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.
Highlights
No consensus was reached regarding defining what constitutes pharmaceutical innovation 1
Thirty-three out of 236 drugs assessed by Brazilian Chamber of Drug Market Regulation (CMED) were rated as therapeutic innovations (Table 1)
Eleven (4.3%) drugs were considered innovative by Prescrire but not by the Brazilian Chamber, whereas another 24 (9.5%) drugs were considered innovative by the CMED and non-innovative by Prescrire
Summary
No consensus was reached regarding defining what constitutes pharmaceutical innovation 1. It is currently accepted that a new compound must have a clinically relevant advantage when compared head-to-head with existing established therapies to be considered innovative [7,8]; such as showing better population indicators for morbidity, mortality and quality of life. This notion of therapeutic advance can be useful to recognize and reward medicine manufacturers that develop products with a high therapeutic value and, to encourage and sustain the innovation [2,9] that meets patients’ needs [10,11]. Therapeutic advance is identified when a the superiority of a drug is shown in methodologically robust studies, using active comparators and hard clinically relevant outcomes [16,18]
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