Payers keep coming back to pre-approval evidence long after it's posted | AMCP Nexus 2026

Payers don't look at pre-approval drug information once and move on, according to a poster being presented at AMCP Nexus 2026 this week. In fact, more than 60% of payer engagement with pre-approval resources happened more than 90 days after the materials were first posted, the poster noted, which is available ahead of the meeting on the Journal of Managed Care & Specialty Pharmacy’s (JMCP) website and through AMCP’s online meeting coverage for attendees.

This year’s fall meeting welcomes experts in managed care from Oct. 26 to 29 in San Diego.

The research, conducted and sponsored by Cencora, looked at how payers used evidence that biopharma companies shared before FDA approval. The findings suggest payers review this information over many months, not just when it first becomes available.

“One of the most interesting findings from this research was that payer engagement continued well beyond what we initially expected,” Cynthiya Ruban, Ph.D., M.Sc., director of digital solutions at Cencora and a co-author of the poster, told Managed Healthcare Executive in an email. “While every product and therapeutic area is different, the findings suggest that evidence review may be an ongoing process rather than a single point in time activity.”

Why timing matters for PIE

Pre-approval information exchange (PIE) lets biopharma companies share clinical and economic evidence with payers before the FDA approves a product. Payers use that information to plan formularies and prepare for therapies still in the pipeline.

In June, the FDA released revised draft guidance on how drug and device manufacturers can communicate with payers and formulary committees. The draft extends the framework to medical devices and carries out a statutory safe harbor for sharing information about investigational products. It would replace the agency's 2018 final guidance on the topic.

Even as PIE use grows, there is little real-world evidence on how payers engage with these materials over time, the authors wrote. Most attention goes to the initial release.

Engagement stretched across months

Researchers analyzed 153 resources for 32 pre-approval products on FormularyDecisions, a Cencora platform where biopharma companies post materials for verified payers. The data covered June 2018 through April 2026. Engagement included clicks, views and downloads by payers. Multiple actions during one visit were counted separately.

The median time from when a resource was posted to a payer's first engagement was 149 days, or about five months. The mean was about 249 days, or roughly eight months. Close to 37% of engagement came within 90 days of a resource being posted, while more than 60% came after that. About 22% came more than a year after posting.

“What this research highlights is that payers are often building their understanding over time as new evidence emerges, market landscapes evolve, and organizations prepare for future coverage and formulary discussions,” Ruban said.

Based on the findings, the authors concluded that biopharma companies should provide pre-approval resources at least eight months before expected FDA approval and update them as needed. Ruban said starting early is important, but so is making sure payers have relevant evidence throughout the product lifecycle.

“The greatest opportunity is not simply sharing information sooner,” she said. “It is creating a meaningful and continuous dialogue that supports informed decision making as payer needs evolve.”

Clinical data first, real-world evidence later

The type of evidence also made a difference. Clinical trial data and PIE presentations drew the most engagement and tended to be opened earlier than other resources. Real-world evidence and disease-state awareness materials were first opened later in the pre-approval period, but engagement with them lasted longer. Payers also returned to the same files on separate days, which the authors said suggests they revisit evidence as their needs change.

Early in the process, Ruban said, payers are often focused on “the foundational clinical value of a therapy, including efficacy, safety, study design, and its potential place within the treatment landscape.”

“As payers move closer to decision-making, the questions they are asking may become broader and more complex,” she said.

At that stage, payers may look at how trial results could play out in real-world practice, including which patients are treated, treatment patterns and effects on the healthcare system, coverage and access.

Ruban cautioned that more research is needed to understand these patterns. But she said the findings reflect something Cencora often hears from its biopharma partners: “no single evidence source answers every question.”

This study does have limits. For example, the authors noted that the analysis spans 2018 to 2026, a period when PIE guidance and manufacturer adoption were still evolving. The data also come from a single platform run by the study's sponsor.

Ruban said the research “begins to shift the conversation from whether evidence is being accessed to understanding how evidence needs may change over time.”