Coverage with evidence development

Coverage with evidence development (CED) is a type of managed entry agreement for new health technologies, especially pharmaceuticals. Under this model, a technology is reimbursed (‘covered’) for a limited period, but with the specific requirement that further evidence is collected and presented to address remaining uncertainties. This approach is used when there is a strong demand for early patient access to new interventions—especially for conditions with high unmet needs—but important uncertainties remain about their clinical and cost-effectiveness.
While the term was popularised by the US Centers for Medicare and Medicaid Services, similar strategies exist globally under different names, such as managed access agreements or conditional reimbursement. These schemes often include a price discount or patient access scheme that can be revised once new evidence becomes available. Implementing and managing these evidence collection schemes has proven challenging for health systems. Concerns have also been raised about the quality and timeliness of the new evidence, its ability to resolve the initial uncertainties, and who is responsible for funding the additional research.