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Session 8: Navigating Market Access and Payor Engagement Strategies: HCEI and PIE, Oh My!
Session Chair(s)
Alyson Andrikanich, PharmD
Senior Director, Advertising and Promotion, Regulatory Affairs Americas, Bayer, United States
Lynn Bowen, PhD
Vice President, Regulatory Affairs Advertising Promotion & Labeling, Alkermes, United States
As the healthcare landscape continues to evolve, timely and effective communication between life sciences companies and key stakeholders is critical to ensure patient access to innovative therapies. This panel will explore the regulatory frameworks and best practices surrounding the use of Real-World Evidence (RWE), Healthcare Economic Information (HCEI) and Preapproval Information Exchange (PIE) in support of market access strategies. Panelists will discuss how companies can responsibly share product value information with payers and healthcare decision-makers, while remaining compliant. The session will address challenges and opportunities for proactive, compliant engagement across the product lifecycle—from pipeline to post-approval.
Interpretation of the Communications with Payors Guidance
Alan Minsk, Arnall Golden Gregory LLP
Navigating Market Access and Payor Engagement Strategies
Gregory Ringenberg, ProPharma
Learning Objective : - Recognize the key types of data supporting payor communications, including RWE and HCEI
- Discuss the current regulatory landscape governing communications with payors
- Describe ways to guide compliant strategies for engaging payors in the pre-approval period
- Identify recent trends, guidance, and enforcement actions impacting market access communications
Speaker(s)
Alan G. Minsk, JD
Partner, Head of Food and Drug Team, Arnall Golden Gregory LLP, United States
Interpretation of the Communications with Payors Guidance
Gregory Ringenberg, PharmD, MS, RPh
Consulting Vice President, ProPharma, United States
Navigating Market Access and Payor Engagement Strategies
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