Optimize your pre-approval information exchange (PIE) approach

Closing the pre-approval communication gap

The Pre-Approval Information Exchange (PIE) Act, codified in the Consolidated Appropriations Act, 2023, enables biopharma companies to share certain health care economic and scientific information with healthcare decision-makers (HCDMs) before their product’s FDA approval.

PIE creates the opportunity for biopharma companies to engage proactively with HCDMs about their pipeline products, provided that certain requirements are met. Biopharma companies that do not participate in PIE are missing an important step in their commercialization process—one that can have implications for their product's uptake.

Despite the progress made since FDA’s Final Guidance on PIE in 2018, challenges in meeting HCDM needs persist. Cencora’s strategy focuses on delivering customized, timely, and clear information. By initiating early engagement and utilizing diverse communication channels, biopharma companies can strengthen relationships and strategically position their products for success.

HCDMs want more pre-approval resources and engagement from biopharma companies

In a survey of 41 HCDMs from Cencora's proprietary Managed Care Network, fielded from May 6-16, 2024:
56%
received pre-approval information on few or none of the products that were FDA approved in 2023
61%
perceived a gap in the pre-approval information needed as compared to what was shared by the biopharma company or publicly available, up from 47% in 2023

Maximize your therapy’s potential with the AMCP Format - Download our guide to get started. 

Want a more successful launch? Prime the market

PIE helps biopharma companies engage HCDMs early to build strong relationships, understand unmet needs, and gather direct feedback on clinical data. Our team of market access experts has built launch strategies and compelling deliverables for 25+ years. We are a leading expert in PIE and the identification and delivery of clinical and economic evidence:

  • 80+ PIE projects
  • 50 PIE clients
  • 4 PIE/HCEI national training programs with the Academy of Managed Care Pharmacy (AMCP) 
 

Achieve strategic payer engagement with FormularyDecisions®

FormularyDecisions connects biopharma companies with HCDMs through a secure, online platform, enabling real-time information exchange that enhances traditional interactions and maximizes your reach. Our Resource Center ensures a 24/7 access to your PIE via the largest online community of HCDMs in the US.

 

Stay ahead of the curve with the latest insights and best practices for implementing PIE

Webinar

The missing PIEce: Best practices for implementing Pre-approval Information Exchange (PIE) in a payer communication plan

meeting

Article

Cencora PayerPulse: The benefits of engaging in pre-approval information exchange (PIE)

Article

Empowering healthcare decision-making: A reflection since FormularyDecisions' five-year acquisition

Article

Insights from AMCP Nexus: Navigating pre-approval information engagement in oncology and rare diseases

Article

Insights from AMCP: 4 questions with Ben Penley

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Explore our FormularyDecisions webinar library

View our curated collection of informative webinars that cover a wide range of healthcare topics. Stay current with the latest sessions by registering for upcoming webinars and accessing past recordings.

We’re here to help

Connect with our team today to learn more about how Cencora is helping to shape the future of healthcare.

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