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A Comprehensive Algorithm for Approval of Health Technologies With, Without, or Only in Research: The Key Principles for Informing Coverage Decisions

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A Comprehensive Algorithm for Approval of Health Technologies With, Without, or Only in Research : The Key Principles for Informing Coverage Decisions. / Claxton, Karl; Palmer, Stephen; Longworth, Louise; Bojke, Laura; Griffin, Susan; Soares, Marta; Spackman, Eldon; Rothery, Claire.

In: Value in Health, Vol. 19, No. 6, 11.05.2016, p. 885-891.

Research output: Contribution to journalArticle

Harvard

Claxton, K, Palmer, S, Longworth, L, Bojke, L, Griffin, S, Soares, M, Spackman, E & Rothery, C 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, vol. 19, no. 6, pp. 885-891. https://doi.org/10.1016/j.jval.2016.03.2003

APA

Claxton, K., Palmer, S., Longworth, L., Bojke, L., Griffin, S., Soares, M., ... Rothery, C. (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, 19(6), 885-891. https://doi.org/10.1016/j.jval.2016.03.2003

Vancouver

Claxton K, Palmer S, Longworth L, Bojke L, Griffin S, Soares M et al. A Comprehensive Algorithm for Approval of Health Technologies With, Without, or Only in Research: The Key Principles for Informing Coverage Decisions. Value in Health. 2016 May 11;19(6):885-891. https://doi.org/10.1016/j.jval.2016.03.2003

Author

Claxton, Karl ; Palmer, Stephen ; Longworth, Louise ; Bojke, Laura ; Griffin, Susan ; Soares, Marta ; Spackman, Eldon ; Rothery, Claire. / A Comprehensive Algorithm for Approval of Health Technologies With, Without, or Only in Research : The Key Principles for Informing Coverage Decisions. In: Value in Health. 2016 ; Vol. 19, No. 6. pp. 885-891.

Bibtex - Download

@article{9570fb19923c44789ba5d1cda92c75ab,
title = "A Comprehensive Algorithm for Approval of Health Technologies With, Without, or Only in Research: The Key Principles for Informing Coverage Decisions",
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.",
author = "Karl Claxton and Stephen Palmer and Louise Longworth and Laura Bojke and Susan Griffin and Marta Soares and Eldon Spackman and Claire Rothery",
note = "{\circledC} 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.",
year = "2016",
month = "5",
day = "11",
doi = "10.1016/j.jval.2016.03.2003",
language = "English",
volume = "19",
pages = "885--891",
journal = "Value in Health",
issn = "1098-3015",
publisher = "Elsevier Inc.",
number = "6",

}

RIS (suitable for import to EndNote) - Download

TY - JOUR

T1 - A Comprehensive Algorithm for Approval of Health Technologies With, Without, or Only in Research

T2 - Value in Health

AU - Claxton, Karl

AU - Palmer, Stephen

AU - Longworth, Louise

AU - Bojke, Laura

AU - Griffin, Susan

AU - Soares, Marta

AU - Spackman, Eldon

AU - Rothery, Claire

N1 - © 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.

PY - 2016/5/11

Y1 - 2016/5/11

N2 - 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.

AB - 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.

U2 - 10.1016/j.jval.2016.03.2003

DO - 10.1016/j.jval.2016.03.2003

M3 - Article

VL - 19

SP - 885

EP - 891

JO - Value in Health

JF - Value in Health

SN - 1098-3015

IS - 6

ER -