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A Review of the Economic Tools for Assessing New Medical Devices

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Abstract

Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012—nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices.

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Acknowledgments

All authors contributed to the conception and design of the work and agreed overall methodologies. Julie Glanville and Andrew Sims devised and ran the literature search strategies. Louise Carr and Joyce Craig selected included studies, synthesised findings and prepared the initial draft of the full report. All authors commented on drafts, revising these to improve intellectual content. All approved the final version for publication. Hayward Medical Communications has contributed both medical writing and editorial support in the development of this manuscript. Joyce Craig is the guarantor for the overall content.

Disclosures

This work was developed as part of a contract with the NICE MTEP for evidence preparation and assessment services. The authors were solely responsible for the design of the methods and retained editorial control throughout the development and publication of the report. At the time of review, Cynthia Iglesias held a personal fellowship in Health Services Research and Health of the Public funded by the Medical Research Council. The authors have no conflicts of interest that are directly relevant to the content of this article.

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Authors and Affiliations

  1. York Health Economics Consortium, University of York, Level 2 Market Square, Vanbrugh Way, Heslington, York, YO10 5NH, UK

    Joyce A. Craig, Louise Carr & Julie Glanville

  2. Department of Health Sciences, University of York, York, UK

    John Hutton

  3. Clinical Measurement and Engineering Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

    Andrew J. Sims

  4. Centre for Health Economics, University of York, Level 2 Market Square, Vanbrugh Way, Heslington, York, YO10 5NH, UK

    Cynthia P. Iglesias

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  1. Joyce A. Craig
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Correspondence to Joyce A. Craig.

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40258_2014_123_MOESM1_ESM.docx

Supplementary material 1 Electronic supplementary material: Online Resource 1—Literature search strategies and sources and evidence table (DOCX 61 kb)

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Craig, J.A., Carr, L., Hutton, J. et al. A Review of the Economic Tools for Assessing New Medical Devices. Appl Health Econ Health Policy 13, 15–27 (2015). https://doi.org/10.1007/s40258-014-0123-8

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