It's NTAP Season!

During the wait between the CMS NTAP town hall in February and the proposed rule on which products will receive an add-on payment, expected in April, Prevision Policy analysts Laura Helbling and Ramsey Baghdadi share their thoughts on drugs seeking NTAPs, recommendations by BIO and the Alliance for Regenerative Medicines to modify NTAP for regenerative medicines, and FDA’s stance that its Breakthrough and RMAT designations don’t mean the agency has determined a drug is an improvement over existing therapy.