Trends, Events, and Developments (TEDs) in the Payer World – A Focus on the Inflation Reduction Act
Good day to you! I am Cynthia Miller, MD, MPH, FACP; Vice President, Medical Director, Access Experience Team; and editor of All Access Newsletter. This edition will focus on the Inflation Reduction Act and the potential impacts on biosimilars, patient affordability, contracting, payer access, and competition. Our expert ex-payers will provide insights into these trends and developments and how they foresee them impacting the healthcare system, especially patients, health systems, and the pharmaceutical industry.
The Growing Emergence of Biosimilars
Amy Martin, Vice President, Access Experience Team
Amy reflects on the growth in biosimilars, particularly in the pharmacy benefit, as well as how the Inflation Reduction Act will impact biosimilar uptake on the medical side, especially given recent ASP erosion for some products.
Patient Affordability After the Inflation Reduction Act: Potential Impacts
Ryan M. Cox, RPh, MBA; Senior Vice President, Director, Access Experience Team
Ryan examines how provisions in the Inflation Reduction Act for lowering out-of-pocket costs and capping insulin in Part D will affect patient access to medications, market access, and pharmaceutical R&D.
Inflation Reduction Act: Squeezing of the Rebate and the Wholesale Acquisition Cost Balloon
Andrew Cournoyer, RPh, MBA; Senior Vice President, Director, Access Experience Team
Andrew details how the Inflation Reduction Act will influence use of rebates vs low WAC drugs in pricing strategy and rebate negotiations—and shares some sample calculations!
The Evolution of Payer Access: Now and Then
Dominic Galante, MD; Chief Medical Officer, Access Experience Team
Dominic shares a futuristic view of how the Inflation Reduction Act will influence payer control over drug spend, new sites of care, as well as mergers and acquisitions.
Price Controls and Competition
Erin Lopata, Vice President, Director, Access Experience Team
Erin reviews the new Inflation Reduction Act provision for drug price negotiations in Medicare and how price controls will affect future competition, formulary placement, contracting, and the need for health economics and outcomes research.
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
Amy Martin
Andrew Cournoyer
Ryan Cox
Dan Danielson
Todd Edgar
Dominic Galante
Ami Gopalan
Maureen Hennessey
Joe Honcz
Erin Lopata
Ray Roth
Janet Serluco
Charline Shan
Jennifer Williams
The Growing Emergence of Biosimilars
After a slow start since the first US biosimilar came to market in 2015, there has been a significant increase in approvals and launches. To date, 41 have been approved in the US, with over 90 biosimilars in development. Additionally, in the upcoming months, several biosimilar launches are anticipated to meaningfully impact formularies and pharmacy benefit specialty drug spend.
Patient Affordability After the Inflation Reduction Act: Potential Impacts
The Inflation Reduction Act of 2022 contains a number of health care provisions, including those that will cut Medicare drug spending by an estimated $287 billion over 10 years, according to the congressional budget office. Some of the most widely discussed changes ushered in by the IRA are several near-term changes to the Medicare Part D benefit. These changes are some of the most significant changes in Medicare regulation since the Medicare Modernization Act of 2003.
Inflation Reduction Act: Squeezing of the Rebate and the Wholesale Acquisition Cost Balloon
When you squeeze a sealed balloon on one end, the air doesn’t simply go away; rather, it just finds another part of the balloon to expand. In other words, the air must go somewhere. The Inflation Reduction Act will create a similar dynamic with drug costs for Medicare payers and drug manufacturers.
The Evolution of Payer Access: Now and Then
The $740 billion Inflation Reduction Act, signed by President Biden on August 16, 2022, will have significant implications for pharma, payers, and seniors.The bill implements several significant changes like beginning in 2026, US Department of Health and Human Services will be negotiating directly with pharmaceutical companies for the 10 most expensive Medicare drugs; number increasing to 20 new Part D and B drugs in 2029.
Price Controls and Competition
The Inflation Reduction Act of 2022, which was signed into law by President Biden on August 16, 2022, represents one of the most significant pieces of healthcare legislation passed since the Patient Protection and Affordable Care Act. The law introduces a number of sweeping changes with impact to Medicare Part D benefit design and price control mechanisms for drugs on the Medicare benefit. While these legislative changes will have ramifications across the healthcare ecosystem, they are likely to have a significant impact on manufacturers.