Hostname: page-component-cd9895bd7-hc48f Total loading time: 0 Render date: 2024-12-25T05:52:53.622Z Has data issue: false hasContentIssue false
  • English
  • Français

Coverage with Evidence Development: Applications and issues

Published online by Cambridge University Press:  08 January 2010

Paul Trueman ,
David L. Grainger  and
Kristen E. Downs
Paul Trueman
Affiliation:
Brunel University
David L. Grainger
Affiliation:
Eli Lilly and Company
Kristen E. Downs
Affiliation:
Relevant Health Outcomes, Inc.
Get access Rights & Permissions [Opens in a new window]

Abstract

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.

Keywords

Coverage with Evidence DevelopmentInsurance coverageEconomicsEvidence-based healthcare
Type
POLICIES
Information
International Journal of Technology Assessment in Health Care , Volume 26 , Issue 1 , January 2010 , pp. 79 - 85
Copyright
Copyright © Cambridge University Press 2010

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. CCRE Therapeutics. Bosentan patient registry. 2005. http://www.bosentanregistry.com.au/ (accessed February 16, 2009).Google Scholar
2. Centers for Medicare and Medicaid Services. National coverage determinations with data collection as a condition of coverage: Coverage with evidence development. 2006. http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=8 (accessed February 10, 2009).Google Scholar
3. Chalkidou, K. Conditional reimbursment based on future research. ISPOR Connect. 2008;14:9–10.Google Scholar
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;11:205–210.Google Scholar
5. Claxton, K. Bayesian approaches to the value of information: Implications for the regulation of new pharmaceuticals. Health Econ. 1999;8:269–274.3.0.CO;2-D>CrossRefGoogle Scholar
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.Google Scholar
7. Claxton, K, Sculpher, MJ. Using value of information analysis to prioritise health research: Some lessons from recent UK experience (Conference Paper). Pharmacoeconomics. 2006;24:1055–1068.CrossRefGoogle Scholar
8. Department of Health. Cost effective provision of disease modifying therapies for people with multiple sclerosis. London: Department of Health; 2002.Google Scholar
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;24:1143–1156.CrossRefGoogle ScholarPubMed
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;23:425–435.CrossRefGoogle ScholarPubMed
11. Medical Services Advisory Committee. Application 1006— Endoluminal grafting for abdominal aortic aneurysm. 2006. http://www.msac.gov.au/internet/msac/publishing.nsf/Content/app1006–1 (accessed February 20, 2009).Google Scholar
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.Google Scholar
13. Multiple Sclerosis Resource Centre. Disease modifying drugs risk sharing scheme. 2002. http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1893&CFID=8452005&CFTOKEN=9967130 (accessed October 20, 2008).Google Scholar
14. Tracleer–A cornerstone of oral therapy. 2007. http://www.tracleer.com/default.asp?page=HCP_AboutTracleer&kw=bosentan&gclid=CPP88t7K-5gCFQ9Jagodah6ToQ (accessed February 5, 2009).Google Scholar
15. Tu, JV, Bowen, J, Chiu, M, et al. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med. 2007;357:1393–1402.CrossRefGoogle ScholarPubMed
16. Tunis, S. Dealing with uncertainty in Medicare coverage decisions. Presented at the Health Technology Assessment International Annual Meeting. 2008. Montreal, Canada.Google Scholar
17. Tunis, SR, Pearson, SD. Coverage options for promising technologies: Medicare's ‘Coverage with Evidence Development’. Health Aff (Millwood). 2006;5:1218–1230.CrossRefGoogle Scholar
18. Steinberg, EP, Tunis, S, Shapiro, D. Insurance coverage for experimental technologies. Health Aff (Millwood). 1995;14:143–158.CrossRefGoogle ScholarPubMed
19. Wlodarczyk, JH, Cleland, LG, Keogh, AM, et al. Public funding of bosentan for the treatment of pulmonary artery hypertension in Australia. Pharmacoeconomics. 2006;24:903–915.CrossRefGoogle ScholarPubMed