Please use this identifier to cite or link to this item:
http://bura.brunel.ac.uk/handle/2438/12724
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Claxton, K | - |
dc.contributor.author | Palmer, S | - |
dc.contributor.author | Longworth, L | - |
dc.contributor.author | Bojke, L | - |
dc.contributor.author | Griffin, S | - |
dc.contributor.author | Soares, M | - |
dc.contributor.author | Spackman, E | - |
dc.contributor.author | Rothery, C | - |
dc.date.accessioned | 2016-06-06T12:25:41Z | - |
dc.date.available | 2016-01-01 | - |
dc.date.available | 2016-06-06T12:25:41Z | - |
dc.date.issued | 2016 | - |
dc.identifier.citation | Value in Health, (2016) | en_US |
dc.identifier.issn | 1098-3015 | - |
dc.identifier.issn | 1524-4733 | - |
dc.identifier.uri | http://www.sciencedirect.com/science/article/pii/S1098301516302893 | - |
dc.identifier.uri | http://bura.brunel.ac.uk/handle/2438/12724 | - |
dc.description.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. | en_US |
dc.description.sponsorship | The Medical Research Council and the National Institute for Health Research Health Technology Assessment (NIHR HTA) program (project no. 06/90/99). | en_US |
dc.language.iso | en | en_US |
dc.publisher | Elsevier | en_US |
dc.subject | Cost-effectiveness | en_US |
dc.subject | Coverage with evidence development | en_US |
dc.subject | Health technology assessment | en_US |
dc.subject | Only in research | en_US |
dc.title | A comprehensive algorithm for approval of health technologies with, without, or only in research: The key principles for informing coverage decisions | en_US |
dc.type | Article | en_US |
dc.identifier.doi | http://dx.doi.org/10.1016/j.jval.2016.03.2003 | - |
dc.relation.isPartOf | Value in Health | - |
pubs.publication-status | Accepted | - |
Appears in Collections: | Health Economics Research Group (HERG) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
Fulltext.pdf | 2.24 MB | Adobe PDF | View/Open |
Items in BURA are protected by copyright, with all rights reserved, unless otherwise indicated.