8. Washington’s Influence on Patient Access

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 

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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

Asembia’s AXS24 Summit, a pinnacle of specialty drug and healthcare discussions, concluded earlier this month. We are thrilled to share that our podcast was selected as a media partner for this esteemed event. This is the first of two episodes dedicated to AXS24, where Scott and Mark had the opportunity to interview several key speakers and attendees. In this episode, we bring you the insights of Melissa Paige, a seasoned healthcare professional and President of the National Association of Medication Access & Patient Advocacy, who led a session on the Patient Financial Impact of IRA. We also present the perspectives of Renee Rayburg, RPh., VP, Clinical Strategy, Pharmaceutical Strategy Group and Morgan Lee, PhD, MPH, CPH, Senior Director, Research & Strategy, PSG, who are renowned for their study and session on Viewpoints in Specialty Drug Benefit Design.

Melissa Paige, President, (NAMAPA)
University of Virginia Health System
Asembia
Inflation Reduction Act
Dr. Madelaine Feldman
Renee Rayburg, Vice President Specialty Clinical Consulting, Artemetrx,
Morgan Lee, PhD, Senior Director, PSG
Pharmacy Benefit Managers (PBMs)
GoodRx
2024 Trends in Specialty Drug Benefits Report
Medical terminology referenced in this episode:
Generic ARBs
Multiple Sclerosis
Humira biosimilars
Albuterol inhaler
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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.

In this important podcast episode, we interview Victor Bulto, President, US for Novartis, to discuss the company’s efforts to develop groundbreaking treatments while ensuring accessibility and affordability for patients. We delve into how the pharmaceutical industry navigates numerous post-FDA approval barriers to launch new drugs and the importance of market access, patient support services, and a commitment by manufacturers to provide patient assistance and other support for patients.

Victor Bulto, President, Novartis

Novartis

FDA

Institute for Clinical and Economic Review (ICER)

American Heart Association (AHA)

Inflation Reduction Act (IRA)

Pharmacy Benefit Manager (PBM)

Medicare

Medical terminology referenced in this episode:

Cell therapy: CART-T

Radioligand therapy

RNA

Entresto

Molecular glues

Targeted protein degradation

Antisense oligonucleotides

Small interfering RNAs: siRNAs

LDL cholesterol

COVID

Hematological malignancies

Refractory autoimmune diseases

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