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Will Breakthrough Therapies Face Reimbursement Challenges?

 
• By Sue Sutter

After an Aetna official suggests there may be reimbursement uncertainty for products developed under the new expedited regulatory pathway, CDER Director Woodcock defends FDA’s review process and says such drugs are expected to be robustly more effective than existing treatments.

FDA and pharmaceutical sponsors may have to combat third-party payer skepticism about the level of evidence supporting approval of breakthrough therapies.

At a Sept. 6 conference on development of companion diagnostics for breakthrough therapies, an Aetna representative said payers are “nervous”...

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More from North America

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• By Cathy Kelly

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