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Sabrina Aery, a 340B expert with more than 30 years of experience across hospitals, health plans, pharmaceutical manufacturers, and consulting, joins Perspectives to provide a 340B 101. She discusses the foundations of the program, how it works in practice, and how the program layers into the broader pharmaceutical pricing system. The episode concludes by discussing how the 340B program can impact the economics of a prescription drug and what biotech investors and executives can consider when evaluating potential 340B exposure. Topics discussed include: Who qualifies as a 340B covered entity and which patients and drugs may fall within the program How 340B ceiling prices are determined How 340B can affect gross-to-net, net price, and revenue forecasting Three things biotech executives and investors can examine to assess a product’s potential 340B exposure Whether you work in biotech or simply want to better understand the U.S. drug pricing system, this episode explains 340B and why it matters. Show links: Report - BRG - The Size of the 340B Program - October 2026_20260928012221.pdf Drug Channels: The 340B Program Hit $100 Billion in 2025: Has It Become Too Big to Reform? Growth in the 340B Drug Pricing Program Analysis of 340B modifier usage in Medicare Part B claims - ADVI Date recorded: October 2, 2026

Inma Hernandez, PharmD, PhD, Senior Advisor for Drug Prices at the Centers for Medicare and Medicaid Services, joins Perspectives to give an overview of drug pricing regulatory dynamics for branded drugs in the US. The episode is a step-by-step walkthrough of the different prices a branded drug can have in the U.S. and how those prices are established across commercial insurance, Medicaid, Medicare Part B, and Medicare Part D. Inma explains the alphabet soup of WAC, AMP, best price, ASP, and MFP; how rebates and statutory discounts translate list prices into the net prices realized by innovators; and how pricing decisions in one market can spill over into others. The episode then layers in 340B and the drug pricing provisions within the Inflation Reduction Act. Consider this a U.S. Branded Drug Pricing 101 taught by a nationally recognized expert in pharmaceutical pricing and policy with a graphical representation linked below that is worth printing for your desk. Topics discussed include: How net prices for branded drugs are established across commercial insurance, Medicaid, Medicare Part B, and Medicare Part D The differences between WAC, AMP, best price, ASP, and MFP How commercial rebates can spill over into Medicaid and 340B through best price How 340B impacts the economics of a drug across different insurance markets How inflation rebates and Medicare drug price negotiation add another layer to this framework Graphical Representation Created by Dr. Hernandez: Microsoft PowerPoint - Keynote_OPENING_Inma_ISPOR 2026

Rob Abbott, CEO of ISPOR, joins Perspectives to talk about why health economics and outcomes research (HEOR) has become more relevant for biotech founders, executives, and investors. The conversation challenges the common perception that HEOR is primarily a post-approval exercise used to support pricing and reimbursement. Instead, Rob discusses how evidence generation, economic modeling, and value strategy can shape clinical development, inform investment decisions, and strengthen the commercial potential of new therapies. The episode concludes with a discussion of ISPOR's Healthcare Investment Summit that will be held in September 2026 and will convene investors, drug developers, and value strategists to translate HEOR into early-stage investment decisions and drug development. Topics discussed include: Two HEOR activities biotech companies should do before Phase III Four questions investors can ask management teams to gauge commercial opportunity Novel applications of HEOR and their usefulness for biotech executives and investors ISPOR's Healthcare Investment Summit and what biotech leaders and investors might get out of attending Show links:  https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-healthcare-investment-summit-2026

Ron Lanton, the Founder and President of Lanton Strategies International, joins Perspectives by the Leerink Center for Pharmacoeconomics to discuss the use of trade mechanisms to address pharmaceutical pricing. Ron provides insight into the growing intersection of pharmaceutical pricing and international trade policy, why recent developments could be significant, and what it could mean for biopharmaceutical companies, investors, and patients. Topics discussed include: U.S. Trade Representative’s recent Section 301 investigation into Germany’s drug pricing and reimbursement practices U.S.-U.K. drug pricing arrangement Use of trade mechanisms to address pharmaceutical pricing Implications for biotech investors and executives

Dr. Tomas Philipson, former Acting Chairman of the White House Council of Economic Advisers and Professor Emeritus at the University of Chicago, joins Perspectives by the Leerink Center for Pharmacoeconomics to discuss a new insurance model he developed that insures biotech investments against clinical trial failure. He explains how this insurance could reshape the way risk is managed in life sciences innovation and could expand access to capital for biotech. The second half of the episode turns to drug pricing policy where Philipson shares his perspectives on current and proposed reforms. Topics discussed include: A new insurance model for clinical trial failure The role of AI in underwriting these insurance policies Perspectives on the Inflation Reduction Act, Medicare drug price negotiations, and Most Favored Nation pricing A NATO-style approach to global drug spending Episode Links: https://www.mciuw.com/service/clinical-trial-funding-insurance/

In this episode of Perspectives by the Leerink Center for Pharmacoeconomics, host Mel Whittington sits down with renowned health economist Dr. Peter Neumann following the annual meeting of the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center. Drawing from conversations that took place at the meeting, Mel and Peter explore some of the questions that are shaping how innovation is valued globally. The discussion covers: Whether cost-effectiveness analysis captures all the factors that are considered when pricing a drug   How payers use outcomes assessments to shape, and sometimes restrict, coverage decisions What Medicare drug price negotiations and MFN proposals reveal about “value-based pricing” The distinction between price and value and whether current frameworks adequately reward innovation The growing debate around centralized health technology assessment in the U.S. Why the field may be moving toward narrower definitions of value over time This episode offers a window into the economic debates influencing how medicines are evaluated, reimbursed, and ultimately brought to patients.  CEVR webpage : https://cevr.tuftsmedicalcenter.org/ US vs. MFN CEA thresholds paper: https://academic.oup.com/healthaffairsscholar/article/4/4/qxag081/8586328 Cost-effective price vs. Medicare negotiated price paper:  https://pubmed.ncbi.nlm.nih.gov/40939703/

In this episode of Perspectives by the Leerink Center for Pharmacoeconomics, Melanie Whittington breaks down a fundamental—and increasingly consequential—question in health economics: what counts as value in cost-effectiveness analysis? For biotech leaders and investors, Mel cautions that this isn’t just an academic debate. The frameworks adopted by HTA bodies influence pricing, access, and ultimately, how innovation is rewarded.

Melanie Whittington, PhD, Head of the Leerink Center for Pharmacoeconomics, talks with Peter Kolchinsky, PhD, Founder and Managing Partner of RA Capital Management, to discuss if the U.S. market-based approach to pricing novel prescription medicines could result in paying more than they are worth and if companies and company builders should use health economic modeling to support their value propositions.

Melanie Whittington, PhD, Head of the Leerink Center for Pharmacoeconomics, interviews James Chambers, PhD, MPharm, Professor of Medicine in the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, to dig into specialty drug coverage and what it might look like in 2026.

Melanie Whittington, PhD, Head of the Leerink Center for Pharmacoeconomics, talks with John M. O'Brien, PharmD, MPH, President and CEO of the National Pharmaceutical Council & Former Trump Drug Pricing Advisor, to tackle some big questions like if it is possible to reward innovation without busting budgets and how to get to a sustainable, innovation-friendly, patient-centered drug pricing system. Additional resources: Subscribe to NPC’s Newsletter https://www.npcnow.org/subscribe-updates IRA Impact on Pharmaceutical Investment: Insights From Investor Interviews (Health Affairs Scholar) https://academic.oup.com/healthaffairsscholar/article/3/9/qxaf156/8223954 How Time Is Accounted For When Modeling Pharmaceutical Impacts: Investment vs Assessment Perspectives (Health Affairs Scholar) https://academic.oup.com/healthaffairsscholar/article/3/9/qxaf169/8244606 The IRA and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials (Therapeutic Innovation & Regulatory Science) https://link.springer.com/article/10.1007/s43441-025-00774-2 Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act (Therapeutic Innovation & Regulatory Science) https://link.springer.com/article/10.1007/s43441-024-00706-6 Unintended Consequences of the Inflation Reduction Act: Clinical Development Toward Subsequent Indications (American Journal of Managed Care) https://www.ajmc.com/view/unintended-consequences-of-the-inflation-reduction-act-clinical-development-toward-subsequent-indications The Impact of the Inflation Reduction Act’s Drug Price Negotiation Program on Incentives for Clinical Development of New Drugs (Value in Health) https://www.valueinhealthjournal.com/article/S1098-3015(25)02527-6/fulltext?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1098301525025276%3Fshowall%3Dtrue Follow John O’Brien on LinkedIn https://www.linkedin.com/in/drjmob/

Melanie Whittington, Head of the Leerink Center for Pharmacoeconomics, talks with Vivek Subbiah, MD, David Hong, MD, and Steve Potts, PhD, MBA to discuss if pan-tumor approval strategies offer a path forward for broader, faster adoption across larger patient populations. Given the slow adoption curves typical of new therapeutics and the potential for government price negotiation as early as nine years after market entry, the experts hash out if pan-tumor approval is a potential development and commercialization pathway to ramp up clinical adoption and sales early on. They discuss the challenges, data requirements, and opportunities of this relatively new development path. Dr. Hong is the Deputy Chair of the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center. Dr. Steve Potts is the CEO and Co-Founder of a Stealth Cancer Biotech. Dr. Subbiah is the Chief of Early Phase Drug Development at the Sarah Cannon Research Institute. All bring firsthand experience – wins and battle scars - with pan-tumor approvals.

Diane Vieira, Head of Marketing & Communications at Leerink Partners, interviews Melanie Whittington, PhD, Head of the Leerink Center of Pharmacoeconomics (CPE), to discuss the one-year anniversary of CPE and everything they thought they knew but actually didn’t.

Melanie Whittington, Head of the Leerink Center for Pharmacoeconomics, interviews Steve Potts, PhD, MBA, CEO and Co-Founder, Stealth Cancer Biotech, to discuss the impact of the Inflation Reduction Act on cancer drug development and a middle ground between a market-based approach and a government-based approach to drug pricing.

Melanie Whittington, Head of the Leerink Center for Pharmacoeconomics, interviews Joshua Kresh and Emily Michiko Morris from The IP Policy Institute at the University of Akron School of Law to discuss the critical importance of protecting intellectual property for the biopharmaceutical innovation ecosystem and their recent research around evergreening and patent thickets.

Melanie Whittington, PhD, Head of the Leerink Center for Pharmacoeconomics, interviews Ulrich Neumann, MBA, MSc, MA, Director of Access and Policy Research at Johnson & Johnson, to discuss the motivation behind the recent launch of the J&J Center for U.S. Healthcare Policy Research, the interconnectedness and importance of the various players within the biopharmaceutical R&D ecosystem, and the private capital that is required to develop new drugs. Resources mentioned in this episode: https://policyresearch.jnj.com https://jnjinnovation.com/home https://www.nature.com/articles/d41573-024-00131-2 https://www.ispor.org/docs/default-source/intl2024/j-j-access-policy-research---ispor-2024---pharma-r-d-ecosystem-investment137860-pdf.pdf?sfvrsn=d28181d4_0 https://www.tandfonline.com/doi/full/10.1080/13696998.2024.2405407