ISSUE: In contrast to ex-US pharmaceutical markets, the US has historically had decentralized decision-making regarding drug value. The Inflation Reduction Act (IRA) moves the US closer to centralized Health Technology Assessment (HTA) as it requires the Secretary for Health and Human Services (HHS) to negotiate maximum prices for select brand-name drugs that are covered under Medicare Part B (physician-administered drugs) and Part D (retail prescription drugs) effective plan year 2026. The Secretary must consider information about development and production (e.g., manufacturing and distribution costs, financial support from the government, patent information, R&D recoupment) and evidence about alternative treatments (e.g., therapeutic advance, prescribing information, comparative effectiveness, unmet need). In this session, panelists will explore the question of price setting or traditional HTA by examining key differences and associated ramifications.

OVERVIEW: There are important similarities and differences in how IRA negotiation and traditional HTA reach the common goal of determining a price. Key differences reside in the evidence and methods used. How will these differences impact the outcomes? And what does it mean for the goal of patient centricity? The panel will begin with Sarah Alwardt providing a brief overview of IRA negotiation. Next, Mike Ciarametaro will highlight key evidence and method differences, including a high-level overview of potential IRA negotiation models. Then, Peter Neumann will examine the unique HTA method challenges and opportunities the government will face when implementing the negotiation process. Topics to be discussed include product life cycle timing, evidence mix, and multiple indications. Last, Emily Freeman will delve into the opportunities and challenges for IRA negotiation incorporating a patient-centered care approach. Topics will include the processes and methods for incorporating patient feedback and patient-centered outcomes to determine a negotiated price. The audience will have the opportunity to ask questions at the end.