Report by Charles River Associates: use of managed entry agreements for products with a conditional or exceptional authorisations

The European Federation of Pharmaceutical Industries and Associations (EFPIA) asked Charles River Associates (CRA) to undertake an interview programme to understand how managed entry agreements (MEA) have been used for products with Conditional Marketing Authorisations or Market Authorisations under exceptional circumstances as a proxy for Medicines Adaptive Pathways to Patients (MAPPs).

The aim of this research was to gather the perspective of manufacturers on the use of MEAs in the context of MAPPs. A parallel process was used to gather the input of HTA bodies and payers. To ensure consistency with the parallel projects, a steering group was set up with both EFPIA and NICE. Interview guides were developed for companies and payers based on a similar set of topics; the HTA/payers part of the project will also be published on this website in due course.The views expressed herein are the views and opinions of the authors and do not necessarily reflect or represent the views of the ADAPT SMART consortium or its members.

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