The first year of Medicare drug price negotiations kicked off in earnest on August 29, when the Centers for Medicare and Medicaid Services (CMS) announced the list of 10 drugs that will be subject to maximum fair prices (MFPs) in 2026. Affected manufacturers have until October 2 to provide CMS with the required data and evidence. CMS will then host initial meetings to discuss additional context related to the submissions and how they map to the factors that the agency will consider in its decision-making.

By February 1, CMS will notify manufacturers of initial price offers and allow them 30 days to accept or submit a counteroffer. If the agency does not accept the counteroffer, then CMS and the manufacturers may meet up to three additional times, after which the agency will make a final written offer by July 15, 2024.

As manufacturers of the 10 selected drugs finalize their data submissions for CMS, they must assess remaining gaps and vulnerabilities in their value messaging and solidify their engagement strategy for the full length of the negotiation period. Manufacturers should consider:

• CMS as a Payer: Anticipate CMS’s perspective on negotiation, considering policy, political, and operational priorities, as well as the market and evidence dynamics for each product and therapeutic area
• Direct and Indirect Engagement Strategy: Align advocacy and engagement strategy to external stakeholders and CMS, including specific messaging points and core meeting attendees
• MFP Scenarios and Counteroffer Preparation: Project scenarios for CMS’s initial MFP offer and develop an internal response plan, including respective counteroffer options and internal governance process to finalize decision-making
• MFP Effectuation: Model the impact of MFP scenarios on Part D plan net cost and access strategy and understand various ways that CMS may operationalize MFP in the market

In developing an initial offer, CMS will consider the net prices of identified therapeutic alternatives relative to the negotiated product and then adjust that further by factoring the clinical evidence and market data submitted by manufacturers. The process for choosing comparators for the 10 selected drugs, especially across multiple indications, will therefore produce cascading ripple effects within the affected therapeutic areas. Manufacturers of products competing with selected drugs should also consider their engagement strategy throughout their competitors’ negotiation process. Key opportunities include:

• Evidence Positioning: Evaluate the current body of evidence for a manufacturer’s product and what work may be necessary to best position a product for future negotiation
• Access Strategy: Model how the introduction of a competitor’s MFP will disrupt Part D formulary decisions and patient access within a class
• CMS Engagement: Assess whether engaging CMS during a competitor’s negotiation process may be beneficial, such as messaging around the value of the class or the appropriate comparators

A Trusted Partner for CMS Engagement

Several key milestones over the next year will offer stakeholders opportunities to engage with CMS on Medicare negotiations. With expertise in policy, market access, and evidence, Avalere can provide guidance every step of the way.

ICR: Information Collection Request; TA: Therapeutic Area

An effective Inflation Reduction Act response strategy requires efficient and strategic collaboration at every inflection point. Avalere’s multidisciplinary experts can effectively prepare a manufacturer for its own or for its competitors’ product negotiation. Connect with us today.