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Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle

Taylor, R.S., Drummond, M.F., Salkeld, G. and Sullivan, S.D. (2004) Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle. BMJ, 329 (7472). pp. 972-975. ISSN 0959-8146

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[INTRODUCTION] Licensing is the main method of regulating and controlling access to pharmaceuticals. New drugs cannot receive a product licence until manufacturers provide evidence of their quality, safety, and efficacy. In a world of rapidly escalating global healthcare costs, evidence of a drug's quality, safety, and efficacy is no longer sufficient to ensure reimbursement for use in public markets. Increasingly, new drugs must show evidence of cost effectiveness. In other words, does the drug produce a useful health gain (over and above currently available treatments) for its additional cost? In industry circles this value for money requirement has become known as the fourth hurdle. In this article, we examine the international development of fourth hurdle policies, analyse their effect, and identify some of the future challenges and likely directions.

Item Type: Article
Institution: The University of York
Academic Units: The University of York > Centre for Health Economics (York)
Depositing User: Repository Officer
Date Deposited: 14 Nov 2008 18:14
Last Modified: 14 Nov 2008 18:19
Published Version: http://dx.doi.org/10.1136/bmj.329.7472.972
Status: Published
Publisher: BMJ Publishing
Refereed: Yes
Identification Number: 10.1136/bmj.329.7472.972
URI: http://eprints.whiterose.ac.uk/id/eprint/4853

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