What is Pharmaceutical Information Exchange (PIE)?
Pharmacuetical Information Exchange refers to the ability for pharma companies to communicate certain information about investigational agents (unapproved drugs) with population health decisionmakers (PHDMs) such as payers. This can include both clinical information as well as healthcare economic information (HCEI). PHDMs have particular interest in this information as it helps them plan for upcoming products including assessments on how it may impact their budgets, etc.
The FDA guidance on payer-manufacturer communications provides guidelines to manufacturers on what is appropriate in preapproval communications with PHDMs. Following publication of the guidance, AMCP updated the AMCP Format for dossiers to reflect the additional clarity.