The FDA’s Accelerated Approval Program (AAP) aims to bring promising, potentially life-saving medicines to patients sooner by allowing approvals based on surrogate endpoints while requiring timely confirmatory evidence. In this episode, we speak with Bridget Doherty, MPH, MS (Johnson & Johnson Innovative Medicine), and Jeff Allen, PhD (Friends of Cancer Research). Bridget discusses her team’s review of the AAP’s real-world impact, showing that hundreds of thousands of meaningful life-years have been gained for patients. Jeff shares findings from work strengthening biomarkers as reliable surrogate endpoints—helping define when increased speed can still preserve scientific rigor. We also explore the core access challenge: how payer coverage and utilization management help or hinder patients the AAP is designed to serve. We close with practical policy steps to ensure that earlier regulatory access truly leads to better outcomes for people who need treatments most.

• Bridget Doherty, MPH, MS, Johnson & Johnson

• Jeff Allen, Friends of Cancer Research

• J&J Center for U.S. Healthcare Policy Research

• Friends of Cancer Research

• Accelerated Approvals in Oncology Tracker

• Drug Development Dashboards

• 30 Years of Accelerated Approval: Data-Driven Insights

• Analysis of FDA Biomarker Qualification Program

• Original JNCCN Study

• How Gleevec Transformed Leukemia Treatment

• Immunotherapy

• Surrogate Endpoints

• Confirmatory Trials

• Years Gained from the FDA Accelerated Approval Program (2024)

• Circulating Tumor DNA (ctDNA)

• ctMoniTR Project

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In this episode, we talk with Richard Xie, Senior Health Economist at RA Capital, and Gunnar Esiason, Senior Director of Patient Engagement at Raven (RA Capital Ventures), about value frameworks in pharma. We unpack how Generalized Cost-Effectiveness Analysis (GCEA) builds on traditional Cost-Effectiveness Analysis (CEA) and differs from ICER’s model. The conversation explores what these approaches mean for pricing, access, and patient voice—especially in rare and high-innovation settings.

Through the Cidara CD388 flu drug case, we discuss how assumptions shape value and trade-offs from manufacturer and patient perspectives. The episode highlights how evidence, incentives, and outcomes align—or conflict—in today’s system, and what reforms could better connect value frameworks to affordability and equitable access.

• Richard Xie, Senior Health Economist, RA Capital Management
• Gunnar Esiason, MBA, MPH, Senior Director, Head of Patient Engagement and Patient-Centered Innovation, Raven (RA Capital Ventures)
• Patient-Centered Value Assessment Models
• Episode 26: Sarah Emond, ICER
• Peter Kolchinski, The Great American Drug Deal
• NICE (UK)
• CDA (Canada)
• Australia CHAP
• Trikafta
• ICER Report on Cystic Fibrosis
• No Patient Left Behind
• GCEA Calculator
• Boomer Esiason Foundation
• Aurora Biosciences
• Most-Favored-Nation Drug Pricing Order

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