AUTHOR=Bouvy Jacoline C. , Sapede Claudine , Garner Sarah 

TITLE=Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 9 - 2018

YEAR=2018

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2018.00280

DOI=10.3389/fphar.2018.00280

ISSN=1663-9812

ABSTRACT=- As per the EMA definition, adaptive pathways is a scientific concept ftor the development of medicines which seeks to facilitate, through a  patient access to promising medicines addressing high unmet need through a prospectively planned approach planned approach patient access to promising products addressing high unmet medical need in Europe in a sustainable way. 
- This review reports the findings of activities undertaken by the ADAPT-SMART consortium to identify enablers and explore the suitability of managed entry agreements for adaptive pathways products in Europe.
- We found that during 2006-2016 outcomes-based managed entry agreements were not commonly used for products with a conditional marketing authorisation or authorised under exceptional circumstances. 
- The barriers and enablers to develop workable managed entry agreements models for adaptive