The Day After Tomorrow: Evidence, Value, and Market Access After the IRA


Sarah Alwardt, PhD1, Kim Caldwell, RPh2, Michael Principal Ciarametaro, MBA3 and Jordan Banks, PhD3, (1)Avalere Health, a member of Fishawack Health, Celebration, FL, USA(2)Texas Star Healthcare Consulting, LLC, McKinney, TX, USA(3)Avalere Health, a member of Fishawack Health, Washington, DC, USA

The Center for Medicaid and Medicare Services (CMS) is moving forward with implementing the Inflation Reduction Act (IRA), with the first round of negotiation slated to begin this September. IRA negotiation is a significant change from the current world. Adapting to this changing ecosystem is made more challenging by the presence of many unknowns.

During this session, panelists will elucidate the latest thinking surrounding these questions. Panelists will leverage their public and private payer, HTA, evidence, and policy experience to debate and elucidate the following key issues:

  • Will CMS set the negotiated price at the max statutory amount in the first few years, or will it base the pricing on a review of the evidence?
  • Is the negotiation model likely to be closer to a clinical-type review or a more formal HTA?
  • What is the potential role of intellectual property and research and development costs factors?
  • What will be the role of subpopulations and health disparities in determining a price?
  • How will CMS balance health system sustainability with supporting meaningful innovation?
  • What are the downstream negotiation impacts on plans?

Seating is limited.

Sponsor: Avalere




Health Policy & Regulatory