Abstract
ObjectivesTo determine the accuracy of pharmaceutical companies' predictions of drug licensing timeframes for their products in late stage clinical development.MethodsWe compared predicted licensing dates provided to the National Institute for Health Research Horizon Scanning Research and Intelligence Centre by pharmaceutical companies against actual marketing authorisation application (MAA) and marketing authorisation (MA) dates published by the European Medicines Agency for drugs granted authorisation between 2009 and 2013.Key findingsOne hundred and twenty‐three drugs met our inclusion criteria. About 78% were new drugs and 16% had orphan designation. Less than half (44%) and less than a quarter (24%) of MAA and MA predictions respectively were considered accurate (same month or 1 month either side of the actual date). Pharmaceutical companies were significantly more accurate in predicting MAA dates than MA dates (P < 0.001). For accurate predictions, the mean duration between the prediction being made and the actual MAA and MA dates were 17.5 and 18.7 months respectively. Out of the total 108 MA predictions, almost two‐thirds (65.4%, 16/26) of short‐term predictions (made in the 2 years prior to the actual MA) were accurate. For predicted dates that were earlier than the actual MA date, there was a positive relationship between accuracy and the time between the prediction and authorisation.ConclusionsEven in predicting near events from well‐informed sources, accuracy is imperfect. There appears to be an optimum time for the provision of accurate information on predicted MAA and MA dates for drugs. This information is crucial for effective early awareness and alert activities.
Highlights
New drugs and new indications for existing licensed drugs have the potential to bring about important change in medical practice leading to benefits for patients, clinicians and health services
One hundred and ninety-four new drugs and new indications for existing licensed drugs were awarded marketing authorisation (MA) by the European Medicines Agency (EMA) in the 5-year study period between 2009 and 2013, of which 123 (63.4%) had a company prediction of the likely marketing authorisation application (MAA) and/or MA date recorded in the National Institute for Health Research (NIHR) HSRIC information system
More than three quarters of the drugs included in the analysis were new drugs (78.3%) rather than new indications for existing licensed drugs, and the majority did not have an orphan designation (84.0%)
Summary
New drugs and new indications for existing licensed drugs have the potential to bring about important change in medical practice leading to benefits for patients, clinicians and health services. They can improve the quality of patients’ lives through improved management of disease, enable patients to remain in their homes rather than in hospitals, simplify treatment schedules, and allow clinicians to treat patients more effectively and efficiently.[1] They can, confer net harm if they displace more cost-effective treatments. Before a drug can be marketed for a specific indication, it undergoes a process of licensing by the applicable medicines regulator, which issues marketing authorisation (MA). In the UK, two regulators perform this function, the European Medicines Agency (EMA), which aims to streamline the licensing process and ensure a homogeneous regulatory policy throughout the European Union, and the UK Medicines and Healthcare Products Regulatory Agency
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