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http://bura.brunel.ac.uk/handle/2438/12724
Title: | A comprehensive algorithm for approval of health technologies with, without, or only in research: The key principles for informing coverage decisions |
Authors: | Claxton, K Palmer, S Longworth, L Bojke, L Griffin, S Soares, M Spackman, E Rothery, C |
Keywords: | Cost-effectiveness;Coverage with evidence development;Health technology assessment;Only in research |
Issue Date: | 2016 |
Publisher: | Elsevier |
Citation: | Value in Health, (2016) |
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. |
URI: | http://www.sciencedirect.com/science/article/pii/S1098301516302893 http://bura.brunel.ac.uk/handle/2438/12724 |
DOI: | http://dx.doi.org/10.1016/j.jval.2016.03.2003 |
ISSN: | 1098-3015 1524-4733 |
Appears in Collections: | Health Economics Research Group (HERG) |
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