Spotlight on Formulary Management

[F4] The Road to Pre-Approval Information Exchange: Where Are We Today?

ACPE UAN: 0233-0000-19-035-L04-P | Contact Hours: 1.25 | Activity Type: Knowledge-based

Faculty(s)

• 

  Elisabeth Brisley, MPH

  Legislative Analyst
  Academy of Managed Care Pharmacy
  Alexandria, Virginia
• 

  Amy Duhig, PhD

  Vice President, Consulting Services
  Xcenda, LLC
  Palm Harbor, Florida
• 

  Sheila M. Thomas, PharmD

  Global Head, Patient Insights and Engagement Strategy
  Sanofi, Inc.
  Bridgewater, New Jersey

Moderator(s)

• ES

  Elizabeth Sampsel, PharmD, MBA, BCPS

  Vice President, Payer Strategy and Relations
  Dymaxium
  Mandeville, Louisiana

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.

Learning Objectives:

At the completion of this activity, participants should be able to:

1. Summarize the latest changes in the legislative and regulatory environment governing proactive communications between manufacturers and payers and the impact on managed care pharmacy.
2. Define the type of information and level of evidence payers need from manufacturers to make informed formulary and coverage decisions.
3. Identify ongoing gaps and possible solutions with the implementation of pre-approval information exchange between manufacturers and payers.
4. Based on recent survey results on pre-approval information exchange, describe trends among payers and manufactures as they relate to pre-approval information exchange.