The recent clarifications around Pre-approval Information Exchange (PIE) have created a prime opportunity for life sciences manufacturers to provide payers and healthcare decision-makers with the insights they need before Federal Drug Administration (FDA) approval to make formulary decisions. But beyond clinical and economic data, there’s another critical element that many companies may be overlooking: Electronic health record (EHR) preparation. 

The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions includes sections such as clinical trial results, FDA approval timelines, and health economics. It also includes sections with information needed to implement a new treatment, such as pricing, distribution networks, and patient support programs.

The Missing Piece in PIE Discussions: EHR Integration 

Providers are constantly balancing new treatments against budget impact and patient outcomes. EHR capabilities offer a way to translate health economics, real-world evidence (RWE), and epidemiological data into custom forecasts and budget impact models, but setting up these reports and automations can be a significant barrier. 

Providers need to operationalize new treatments in the EHR to provide access to patients. The EHR workflow needs to be configured so new treatments can be prescribed and administered to patients at FDA approval. 

This is where life sciences manufacturers have an opportunity to add real value. Instead of just providing economic models and clinical data, consider including detailed EHR configuration instructions in your PIE dossier. These instructions can help providers and payers: 

• Identify the right patient population – Establishing EHR-based screening criteria to flag patients who may benefit from early intervention. 

• Establish New Testing Protocols – Helping providers in planning for new tests or increased testing to identify appropriate patients, plus, ensure that test results are available for query in the EHR. track patient enrollment in digital health programs or other pilot initiatives. 

• Set up the new treatment in their EHR – Ensuring accurate order sets, treatment protocols, and patient support resources are in place from day one. A Win-Win for Market Access and Real-world Evidence 

Many manufacturers include EHR setup as part of their post-approval launch planning, but by that point, valuable time has already been lost. Incorporating these resources into the earlier pre-approval discussions ensures that the necessary EHR configurations are already in place when a treatment is approved. This proactive approach eliminates delays in provider adoption, making for a smoother, faster market entry. 

By including EHR implementation guidance in your PIE dossier, you’re not just helping providers—you’re also strengthening your case with payers. With structured, real-world data collection baked into the EHR setup from the start, manufacturers can facilitate easier value assessments, outcomes tracking, and budget impact modeling, making it simpler for payers to make favorable coverage decisions. 

Take the Next Step in Maximizing Pre-approval EHR Planning 

Life sciences companies that go beyond the basic requirements of PIE and integrate EHR implementation guidance into their activities will be the ones that stand out. The question is: Are you taking full advantage of this opportunity? 

At POCP, we specialize in helping manufacturers craft strategic, high-impact EHR Readiness Tools that don’t just meet regulatory requirements but actively help health systems and other providers implement and assess new therapies. 

Let’s talk about how to make your Pre-Approval EHR Readiness resources work harder for you. Reach out today.