Accuracy of drug company licensing predictions- projected vs actual licensing dates

Background: Providing timely information on new drugs is crucial to enable decision-makers to plan future allocation of resources and facilitate appropriate adoption. The optimal timing for the provision of information depends on the accuracy of predictions of launch in the health system. Objectives: To determine how accurate pharmaceutical companies are in predicting drug licensing timeframes for their products in late stage clinical development. Methods: A cross sectional study comparing predicted licensing dates obtained from the English NIHR Horizon Scanning Centre (HSC) contact with pharmaceutical companies against actual market authorisation application (MAA) and authorisation (MA) dates published by the European Medicines Agency (EMA) for all MAs (separate drug-indications) granted between 2009 and 2013 (inclusive). Data on generic drugs, biosimilars, blood products and vaccines were excluded. Predictions were defined as accurate if within 1½ months of the subsequent actual date. Results: 194 separate drug-indications met our inclusion criteria, of which 78% were new drugs and 16% had orphan designations. Pharmaceutical companies were significantly more accurate in predicting MAA dates (44%) than MA dates (24%) (p<0.001).There were no statistically significant differences in the accuracy of predictions by drug type. For predictions that were earlier than the actual MA date, there was an inverse relationship between the accuracy of prediction and the length of time from the pharmaceutical company making the prediction to the actual authorisation date (χ2=0.71, p<0.0001). For predictions that were accurate, the mean duration between the prediction being made and actual MAA and MA dates was 17.5 and 18.7 months respectively. Conclusion: We have demonstrated that there is an optimum time for the provision of accurate information on predicted dates of MAA and MA for pharmaceuticals. This information is crucial for effective early awareness and alert activities and demonstrates the inherent difficulties horizon scanning for future licensing timeframes. References: -European Medicine Agency. Available on http://www.ema.europa.eu/ema/ (Accessed May 2014).