VBAs and Warranties in an Uncertain CMS World: Opportunities or Challenges?

ISSUE: CMS implementation of IRA will likely challenge pharmaceutical developers to re-assess pipeline priorities and commercialization strategies, potentially impacting development of future medicines, as well as go-to-market tactics. As a byproduct of IRA, CMS is simultaneously developing a pilot to re-imagine value frameworks through its Cell and Gene Therapy Access Model. With the goal to launch in 2026, the CMS CGT Access Model will explore payment and performance models as it will begin negotiation on behalf of states, including a role for CMS as centralized outcomes monitor for therapies utilized through the pilot. Further spillover into commercial payers will increase market uncertainty.

OVERVIEW: This panel will discuss the impact IRA and CMS pilots might have on value-based agreements (VBAs), as well as emerging performance frameworks in the face of rising public and private payer demands for stronger recourse if therapies are not effective. Attendees will be challenged to reimagine how value can be quantified and defended amidst a changing landscape, specifically using drug warranties aimed at true end payers and next generation VBAs. Panelist will discuss trends with innovative access agreements in the oncology space as drug developers seek to distinguish their drugs with providers and patients. Furthermore the role of evolving value frameworks for CGTs and how they can be applied to support VBAs for next-generation products will be discussed. Finally the role drug warranties can play to mitigate uncertainty for cell, gene and even specialty therapies will be reviewed. Overall how could VBAs and Warranty programs be applied to assets in response to payer pressure in the form of IRA and the CMS CGT Access Model will be debated. Attendees will learn about these and other trends and ways HEOR and market access teams can assist their organizations adapt and respond to the implications of the IRA.