Spotlight on Formulary Management
ACPE UAN: 0233-0000-19-035-L04-P | Contact Hours: 1.25 | Activity Type: Knowledge-based
Pre-approval information exchange (PIE) provides an opportunity for biopharmaceutical manufacturers and health care decision-makers to proactively discuss health care economic information related to investigational (i.e., unapproved) drug products. The Food and Drug Administration released final guidance in June 2018 that provides opportunities for this information to be shared, provided that the manufacturer complies with certain requirements.
What is happening with PIE today? What are manufacturers and payers doing with PIE and what barriers currently exist? What benefits does PIE bring to both payers and manufacturers?
This session will review the status of current legislation surrounding pre-approval information exchange including the possible path forward. This session will discuss survey results among both manufacturers and payers on pre-approval exchange. In addition, this session will provide a pharmaceutical industry perspective on the current barriers to PIE implementation and potential opportunities for success.
At the completion of this activity, participants should be able to: