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Mikudina Boglárka (Erasmus University,The Netherlands), Redekop Ken (Erasmus University, Rotterdam, The Netherlands)
Early Medical Technology Assessments of Medical Devices and Tests
Journal of Health Policy and Outcomes Research, 2013, nr 1, s. 26-37, tab., bibliogr. 37 poz.
Słowa kluczowe
Technologia medyczna, Medycyna, Badanie diagnostyczne
Medical technology, Medicine, Diagnostic test
Background: Classic medical technology assessment (MTA) is typically conducted at the end of the development process to assess the overall value of a drug, medical device or diagnostic test. Recently, researchers and manufacturers have recognized that MTA in the early phases could help to make better decisions about further development, the regulatory and reimbursement strategy, and allocating public support for new technologies. The aim of this study is to introduce the most commonly used methods in early MTAs of emerging technologies and examine which methods have been used in the early MTAs of medical devices and tests. Methods: An explorative literature review. Results: Classic MTA supports particularly regulators and payers in market and reimbursement decisions, while early MTA primarily supports decisions of manufacturers about investments and strategies regarding further development as well as decisions by policymakers about public support. Important methods that can be used in early MTAs of medical devices include early health economic modelling, the headroom method, the Bayesian analytical framework, clinical trial simulation, multi-criteria decision analysis and value of information analysis. Only a few articles have been described early HTAs of devices and tests and most of these have used economic modelling, sometimes in combination with other methods. Conclusions: Various methods can be applied in performing early MTA. While early MTA follows the same steps as classic MTA, repeated assessments and sensitivity analysis play a more significant role.(original abstract)
Pełny tekst
  1. Pietzsch JB., Pate-Cornell ME.: Early technology assessment of new medical devices. Int J Technol Assess Health Care 2008 Winter; 24(1): 36-44
  2. Douw K., Vondeling H., Eskildsen D., Simpson S.: Use of the Internet in scanning the horizon for new and emerging health technologies: a survey of agencies involved in horizon scanning. J Med Internet Res 2003 Jan-Mar; 5(1): e6
  3. Hartz S., John J.: Public health policy decisions on medical innovations: what role can early economic evaluation play? Health Policy 2009 Feb; 89(2): 184-192
  4. 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 Fall; 24(4): 465-472
  5. Drummond MF., O'Brien B., Stoddart GL., Torrance GW. Methods for the economic evaluation of health care programmes. 2nd edit. Oxford (UK), Oxford University Press 1997
  6. McAteer H., Lilford R. Investing in Medical Technologies: The Headroom Method [monograph on the internet]. Birmingham:College of Medicine and Dentistry, School of Health and Population Sciences, Public Health, Epidemiology and Biostatistics, University of Birmingham 2009; Available from:; [Accessed: 2011 March 3]
  7. IJzerman MJ., Steuten LM.: 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
  8. Vallejo-Torres L., Steuten LM., 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 Fall; 24(4): 459-464
  9. Health Council of the Netherlands. Value for our money. Deciding on publicinvestments in health research [mongraph on the internet] The Hague: Health Council of the Netherlands; publication no. 2010/16. Available from:; [Accessed: 2011 Apr 4]
  10. Guston D., Sarewitz D.: Real-time technology assessment. Technology in Society, 2002 -01-01; 24(1-2): 93-109
  11. Wild C., Langer T.: Emerging health technologies: informing and supporting health policy early. Health Policy, 2008 Aug; 87(2): 160-171
  12. Trikalinos TA., Siebert U., Lau J.: Decision-analytic modeling to evaluate benefits and harms of medical tests: uses and limitations. Med Decis Making, 2009 Sep-Oct; 29(5): E22-9
  13. Annemans L., Geneste B., Jolain B.: Early modelling for assessing health and economic outcomes of drug therapy. Value Health, 2000 Nov-Dec; 3(6): 427-434
  14. Gaultney JG., Sanhueza E., Janssen JJ., Redekop WK., Uyl-de Groot CA.: Application of cost-effectiveness analysis to demonstrate the potential value of companion diagnostics in chronic myeloid leukemia. Pharmacogenomics, 2011 Mar; 12(3): 411-421
  15. O'Prinsen AC., Gaultney JG., Redekop WK. Universal Steps for Conducting Early-Stage Medical Technology Assessment. ISPOR Connections 2009; 15(6): 4-6
  16. Spiegelhalter DJ., Myles JP., Jones DR., Abrams KR.: Methods in health service research. An introduction to Bayesian methods in health technology assessment. Br Med J, 1999 Aug 21; 319(7208): 508-512
  17. Spiegelhalter DJ., Myles JP., Jones DR., Abrams KR.: Bayesian methods in health technology assessment: a review. Health Technol Assess, 2000; 4(38): 1-130
  18. Miller P.: Role of Pharmacoeconomic Analysis in R&D Decision Making: When, Where, How? Pharmacoeconomics, 2005 01; 23(1): 1-12
  19. Hughes DA., Walley T.: Economic evaluations during early (phase II) drug development: a role for clinical trial simulations? Pharmacoeconomics, 2001; 19(11): 1069-1077.
  20. Girard P.: Clinical trial simulation: a tool for understanding study failures and preventing them. Basic Clin Pharmacol Toxicol, 2005 Mar; 96(3): 228-234
  21. Abbas I., Rovira J., Casanovas J. Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment. Contemp Clin Trials, 2007 May; 28(3): 220-231
  22. Holford NHG., Kimko HC., Monteleone JPR., Peck CC.: Simulation of clinical trials. Annu Rev Pharmacol Toxicol, 2000; 40: 209-234
  23. Saaty TL.: Highlights and critical points in the theory and application of the Analytic Hierarchy Process. Eur J Oper Res, 1994 5/5; 74(3): 426-447
  24. Hummel M., Steuten L., Groothuis-Oudshoorn K., IJzerman M. Using the analytic hierarchy process to filling missing gaps in early health economic modeling. Meeting of the Lowlands Health Economics Study Group 2011; The Netherlands, 2011
  25. Briggs A., Sculpher M.: An Introduction to Markov Modelling for Economic Evaluation. Pharmacoeconomics, 1998 04; 13(4): 397-409
  26. Dong H., Coyle D., Buxton M.: Value of information analysis for a new technology: computer-assisted total knee replacement. Int J Technol Assess Health Care, 2007 Summer; 23(3): 337-342
  27. Boyd KA., Fenwick E., Briggs A.: Using an iterative approach to economic evaluation in the drug development process. Drug Dev Res 2010; 71(8): 470-477
  28. Claxton K., Ginnelly L., Sculpher M., Philips Z., Palmer S.: A pilot study on the use of decision theory and value of information analysis as part of the NHS Health Technology Assessment programme. Health Technol Assess, 2004 Jul; 8(31): 1-103, iii
  29. Dong H., Buxton M. Early assessment of the likely cost-effectiveness of a new technology: A Markov model with probabilistic sensitivity analysis of computer-assisted total knee replacement. Int J Technol Assess Health Care, 2006 Spring; 22(2): 191-202
  30. McAteer H., Cosh E., Freeman G., Pandit A., 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 Sep-Oct; 1(5): 343-349
  31. Postmus D., de Graaf G., Hillege HL., Steyerberg EW., Buskens E.: A method for the early health technology assessment of novel biomarker measurement in primary prevention programs. Stat Med, 2012 Oct 15; 31(23): 2733-44
  32. Chicoye A., Wilson G., Griffin A., Goeau-Brissoniere PO. How should HTA methods be adapted to meet the rising expectations of decision makers for medical devices and diagnostics reimbursement?. Presented at the ISPOR 12th Annual European Congress. Athens, 2009.; [Accessed: 06 June 2011]
  33. Bossuyt PMM. Evidence-based Medical Testing. Report prepared for theDutch Health Care Insurance Board [monograph on the internet] Amsterdam: Dutch Health Care Insurance Board. Available from:; [Accessed: 2011 June 30]
  34. Fineberg HV.: Evaluation of computed tomography: achievement and challenge. AJR Am J Roentgenol, 1978 Jul; 131(1): 1-4
  35. Holmstrom S., Chicoye A., Xie F., Garfield S. Moving forward with HTA for medical devices and diagnostic products! The ISPOR global health care systems road map. Presented at the ISPOR 15th International Meeting. Atlanta, Georgia, 2010. Available from:; [Accessed: 06 June 2011]
  36. Akekurst R., Landa K. Considerations for technology assessment of diagnostic products. Presented at the ISPOR 13th Annual European Congress, Prague 2010. Available from:; [Accessed: 06 June 2011]
  37. Siebert M., Clauss LC., Carlisle M., Casteels B., de Jong P., Kreuzer M. et al. Health technology assessment for medical devices in Europe. What must be considered. Int J Technol Assess Health Care, 2002 Summer; 18(3): 733-740
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