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Towards a coordinated approach for managing accelerated patient access to potentially beneficial medicines: reporting the perspectives of a multi-stakeholder, international workshop

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dc.contributor.authorPhillips, M.
dc.contributor.authorSynnott, P.
dc.contributor.authorHenshall, C.
dc.contributor.authorTunis, S.
dc.contributor.authorSansom, L.
dc.contributor.authorOllendorf, D.
dc.date.issued2024
dc.descriptionData source: Supplementary materia, http://academic.oup.com/haschl/article-lookup/doi/10.1093/haschl/qxae069#supplementary-data
dc.description.abstractAccelerated and conditional regulatory pathways for drug approvals are intended to enable earlier patient access to potentially life-saving treatments, or treatments that provide benefits in addressing a significant unmet need. However, there are questions about how well such pathways work, how appropriately they are applied, and how the work of regulators can be better coordinated with that of health technology assessment (HTA) and payer bodies, providers and health systems, and other stakeholders. In June 2023, a multi-stakeholder, international workshop was convened in Adelaide, Australia, to deliberate the challenges, goals, and opportunities to improve accelerated access pathways. Workshop attendees included representatives from patient organizations, regulators, HTA/payer bodies, universities (ethicists, health economists), and companies developing and marketing new medicines from Australia, Asia, Europe, and North America. We reviewed the contents of this workshop to identify areas of agreement and disagreement, report the key themes of the discussion, and delineate next steps for improving accelerated access pathways. We found that there was general agreement among workshop attendees that accelerated access could be improved significantly by strengthening processes for stakeholder coordination, and that coordinated efforts will be required to implement meaningful change moving forward.
dc.identifier.citationHealth Affairs Scholar, 2024; 2(6, article no. qxae069):1-9
dc.identifier.doi10.1093/haschl/qxae069
dc.identifier.issn2976-5390
dc.identifier.issn2976-5390
dc.identifier.urihttps://hdl.handle.net/11541.2/41565
dc.language.isoen
dc.publisherOxford University Press
dc.relation.fundingAMGE
dc.relation.fundingCenter for the Evaluation of Value and Risk in Health at Tufts Medical Center
dc.relation.fundingAMGEN
dc.relation.fundingAstraZeneca
dc.relation.fundingJohnson Johnson
dc.relation.fundingSharp Dohme
dc.rightsCopyright 2024 The Author(s). Published by Oxford University Press on behalf of Project HOPE - The People-To-People Health Foundation, Inc. This is an Open Access article distributed under the terms of the Creative Commons Attribution License. (https://creativecommons.org/licenses/by/4.0/)
dc.source.urihttps://doi.org/10.1093/haschl/qxae069
dc.subjectaccelerated approvals
dc.subjectexpedited approvals
dc.subjectfda
dc.subjectema
dc.subjecthealth technology assessment
dc.titleTowards a coordinated approach for managing accelerated patient access to potentially beneficial medicines: reporting the perspectives of a multi-stakeholder, international workshop
dc.typeJournal article
pubs.publication-statusPublished
ror.fileinfo12297905100001831 13297915060001831 Open Access Published Version
ror.mmsid9916939742001831

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