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Coverage with Evidence Development for Pharmaceuticals: A Policy in Evolution?

Coverage with evidence development (CED) has been developed as a response to the uncertainty in evidence when new technologies, including pharmaceuticals, are introduced into the market. Rather than deny coverage for these technologies or grant them unlimited coverage, CED attempts to ensure that patients' access to new medications is not prevented but is managed in a coordinated way, while also generating additional evidence to reduce any uncertainty about the value of the medications. CED projects are currently operating in Australia, Canada, the United Kingdom, and the United States. However, decision-making about these projects is haphazard, and basic information about the projects is not publicly available. As a new policy development there are many unanswered policy questions, and no organized comprehensive strategy seems to be in place in any country for resolving these questions. Until these policy issues have been addressed, CED will have difficulty achieving its potential.