Meet the Authors

Jay Jackson

Partner, Market Access Practice Lead

Pre-approval Information Exchange Playbook

Strategies for incorporating Pre-approval Information Exchange (PIE) into product launches

The Pre-approval Information Exchange (PIE) Act, also known as the 2023 Omnibus Consolidated Appropriations Bill (Section 3630), is more complex than expected. In this playbook, we clarify the gray zones, share how to interpret the policy, and how to take advantage of these new rules when launching


Herspiegel has identified 5 key questions companies should think through and gain clarity on, to maximize the impact of PIE for all stakeholders. 

  1. How does PIE benefit payers and manufacturers? 
  2. What is the process for communicating and leveraging PIE?
  3. Who can deliver the information and to what audience?
  4. When can/should information be delivered: ideal process, timing,
    key steps, milestones, and key deliverables? 
  5. What are the challenges for manufacturers to successfully
    incorporate PIE into their current workflows?
While PIE has been much anticipated and needed, there are still areas that require careful interpretation. This is why Herspiegel has put together this playbook for companies who need strategies for incorporating PIE into their product launches.

Pre-approval Information Exchange Playbook

Strategies for Incorporating PIE into Product Launches

With the experience of 125+ product launches, Herspiegel knows that early dialogue between payers and pharmaceutical manufacturers is critical for success.

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Herspiegel is a leading professional services firm helping biotech start-ups and the world’s largest pharmaceutical companies navigate the path from science to brand performance and change patients’ lives. We are committed to using strategic insights from medical to commercial to market access to solve critical problems.