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.

Medical terminology referenced in this episode:

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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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Biosimilars are entering the market at their fastest pace ever. In this episode, we interview a renowned health economist and an expert consultant in biosimilar distribution and patient support to explore the complex landscape of biosimilars, including examining the hurdles and breakthroughs in achieving acceptance by payers and providers and how best to improve patient access and affordability in a market dominated by established brands.

Dr. Jason Shafrin, Senior Managing Director, Center for Healthcare Economics and Policy at FTI Consulting

Marina Allen, SVP, Fingerpaint Market Access, Patient Support & Access Strategy Leader in Pharma-Biotech

Biosimilars

The Biologics Price Competition and Innovation Act of 2009

PBMs (Pharmacy Benefit Managers)

Medicare Advantage

Humira (biosimilars)

340B program

Inflation Reduction Act

Medicare Part D

"brown bagging and white bagging"

Mark Cuban (CostPlusDrugs)

GoodRx

average sales price (ASP)

electronic health record (EHR) system

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Scott and Mark welcome Dr. Mark McClellan, a distinguished health policy expert who has served as the Commissioner of the FDA and the Administrator of CMS, to look ahead at the major policy activities in 2024. They discuss how the government's role as regulator and purchaser of drugs will influence the drug industry and the patient's ability to access and afford medicines this year. They also discuss the challenges and opportunities for improving public health and the emerging role of artificial intelligence.

Dr. Mark McClellan, PhD, Director and Professor of Business, Medicine and Policy at the Duke-Margolis Center for Health Policy at Duke University

IRA

Medicare Part D

Pharmacy Benefit Managers (PBMs)

Medicare Advantage

FDA commissioner Rob Califf 

The Ryan White HIV/AIDS Program (RWHAP) Part B

Medicare Modernization Act

FDA

FDA's Office of Regulatory Affairs

Centers for Medicare & Medicaid Services (CMS) 

Centers for Disease Control and Prevention (CDC)

Per Member Per Month (PMPM) billing 

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In our 2023 podcasts, there have been a series of revelations about the complexity and unintended consequences related to drug access and affordability. This episode explores the essential underlying tension between the notion that affordability and access are deteriorating while science is advancing so rapidly. We interview Rachel King, CEO of Biotechnology Innovation Organization (BIO), to explore the priorities for the industry and how the challenges related to patient access and affordability could jeopardize innovation for patients today and in the future.

Rachel King, CEO, BIO (Biotechnology Innovation Organization) 

John Crowley, Executive Chairman, Amicus Therapeutics

James Robinson PhD, MPH, Chair, Health Policy and Management Division, Berkeley School of Public Health

The Inflation Reduction Act

Orphan Drug Act

Orphan Cures Act

PBM (pharmacy benefit management)

Medicare Part D

Step Therapy

Cystic Fibrosis Foundation

Therapies mentioned in this episode:

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In this episode, we investigate the rise of Alternative Funding Programs (AFPs) that bypass coverage for vital specialty drugs.  Kyle Crowell, an expert consultant on AFPs, discusses how payers avoid their responsibility for costs by collaborating with third-party companies to exclude specific drug coverage and directing patients towards manufacturer-sponsored patient assistance programs (PAPs).  Patient advocate, Amy Niles from the PAN Foundation, describes how the mounting tension caused by AFPs are leaving patients to navigate the uncertain waters of their medication coverage and access, potentially risking their health and even their lives.

Kyle Crowell, Principal (Partner) at ZS Associates

Amy Niles, Chief Advocacy and Engagement Officer, PAN Foundation

Patient Assistance programs (PAPs)

Alternative funding programs (AFPs)

“AFP Caution For Patients”

“Pharma faces tough choices as alternative funding programs exploit charitable giving”

Medicare Part D

“AbbVie sues a behind-the-scenes company for exploiting its patient assistance program”

Federal Trade Commission

Carl Schmidt from the HIV and Hepatitis Policy Institute

Copay Accumulator Adjustment Programs Lawsuit

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[email protected].

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Patients are experiencing remarkable weight loss thanks to the new generation of GLP-1’s and the downstream health benefits may go well beyond diabetes. In spite of the dramatic results for patients, insurance plans have started to put up more barriers and are even denying the drugs on a more consistent basis. For this special Obesity Week 2023 episode, we interview Dr. Angela Fitch, President of the Obesity Medicine Association, a faculty member at Harvard Medical School and most recently a Co-Founder and Chief Medical Officer for knownwell, a new obesity-focused primary care company.

Show Notes:

Dr. Angela Fitch, President, OMA

Obesity Week

Obesity Medical Association

Dr. Fitch’s patient care center: Knownwell

Seeking treatment for obesity? Find a clinician here or here.

The Treat and Reduce Obesity Act of 2023

The drugs discussed in this episode: 

An article on the use of “bootlegged” Semaglitude: Demand Rising for 'Bootlegged' Weight-Loss Drug | MedPage Today

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