title: Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities.
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.
authors.affiliation: National Institute for Health and Care Excellence (NICE), London, England, United Kingdom.
authors.forename: J C
authors.initials: JC
authors.lastname: Bouvy
authors.affiliation: National Institute for Health and Care Excellence (NICE), London, England, United Kingdom.
authors.forename: P
authors.initials: P
authors.lastname: Jonsson
authors.affiliation: National Institute for Health and Care Excellence (NICE), London, England, United Kingdom.
authors.forename: C
authors.initials: C
authors.lastname: Longson
authors.affiliation: National Institute for Health and Care Excellence (NICE), London, England, United Kingdom.
authors.forename: N
authors.initials: N
authors.lastname: Crabb
authors.affiliation: National Institute for Health and Care Excellence (NICE), London, England, United Kingdom.
authors.forename: S
authors.initials: S
authors.lastname: Garner
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D006077:Government Agencies; D006801:Humans; D010865:Pilot Projects; D013673:Technology Assessment, Biomedical / Q000379:methods*