Added therapeutic value of new drugs approved in Brazil from 2004 to 2016
Bibliographic Data
| ID | 5166146 |
|---|---|
| Authors | Rogério Hoefler (0000-0003-3851-7833, Universidade de Brasília, Brazil; Conselho Federal de Farmácia, Brasil), Teresa Leonardo Alves (0000-0003-4967-1916, Utrecht Institute for Pharmaceutical Sciences, Netherlands), Hubert G Leufkens (0000-0002-7175-1499, Utrecht Institute for Pharmaceutical Sciences, Netherlands), Janeth De Oliveira Silva Naves (0000-0003-4793-2836, Universidade de Brasília) |
| Year | 2019 |
| Volume | 35 |
| Issue | 5 |
| Pages | e00070018-e00070018 |
| Publication date | 2019-01-01 |
| Peer Reviewed | Yes |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Cadernos de Saude Publica (JOURNAL) |
| Journal identifiers | ISSN: 0102-311X • E-ISSN: 1678-4464 |
| Publisher | FapUNIFESP (SciELO) (PUBLISHER) |
| DOI | 10.1590/0102-311x00070018 |
| PMID | 31141027 |
| OpenAlex | W2946564743 |
| SCIELO_PID | S0102-311X2019000605006 |
| Language | EN |
| Citations received | 4 |
| References cited | 18 |
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
Alternative medicine · Approved drug · Disease · Drug · Environmental health · Family medicine · Government (linguistics) · Pathology · Public health · Traditional medicine · Health Systems, Economic Evaluations, Quality of Life · Internal Medicine · Medicine · Pharmaceutical Economics and Policy · Pharmaceutical industry and healthcare · Pharmacology
| Unique citing works | 4 |
|---|---|
| Citations per year | 1 |
| Citation span | 2022 - 2025 (4) |
| Citation velocity | recent |
| Highly cited | No |
| Citation types | Neutral: 3 |