Coverage with evidence development (CED) is a form of managed entry agreement for new health technologies, especially pharmaceuticals, where the technology is reimbursed (‘covered’) a limited period of time with a specific requirement for the collection and presentation of further evidence.  The term was popularised by the US Centers for Medicare and Medicaid Services (CMS), and similar approaches carrying different names (e.g. managed access agreement, ‘conditional reimbursement’, ‘interim funding’) are applied in many other countries.  The use of CED reflects the increasing demand for early access to new interventions for patients with high level of unmet need, when there remain important uncertainties about clinical and cost-effectiveness. Frequently CED is applied with a price discounts or a patient access scheme, which can be revised when more evidence is available.  Health care systems have found it challenging to put into place a large number of (varied) evidence generation schemes, and there have been questions about the usefulness of the new evidence (timeliness, failing to resolve uncertainty) and who pays for the new activity.


How to cite: Coverage with Evidence Development [online]. (2016). York; York Health Economics Consortium; 2016.