Claxton, Karl orcid.org/0000-0003-2002-4694, Palmer, Stephen orcid.org/0000-0002-7268-2560, Longworth, Louise et al. (5 more authors) (2016) A Comprehensive Algorithm for Approval of Health Technologies With, Without, or Only in Research:The Key Principles for Informing Coverage Decisions. Value in Health. pp. 885-891. ISSN 1524-4733
Abstract
BACKGROUND: The value of evidence about the performance of a technology and the value of access to a technology are central to policy decisions regarding coverage with, without, or only in research and managed entry (or risk-sharing) agreements. OBJECTIVES: We aim to outline the key principles of what assessments are needed to inform "only in research" (OIR) or "approval with research" (AWR) recommendations, in addition to approval or rejection. METHODS: We developed a comprehensive algorithm to inform the sequence of assessments and judgments that lead to different types of guidance: OIR, AWR, Approve, or Reject. This algorithm identifies the order in which assessments might be made, how similar guidance might be arrived at through different combinations of considerations, and when guidance might change. RESULTS: The key principles are whether the technology is expected to be cost-effective; whether the technology has significant irrecoverable costs; whether additional research is needed; whether research is possible with approval and whether there are opportunity costs that once committed by approval cannot be recovered; and whether there are effective price reductions. Determining expected cost-effectiveness is only a first step. In addition to AWR for technologies expected to be cost-effective and OIR for those not expected to be cost-effective, there are other important circumstances when OIR should be considered. CONCLUSIONS: These principles demonstrate that cost-effectiveness is a necessary but not sufficient condition for approval. Even when research is possible with approval, OIR may be appropriate when a technology is expected to be cost-effective due to significant irrecoverable costs.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details. |
Keywords: | cost-effectiveness,coverage with evidence development,health technology assessment,only in research |
Dates: |
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Institution: | The University of York |
Academic Units: | The University of York > Faculty of Social Sciences (York) > Economics and Related Studies (York) The University of York > Faculty of Social Sciences (York) > Centre for Health Economics (York) |
Depositing User: | Pure (York) |
Date Deposited: | 17 May 2016 16:00 |
Last Modified: | 16 Oct 2024 12:55 |
Published Version: | https://doi.org/10.1016/j.jval.2016.03.2003 |
Status: | Published |
Refereed: | Yes |
Identification Number: | 10.1016/j.jval.2016.03.2003 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:99851 |