[PHP31] Gap Between Payers And Regulators Management Of Risk Prevents And Delays Patient Access To New Therapy
2014 Value in health
Zard, J. | Kornfeld, A. | Remuzat, C. | Toumi, M. |
payers, Risk, therapy,
Recent decision suggested that regulatory bodies, especially European Medicines Agency (EMA), might be more open to risk management, while payers, show high risk aversion, especially with drug prices increasing. The objective of the project was to document the potential antagonism between regulators and payers in Europe, illustrated by specific examples of market access decisions.