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Monday, June 24 • 11:00am - 12:00pm
#120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA Payer Guidance released in 2018 has provided some clarity to industry and payers. The FDA explicitly noted the important difference between information required for medical product approval and what is needed by payers to make decisions about population-based coverage and reimbursement. The FDA Payer Guidance is largely pragmatic regarding HCEI communications and advances industry’s proactive dialogue with payers. However, there remains areas of uncertainty within the guidance. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the challenges with developing a guidance for industry and payers, the practical challenges of operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions.

Learning Objectives

Discuss how to decrease the anxiety in proactively communicating relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.


Sissi Pham, PharmD


FDA Perspective
Sheila Ryan, MPH, RAC

Chris Leo Pashos, PhD

Mitchell Higashi, PhD

Denise Sanchez, JD, MPH, MS

avatar for Mitchell Higashi

Mitchell Higashi

Vice President, Health Economics and Outcomes Research, Bristol-Myers Squibb
Mitch is the Vice President of HEOR at Bristol-Myers Squibb. Prior to joining BMS, he was the Chief Economist for GE Healthcare, where he led global efforts in health economics, pricing, reimbursement, and health policy. Mitch is a published author, including JAMA, and his work in... Read More →
avatar for Chris Pashos

Chris Pashos

Vice President, Global Evidence Strategy, AbbVie Inc.
Dr. Pashos oversees AbbVie’s Real-World Evidence Generation and Patient Centric Research Center of Excellence, demonstrating the value of medicines in addressing needs perceived by regulators, health technology assessment agencies & payers, the medical community and patients. He... Read More →
avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA, United States
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →

Sheila Ryan

Acting Director, Division of Supply Chain Integrity, Fda/cder/Office Of Compliance/Office of Drug Security, Integrity and Response
Sheila Ryan, PharmD, MPH, RAC is currently the Acting Director of the Division of Supply Chain Integrity in the Office of Drug Security, Integrity and Response within CDER's Office of Compliance at FDA. She has over 15 years of FDA regulatory experience, including over 10 years in... Read More →
avatar for Denise Sanchez

Denise Sanchez

Executive Director, Commercial Regulatory Affairs, Allergan
Denise is a leader in the commercial regulatory space with 15 years of combined industry, government and law firm experience. Industry roles include Regulatory overview of commercial promotion and practices at Allergan Aesthetics, Ironwood, Celgene, & Cubist. At the law firm of Hughes... Read More →

Monday June 24, 2019 11:00am - 12:00pm PDT
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  12: Value-Access, Session |   05: Patient Engagement, Session |   04: MedAffairs-SciComm, Session