title: Accelerated access to innovative medicines for patients in need.
abstract: There is broad agreement among health-care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines. Assuming that industry will continue to develop such medicines at a sustainable rate, regulators and payers become the gatekeepers. Regulators, starting in the late 1980s/early 1990s, and, more recently, payers have implemented a variety of early-access pathways or initiatives, and this practice is continuing even today. This article describes the specific approaches that have been taken in four economically developed regions, reviews their success rates, and suggests possible new directions.
authors.affiliation: Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
authors.forename: L G
authors.initials: LG
authors.lastname: Baird
authors.affiliation: Institut national d'excellence en santé et en services sociaux, Québec, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Banken
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: H-G
authors.initials: HG
authors.lastname: Eichler
authors.affiliation: Danish Health and Medicines Authority, Copenhagen, Denmark.
authors.forename: F B
authors.initials: FB
authors.lastname: Kristensen
authors.affiliation: Health Canada, Ottawa, Canada.
authors.forename: D K
authors.initials: DK
authors.lastname: Lee
authors.affiliation: Singapore Health Sciences Authority, Singapore.
authors.forename: J C W
authors.initials: JC
authors.lastname: Lim
authors.affiliation: Health Canada, Ottawa, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Lim
authors.affiliation: National Institute for Health and Care Excellence, London, UK.
authors.forename: C
authors.initials: C
authors.lastname: Longson
authors.affiliation: Aetna, Hartford, Connecticut, USA.
authors.forename: E
authors.initials: E
authors.lastname: Pezalla
authors.affiliation: Swedish Medical Products Agency, Uppsala, Sweden.
authors.forename: T
authors.initials: T
authors.lastname: Salmonson
authors.affiliation: Institut national d'excellence en santé et en services sociaux, Québec, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Samaha
authors.affiliation: Center for Medical Technology Policy, Baltimore, Maryland, USA.
authors.forename: S
authors.initials: S
authors.lastname: Tunis
authors.affiliation: Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: J
authors.initials: J
authors.lastname: Woodcock
authors.affiliation: Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
authors.forename: G
authors.initials: G
authors.lastname: Hirsch
mesh_terms: D020811:Biomedical Technology; D002170:Canada; D006297:Health Services Accessibility; D006301:Health Services Needs and Demand; D006801:Humans; D004364:Pharmaceutical Preparations / Q000600:supply & distribution*; D012051:Reimbursement Mechanisms; D012846:Singapore; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations