Are You Maximizing PIE's Potential? 

Pre-Approval Information Exchange (PIE) enables life sciences manufacturers to provide clinical, health economic, and other information to Health Care Decision Makers (HCDM) before FDA approval to help make formulary and patient access decisions. 

Recent legislation and clarified FDA guidance on PIE eliminated long-standing ambiguity around what can and cannot be shared with payers and HCDMs. Now, with firmer regulatory guardrails in place, you can fully leverage the PIE process to bring valuable clinical and economic insights to the right stakeholders at the right time. We have successfully worked with companies to create EHR Readiness Tools that can be used to respond to questions from health systems about how to identify patients and requirements for new treatment protocols.  These tools have been well received by health systems and help to continue discussions from initial pre-approval information exchange information through approval. 

The Shift: Clarity Unlocks Opportunity 

With new legislation providing greater certainty around PIE customer engagements, there is no need for manufacturers to navigate a gray area. You now have explicit guidance on how to communicate with payers, integrated delivery networks (IDNs), and other decision-makers about new products and indications in advance of FDA approval. This is a crucial shift. Why? Because it allows you to: 

• Ensure payer readiness – Giving market access teams the ability to proactively share pre-approval data means that when your product launches, reimbursement and coverage decisions are already well-informed. 

• Support providers with better insights – By strategically sharing economic and clinical data early, you help equip providers with the evidence they need to understand patient utilization projections, make formulary decisions, and provide patients with access to innovative therapies. 

• Align internal teams – With clearer regulatory boundaries, marketing, health economics (HECON), managed care, and market access teams can collaborate more effectively to craft compelling, compliant pre-approval information to assist health systems in preparing to implement a new treatment. 

Strengthening Your PIE Dossier: Beyond the Basics 

The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions is a widely accepted template for presenting products, clinical trials, health economics, and other supporting evidence to HCDMs. A critical component of PIE dossiers is guidance for providers on configuring EHR systems to support real-world implementation of a new treatment. 

• Identifying the right patient population – Providers can use their EHRs to identify eligible patients who may benefit from the new treatment to make forecasts and budget impact models. 

• Setting up EHR and other digital health workflows – Information and instructions needed to configure the EHR workflow to prescribe and administer a new treatment along with patient support programs and distribution networks 

• Tracking outcomes – Using EHR-based mechanisms, to track and analyze data that informs future formulary decisions. 

These strategic additions can make a significant impact on payer and provider readiness, making your pre-approval resources much more valuable and practical tools for planning when an approval does occur. 

Seizing the PIE Advantage for Health System Customers 

The firms that get PIE right won’t just be compliant—they’ll gain a competitive edge. Instead of waiting until launch to begin market education, your team can use PIE to provide providers with the information they need to implement a new treatment. This includes the EHR information and instructions needed to streamline prescribing and provide patients access at FDA approval.  

That’s where we come in. At POCP, our experts deeply understand the EHR and can help you develop an essential component of your pre-approval materials for EHR Readiness. Our broad market experience across technology vendors and providers makes us a valuable member of your PIE team.  

The Time to Act is Now 

With clearer regulatory guidance in place, the window to fully capitalize on pre-approval EHR discussions is wide open—but only for those who take action. Are you ready to ensure your market access and payer engagement strategies are ahead of the curve? 

Let POCP’s deeply knowledgeable team help you build the critical EHR pieces to support an upcoming launch, ensuring you not only meet compliance requirements, and address health system requests for information, but also speed adoption by assisting health systems to prepare for your launch in advance. Reach out today to start the conversation.