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Frontiers in pharmacology · Jan 2018
Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe.
- Jacoline C Bouvy, Claudine Sapede, and Sarah Garner.
- Science Policy and Research Programme, National Institute for Health and Care Excellence, London, United Kingdom.
- Front Pharmacol. 2018 Jan 1; 9: 280.
AbstractAs 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.
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