This session will provide a critical update on implementation of the Medicare Prescription Drug Price Negotiation Program, including a discussion of progress and challenges faced by Medicare and Industry.

After decades of debate, the U.S. Congress passed legislation in 2022 authorizing Medicare to negotiate prescription drug prices. The first ten drugs subject to negotiation were selected in 2023. Evidence of comparative effectiveness, net prices, and unmet need alongside industry R/D and productions costs have been submitted to CMS for consideration in the negotiation. The negotiated Maximum Fair Price (MFP) will be published for the ten drugs by September 2024. This session will provide an update on implementation and future steps with viewpoints from CMS, the pharmaceutical industry, and a drug pricing policy expert. Dr. Sullivan will serve as moderator and provide a brief overview of the Medicare Prescription Drug Price Negotiation Program (DPNP). He will introduce the three panelists. Ms. Martin will discuss implementation, progress and challenges of the DPNP from the perspective of CMS. She will comment on the initial product selection, the evidence submission process, the patient and stakeholder listening sessions and the formal negotiation process. What has CMS learned, what is working well, and what might CMS do differently in subsequent rounds of negotiation? Dr. Blanchette will discuss how companies like Novo Nordisk have organized internally to respond to the initial round of the DPNP. He will discuss lessons learned for HEOR departments on how best to prepare for future engagements with CMS. Finally, Dr. Hernandez will conclude by discussing sources of savings associated with negotiation, and implications of the DPNP for formulary coverage and pricing within Medicare Part D and private health insurance. We will finish with a moderated Q/A session.