Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities

Eric NormanAdaptive Licensing, Articles

Clinical Pharmacology & Therapeutics, December 1, 2016
C. Bouvy, P. Jonsson, C. Longson, N. Crabb, and S. Garner

Adaptive pathways for medicines have gained momentum and, in Europe, adaptive pathways have recently been introduced into the European Medicines Agency (EMA) processes after a successful 2-year pilot. Although the concept, as initially proposed, contained several elements that would have required regulatory reforms, the adaptive pathways program has developed a more pragmatic scope (Box 1). In this article, we explore the main challenges and opportunities adaptive pathways pose from a European health technology assessment (HTA) perspective.

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