Inflation Reduction Act Readiness: Key Lessons From Early Medicare Drug Price Negotiations

Key Takeaways

• Inflation Reduction Act (IRA) readiness must be treated as an enterprise-wide effort. Panelists stressed that successful preparation requires centralized leadership, clear governance, and coordination across market access, finance, clinical, legal, policy, operations, and communications teams. 
• Manufacturers need to begin planning far earlier than the selection date. Speakers emphasized that preparation should start as soon as a product appears at risk for selection, with some suggesting at least a 9-month runway to align stakeholders, develop evidence, and rehearse negotiation strategy. 
• The biggest gaps are often operational and financial, not clinical. While most companies already know how to build a clinical value story, many are less prepared to assemble historical cost data, create Medicare-specific evidence packages, and operationalize negotiated prices. 
• Part B implementation is likely to be the next major challenge. Panelists warned that provider-administered drugs will introduce added reimbursement, buy-and-bill, and patient access complexities that could create disruption if manufacturers, providers, and the Centers for Medicare & Medicaid Services (CMS) are not aligned. 

At Asembia’s AXS26 Summit, speakers underscored just how profoundly the IRA is reshaping pharmaceutical market access strategy. A panel brought together cross-industry leaders to reflect on real-world experience navigating the first 3 cycles of Medicare drug price negotiation. Panelists included Brian Corvino, principal value and access practice leader at Deloitte Consulting; Ritesh Parekh, vice president of US Market Access and Channel Strategy at Takeda; Shaili Shah, US Ibrance lead at Pfizer; and Michael Valenta, chief strategic customer officer at Johnson & Johnson.

Panelists emphasized that IRA readiness is no longer theoretical—it is an operational imperative requiring enterprise-wide transformation.

From Policy to Practice: A Defining Moment for Market Access

Panelists framed the IRA as part of a broader wave of policy changes—including 340B and international reference pricing—that are collectively redefining the drug pricing landscape. However, the IRA’s Maximum Fair Price (MFP) provisions stand out for their direct and immediate implications across the health care ecosystem.

“This is one of the most significant reflection points in decades,” Corvino noted, emphasizing that manufacturers must consider not only IRA compliance but also how it interacts with other policy pressures.

Enterprise Readiness: A Cross-Functional Mandate

A consistent theme across all speakers was the need to treat IRA readiness as an enterprise-level program rather than a siloed market access initiative.

Valenta highlighted the importance of centralized governance, including a single accountable leader responsible for coordinating across functions. “There’s a tremendous amount that needs to get done in a compressed timeframe,” he said, pointing to the need for clear roles, responsibilities, and decision-making structures.

Parekh expanded on this, describing a 3-tiered team model:

• A “pilot-in-command” with cross-functional fluency in clinical, commercial, and evidence strategy 
• Subject matter experts empowered to execute quickly 
• Dedicated project management support to maintain momentum 

Shah reinforced the importance of organizational alignment and proactive communication, noting that IRA implications extend to stakeholders who may not traditionally engage in pricing discussions.

Start Early—or Risk Falling Behind

If there was one unequivocal takeaway, it was timing: start early.

“Now,” Shah said when asked when organizations should begin preparing. “If you’re thinking about it, you should already be planning.”

Panelists noted that identifying the right internal and external stakeholders—often across global teams—can take months. Additionally, developing the necessary data infrastructure, particularly around real-world evidence and cost inputs, requires long-term planning.

Valenta suggested a minimum 9-month runway for meaningful preparation, particularly given the iterative nature of internal alignment and “challenge sessions” used to refine value narratives.

The Data Challenge: Beyond Traditional Value Dossiers

While manufacturers are accustomed to developing clinical value dossiers, IRA submissions introduce new complexity—particularly on the financial side.

Corvino highlighted that many organizations underestimate the effort required to compile historical cost data, including research and development investments that may span a decade or more. “This is a muscle that doesn’t exist in many organizations,” he said.

Panelists stressed the importance of the following:

• Integrating finance early in the process 
• Aligning on assumptions where data is incomplete 
• Building a Medicare-specific value narrative supported by real-world evidence 

Equally critical is the ability to communicate that value clearly. “You have to translate highly complex information into something simple and accessible,” Valenta noted, emphasizing the need to tailor messaging for CMS audiences who may lack deep therapeutic expertise.

Preparing for Negotiation: Practice, Alignment, and Consistency

As manufacturers move from submission to negotiation, execution becomes just as important as strategy.

Shah emphasized the role of repeated “pressure testing” through mock negotiations to ensure clarity and consistency. Maintaining a stable negotiation team—limited to 6 participants in CMS meetings—was also cited as a key success factor.

Communication remains central throughout this phase. “If you don’t proactively communicate, others will create their own narrative,” Shah warned.

Effectuation: Early Lessons and Emerging Complexity

For products in the first implementation cycle (2026), manufacturers are now gaining real-world experience with “effectuation”—the operationalization of negotiated prices.

Valenta outlined 3 critical pillars:

• People: Ensuring the right expertise and governance structures 
• Process: Defining clear decision-making pathways 
• Technology: Building or adapting systems to handle new pricing workflows 

While Part D implementation has been complex, panelists noted that upcoming Part B implications—beginning with the 2028 cycle—introduce additional challenges.

Parekh highlighted the following risks specific to provider-administered drugs:

• Disruption to buy-and-bill economics 
• Increased complexity in reimbursement and inventory management 
• Potential unintended consequences such as non-medical switching or site-of-care changes 

“This is not a core competency for many providers,” he said, warning that missteps could impact both providers and patients.

Looking Ahead: Embedding IRA Into Lifecycle Strategy

Beyond immediate compliance, panelists urged manufacturers to integrate IRA considerations into long-term asset strategy—from early pipeline development to lifecycle management.

This includes:

• Incorporating real-world evidence generation earlier in development 
• Assessing IRA selection risk across portfolios 
• Evaluating competitive dynamics in markets with negotiated products 

Importantly, IRA impact is not limited to selected drugs. “There are direct and indirect effects across the entire portfolio,” Valenta noted, particularly as negotiated prices influence broader payer behavior.

Key Takeaways for Manufacturers

Across the discussion, several themes emerged as critical for success:

• Treat IRA readiness as an enterprise-wide transformation 
• Start preparation early—ideally 9+ months in advance 
• Build robust, Medicare-focused data and evidence strategies 
• Simplify and align value communication for CMS audiences 
• Invest in operational readiness for implementation, especially as Part B complexity grows 

As IRA policies continue to evolve, manufacturers that proactively adapt their organizational structures, data capabilities, and access strategies will be best positioned to navigate the next rounds of negotiation—and the broader transformation of the pricing landscape.

Reference

Corvino B, Parekh R, Shah S, Valenta M. Inflation Reduction Act – IRA readiness and lessons learned from rounds 1, 2 and 3. Presented at: Asembia; April 26-30, 2026; Las Vegas, NV.