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Clin Pharmacol Ther. 2014 Nov;96(5):559-71. doi: 10.1038/clpt.2014.145. Epub 2014 Jul 9.

Accelerated access to innovative medicines for patients in need.

Author information

1
Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
2
Institut national d'excellence en santé et en services sociaux, Québec, Canada.
3
European Medicines Agency, London, UK.
4
Danish Health and Medicines Authority, Copenhagen, Denmark.
5
Health Canada, Ottawa, Canada.
6
Singapore Health Sciences Authority, Singapore.
7
National Institute for Health and Care Excellence, London, UK.
8
Aetna, Hartford, Connecticut, USA.
9
Swedish Medical Products Agency, Uppsala, Sweden.
10
Center for Medical Technology Policy, Baltimore, Maryland, USA.
11
Food and Drug Administration, Silver Spring, Maryland, USA.

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.

PMID:
25006877
DOI:
10.1038/clpt.2014.145
[Indexed for MEDLINE]

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