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Optimize your pre-approval information exchange strategy

By Charles Dragovich

Why biopharma companies should consider fully embracing the FDA’s pre-approval communication guidance

Disclaimer: The material contained in this publication is not legal advice. The writers of this material are not lawyers. The reader must make their own decisions about the accuracy of the opinions expressed. Readers are encouraged to consult their own legal counsel and other professional advisors before taking any actions based on information found in this publication.

Biopharma companies that do not fully participate in pre-approval information exchange (PIE) with payers are missing an important step in their commercialization process. The PIE Act of 2022 was included the Consolidated Appropriations Act, 2023, signed into law on December 29, 2022, and reinforces the opportunity to further engage payers prior to a new product launch.1 This law is a permanent change—not merely guidance— that provides a safe harbor for pre-approval communications. 

AmerisourceBergen was part of a large number of companies, led by The Academy of Managed Care Pharmacy (AMCP) that supported this legislation. The Government Accountability Office (GAO) also plans to create a report on PIE utilization five and a half years after the bill is enacted.

What is PIE?

PIE is the communication of information to healthcare decision makers (HCDMs) about therapies in development that allows for better budget planning, earlier formulary coverage discussions, and may accelerate patient access. PIE creates the opportunity for biopharma companies to engage proactively with HCDMs about their pipeline products, provided that certain requirements are met. It is important to note that PIE presents an opportunity to exchange pre-FDA approval information as early as 12 to 18 months in advance.

Pre-approval communication between biopharmaceutical companies and population HCDMs also enables manufacturers to obtain feedback from payers on clinical data and other information that may inform final launch plans and post-approval evidence strategy.

PIE implementation across the industry

The 2021 AmerisourceBergen biopharma and payer survey2 provided valuable insights into to how PIE has been adopted across the industry prior to the passage of the Consolidated Appropriations Act, 2023. The survey results showed that:

  • 74 percent of payers said factual presentations of study results and product pricing are extremely important to receive proactively
  • More than 80 percent of respondents prefer to conduct PIE up to 12 months prior to approval
  • The top preferred method for manufacturer representatives to conduct PIE with payers is in-person meetings, followed by individual web-based meetings
  • 67 percent of payers believe that formulary decision making would be very much or extremely improved by leveraging PIE to close information gaps
  • More than a third of payers would like PIE earlier for cell and gene therapy, followed by innovative therapies, rare disease and oncology, compared to other categories
  • The most valuable pre-approval communications prior to phase 3 results are information on the trial, indication, place in therapy, and pricing

Common misperceptions regarding PIE implementation

Although the Consolidated Appropriations Act, 2023 clarifies a number of factors related to PIE, there have long been misperceptions in the industry, including: 

  1. Only clinical data are allowed or wanted
    The FDA allows exchange of clinical information along with certain economic information or analysis that measures or describes the economic consequences of the use of a product, including utilization projections, burden of illness and other types of data.
    2. PIE creates new intended uses for products
    The FDA guidance is very clear that PIE does not create new intended uses if PIE complies with certain requirements.
    3. Only medical teams may present PIE information to HCDMs
    The FDA guidance does not address who should provide the information. It only provides guidance on who should receive it from the healthcare side by defining the healthcare decision makers. 
    4. Pre-approval dossiers are large, complicated documents
    Pre-approval dossiers are typically not as large as post-approval dossiers. In addition, companies can use the pre-approval dossier as the foundation for their post-approval dossier and save time and money during development.
    5. Payers only want the price of the unapproved product or unapproved indication
    Most payers understand that final pricing is difficult to provide until the FDA issues final labeling for the product upon approval. Payers do want to hear any information about potential pricing ranges if possible. However, as noted above, payers are also interested in clinical trial and other economic information.
    6. Manufacturers are not providing any pricing information during PIE
    Some manufacturers are giving a target price range because they want to discuss potential contracting with payers. What type of information is provided to an HCDM is at the discretion of the manufacturer as long as it meets the requirements of the Consolidated Appropriations Act, 2023 
    7. Posters and abstracts do not meet PIE guidelines
    Clinical data that can be shared as part of PIE is not determined by the format, but more by the content.  What’s more important is that it adheres to the content guidance, i.e., truthful, non-misleading, etc.  and the appropriate guardrails.


  1. H.R.2617 - Consolidated Appropriations Act, 2023. 29 December 2022. Accessed 21 Feb 2023 Available at:
  2.  Xcenda. PIE and HCEI Managed Care Trends Report. 2021



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