Prescription for Better Access Mark Hansan and Dr. Scott Howell

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.


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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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:


RNAi
Antisense
mRNA
Monoclonal antibody

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