Rob Philo

In response to the rising importance of real-world evidence (RWE) in showing value to payers beyond traditional clinical trials, key opinion leaders emphasize finding cost-effective approaches, considering diverse patient populations, and using AI to pinpoint which patients will benefit most from treatment.

Delivering Value Beyond the Trial with Real-World Evidence

Real-world evidence (RWE) is no longer optional—it's expected. This episode dives into how payers assess RWE alongside clinical trial data, especially in competitive therapeutic areas. The panel stresses the importance of linking RWE to financial outcomes and making data relevant to specific patient populations. It's not just about data quality; it's about context and credibility.

How payers evaluate the financial impact of real-world evidence.

Distinguishing clean trial populations and diverse real-world patients.

Using AI to identify high-response patient populations and refine access.

The role of health equity and demographic alignment in data credibility.

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A panel of industry leaders emphasize the importance of early engagement with payers, real-world evidence, and value-based endpoints to ensure successful access, pricing, and long-term market viability—especially in a more complex, globally integrated reimbursement landscape.

Overcoming Regulatory Barriers to Market Access

As international price referencing tightens and payer expectations rise, companies face a shrinking margin for error. The panel explores how clinical trial design and early payer engagement are key to meeting both regulatory and reimbursement demands across global markets. With real-world evidence (RWE) from markets like Korea and Japan in hand, forward-thinking strategies can prove valuable.

Navigating international price referencing and fragmented regulatory standards.

Why payer engagement should begin as early as clinical trial design.

RWE as a tool for value messaging in global markets.

The diminishing threat of generics for advanced therapies like cell therapy.

Leading stakeholders in the industry react to how evolving US policies, payer demands, and vertical integration are reshaping market access strategy, stressing the importance of early planning and the urgency of ensuring that innovative therapies are available and affordable for patients.

Current Perspective on Pricing and Reimbursement Models

This Peer Exchange® starts off with an introduction of the panel: Edward Ahn, CEO of MEDIPOST, Inc.; Rob Philo, Founder and CEO of Core Market Access Advisors; and Shana Gunderson Hua, PharmD, Vice President of Value & Access at Petauri Advisors. Moderated by Ed Schoonveld, Value and Access Advisor at Schoonveld Advisory, LLC and columnist for 

, the discussion begins with the panelists reflecting on recent policy changes, including the anticipated Medicare Part D updates, and clinical trial design that satisfies FDA requirements and payer expectations.

Recent policy changes in the pharmaceutical landscape and what this could mean for payers.

The current design of trial, pricing, and reimbursement models.

Rob Philo

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