Coverage with Evidence Development: applications and issues.
OBJECTIVE
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.
Trueman
Paul
P
Health Economics Research Group, Brunel University, Uxbridge, Middlesex UB8 3PPH, UK. Paul.Trueman@brunel.ac.uk
Grainger
David L
DL
Downs
Kristen E
KE
D003362:Cost-Benefit Analysis; D004864:Equipment and Supplies / Q000191:economics; D019317:Evidence-Based Medicine / Q000191:economics / Q000458:organization & administration*; D006801:Humans; D019458:Insurance Coverage / Q000191:economics / Q000458:organization & administration*; D007348:Insurance, Health / Q000191:economics / Q000458:organization & administration*; D055553:Prescription Drugs / Q000191:economics; D020414:Risk Sharing, Financial; D013514:Surgical Procedures, Operative / Q000191:economics; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000458:organization & administration*; D016896:Treatment Outcome
D055553:Prescription Drugs