5 questions on payer engagement with pre-approval information exchange (PIE)

Jasper Chang: Pre-approval information exchange (PIE) has been growing in use, and we wanted to better understand what that engagement looks like in practice. As we explored the topic, we found limited real-world evidence showing how payers engage with pre-approval information over time, before FDA approval. 

We were also uniquely positioned to help address this gap. By analyzing FormularyDecisions engagement data related to formulary decision-making, we had an opportunity to study how payers interact with information and evidence before a product reaches the market. The goal was to better understand that behavior using real-world data and contribute additional evidence to an area where research remains limited.

Sydney Harkins: Interestingly, the data did not fully support our original hypothesis. Before conducting the analysis, we believed engagement would be heavily concentrated immediately after a resource was posted and would then decline fairly quickly. 

Although engagement did increase after publication, it continued longer than we expected. That finding challenged one of our core assumptions and reinforced the importance of letting the data guide conclusions. As researchers, we want to understand real-world behavior, even when it differs from what we initially anticipated.

Sydney Harkins: One of the key findings was that payer engagement continued longer than we initially expected. Our analysis showed sustained engagement with resources for up to eight months after publication. Based on what we observed, that represented the longest period of meaningful engagement in our analysis. 

We also found that providing a mix of evidence resources may be valuable. Rather than focusing on a single type of information, the analysis suggested that organizations may benefit from making multiple forms of evidence available, including product information alongside clinical trial results. 

Cynthiya Ruban: One important takeaway is that pre-approval engagement may be more sustained than organizations expect. In this analysis, we observed engagement for up to eight months after publication, suggesting that evidence exchange should be considered an ongoing strategy rather than a single publication event. However, the eight-month period is specific to this dataset and should not be interpreted as a universal benchmark. Engagement may vary based on the evidence, product, therapeutic area, and timing relative to approval.

Jasper Chang: One surprising find was that payer engagement remained active for longer than we expected. Going into the study, we expected activity to concentrate shortly after publication and then decline quickly. Instead, the data showed continued engagement beyond that initial period.

Sydney Harkins: When we looked at engagement over time, we could see activity increase after a resource was published, which aligned with our expectations. What surprised us was that engagement remained relatively steady rather than dropping off immediately. 

That finding reinforced the value of studying real-world behavior. If we had relied only on assumptions, we might not have recognized the sustained engagement patterns that emerged from the analysis. 

Cynthiya Ruban: This study provides a baseline understanding of payer engagement with pre-approval resources in a real-world setting. The next step is to explore what may shape those engagement patterns, including evidence type, therapeutic area, payer organization, and timing relative to approval. We also want to better understand whether engagement differs across individual resources or combinations of evidence. This will help us move from describing when engagement occurs to generating more practical insights for future evidence-planning strategies.

One of the pieces in close collaboration with this poster is a white paper on this topic. That will have a more in-depth analysis, more practical recommendations, and emerging best practices.