18. Interviews from Asembia’s AXS24 Summit, Part 1 of 2

In this episode, we sit down with Stacie Dusetzina, Ph.D., a leading health economist from Vanderbilt University Medical Center to discuss the critical healthcare and policy trends shaping 2025. From shifts in federal leadership to the evolving impact of the Inflation Reduction Act, our guest provides expert insights on what to expect in drug pricing, health insurance, and patient access in the coming year. We explore how the public and private sectors are addressing affordability challenges and highlight innovative approaches to improve access to essential medications. With a focus on the future, this conversation offers a thoughtful outlook on the policies and market dynamics set to redefine healthcare in 2025.

Stacie Dusetzina, Ph.D., Vanderbilt University

Vanderbilt University Medical Center

A primer on copay accumulators, copay maximizers, and alternative funding programs

CMS
FDA

IRA

Medicare Part D

Pharmacy Benefit Managers (PBMs)

Medicaid

CMMI’s Medicaid group negotiation 

COVID-19

Statins

PCSK9 inhibitors

Imatinib

340B Drug Pricing Program

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In our second of three episodes in conjunction with members of ACCESS Forum, we engage with leading experts to uncover the multifaceted challenges of access and affordability in cell and gene therapies. Our conversation investigates how these treatments’ innovative yet complex landscape leads to challenging regulatory pathways, pricing models, and reimbursement strategies. We examine the high costs associated with these therapies, the implications for healthcare systems, and the delicate balance between innovation, patient needs, and sustainable funding. Tune in as we explore the current barriers and opportunities in the evolving world of cell and gene therapy and what this means for the future of patient access and affordability.

In this episode, we sit down with leading Market Access experts and members of ACCESS Forum to compare and contrast the drug pricing and access systems worldwide and the US. Our discussion delves into the distinct approaches taken by government vs. private markets, examining how regulatory environments, pricing controls, and reimbursement processes impact patient access to innovative therapies. We explore the challenges each approach faces, from cost pressures to affordability and access, and how they balance the interests of patients, governments, and pharmaceutical companies. Join us for a deep dive into how the global healthcare landscape is evolving and what lessons can be learned.

Nikos Maniadakis, Ph.D., Professor, Health Management & Policy, University of West Attica
Kimberly Baldwin, Senior Vice President, Value & Access, Ipsen Biopharmaceuticals
Fauzea Hussain, Vice President, Public Policy, McKesson
CMS (Centers for Medicare & Medicaid Services)
European Medicines Agency
Health technology assessments (HTAs)
IRA (Inflation Reduction Act)
Medicaid
Medicare
National Institute of Clinical Excellence (NICE)
NCCN guidelines
P&T committee (Pharmacy and Therapeutics Committee)
PAP (Patient Assistance Program)
Part B (Medicare)
Part D (Medicare)
Pharmacy Benefit Managers (PBMs)
Quality-Adjusted Life Years
Tricare
Veterans Administration
Medical terminology referenced in this episode:

• Cell and gene therapies (CGT)
• Insulin
• Orphan drugs

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In this episode, we explore the evolving role of healthcare and patient advocates and how this profession has become an essential part of the healthcare system. We begin by defining what a healthcare advocate is and tracing the development of the profession over the years. Key milestones are discussed, such as establishing codes of ethics, training, and certification processes. We also share real-world examples of how advocates help patients navigate the complexities of healthcare, making a measurable impact on patient outcomes. The discussion covers the scale of advocacy in the U.S., examining the roles of professional advocates compared to family members and volunteers. We also address how advocates are helping patients overcome barriers to accessing and affording medicines. Finally, we look to the future of advocacy, discussing potential healthcare reforms, the impact of technology, and practical advice for patients seeking an advocate in today’s challenging healthcare environment.

Rachel Westlake, Managing Director, Coalition of Health Care Advocacy Organizations
Danielle Marshall, Executive Director, Patient Advocate Certification Board
Fred Larbi, Chief Operations Officer, HealthWell Foundation
CHCAO
Patient Advocate Cerification Board
Healthwell Foundation
Greater National Advocates
NAHAC
HealthAdvocateX
Umbra
Solace 

Questions or comments?
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In this episode, we explore the evolution and future of the Pharmacy Benefit Management (PBM) industry with insights from two seasoned pharma managed care executives. We discuss the early role of PBMs, their acquisition by pharmaceutical companies, and subsequent industry consolidation. We examine how vertical integration of the PBMs transformed their business model, including the restricted formularies that gave rise to rebates. We also address evolving PBM-manufacturer relationships, the effects of public scrutiny, and predictions for key trends. Join us for a comprehensive look at the past, present, and future of PBMs, focusing on the changes needed to better serve patients.

Steve Stefano, Managing Director, ReprizioRx 

Steve.Stefano@repriziorx.com

Bill Leonard, Managing Director, ReprizioRX

wjl@repriziorx.com

ReprizioRX

PBMs

IPA model HMO

Medco

Metro Containment Services

Medicare Catastrophic Coverage Act of 1988

Merck

SmithKline Beecham

Eli Lilly

340B

NDC blocks

Group Purchasing Organizations (GPOs) 

Medicare

United Healthcare

FTC

CostPlusDrugs

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In this episode, we dive into the pharmaceutical industry’s research and drug development side and the real threat that today’s access and affordability challenges and policies pose to innovation. While innovation often starts in universities with government support, biotech, and pharma companies take on the tough, costly job of clinical trials, development, and approval of new drugs. Investment dollars are limited, only the most promising projects get funded, with an expectation there will be a return. However, our current drug payment process and policies like the IRA have added new considerations for investors, risking fewer new drugs being developed. Without changes, patients could face the closing of our nation’s medicine cabinet, with fewer new treatments available. This would be an outcome that would be catastrophic for all of us.

Erin Mistry, EVP and Chief Commercial Officer, Cormedix, Inc.

Imran Nasrullah, JD., formerly VP & US Head of BD&L at Bayer, and now Founder, SNAP Life Sciences

Research and development (R&D)

FDA

CF Foundation

Vertex

NIH

AMR (antimicrobial resistance)

The Pasteur Act

HIV

Malaria

Flagship Pioneering Launches Metaphore Biotechnologies to Unlock the Therapeutic Potential of Biomimicry

Novo Nordisk Bets Up to $600 Million on Ozempic 2.0. Here’s Why the Stock Is a Buy.

Genentech

Genzyme (Now Sanofi)

Medicare

IRA (Inflation Reduction Act)

COVID-19

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This is the second of two episodes dedicated to Asembia’s AXS24 Summit, where we were honored to be a media partner. In this episode, we learn from Sarah Butler, Chief Commercial Officer of ADVI Health and Lindsay Greenleaf, JD, MBA, Head of Federal and State Policy for ADVI Health how the 2024 election will impact patient access and affordability. Umar Afridi, Founder and CEO of Foundation Health, summarizes his session, From Opaque to Transparent: Transforming the Way We Pay for Drugs. Finally, we get a few minutes with Joe Boswell, the President of ACCESS Forum, leading an effort to create a network for market access professionals.

ADVI:
Sarah Butler (Chief Commercial Officer)
Lindsey Greenleaf (Consulting and Government Affairs Head)
R&D
Inflation Reduction Act
NCCN Compendia
Part D
CMS
Pharmacy Benefit Managers (PBMs)
Part B
FTC and Office of Inspector General (IG)
FTC’s Section 6B study
Foundation Health:Umar Afridi, Founder and CEO
Session: “From Opaque to Transparent: Transforming the Way We Pay for Drugs.”
Pharmacy Benefit Managers (PBMs)
Truepill
API platforms
International Access Professional Society:Joe Boswell. President
GenMAV
Asembia

In this episode, we explore the 340B Drug Pricing Program, an essential yet complex component of the American drug supply landscape that aims to enable healthcare entities to offer more affordable medication to underserved populations. We interview Antonio Ciaccia, a drug pricing and 340B expert who provides an in-depth look at how the program works, its financial incentives, and how stakeholders have exploited this well-intentioned program, all to the detriment of patients.