• Understanding 340B Programs: An Interview with Antonio Ciaccia, CEO, 46brooklyn Research
    Apr 25 2024

    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.

    • Antonio Ciaccia, President, 3 Axis Advisors and CEO, 46brooklyn Research, an Ohio non-profit Corporation
    • 46brooklyn
    • Ohio Pharmacist Association
    • 3 Axis Advisors
    • Medicaid
    • 340B Program
    • 340B Litigation
    • 340 Eligibility, HRSA
    • Covered Entities
    • Medicaid Drug Rebate Program
    • Obamacare
    • Indian Health Service
    • "Money from Sick People," Report from 46Brooklyn
    • Medicare
    • Pharmacy Benefit Managers (PBMs)
    • Jamie Robinson, Health Economist

    Medical terminology referenced in this episode:

    • Novolog

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    47 min
  • Interview with Victor Bulto, President, US, Novartis
    Mar 28 2024

    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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    44 min
  • Biosimilar's Role in Improving Patient Access
    Feb 27 2024

    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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    43 min
  • 2024 Policy Preview: An Interview with Dr. Mark McClellan
    Jan 30 2024

    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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    50 min
  • Episode 13: The Sustainability of Innovation: An Interview with Rachel King, CEO, BIO
    Dec 22 2023

    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:

    • RNAi
    • Antisense
    • mRNA
    • Monoclonal antibody

    Email us at comments@prescriptionforbetteraccess.com.
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    35 min
  • Episode 12: How Alternative Funding Programs Exploit Patient Assistance Programs
    Nov 16 2023

    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

    Like this episode and want to hear more? Listen to past episodes here!

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    comments@prescriptionforbetteraccess.com.

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    40 min
  • Episode 11: Obesity Week 2023: An Interview with Dr. Angela Fitch, President, Obesity Medicine Association
    Oct 17 2023

    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:

    • GLP-1 (Glucagon-like peptide-1)
    • Wegovy (Semaglitude)
    • Victoza (Liraglutide)

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

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    Email us at comments@prescriptionforbetteraccess.com.

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    55 min
  • Episode 10: Empowering Employers to Improve Patient Access
    Sep 29 2023

    Employers are discovering this fall that they are expected to shoulder a 6% health insurance increase for 2024. What can employers do to combat the accelerating cost of health insurance without jeopardizing access to vital drugs? In this podcast episode, we talk with Matt Ohrt, a former HR executive who achieved a 20% reduction in health insurance costs for his employer. Matt has a new book and new company to help other self-funded employers strategically lower their sponsored health insurance costs for 2024 while ensuring employees have optimal access to care and treatments. This is an essential listen for employers seeking to balance cost-efficiency with the provision of comprehensive, high-quality healthcare benefits to their employees.

    Matt Ohrt, Co-founder, Chief Healthcare Officer, Self Fund Health

    Self Fund Health

    Merrill Steel

    How Does Direct Primary Care Work?

    Matt Ohrt’s book: Save Your Company: Don't Feed the Beast: The Employer Healthcare Success Formula”

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    42 min