Bouvy Jacoline C, Sapede Claudine, Garner Sarah
Science Policy and Research Programme, National Institute for Health and Care Excellence, London, United Kingdom.
Global Pricing and Market Access, F. Hoffman-La Roche, Basel, Switzerland.
Front Pharmacol. 2018 Mar 27;9:280. doi: 10.3389/fphar.2018.00280. eCollection 2018.
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.
根据欧洲药品管理局（EMA）的定义，适应性途径是药物研发的一个科学概念，旨在通过一种前瞻性规划的方法，以可持续的方式促进患者获得有望满足未满足医疗需求的药物。本综述报告了ADAPT-SMART联盟开展的活动结果，以确定促进因素，并探讨在欧洲针对适应性途径产品的有管理的进入协议的适用性。我们发现，在2006年至2016年期间，基于结果的有管理的进入协议并不常用于有条件上市许可或在特殊情况下获批的产品。通过访谈和一个多利益相关方研讨会，讨论了为适应性途径产品开发可行的有管理的进入协议模式的障碍和促进因素，并在本文中提出了一些建议。
