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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Format: | Article |
Language: | English |
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Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz
2019-05-01
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Series: | Cadernos de Saúde Pública |
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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. |
first_indexed | 2024-12-11T23:46:22Z |
format | Article |
id | doaj.art-ef92de75aa9244a791c187e1266cc660 |
institution | Directory Open Access Journal |
issn | 1678-4464 |
language | English |
last_indexed | 2024-12-11T23:46:22Z |
publishDate | 2019-05-01 |
publisher | Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz |
record_format | Article |
series | Cadernos de Saúde Pública |
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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