How innovative are new drugs launched in the UK? A retrospective study of new drugs listed in the British National Formulary (BNF) 2001–2012

Abstract

ObjectivesInnovative new drugs offer potential benefits to patients, healthcare systems, governments and the pharmaceutical industry. Recent data suggest annual numbers of new drugs launched in the UK have increased in recent years, and we sought to understand whether this represents increasing numbers of highly innovative drugs being made available or the introduction of increasing numbers of drugs with limited additional therapeutic value.Design and settingRetrospective observational study of new drug entries in the British National Formulary (BNF).Primary and secondary outcome measuresNumber of new drugs launched in the UK each year (based on first appearance in the BNF) from 2001 to 2012, including new chemical entities and new biological drugs, categorised by degree of innovativeness according to published criteria that incorporate both clinical usefulness and the nature of the innovation.ResultsHighly innovative, moderately innovative and slightly innovative drugs made up 26%, 18% and 56% of all newly launched drugs, respectively, for the study period (n=290). There was an upward trend in annual numbers of slightly innovative drugs from 2004 onwards (R2=0.44), which aligned closely with the recovery in total numbers of new drugs launched each year since that time. There were no discernible time trends in the highly or moderately innovative categories. New drugs for malignancy and skin disease were most likely to be characterised as highly innovative (44% and 57%, respectively).ConclusionsHighly innovative new drugs comprise only around a quarter of all new drug launches in the UK. In contrast, drugs categorised as only slightly innovative comprised well over half of all new drugs and annual numbers in this category are increasing. Current policy initiatives that seek to increase the supply of innovative new drugs have long-lead times to impact, and will need careful assessment to ensure they deliver their aims without unintended consequences.

Análise de medicamentos novos registrados no Brasil na perspectiva do Sistema Único de Saúde e da carga de doença

“…This study analyzes innovation in the perspective of the therapeutic value measurement. The number of drugs with important and moderate innovation, launched in 2003-2013 Brazil, was not high, and the same happened for the first in class, reflecting the international declining trend in the launch of innovative medicines identified in the UK, Canada, USA and other countries 6,48 . Among the first in class, a larger number of moderate and pharmacological innovations was found compared to important innovations, which highlights the relevance of employing broader concepts and not considering just the chemical innovation to define the clinical benefit of a drug 6,7 .…”

“…This controversy arises because different methods of defining pharmaceutical innovation are used 1,6,7,48 . A systematic review with the objective of identifying the methods used in determining pharmaceutical innovation trends developed a taxonomy of the strategies employed in the studies.…”

“…• New drug: drug registered by the drug regulatory agency, corresponding to a new molecular entity or new active ingredient of synthetic, semi-synthetic or biological nature, registered for the first time in the country 6,27 .…”

“…Transnational corporations invest considerable resources in scientific drug production due to the high value of innovative medicines and the marketing monopoly guaranteed by patents 5 . For public health, the importance of a new drug is in the therapeutic value and the benefit that it provides for the patient and for society in terms of years of life saved and improved quality of life 6,7 . The therapeutic value should be considered in a broader dimension that goes beyond chemical innovation, based on a wider view of clinical benefit 6 .…”

“…For public health, the importance of a new drug is in the therapeutic value and the benefit that it provides for the patient and for society in terms of years of life saved and improved quality of life 6,7 . The therapeutic value should be considered in a broader dimension that goes beyond chemical innovation, based on a wider view of clinical benefit 6 . The benefit of a drug includes its ability to improve population health.…”