Optimal global value of information trials: better aligning manufacturer and decision maker interests and enabling feasible risk sharing

Journal Article


Abstract


  • Risk sharing arrangements relate to adjusting payments for new health technologies given evidence of

    their performance over time. Such arrangements rely on prospective information regarding the incremental

    net benefit of the new technology, and its use in practice. However, once the new technology has been

    adopted in a particular jurisdiction, randomized clinical trials within that jurisdiction are likely to be

    infeasible and unethical in the cases where they would be most helpful, i.e. with current evidence of

    positive while uncertain incremental health and net monetary benefit. Informed patients in these cases

    would likely be reluctant to participate in a trial, preferring instead to receive the new technology with

    certainty. Consequently, informing risk sharing arrangements within a jurisdiction is problematic given the

    infeasibility of collecting prospective trial data. To overcome such problems, we demonstrate that global

    trials facilitate trialling post adoption, leading to more complete and robust risk sharing arrangements that

    mitigate the impact of costs of reversal on expected value of information in jurisdictions who adopt while

    a global trial is undertaken. More generally, optimally designed global trials offer distinct advantages over

    locally optimal solutions for decision makers and manufacturers alike: avoiding opportunity costs of delay

    in jurisdictions that adopt; overcoming barriers to evidence collection; and improving levels of expected

    implementation. Further, the greater strength and translatability of evidence across jurisdictions inherent in

    optimal global trial design reduces barriers to translation across jurisdictions characteristic of local trials.

    Consequently, efficiently designed global trials better align the interests of decision makers and

    manufacturers, increasing the feasibility of risk sharing and the expected strength of evidence over local

    trials, up until the point that current evidence is globally sufficient.

Publication Date


  • 2013

Citation


  • S. Eckermann & A. R. Willan, "Optimal global value of information trials: better aligning manufacturer and decision maker interests and enabling feasible risk sharing", PharmacoEconomics 31 5 (2013) 393-401.

Scopus Eid


  • 2-s2.0-84877966637

Ro Metadata Url


  • http://ro.uow.edu.au/ahsri/219

Number Of Pages


  • 8

Start Page


  • 393

End Page


  • 401

Volume


  • 31

Issue


  • 5

Place Of Publication


  • http://www.ncbi.nlm.nih.gov/pubmed/23529209

Abstract


  • Risk sharing arrangements relate to adjusting payments for new health technologies given evidence of

    their performance over time. Such arrangements rely on prospective information regarding the incremental

    net benefit of the new technology, and its use in practice. However, once the new technology has been

    adopted in a particular jurisdiction, randomized clinical trials within that jurisdiction are likely to be

    infeasible and unethical in the cases where they would be most helpful, i.e. with current evidence of

    positive while uncertain incremental health and net monetary benefit. Informed patients in these cases

    would likely be reluctant to participate in a trial, preferring instead to receive the new technology with

    certainty. Consequently, informing risk sharing arrangements within a jurisdiction is problematic given the

    infeasibility of collecting prospective trial data. To overcome such problems, we demonstrate that global

    trials facilitate trialling post adoption, leading to more complete and robust risk sharing arrangements that

    mitigate the impact of costs of reversal on expected value of information in jurisdictions who adopt while

    a global trial is undertaken. More generally, optimally designed global trials offer distinct advantages over

    locally optimal solutions for decision makers and manufacturers alike: avoiding opportunity costs of delay

    in jurisdictions that adopt; overcoming barriers to evidence collection; and improving levels of expected

    implementation. Further, the greater strength and translatability of evidence across jurisdictions inherent in

    optimal global trial design reduces barriers to translation across jurisdictions characteristic of local trials.

    Consequently, efficiently designed global trials better align the interests of decision makers and

    manufacturers, increasing the feasibility of risk sharing and the expected strength of evidence over local

    trials, up until the point that current evidence is globally sufficient.

Publication Date


  • 2013

Citation


  • S. Eckermann & A. R. Willan, "Optimal global value of information trials: better aligning manufacturer and decision maker interests and enabling feasible risk sharing", PharmacoEconomics 31 5 (2013) 393-401.

Scopus Eid


  • 2-s2.0-84877966637

Ro Metadata Url


  • http://ro.uow.edu.au/ahsri/219

Number Of Pages


  • 8

Start Page


  • 393

End Page


  • 401

Volume


  • 31

Issue


  • 5

Place Of Publication


  • http://www.ncbi.nlm.nih.gov/pubmed/23529209