Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities. Issue 6 (17th October 2016)

• Record Type: Journal Article
• Authors: Bouvy, JC; Jonsson, P; Longson, C; Crabb, N; Garner, S
• Is Part Of: Clinical pharmacology & therapeutics. Volume 100:Issue 6(2016:Dec.)
• Page Start: 594
• Page End: 597
• Publication Date: 2016-10-17
• Subjects: Pharmacology -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1002/cpt.448
• Languages: English
• ISSNs: 0009-9236

Abstract

Abstract : 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 .