An AMCP and Xcenda Training Program.
It’s been nearly two years since the U.S. Food and Drug Administration (FDA) provided final guidance on preapproval information exchange (PIE). Since then, payors have received information from manufacturers about medical products that are not yet approved by the FDA for any use as well as unapproved uses of already approved medical products. This information may allow payors to plan and budget for future coverage and reimbursement decisions before FDA approval.
This AMCP Corporate Training will outline how to leverage PIE within FDA’s guidance, especially for oncology products and rare diseases given the disproportional number of these products in the biopharmaceutical pipeline.