Summary of workshop held November 2011 to explore the barriers and potential solutions of aligning adaptive licensing with coverage with evidence development (CED).

In November 2011, CMTP hosted a workshop in collaboration with MIT’s Center for Biomedical Innovation New Drug Development Paradigms (NEWDIGS), to  explore the barriers and potential solutions of aligning adaptive licensing with coverage with evidence development.

Using adaptive licensing, companies recieve regulatory clearance to bring health technologies to market more quickly, recognizing that the technology (and related benefits and risks) evolve over time. Adaptive approaches go through an iterative process of evaluating the benefits and risks of emerging technologies with several smaller steps, as the technology is used in real-world clinical settings.

Meanwhile, CED enables payment for approved therapies if patients agree to further data collection so researchers can assess real world effectiveness. 

While adaptive liscensing and CED are often seen as distinct areas of policy reform, both approaches encourage faster and safer introduction  of new products and ongoing data collection.  This workshop explored the benefits and risks of linking these regulatory reimbursement schemes. 

A summary report on the workshop is available here.

Tags:

• Coverage with Evidence Development
• Health Policy
• Meeting Summaries

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• Adaptive Licensing & CED Workshop