Practical Guidelines for Economic Evaluations Alongside Equivalence Trials

Authors

  • Judith E. Bosmans PhD,

    Corresponding author
    1. Health Technology Assessment Unit, Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands;
    2. Institute for Health Sciences, Faculty of Earth and Life Sciences, Vrije Universiteit, Amsterdam, The Netherlands;
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  • Martine C. De Bruijne PhD/MD,

    1. Health Technology Assessment Unit, Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands;
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  • Hein P. J. Van Hout PhD,

    1. Department of General Practice, Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands;
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  • Marleen L. M. Hermens PhD,

    1. Department of General Practice, Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands;
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  • Herman J. Adèr PhD,

    1. Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands
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  • Maurits W. Van Tulder PhD

    1. Health Technology Assessment Unit, Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands;
    2. Institute for Health Sciences, Faculty of Earth and Life Sciences, Vrije Universiteit, Amsterdam, The Netherlands;
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Judith E. Bosmans, Vrije Universiteit, Faculty of Earth and Life Sciences, Institute for Health Sciences, W&N Building, Room U435, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands. E-mail: judith.bosmans@falw.vu.nl

ABSTRACT

An effective treatment already exists for many diseases. In these cases the effectiveness of a new treatment may be established by showing that the new treatment is as effective as (i.e., equivalent to) or at least as effective as (i.e., noninferior to) the old treatment. For an economic evaluation accompanying a clinical equivalence or noninferiority trial it is important to decide before the start of the study on the appropriate research question. In many cases the objective of the economic evaluation will be to show equivalence or noninferiority of the cost-effectiveness of the treatments. This has major implications for the design and analysis of the economic evaluation. In this article we propose methods for the analysis of economic equivalence and noninferiority studies that are similar to the methods applied to clinical equivalence and noninferiority trials. Furthermore, cost-effectiveness planes prove to be a valuable tool in the interpretation of the results in an economic equivalence or noninferiority trial. The concepts described in the article are illustrated using the results from an economic noninferiority trial.

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