Match!

Accuracy of pharmaceutical company licensing predictions: projected versus actual licensing dates

Published on Jun 1, 2016in Journal of Pharmaceutical Health Services Research
· DOI :10.1111/jphs.12132
Lucy Doos7
Estimated H-index: 7
(University of Birmingham),
Derek J. Ward8
Estimated H-index: 8
(University of Birmingham)
+ 1 AuthorsClaire Packer12
Estimated H-index: 12
(University of Birmingham)
Sources
Abstract
Objectives To determine the accuracy of pharmaceutical companies' predictions of drug licensing timeframes for their products in late stage clinical development. Methods We 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 findings One 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. Conclusions Even 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.
Figures & Tables
  • References (14)
  • Citations (0)
References14
Newest
#1Jeffrey C. Lerner (ECRI Institute)H-Index: 3
#2Diane C. Robertson (ECRI Institute)H-Index: 2
Last. Sara M. Goldstein (ECRI Institute)H-Index: 1
view all 3 authors...
Health technology forecasting is designed to provide reliable predictions about costs, utilization, diffusion, and other market realities before the technologies enter routine clinical use. In this article we address three questions central to forecasting’s usefulness: Are early forecasts sufficiently accurate to help providers acquire the most promising technology and payers to set effective coverage policies? What variables contribute to inaccurate forecasts? How can forecasters manage the var...
8 CitationsSource
8 CitationsSource
Objectives: Early awareness and alert (EAA) activities are increasingly recognized to be an important component of the health technology assessment (HTA) process. Sharing information on methods used in this discipline is vital to ensure the development of sustainable systems. The objectives of this study is to outline the approach taken to share the different methods that members of the EuroScan International Network use by producing a methods toolkit; and to provide an overview of the similarit...
14 CitationsSource
#1Claire Packer (University of Birmingham)H-Index: 12
Last. Sue Simpson (University of Birmingham)H-Index: 13
view all 3 authors...
In this theme section on early awareness and alert (EAA) systems and activities, we are pleased to present a series of articles covering the structure of EAA systems, their development and integration into decision making for the adoption and use of new and emerging health technologies, and the methods used by current networks, systems, and organizations.
6 CitationsSource
#1Claire Packer (University of Birmingham)H-Index: 12
#2Matthew Fung (University of Birmingham)H-Index: 3
Last. Andrew Stevens (University of Birmingham)H-Index: 30
view all 3 authors...
Objectives: The aim of this study was to assess the accuracy of the English National Horizon Scanning Centre (NHSC) in identifying and filtering pharmaceutical developments using end user and international collaborator databases of emerging technologies as proxies for new drugs of likely significance to health services and/or patients. Methods: We used the NHSC information system and the list of National Institute for Health and Clinical Excellence (NICE) technology appraisals to estimate the fa...
15 CitationsSource
#1Anna NachtnebelH-Index: 5
Last. Claudia WildH-Index: 16
view all 4 authors...
Abstract Background Due to increasing expenditures for cancer therapies, an instrument was needed in Austria to facilitate the evidence-based use of new anticancer drugs and to pre-estimate their financial implications. Objectives To describe and analyse the development and implementation of a Horizon Scanning System (HSS) in Austria that allows for the evaluation of new anticancer drugs before their routine introduction into clinical practice in order to inform decision-makers. Methods Common s...
13 CitationsSource
#1Claudia Canongia (UFRJ: Federal University of Rio de Janeiro)H-Index: 3
#2Adelaide Maria de Souza Antunes (UFRJ: Federal University of Rio de Janeiro)H-Index: 9
Last. Maria de Nazaré Freitas Pereira (UFRJ: Federal University of Rio de Janeiro)H-Index: 2
view all 3 authors...
Abstract The aim of the study is to demonstrate knowledge and information management as a mechanism for developing technological foresight regarding the use of biotechnology in drugs for breast cancer. The methodology applies competitive intelligence (CI) tools to identify international trends concerning drugs for treatment and/or diagnosis, and to identify leading institutions. The study was performed by collecting, treating and analyzing information extracted from specialized databases and pat...
19 CitationsSource
#1James Kalamas (McKinsey & Company)H-Index: 2
#2Gary Pinkus (McKinsey & Company)H-Index: 2
12 CitationsSource
#1Bernard S. Bloom (UPenn: University of Pennsylvania)H-Index: 31
#2Nathalie de Pouvourville (University of Paris)H-Index: 2
Last. A. Mark Fendrick (UM: University of Michigan)H-Index: 49
view all 4 authors...
Abstract Objective : To compare five-year predictions made in 1992 by academic surgeon leaders in UK, US and Canada, with actual experiences in 1997, of increased rates of minimal invasive therapy (MIT) for surgical operations. Method : We compared 1992 predictions of percent of operations done by minimal invasive therapy and length of stay in the US with actual 1997 percents found by literature searches. Results : We found sufficient data on 12 operations done by MIT in 1997 of the original 34 ...
5 CitationsSource
#1Andrew Stevens (University of Birmingham)H-Index: 30
#2Ruairidh MilneH-Index: 27
Last. John GabbayH-Index: 24
view all 4 authors...
Of the three major pressures on health services worldwide—changing demography, growing expectations, and new healthcare interventions (technologies) —the last is generating the most concern and the most dramatic responses. New healthcare technologies are becoming more numerous, more expensive, and possibly more effective than ever before. About 50 new drugs are launched each year, and the number of new devices, procedures, and ways of providing care is growing all the time. #### Summary points N...
23 CitationsSource
Cited By0
Newest