Health Technology Assessment and Its Interface with Regulation, Policy and Management
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The purpose of health technology assessment (HTA) is to assist those who make key decisions regarding the allocation of scarce healthcare resources. However, although considerable attention has been paid to developing appropriate methods for conducting HTA, much less attention has been paid to ensuring that those conducting HTA are sufficiently well-connected to, and perceived as being relevant by, those making the resource allocation decisions. Therefore, this chapter explores how those conducting HTA can interface better with the key decision makers. Three groups in particular are discussed: regulators, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who give approval for new health technologies to enter the market; policy makers, who influence the diffusion and use of health technologies by providing reimbursement or issuing guidance; and health service managers, who are responsible for implementing policies and managing the day-to-day use of health technologies.
KeywordsHealth Technology Assessment Health Policy Maker Resource Allocation Decision Reimbursement Decision Health Service Manager
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- 1.Drummond MF, Griffin A, Tarricone R. Economic evaluation for devices and drugs. Same or different? Value in Health. 2009;12(4):402-4.Google Scholar
- 2.International Society of Pharmacoeconomics and Outcomes Research. Pharmacoeconomic guidelines around the world. www.ispor.org (assessed May 9, 2014).
- 3.Backhouse ME. Raising the standards of trial-based economic evaluation: the devil is in the detail. Value in Health. 2005;8(5):519-20.Google Scholar
- 4.Backhouse M, Wonder M, Hornby E, Kilburg A, Drummond MF, Mayer FK. Early dialogue between the developers of new technologies and pricing and reimbursement agencies. Value in Health. 2011;14(4):608-15.Google Scholar
- 5.Eichler H-G, Bloechl-Daum B, Abadie E, Barnett D, Konig F, Pearson S. Relative efficacy of drugs: an emerging issue between regulators and third-party payers. Nature Rev Drug Discovery. 2010;9(4):277-91.Google Scholar
- 6.Ljungberg B. Presentation at the Health Technology Assessment International (HTAi) Annual Conference, Dublin, June 2010.Google Scholar
- 7.Berntgen M, Gourvil A, Pavlovic M, Goettsch W, Eichler H-G, Kristensen FB. Improving the contribution of regulatory assessment reports to health technology assessments —A collaboration between the European Medicines Agency and the European network for Health Technology Assessment. Value in Health. 2014. Published online 25 June 2014. In press http://dx.do.org/10.1016/j.jval.2014.04.006
- 8.Tsoi B, Masucci L, Campbell K, Drummond MF, O’Reilly D, Goeree R. Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences. Expert Rev Pharmacoecon Outcomes Res. 2013;13(4):497-511.Google Scholar
- 9.Ferré F, Torbica A, Tarricone R, Drummond M. Regulatory framework for medical devices. Workpackage 1, Deliverable D 1.1, August 2013. www.medtechta.eu.
- 10.Busse FR, Orvain J, Velasco M, Perleth M, et al. Best practice in undertaking and reporting health technology assessments. Int J Technol Assess Health Care. 2002;18:361-422.Google Scholar
- 11.European Federation of Pharmaceutical Industries and Associations. The use of health technology assessments (HTA) to evaluate medicines:EFPIA key principles. EFPIA Position Paper. 2005. Available at:www.efpia.org/Objects/2/Files/HTAprinciplesEPIApositionpaperfinal.pdf.
- 12.Emanuel EJ, Fuchs VR, Garber AM. Essential elements of a technology and outcomes assessment initiative. JAMA. 2007;298:1323-5.Google Scholar
- 13.Drummond MF, Schwartz JS, Jönsson B, Luce BR, Neumann PJ. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care. 2008;24(3):244-58.Google Scholar
- 14.Neumann PJ, Drummond MF, Jönsson B, Luce BR, Schwartz JS, Siebert U, Sullivan S. Are key principles for improved health technology assessment supported and used by health technology assessment organizations? Int J Technol Assess Health Care. 2010;26(1):71-8.Google Scholar
- 15.Drummond MF, Neumann PJ, Jönsson B, Luce BR, Schwartz JS, Siebert U, Sullivan S. Can we reliably benchmark health technology assessment organizations? Int J Technol Assess Health Care. 2012;28(2):159-65.Google Scholar
- 16.Drummond MF. Twenty years of using economic evaluations for drug reimbursement decisions. What has been achieved? J Health Polit Policy Law. 2013;38(6):1083-104.Google Scholar
- 17.Clement F, Harris MA, Li JJ, Yong K, Lee KM, Manns BJ. Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA. 2009;302:1437-43.Google Scholar
- 18.Mason A, Drummond M, Ramsey S, Campbell J, Raisch D. Comparison of anticancer drug coverage decisions in the United States and United Kingdom: does the evidence support the rhetoric? J Clin Oncol. 2010;28:3234-8.Google Scholar
- 19.Malin JL. Wrestling with the high price of cancer care: should we control costs by individuals’ ability to pay or society’s willingness to pay? J Clin Oncol. 2010;28:3212-14.Google Scholar
- 20.Devlin N, Parkin D. Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis’. Health Economics. 2004;13:437-52.Google Scholar
- 21.Dakin H, Devlin ANJ, Odeyemi IAO. “Yes “No” or “Yes, but”? multinomial modelling of NICE decision-making. Health Policy. 2006;77:352-67.Google Scholar
- 22.Dakin H, Devlin N, Feng Y, Rice N, O’Neill, P, Parkin D. The influence of cost-effectiveness and other factors on NICE decisions. HERC Research Paper 05/14, Health Economics Research Centre, University of Oxford, 2014.Google Scholar
- 23.Tappenden P, Brazier J, Ratcliffe J, Chilcott J. A stated preference binary choice experiment to explore NICE decision making. Pharmacoeconomics. 2007;25:685-93.Google Scholar
- 24.Koopmanschap MA, Stolk EA, Koolman X. Dear policy maker: have you made up your mind? a discrete choice experiment among policy makers and other health professionals. Int J Technol Assess Health Care. 2010;26:198-204.Google Scholar
- 25.George B, Harris A, Mitchell A. Cost effectiveness analysis and the consistency of decision making – evidence from pharmaceutical reimbursement in Australia (1991 to 1996). Pharmacoeconomics. 2001;19:1103-9.Google Scholar
- 26.Birch S, Gafni A. Economists’ dream or nightmare? Maximizing health gains from available resources using the NICE guidelines. Health Economics Policy and Law. 2007;2:193-202.Google Scholar
- 27.Sheldon T, Cullum AN, Dawson D, Lankshear A, Lowson K, Watt I, West P, Wright D, Wright J. What’s the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients’ notes and interviews. BMJ 2004;329:999.Google Scholar
- 28.Christensen CM. The innovator’s dilemma. New York, Harper Collins, 1997.Google Scholar