Prescription for Better Access

In this episode, we welcome back Sarah Emond, President and CEO of the Institute for Clinical and Economic Review (ICER), to discuss an exciting new development in the industry: the release of ICER’s second annual Launch Price and Access Report. We dig into the report’s findings and explore why median net launch prices have climbed over the past several years, what the data show about delays and cost sharing for patients trying to get newly approved drugs, and what manufacturers, payers, and employers could do differently. Sarah makes the case for a voluntary de-escalation, with prices set in line with value and met by streamlined access. We also explore the role of purchasers, her call for a federally funded consortium of independent assessment groups, and her concerns about MFN.

• Sarah Emond, ICER

• Institute for Clinical and Economic Review (ICER) 

• Episode 26: An Interview with Sarah Emond, MPP, President and CEO, ICER

• Episode 30: The Future of Access, a Live Podcast Recording from the ACCESS US 2025 Conference

• 2026 Launch Price and Access Report

• ICER Fair Access Criteria: Cornerstones of “Fair” Drug Coverage

• Medicare Part D Out-of-Pocket Cap (CMS)

• Medicaid Drug Rebate Program

• ICER Scientific Advice

• Medicare Drug Price Negotiation Program

• Peterson Health Technology Institute

• Most Favored Nation Drug Pricing

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• Casey Cormier, Stratis Group

• Emily Gibb, Novartis

• Stratis Group | Nexus Health

• Novartis

• Breaking Down Barriers: An Interview with Peyton Howell

• An Interview with Kathryn Carey, President, Optum Rx Pharmacy Benefit Manager

• One Big Beautiful Bill Act: Medicaid Work Requirements

• 340B Drug Pricing Program

• Medicare Drug Price Negotiation Program (Maximum Fair Price)

• Most Favored Nation Drug Pricing

• KFF: Copay Adjustment Programs (Accumulators and Maximizers)

In this episode, we sit down with Kathryn Carey, President, Optum Rx Pharmacy Benefit Manager, to discuss one of the most significant shifts underway in the pharmacy benefit management industry. We explore their new transparent, fixed-fee model, what is driving it, and what it actually means for patients, providers, pharmacies, and manufacturers. We also examine Optum Rx’s digital tools and how they are reshaping the prescribing experience, and the broader effort to reduce friction in patient access. At its core, this is a conversation about whether these changes are early stages of a new model for how medicines are accessed and paid for in the United States.

• Optum Rx

• New PMPM Model

• PBMs Explained

• PreCheck Prior Authorization

• PreCheck MyScript

• Shop MyScript

• Price Edge

• Price Wise

• Savings IQ

• Critical Drug Affordability Program
  

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In this episode, we interview Stephen Ubl, President and CEO of PhRMA, to discuss what is happening across the industry at a time of significant change. We talk about biopharma’s continued commitment to innovation, what member companies are doing to help patients access medicines more directly, and how new tools from the organization are supporting patient affordability. We also cover the impact of policies like the IRA and MFN, along with the growing focus on PBM reform and other structural challenges in the system. It is a wide-ranging conversation about where the industry is headed and what it will take to ensure the country continues to lead the world in bringing new treatments to patients in need.

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In this episode, we sit down with Alexander Hardy, President and CEO of BioMarin, to talk about his path to leading one of the world's premier rare disease companies. Alexander reflects on his experience across small molecules, biologics, oncology, and rare diseases, and how his work in access and patient services has shaped his thinking about leadership. We discuss the policy environment coming out of Washington — including the IRA and other pricing reforms — and how those factors influence long-term innovation and investment decisions. We also explore the real-world challenges facing rare disease patients, employer concerns about high-cost therapies, and what needs to change over the next five years to improve access and affordability.

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Employers sit at the center of the U.S. health system as the primary funders of coverage for more than 150 million Americans, yet they struggle with rising costs, fragmented vendors, and uneven outcomes. In this episode, we talk with Dan Mendelson, MPP, CEO of Morgan Health at JPMorgan Chase & Co. and Founder and former CEO of Avalere Health. We explore his journey from health policy to now leading Morgan Health’s efforts to improve the quality, affordability and equity of employer-sponsored healthcare. We’ll learn how Morgan Health evaluates the employer market, where they’re placing investment bets, and how they are testing new care models inside JPMorgan’s own benefit. We then turn to Washington: Dan shares his take on the policy currents that matter most for employers and innovators over the next few years.

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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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