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Harmonization of evidence requirements for health technology assessment in reimbursement decision making

  • John Hutton (a1), Paul Trueman (a1) and Karen Facey (a2)

Abstract

As more countries use HTA to inform decisions on the reimbursement of health technologies, harmonization of evidence requirements between jurisdictions has been proposed, mainly on the grounds of improved efficiency. Harmonization has the potential to avoid duplication of effort for both manufacturers and HTA bodies involved in preparing and reviewing HTA submissions for innovative technologies. However, it also carries risks of loss of local control over decisions, the application of general data standards which are not universally accepted and slowing the rate of development of innovation in the analytical disciplines supporting HTA. This study reviews the issues associated with harmonization taking into account the perspectives of the multiple stakeholders. This study draws on experiences from recent initiatives intended to promote the harmonization of HTA and experience from related fields, particularly regulatory approval of new medical technologies.

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References

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1. AHRQ. Comparative effectiveness review. http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr&action=cer. Accessed 1 February 2008.
2. Australia New Zealand Therapeutic Products Authority. About the trans Tasman therapeutic products agency project. http://www.anztpa.org/about.htm. Accessed 1 February 2008.
3. Autti-Rämö, I, Mäkelä, M. Ethical evaluation in health technology assessment reports: An eclectic approach. Int J Technol Assess Health Care. 2007;23:18.
4. Banta, D, Oortwijn, W. Introduction: Health technology assessment and the European Union. Int J Technol Assess Health Care. 2000;16:299302.
5. Banta, D, Oortwijn, W. Conclusion: Health technology assessment and health care in the European Union. Int J Technol Assess Health Care. 2000;16:626-35.
6. Banta, D. The development of health technology assessment. Health Policy. 2003;63:121132.
7. Banta, HD, Werko, L, Cranovsky, R, et al. Report from the EUR-ASSESS Project. Int J Technol Assess Health Care. 1997;13:133340.
8. Cappuccio, FP, Oakeshott, P, Strazzullo, P, Kerry, SM. Application of Framingham risk estimates to ethnic minorities in United Kingdom and implications for primary prevention of heart disease in general practice: Cross sectional population based study. BMJ. 2002;325:12711274.
9. Cranovsky, R, Matillion, Y, Banta, HD. EUR-ASSESS project subgroup on coverage. Int J Technol Assess Health Care. 1997;13:287332.
10. Culyer, AJ, Lomas, J. Deliberative processes and evidence-informed decision-making in health care: Do they work and how might we know? Evid Policy. 2006;2:357371.
11. Detsky, AS. Guidelines for economic analysis of pharmaceutical products: A draft for Ontario and Canada. Pharmacoeconomics. 1993;3:354361.
12. Drummond, MF, Dubois, D, Garattini, L, et al. Current trends in the use of pharmacoeconomics and outcomes research in Europe. Value Health. 1999;2:323332.
13. EUnetHTA. Proposal for the EUnetHTA Collaboration. http://www.eunethta.net/Communication/Press_Releases/EUnetHTA_Collaboration_Proposal_-_way_forward_for_HTA_in_Europe/. Accessed 1 February 2008.
14. Greiner, W, Weijnen, T, Nieuwenhuizen, M, et al. A single European currency for EQ-5D health states. Results from a six-country study. Eur J Health Econ. 2003;4:222231.
15. Grieve, R, Hutton, J, Green, C. Selecting methods for the prediction of future events in cost-effectiveness models: A decision-framework and example from the cardiovascular field. Health Policy. 2003;64:311324.
16. Hailey, D. Health technology assessment in Canada: Diversity and evolution. Med J Aust. 2007;187:286288.
17. Haynes, B. Can it work? Does it work? Is it worth it? The testing of healthcare interventions is evolving. BMJ. 1999;319:652653.
18. Henry, D. The Australian guidelines for subsidisation of pharmaceuticals. Pharmacoeconomics. 1992;2:422426.
19. Hjelmgren, J, Berggren, F, Andersson, F. Health economic guidelines—similarities, differences and some implications. Value Health. 2001;4:225250.
20. Hofmann, B. Toward a procedure for integrating moral issues in health technology assessment. Int J Technol Assess Health Care. 2005;21:312318.
21. Hutton, J, McGrath, C, Frybourg, J-M, et al. Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems). Int J Technol Assess Health Care. 2006;22:1018.
22. International Conference of Harmonisation. www.ich.org. Accessed 1 February 2008.
23. Jonsson, E, Banta, HD, Henshall, C, Sampietro-Colom, L. Executive summary of the ECHTA/ACAHI Project. Int J Technol Assess Health Care. 2002;18:213217.
24. Jonsson, E, Banta, HD, Henshall, C, Sampietro-Colom, L. Summary report of the ECHTA/ECAHI Project. Int J Technol Assess Health Care. 2002;18:218237.
25. Juillet, Y. Internationalization of regulatory requirements. Fundam Clin Pharmacol. 2003;17:2125.
26. McDaid, D. Co-ordinating health technology assessment in Canada: A European perspective. Health Policy. 2003;63:205213.
27. Menon, D, Topfer, LA. Health technology assessment in Canada. A decade in review. Int J Technol Assess Health Care. 2000;16:896902.
28. National Institute for Health and Clinical Excellence (NICE). Social value judgements: Principles for the development of NICE guidance. London: NICE; 2007.
29. Pharmaceutical Benefits Advisory Committee. Guidelines for the pharmaceutical industry on preparation of submissions to the Pharmaceutical Benefits Advisory Committee: Including major submissions involving economic analyses. Woden, Australia: PBAC; 1995.
30. Rockfold, FW. Industry perspectives on ICH guidelines. Stat Med. 2002;21:29492957.
31. Sanders, JM. Challenges, choices and Canada. Int J Technol Assess Health Care. 2002;18:199202.
32. Sassi, F. The European way to health technology assessment. Int J Technol Assess Health Care. 2001;16:282290.
33. Taylor, RS, Drummond, MF. Inclusion of cost effectiveness in licensing requirements of new drugs. BMJ. 2004;329:972975.
34. Watt, A, Cameron, A, Sturm, L, et al. Rapid versus full systematic reviews: An inventory of current methods and practice in health technology assessment. Int J Technol Assess Health Care. 2008;24:133139.

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