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. 2018 Mar 27:9:280.
doi: 10.3389/fphar.2018.00280. eCollection 2018.

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

Jacoline C Bouvy  1 , Claudine Sapede  2 , Sarah Garner  1   2
Affiliations

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

Jacoline C Bouvy et al. Front Pharmacol. .

Abstract

As per the EMA definition, adaptive pathways is a scientific concept for the development of medicines which seeks to facilitate patient access to promising medicines addressing high unmet need through a prospectively planned approach 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 authorization or authorized under exceptional circumstances. The barriers and enablers to develop workable managed entry agreements models for adaptive pathways products were discussed through interviews and a multi-stakeholder workshop with a number of recommendations made in this paper.

Keywords: Europe; adaptive pathways; drug development; managed entry agreements; marketing authorization.

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Figures

Figure 1
Figure 1
Types of marketing authorization and adaptive pathways for medicinal products in Europe. Adaptive pathways is not a type of marketing authorization but a scientific concept for medicine development and data generation.
Figure 2
Figure 2
Managed entry agreements—Taxonomy used during the interviews.
Figure 3
Figure 3
Methods used. MEA, managed entry agreement; EUnetHTA, European network for Health Technology Assessment; AIM, The international Association of Mutual Benefit Societies; MEDEV, medicines evaluation committee; CMA, conditional marketing authorization; ECMA, Exceptional circumstances marketing authorization.
See this image and copyright information in PMC

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