsHealth Technology Assessment
spellingShingle Rogério Hoefler
Teresa Leonardo Alves
Hubertus G. Leufkens
Janeth de Oliveira Silva Naves
Added therapeutic value of new drugs approved in Brazil from 2004 to 2016
Cadernos de Saúde Pública
Drug Evaluation
Drug Industry
Products Registration
Diffusion of Innovations
Health Technology Assessment
title Added therapeutic value of new drugs approved in Brazil from 2004 to 2016
title_full Added therapeutic value of new drugs approved in Brazil from 2004 to 2016
title_fullStr Added therapeutic value of new drugs approved in Brazil from 2004 to 2016
title_full_unstemmed Added therapeutic value of new drugs approved in Brazil from 2004 to 2016
title_short Added therapeutic value of new drugs approved in Brazil from 2004 to 2016
title_sort added therapeutic value of new drugs approved in brazil from 2004 to 2016
topic Drug Evaluation
Drug Industry
Products Registration
Diffusion of Innovations
Health Technology Assessment
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2019000605006&lng=en&tlng=en
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AT teresaleonardoalves addedtherapeuticvalueofnewdrugsapprovedinbrazilfrom2004to2016
AT hubertusgleufkens addedtherapeuticvalueofnewdrugsapprovedinbrazilfrom2004to2016
AT janethdeoliveirasilvanaves addedtherapeuticvalueofnewdrugsapprovedinbrazilfrom2004to2016