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Thursday, June 18 • 5:00pm - 6:00pm
#564 OD: On DEMAND - Communicating Value to Payers Pre-Approval in the US

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Component Type: Session
Level: Intermediate

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. In addition to clarifying the amendments to the Section 502(a) of Food Drug and Cosmetic Act about, the FDA provided an opportunity to further communicate about unapproved products and uses as it relates to Title 21 of the Code of Federal Regulations. However, there remains much uncertainty around pre-approval communication to payers. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the practical challenges with interpretation and operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions pre-approval.

Learning Objectives

Discuss how to proactively and compliantly communicate during pre-approval phase relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.


Sissi Pham, PharmD


Baking the PIE: The Recipe for Expedient Payer Decisions - How Early Data Sharing Can Improve Patient Access
Susan A Cantrell, RPh

Regulatory Considerations for Pre-Approval Communications with Payers
Denise Sanchez, JD, MPH, MS

Considerations for Pre-Approval Dossiers
Cosmina Hogea, PhD, MS

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 →
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 →
avatar for Susan Cantrell

Susan Cantrell

Chief Executive Officer, Academy of Managed Care Pharmacy (AMCP), United States
Susan A. Cantrell, RPh, CAE Academy of Managed Care Pharmacy Susan Cantrell is Chief Executive Officer of AMCP, the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP’s diverse membership of pharmacists, physicians... Read More →
avatar for Cosmina Hogea

Cosmina Hogea

Director, Value, Evidence, and Outcomes, GlaxoSmithKline
Cosmina Hogea is a seasoned professional with two decades of inter-disciplinary scientific research experience in diverse environments. She holds advanced degrees in Mathematics and Engineering and spent the past 15 years committed to evidence-based medicine and decision-making. She... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Session