Achieving Balance with the AMCPFormat for Formulary Submissions, Version 4.0: A Dossier Producer’s Perspective

Abstract

Both authors are employed by Xcenda and develop AMCP Format dossiers.

Evolution of the AMCP Format for Formulary Submissions

“…For guidance on modeling economic outcomes, it made reference to ISPOR's best practice guidance for costeffectiveness and budget impact models. [17][18][19][20][21] The most recent version, Version 4.1, provides guidance for the communication of information about unapproved products and indications in the form of pre-approval dossiers in response to the 21st Century Cures Act and the FDA Final Guidance on industry communications with payers. [22][23][24]…”