menu toggle

Leveraging Pre-Approval Information Exchange to Accelerate Product Success and Patient Access

By Alvana Maliqi

This article was originally published on

In the ever-evolving landscape of pharmaceuticals, effective communication between biopharma companies and payers is pivotal for bringing innovative therapies to market successfully.

Taking center stage on multiple occasions, Cencora was a proud supporter of this year’s AMCP Annual conference in New Orleans. From informative sessions on the evolution of the AMCP Format for Formulary Submissions 5.0 and the pivotal role of pre-approval dossiers in successful product launches, to award-winning research, our experts showcased our commitment to helping our biopharma partners accelerate product success.

Alvana Maliqi, PharmD, MBA, Associate Director of Value and Access Strategy at Cencora, part of the Commercialization Strategy and Access Solutions division, was at the forefront of groundbreaking research on pre-approval information exchange (PIE) and on how biopharma manufacturers can utilize this information more efficiently. In an interview with PharmExec, she discusses the benefits of the PIE legislation, which allows biopharma companies to share unbiased information on upcoming products and indications with payers.

Key highlights:

  • The PIE legislation offers a strategic pathway for biopharma companies to engage with payers on new products and indications within a safe harbor framework.
  • Despite progress in pre-approval communication, there remains a disparity between the information payers value and what manufacturers provide, emphasizing the need for tailored and transparent data exchanges.
  • Payers' preferences for receiving pre-approval information vary, with an increasing demand for early insights into high-cost or high-utilization categories such as cell and gene therapies, oncology, and rare diseases.

To bridge these gaps and pave the way for enhanced collaboration:

  • Manufacturers are encouraged to initiate discussions with payers early in the development cycle to align informational needs effectively.
  • Tailored data delivery tailored to each payer's unique requirements can significantly improve decision-making processes.
  • Clear, transparent and timely updates are paramount in fostering a compliant but impactful communication channels between stakeholders.

For more insights on improving communication between biopharma manufacturers and payers regarding pre-approval information exchange, read the full interview here.

We are Cencora. Our shared identity unites us.

Cencora brings the companies and services of AmerisourceBergen together under one new name. Check out our full life cycle commercialization solutions, and contact us today to learn more.

About The Author

Alvana Maliqi
Associate Director of Value and Access Strategy
View Bio