Skip to main content Accessibility help

Coverage with Evidence Development: Applications and issues

  • Paul Trueman (a1), David L. Grainger (a2) and Kristen E. Downs (a3)


Objectives: The aim of this study was to describe the current issues surrounding Coverage with Evidence Development (CED). CED is characterized by restricted coverage for a new technology in parallel with targeted research when the stated goal of the research or data collection is to provide definitive evidence for the clinical or cost-effectiveness impact of the new technology.

Methods: Presented here is information summarized and interpreted from presentations and discussions at the 2008 Health Technology Assessment International (HTAi) meeting and additional information from the medical literature. This study describes the differences between CED and other conditional coverage agreements, provides a brief history of CED, describes real-world examples of CED, describes the areas of consensus between the stakeholders, discusses the areas for future negotiation between stakeholders, and proposes criteria to assist stakeholders in determining when CED could be appropriate.

Results: Payers could interpret the evidence obtained from a CED program either positively or negatively, and a range of possible changes to the reimbursement status of the new technology may result. Striking an appropriate balance between the demands for prompt access to new technology and acknowledging that some degree of uncertainty will always exist is a critical challenge to the uptake of this innovative form of conditional coverage.

Conclusions: When used selectively for innovative procedures, pharmaceuticals, or devices in the appropriate disease areas, CED may provide patients access to promising medicines or technologies while data to minimize uncertainty are collected.



Hide All
1. CCRE Therapeutics. Bosentan patient registry. 2005. (accessed February 16, 2009).
2. Centers for Medicare and Medicaid Services. National coverage determinations with data collection as a condition of coverage: Coverage with evidence development. 2006. (accessed February 10, 2009).
3. Chalkidou, K. Conditional reimbursment based on future research. ISPOR Connect. 2008;14:910.
4. Chapman, S, Reeve, E, Price, D, Rajaratnam, G, Neary, R. Outcomes guarantee for lipid-lowering drugs: results from a novel approach to risk sharing in primary care. Br J Cardiol. 2004;11:205210.
5. Claxton, K. Bayesian approaches to the value of information: Implications for the regulation of new pharmaceuticals. Health Econ. 1999;8:269274.
6. Claxton, K. Pricing, innovation and NICE in the UK. Presented at the Second Biennial Conference of the American Society of Health Economists. Equity and efficiency in health and healthcare. 2008, June 22–25. Duke University.
7. Claxton, K, Sculpher, MJ. Using value of information analysis to prioritise health research: Some lessons from recent UK experience (Conference Paper). Pharmacoeconomics. 2006;24:10551068.
8. Department of Health. Cost effective provision of disease modifying therapies for people with multiple sclerosis. London: Department of Health; 2002.
9. Goeree, R, Levin, L. Building bridges between academic research and policy formulation: The PRUFE Framework–an Integral Part of Ontario's Evidence-Based HTPA Process. Pharmacoeconomics. 2006;24:11431156.
10. Hutton, J, Trueman, P, Henshall, C. Coverage with evidence development: An examination of conceptual and policy issues. Int J Technol Assess Health Care. 2007;23:425435.
11. Medical Services Advisory Committee. Application 1006— Endoluminal grafting for abdominal aortic aneurysm. 2006.–1 (accessed February 20, 2009).
12. Medicare Australia. Physician's guide. A guide to prescribing treatment for primary pulmonary hypertension and pulmonary arterial hypertension within the Pharmaceutical Benefits Scheme Selection 100 restriction criteria. Sydney: Australian Government; 2008.
13. Multiple Sclerosis Resource Centre. Disease modifying drugs risk sharing scheme. 2002. (accessed October 20, 2008).
14. Tracleer–A cornerstone of oral therapy. 2007. (accessed February 5, 2009).
15. Tu, JV, Bowen, J, Chiu, M, et al. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med. 2007;357:13931402.
16. Tunis, S. Dealing with uncertainty in Medicare coverage decisions. Presented at the Health Technology Assessment International Annual Meeting. 2008. Montreal, Canada.
17. Tunis, SR, Pearson, SD. Coverage options for promising technologies: Medicare's ‘Coverage with Evidence Development’. Health Aff (Millwood). 2006;5:12181230.
18. Steinberg, EP, Tunis, S, Shapiro, D. Insurance coverage for experimental technologies. Health Aff (Millwood). 1995;14:143158.
19. Wlodarczyk, JH, Cleland, LG, Keogh, AM, et al. Public funding of bosentan for the treatment of pulmonary artery hypertension in Australia. Pharmacoeconomics. 2006;24:903915.



Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed