2023 Trends, Events, and Developments (TEDs) in the Payer World —Trends for 2024

Welcome to the Trends for 2024 issue! I am Cynthia Miller, MD, MPH, FACP, Vice President Medical Director—Access Experience Team, editor of the All Access Newsletter. This edition will focus on the emerging trends to look out for in 2024 occurring in various segments of the payer world. Our expert ex-payers will provide insights into these trends and developments and how they foresee them impacting the health care system, especially patients, health systems, and the pharmaceutical industry.

Will the US Move Away from Interchangeable Designations for Biosimilars?
Amy Martin, VP, Access Experience Team–PRECISIONvalue
Amy discusses the possibility of the FDA removing the interchangeable indication for biosimilars in the US. She proposes that this may have a greater impact on biosimilars under the pharmacy benefit versus the medical benefit. Amy helps us to understand how removing interchangeability may impact future research, payers, and prescribers.

Forecasting Payer Actions in the Unknown World of IRA
Andrew Cournoyer, SVP, Director – Access Experience Team–PRECISIONvalue
In his article, Andrew uses financial models and industry insights to help us better understand how payers may respond to the IRA. The models analyze high WAC/high rebate and low WAC/low rebate scenarios, which Andrew then illustrates how payers will evaluate which pricing model to determine target opportunities to offset IRA provisions. This is a must read to better understand the how payers will approach drug manufacturer contracting strategies in an IRA environment.

The Future of the 340B Program
Dominic Galante, MD, Chief Medical Officer, Access Experience Team–PRECISIONvalue
Dominic tackles the intricacies of the 340B program moving forward. Given changing legislation with the IRA and regulations from CMS, stakeholders will be charged with developing methods to stay compliant in this newly complex environment. Dominic breaks this down for our readers so that we can be prepared moving into 2024.

2024 Trends in Behavioral Health
Maureen Hennessey, PhD, CPCC, CPHQ, SVP, Director, Value Transformation, Access Experience Team–PRECISIONvalue
Next, our behavioral health expert, Maureen, dives into how important a personalized, preventative approach to mental health will determine the strength of brand loyalty moving into 2024. In addition, she updates us on the upcoming quality measures around mental health and social determinants of health. Her article provides manufacturers with strategies to ensure the best positioning for their products.

All Access: 2024 Trends in Medicare Advantage
Karina Abdallah, Senior Director, Access Experience Team–PRECISIONvalue
Finally, Karina gives us a view into the changes for Medicare Advantage into 2024. As this segment of health insurance continues to grow, it may have growing influence on access to therapeutics. She provides several strategies to ensure manufacturers stay abreast of changes and position themselves favorably

We believe you will find these Trends for 2024 and their impact on market access insightful as you navigate the payer landscape. As always, please feel free to drop me a note and let me know if you have a topic suggestion for the payer team to address, and we’ll do our best to cover it in a future edition.

Best Regards,

Cynthia Miller
MD, MPH, FACP
VP, Medical Director
Access Experience Team
EMAIL CYNTHIA

All Access is a bimonthly newsletter featuring key insights from our team of former payers intended specifically for market access leaders. It is published by PRECISIONvalue.

Guest Editor
Cynthia Miller

Contributors
Andrew Cournoyer
Ryan Cox
Dan Danielson
Todd Edgar
Jorge Font
Dominic Galante
Ami Gopalan
Maureen Hennessey
Barbara Henry
Joe Honcz
Sejal Jonas
Kris Kang
Erin Lopata
Amy Martin
Ray Roth
Janet Serluco
Charline Shan
Jennifer Williams

2024 Trends in Behavioral Health

An overarching theme throughout the health care ecosystem—including behavioral health—is that within a landscape fraught with post-pandemic and economic transitional uncertainty, patients and their care partners expect health care stakeholders to simplify complexity, help manage risks, and solve their problems. A 2023 Bain survey, and an NEJM article, “Health Care 2030: The Coming Transformation,” are calling for the abandonment of traditional perspectives, and adoption of transformative mindsets and systems focused on providing solutions and offering personalized, preventive care for populations.

The Future of the 340B Program

The Public Health Service Act 340B Drug Pricing Program enables providers that serve vulnerable patient populations to access outpatient drugs at significantly lower costs, which helps improve overall patient care. Since the Medicaid Drug Rebate Program and the 340B Drug Pricing Program were established in the early 1990s, stakeholders have struggled to resolve questions surrounding duplicate discounts. Expanding these programs under the Affordable Care Act in 2010 exacerbated the issue and further complexity will be added through the Inflation Reduction Act.

Forecasting Payer Actions in the Unknown World of IRA

American author H.P. Lovecraft wrote that “the oldest and strongest emotion of mankind is fear, and the oldest and strongest kind of fear is fear of the unknown.” And unknown territory is where we are heading when it comes to forecasting payer actions in response to the impending liabilities and costs stemming from the Inflation Reduction Act. What we know for sure, however, is that payer liability is increasing.

Will the US Move Away from Interchangeable Designations for Biosimilars?

On September 15, 2023, the Food and Drug Administration released draft guidance entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” The agency is accepting comments through November 17, 2023, and the finalized guidance will revise and replace the 2018 guidance for the industry entitled “Labeling for Biosimilar Products.”