A Review of the Economic Tools for Assessing New Medical Devices

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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References

  1. 1.

    U. S. Food Drug Administration. Medical devices: is the product a medical device? U. S. Food Drug Administration, Maryland. 2013. www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm. Accessed 2 April 2014.

  2. 2.

    MedTech Europe. The European Medical Technology Industry in figures. Brussels: MedTech Europe; 2013.

    Google Scholar 

  3. 3.

    Udvarhelyi IS, Colditz GA, Rai A, Epstein AM. Cost-effectiveness and cost-benefit analyses in the medical literature. Are the methods being used correctly? Ann Intern Med. 1992;116:238–44.

    CAS  PubMed  Article  Google Scholar 

  4. 4.

    Cookson R, Hutton J. Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective. Health Policy. 2003;63:167–78.

    PubMed  Article  Google Scholar 

  5. 5.

    National Institute for Health Care Excellence. Medical technologies evaluation programme. London: NICE; 2013.

    Google Scholar 

  6. 6.

    French-Mowat E, Burnett J. How are medical devices regulated in the European Union? J R Soc Med. 2012;105(Suppl 1):S22–8.

    PubMed  Article  Google Scholar 

  7. 7.

    National Institute for Health and Clinical Excellence. Medical technologies evaluation programme: methods guide. London: NICE; 2011.

    Google Scholar 

  8. 8.

    National Institute for Health and Clinical Excellence. 1999–2009 a decade of excellence. London: NICE; 2009.

    Google Scholar 

  9. 9.

    Taylor RS, Iglesias CP. Assessing the clinical and cost-effectiveness of medical devices and drugs: are they that different? Value Health. 2009;12:404–6.

    PubMed  Article  Google Scholar 

  10. 10.

    Drummond M, Griffin A, Tarricone R. Economic evaluation for devices and drugs—same or different? Value Health. 2009;12:402–4.

    PubMed  Article  Google Scholar 

  11. 11.

    Sorenson C, Tarricone R, Siebert M, Drummond M. Applying health economics for policy decision making: do devices differ from drugs? Europace. 2011;13(Suppl 2):54–8.

    Article  Google Scholar 

  12. 12.

    National Institute for Health and Care Excellence. Medical technology evaluation programme: definition of technologies which fall within the remit of the programme. London: NICE; 2013.

    Google Scholar 

  13. 13.

    Medical Services Advisory Committee. Funding for new medical technologies and procedures: application and assessment guidelines. Canberra: Medical Services Advisory Committee; 2005.

    Google Scholar 

  14. 14.

    Medical Services Advisory Committee. Guidelines for the assessment of diagnostic technologies. Canberra: Medical Services Advisory Committee; 2005.

    Google Scholar 

  15. 15.

    Medical Services Advisory Committee. Economics section of the MSAC guidelines. Canberra: Medical Services Advisory Committee; 2009.

    Google Scholar 

  16. 16.

    Canadian Agency for Drugs Technologies in Health. Guidelines for the economic evaluation of health technologies: Canada. Ottowa: CADTH; 2006.

    Google Scholar 

  17. 17.

    Canadian Agency for Drugs Technologies in Health. Indirect evidence: indirect treatment comparisons in meta-analysis. Ottowa: CADTH; 2009.

    Google Scholar 

  18. 18.

    Haute Autorité de Santé. Rapid assessment method for assessing medical and surgical procedures. Paris: Haute Autorité de Santé; 2007.

    Google Scholar 

  19. 19.

    Haute Autorité de Santé. General method for assessing health technologies. Paris: Haute Autorité de Santé; 2007.

    Google Scholar 

  20. 20.

    Haute Autorité de Santé. Medical device assessment in France: guidebook. Paris: Haute Autorité de Santé; 2009.

    Google Scholar 

  21. 21.

    Kristensen F, He S. Health technology assessment handbook. Copenhagen: Danish Centre for Health Technology Assessment, National Board of Health; 2007.

    Google Scholar 

  22. 22.

    National Institute for Health and Care Excellence. Published medical technologies guidance. NICE, London. 2014. http://www.nice.org.uk/guidance/mt/published/index.jsp. Accessed 5 Jan 2014.

  23. 23.

    Ferrusi IL, Ames D, Lim ME, Goeree R. Health technology assessment from a Canadian device industry perspective. J Am Coll Radiol. 2009;6:353–9.

    PubMed  Article  Google Scholar 

  24. 24.

    Foley K, Lim S, Schulman KL. Methodological considerations in modeling the economic value of diagnostic accuracy. In: ISPOR 16th Annual International Meeting; Baltimore; 21–25 May 2011.

  25. 25.

    Gimenes F, de O Machado F, Quiroz ME. Health technology assessment applied to medical devices in Latin America: what must be assessed. In: ISPOR 3rd Latin America Conference; Mexico City; 8–10 September 2011.

  26. 26.

    Hutton J, Trueman P, Henshall C. Coverage with evidence development: an examination of conceptual and policy issues. Int J Technol Assess Health Care. 2007;23:425–32.

    PubMed  Article  Google Scholar 

  27. 27.

    Manca A. Economic evaluation of medical devices and drugs—same or different? Value Health. 2009;12(4):401.

    PubMed  Article  Google Scholar 

  28. 28.

    Tesar T, Babela R. Quality assurance of fourth hurdle concerning medical devices. In: ISPOR 13th Annual European Congress; Prague; 6–9 November 2010.

  29. 29.

    Drummond M, Weatherly H, Ferguson B. Economic evaluation of health interventions. BMJ. 2008;337:a1204.

    PubMed  Article  Google Scholar 

  30. 30.

    Ho PM, Peterson PN, Masoudi FA. Evaluating the evidence: is there a rigid hierarchy? Circulation. 2008;118:1675–84.

    PubMed  Article  Google Scholar 

  31. 31.

    National Institute for Health and Care Excellence. Guide to the methods of technology appraisal 2013. London: NICE; 2013.

    Google Scholar 

  32. 32.

    Sassi F, McKee M, Roberts JA. Economic evaluation of diagnostic technology. Methodological challenges and viable solutions. Int J Technol Assess Health Care. 1998;13:613–30.

    Article  Google Scholar 

  33. 33.

    Poley MJ, Edelenbos KI, Mosseveld M, van Wijk MA, de Bakker DH, van der Lei J, et al. Cost consequences of implementing an electronic decision support system for ordering laboratory tests in primary care: evidence from a controlled prospective study in the Netherlands. Clin Chem. 2006;53:213–9.

    PubMed  Article  Google Scholar 

  34. 34.

    Cole JH, Chunn VM, Morrow JA, Buckley RS, Phillips GM. Cost implications of initial computed tomography angiography as opposed to catheterization in patients with mildly abnormal or equivocal myocardial perfusion scans. J Cardiovasc Comput Tomogr. 2007;1:21–6.

    PubMed  Article  Google Scholar 

  35. 35.

    Rihal CS, Ryan JL, Singh M, Lennon RJ, Bresnahan JF, Liesinger JT, et al. Clinical and economic outcomes after introduction of drug-eluting stents. Am J Manag Care. 2010;16:580–7.

    PubMed  Google Scholar 

  36. 36.

    Clegg JP, Guest JF. Modelling the cost-utility of bio-electric stimulation therapy compared to standard care in the treatment of elderly patients with chronic non-healing wounds in the UK. Curr Med Res Opin. 2007;23:871–83.

    PubMed  Article  Google Scholar 

  37. 37.

    Regier DA, Petrou S, Henderson J, Eddama O, Patel N, Strohm B, et al. Cost-effectiveness of therapeutic hypothermia to treat neonatal encephalopathy. Value Health. 2010;13:695–702.

    PubMed  Article  Google Scholar 

  38. 38.

    Palmer AJ, Valentine WJ, Chen R, Mehin N, Gabriel S, Bregman B, et al. A health economic analysis of screening and optimal treatment of nephropathy in patients with type 2 diabetes and hypertension in the USA. Nephrol Dial Transpl. 2008;23:1216–23.

    Article  Google Scholar 

  39. 39.

    Watkins RG, Gupta A, Watkins RG. Cost-effectiveness of image-guided spine surgery. Open Orthop J. 2011;4:228–33.

    Article  Google Scholar 

  40. 40.

    Department of Health. Reference costs 2005–06. London: Department of Health; 2006.

    Google Scholar 

  41. 41.

    Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010;5(7):826–32.

    PubMed  Article  Google Scholar 

  42. 42.

    Bradley SM, Levy WC, Veenstra DL. Cost-consequences of ultrafiltration for acute heart failure: a decision model analysis. Circ Cardiovasc Qual Outcomes. 2009;2:566–73.

    PubMed  Article  Google Scholar 

  43. 43.

    Krug B, Van Zanten A, Pirson AS, Crott R, Borght TV. Activity-based costing evaluation of a [(18)F]-fludeoxyglucose positron emission tomography study. Health Policy. 2009;92:234–43.

    PubMed  Article  Google Scholar 

  44. 44.

    Tarricone R, Aguzzi G, Musi F, Fariselli L, Casasco A. Cost-effectiveness analysis for trigeminal neuralgia: cyberknife vs microvascular decompression. Neuropsychiatr Dis Treat. 2008;4:647–52.

    PubMed Central  PubMed  Google Scholar 

  45. 45.

    Lowrance WT, Tarin TV, Shariat SF. Evidence-based comparison of robotic and open radical prostatectomy. Sci World J. 2010;10:2228–37.

    Article  Google Scholar 

  46. 46.

    Meads CA, Cnossen JS, Meher S, Juarez-Garcia A, ter Riet G, Duley L, et al. Methods of prediction and prevention of pre-eclampsia: systematic reviews of accuracy and effectiveness literature with economic modelling. Health Technol Assess. 2008;12:1–270.

    Article  Google Scholar 

  47. 47.

    Mueller D, Gandjour A. Cost-effectiveness of using clinical risk factors with and without DXA for osteoporosis screening in postmenopausal women. Value Health. 2009;12:1106–17.

    PubMed  Article  Google Scholar 

  48. 48.

    O’Connor DP, Knoblauch MA. Electrocardiogram testing during athletic preparticipation physical examinations. J Athl Train. 2010;45:265–72.

    PubMed Central  PubMed  Article  Google Scholar 

  49. 49.

    Collins R, Cranny G, Burch J, Aguiar-Ibanez R, Craig D, Wright K, et al. A systematic review of duplex ultrasound, magnetic resonance angiography and computed tomography angiography for the diagnosis and assessment of symptomatic, lower limb peripheral arterial disease. Health Technol Assess. 2007;11:1–184.

    Google Scholar 

  50. 50.

    Wordsworth S, Buchanan J, Regan R, Davison V, Smith K, Dyer S, et al. Diagnosing idiopathic learning disability: a cost-effectiveness analysis of microarray technology in the National Health Service of the United Kingdom. Genomic Med. 2008;1:35–45.

    Article  Google Scholar 

  51. 51.

    National Institute for Health and Clinical Excellence. The EOS 2D/3D imaging system (NICE diagnostic guidance 1). London: NICE; 2011.

    Google Scholar 

  52. 52.

    National Institute for Health and Clinical Excellence. Elucigene FH20 and LIPOchip for the diagnosis of familial hypercholesterolaemia (NICE diagnostic guidance 2). London: NICE; 2011.

    Google Scholar 

  53. 53.

    National Institute for Health and Care Excellence. New generation cardiac CT scanners (Aquilion ONE, Brilliance iCT, Discovery CT750 HD and Somatom Definition Flash) for cardiac imaging in people with suspected or known coronary artery disease in whom imaging is difficult with earlier generation CT scanners (NICE diagnostic guidance 3). London: NICE; 2012.

  54. 54.

    National Institute for Health and Clinical Excellence. SeQuent please balloon catheter for in-stent coronary restenosis (NICE medical technology guidance 1). London: NICE; 2010.

    Google Scholar 

  55. 55.

    National Institute for Health and Clinical Excellence. moorLDI2-BI: a laser doppler blood flow imager for burn wound assessment (NICE medical technology guidance 2). London: NICE; 2011.

    Google Scholar 

  56. 56.

    National Institute for Health and Clinical Excellence. CardioQ-ODM oesophageal Doppler monitor (NICE medical technology guidance 3). London: NICE; 2011.

    Google Scholar 

  57. 57.

    National Institute for Health and Clinical Excellence. BRAHMS copeptin assay to rule out myocardial infarction in patients with acute chest pain (NICE medical technology guidance 4). London: NICE; 2011.

    Google Scholar 

  58. 58.

    National Institute for Health and Clinical Excellence. MIST therapy system for the promotion of wound healing in chronic and acute wounds (NICE medical technology guidance 5). London: NICE; 2011.

    Google Scholar 

  59. 59.

    National Institute for Health and Clinical Excellence. Ambulight PDT for the treatment of non-melanoma skin cancer (NICE medical technology guidance 6). London: NICE; 2011.

    Google Scholar 

  60. 60.

    National Institute for Health and Clinical Excellence. Inditherm patient warming mattress for the prevention of inadvertent hypothermia (NICE medical technology guidance 7). London: NICE; 2011.

    Google Scholar 

  61. 61.

    National Institute for Health and Clinical Excellence. The VeriQ system for assessing graft flow during coronary artery bypass graft surgery (NICE medical technology guidance 8). London: NICE; 2011.

    Google Scholar 

  62. 62.

    Claxton K. Bayesian approaches to the value of information: implications for the regulation of new pharmaceuticals. Health Econ. 1999;8:269–74.

    CAS  PubMed  Article  Google Scholar 

  63. 63.

    Henshall C, Mardhani-Bayne L, Fronsdal KB, Klemp M. Interactions between health technology assessment, coverage, and regulatory processes: emerging issues, goals, and opportunities. Int J Technol Assess Health Care. 2011;27:253–60.

    PubMed  Article  Google Scholar 

  64. 64.

    Mauskopf JA, Paul JE, Grant DM, Stergachis A. The role of cost-consequence analysis in healthcare decision-making. Pharmacoeconomics. 1998;13:277–88.

    CAS  PubMed  Article  Google Scholar 

  65. 65.

    Schreyogg J, Baumler M, Busse R. Balancing adoption and affordability of medical devices in Europe. Health Policy. 2009;92:218–24.

    PubMed  Article  Google Scholar 

  66. 66.

    Bonangelino P, Irony T, Liang S, Li X, Mukhi V, Ruan S, et al. Bayesian approaches in medical device clinical trials: a discussion with examples in the regulatory setting. J Biopharm Stat. 2011;21:938–53.

    PubMed  Article  Google Scholar 

  67. 67.

    Campbell G. Bayesian statistics in medical devices: innovation sparked by the FDA. J Biopharm Stat. 2011;21:871–87.

    PubMed  Article  Google Scholar 

  68. 68.

    Grunkemeier GL, Payne N. Bayesian analysis: a new statistical paradigm for new technology. Ann Thorac Surg. 2003;74:1901–8.

    Article  Google Scholar 

  69. 69.

    Hobbs BP, Carlin BP. Practical Bayesian design and analysis for drug and device clinical trials. J Biopharm Stat. 2007;18:54–80.

    Article  Google Scholar 

  70. 70.

    US Food and Drug Administration. Guidance for the use of Bayesian statistics in medical device clinical trials. Maryland: US Food and Drug Administration; 2010.

  71. 71.

    Ades AE, Sutton AJ. Multiparameter evidence synthesis in epidemiology and medical decision-making: current approaches. J R Stat Soc Ser A (Statistics in Society). 2006;169:5–35.

    Article  Google Scholar 

  72. 72.

    Armero C, Garcia-Donato G, Lopez-Quilez A. Bayesian methods in cost-effectiveness studies: objectivity, computation and other relevant aspects. Health Econ. 2009;19:629–43.

    Google Scholar 

  73. 73.

    Claxton K. The irrelevance of inference: a decision-making approach to the stochastic evaluation of health care technologies. J Health Econ. 1999;18:341–64.

    CAS  PubMed  Article  Google Scholar 

  74. 74.

    Haro JM, Kontodimas S, Negrin MA, Ratcliffe M, Suarez D, Windmeijer F. Methodological aspects in the assessment of treatment effects in observational health outcomes studies. Appl Health Econ Health Policy. 2006;5:11–25.

    PubMed  Article  Google Scholar 

  75. 75.

    Healthcare Improvement Scotland. Coverage with evidence development in NHS Scotland. Edinburgh: Healthcare Improvement Scotland; 2008.

    Google Scholar 

  76. 76.

    Pietzsch JB, Pate-Cornell ME. Early technology assessment of new medical devices. Int J Technol Assess Health Care. 2008;24:36–44.

    PubMed  Article  Google Scholar 

  77. 77.

    Spiegelhalter DJ, Myles JP, Jones DR, Abrams KR. Bayesian methods in health technology assessment: a review. Health Technol Assess. 2001;4:1–130.

    Google Scholar 

  78. 78.

    Cook JA, Ramsay CR, Fayers P. Using the literature to quantify the learning curve: a case study. Int J Technol Assess Health Care. 2007;23:255–60.

    PubMed  Article  Google Scholar 

  79. 79.

    Douma KF, Karsenberg K, Hummel MJ, Bueno-de-Mesquita JM, van Harten WH. Methodology of constructive technology assessment in health care. Int J Technol Assess Health Care. 2007;23:162–8.

    PubMed  Article  Google Scholar 

  80. 80.

    Martin JL, Clark DJ, Morgan SP, Crowe JA, Murphy E. A user-centred approach to requirements elicitation in medical device development: a case study from an industry perspective. Appl Ergon. 2011;43:184–90.

    PubMed  Article  Google Scholar 

  81. 81.

    Mushlin AI, Kern LM, Paris M, Lambert DR, Williams G. The value of diagnostic information to patients with chest pain suggestive of coronary artery disease. Med Decis Making. 2005;25:149–57.

    PubMed  Article  Google Scholar 

  82. 82.

    National Institute for Health Clinical and Excellence. Transcatheter aortic valve implantation for aortic stenosis (NICE interventional procedures guidance 421). London: NICE; 2012.

    Google Scholar 

  83. 83.

    Girling A, Young T, Brown C, Lilford R. Early-stage valuation of medical devices: the role of developmental uncertainty. Value Health. 2010;13(5):585–91.

    PubMed  Article  Google Scholar 

  84. 84.

    McAteer H, Cosh E, Freeman G, Pandit G, Wood P, Lilford R. Cost-effectiveness analysis at the development phase of a potential health technology: examples based on tissue engineering of bladder and urethra. J Tissue Eng Regen Med. 2007;1:343–9.

    CAS  PubMed  Article  Google Scholar 

  85. 85.

    Ijzerman MJ, Steuten LMG. Early assessment of medical technologies to inform product development and market access: a review of methods and applications. Appl Health Econ Health Policy. 2011;9(5):331–47.

    PubMed  Article  Google Scholar 

  86. 86.

    Hartz S, John J. Contribution of economic evaluation to decision making in early phases of product development: a methodological and empirical review. Int J Technol Assess Health Care. 2008;24(4):465–72.

    PubMed  Article  Google Scholar 

  87. 87.

    Vallejo-Torres L, Steuten LMG, Buxton MJ, Girling AJ, Lilford RJ, Young T. Integrating health economics modeling in the product development cycle of medical devices: a Bayesian approach. Int J Technol Assess Health Care. 2008;24(4):459–64.

    PubMed  Article  Google Scholar 

  88. 88.

    Mushlin AI, Kern LM, Paris M, Lambert DR, Williams G. The value of diagnostic information to patients with chest pain suggestive of coronary artery disease. Med Decis Making. 2005;25(2):149–57.

    PubMed  Article  Google Scholar 

  89. 89.

    Chapman AM, Taylor CA, Girling AJ. Are the UK systems of innovation and evaluation of medical devices compatible? The role of NICE’s medical technologies evaluation programme (MTEP). Appl Health Econ Health Policy. 2014;12(4):347–57.

  90. 90.

    Kirisits A, Redekop WK. The economic evaluation of medical devices: challenges ahead. Appl Health Econ Health Policy. 2013;11(1):15–26. doi:10.1007/s40258-012-0006-9.

    PubMed  Article  Google Scholar 

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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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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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Keywords

  • Economic Evaluation
  • Medical Device
  • Health Technology Assessment
  • Transcatheter Aortic Valve Implantation
  • Data Quality Issue