Why licensing authorities need to consider the net value of new drugs in assigning review priorities: Addressing the tension between licensing and reimbursement

McCabe, Christopher, Claxton, Karl and O'Hagan, Anthony (2008) Why licensing authorities need to consider the net value of new drugs in assigning review priorities: Addressing the tension between licensing and reimbursement. International Journal of Technology Assessment in Health Care. pp. 140-145. ISSN 0266-4623

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Abstract

Pharmaceutical regulators and healthcare reimbursement authorities operate in different intellectual paradigms and adopt very different decision rules. As a result, drugs that have been licensed are often not available to all patients who could benefit because reimbursement authorities judge that the cost of therapies is greater than the health produced. This finding creates uncertainty for pharmaceutical companies planning their research and development investment, as licensing is no longer a guarantee of market access. In this study, we propose that it would be consistent with the objectives of pharmaceutical regulators to use the Net Benefit Framework of reimbursement authorities to identify those therapies that should be subject to priority review, that it is feasible to do so and that this would have several positive effects for patients, industry, and healthcare systems.

Item Type:	Article
Copyright, Publisher and Additional Information:	Copyright © Cambridge University Press 2007. This is an author produced version of a paper published in International Journal of Technology Assessment in Health Care. Uploaded in accordance with the publisher's self-archiving policy.
Keywords:	public health, licensing, cost effectiveness analysis, reimbursement
Academic Units:	The University of York > Economics and Related Studies (York)
Depositing User:	Mrs JM Wright
Date Deposited:	25 Jul 2008 10:14
Last Modified:	01 May 2013 23:04
Published Version:	http://dx.doi.org/10.1017/S0266462308080197
Status:	Published
Refereed:	Yes
Related URLs:	http://www.leeds.ac.uk/lihs/auhe/ http://dx.doi.org/10.1017/S0266462308080...
URI:	http://eprints.whiterose.ac.uk/id/eprint/3956

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