Abstract:
Aim: The main purpose of this study was to identify each sequential phase followed by an oncology product, from European assessment until to patient access in each Italian region (IR). Methods: A panel of oncology products approved by the European Medicines Agency (EMA) in the period 2006–2008 was considered. The explored sequential phases included the times to market for: the EMA; pharmaceutical companies; the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA); and IRs as final providers of health care. The IR’s time to market was also analyzed by a Cox regression model. Results: The overall mean time required before patients access was 2.3 years. EMA accounted for the greater proportion of time (31.8%), followed by AIFA (28.2%). However, the duration for both pharmaceutical companies and IRs was associated with the highest variability. An oncology product authorized with a risk-sharing agreement showed an early access in the IRs. On the contrary, the introduction in IRs having a compulsory formulary was delayed. Both a high forecast of economic impact and a high oncology product price can also delay the patient access. Conclusion: The process before patient access to an oncology product is time and cost consuming. This study identifies the main predictors that affect the missing overlap between market and patient access in Italy.

Brief Biography of the Speaker:
Prof. Francesco Saverio Mennini, is presently Professor for Health Economics and Political Economics at University of Rome "Tor Vergata” (both at the Faculty of Economics and Science). He is also Professor for Health Economics at University of Rome "La Sapienza”, Faculty of Statistics. Formerly, he has led a career as a researcher in the field of Health Economics and Industrial Economics, at the University of Rome "Tor Vergata” and the National Research Council. His main contributions have dealt with welfare policies, health system analysis, health technology assessment and pharmaco-economics, and pharmaceutical economics. Prof. Mennini has been the scientific coordinator of the Master in Health Economics at University of Rome "Tor Vergata for several years; he has been a scientific coordinator and member of the Regional Observatory for the HTA, from 2003 to 2006. Prof. Mennini is the chair of the Scientific Committee of the European Conference on Health Economics (ECHE). Prof. Mennini is author of numerous publications, national and international, of Health economics and Economic Evaluation.