In a packed session at Asembia 2025, Brian Corvino, lead partner at Deloitte Consulting, and Blasine Penkowski, former chief strategic customer officer at Johnson & Johnson, walked attendees through key lessons from early implementation of the Inflation Reduction Act (IRA) and the urgent operational, financial, and strategic demands it places on drug manufacturers and the broader healthcare ecosystem.

Corvino, who leads Deloitte’s IRA readiness efforts, emphasized that implementation is not a short-term project. Instead, it is a multi-year, organization-wide transformation with significant implications for portfolio strategy, evidence development, resource allocation, and market access operations. The speakers organized their insights into 5 recurring stages experienced by manufacturers: diagnostic, deploy, develop, defend, and deliver.

Diagnose: Portfolio Impact Assessment

The diagnostic phase requires rigorous, ongoing evaluation of the manufacturer’s in-line and pipeline portfolios against IRA selection criteria. Manufacturers must consider not only whether their products may be selected, but also how changes to competitor pricing may shift therapeutic landscapes. Penkowski stressed that manufacturers must incorporate IRA-specific thinking early in the research and development (R&D) process, especially as strategies such as indication stacking become less viable under the law’s constraints.

Deploy: Organizational Readiness

Following assessment, manufacturers must mobilize cross-functional teams to lead the IRA response. Readiness efforts often involve dozens of employees, include input from more than a dozen departments, and demand senior-level oversight to support executive attestation of submitted information.

The presenters stressed that finance, medical affairs, regulatory, R&D, policy, legal, and communications professionals all need to be engaged. Penkowski pointed out that many of these teams—especially those not typically involved in value or access planning—require education on IRA requirements to contribute effectively.

Develop: Information Collection Request

Developing the necessary evidence packages was described as resource-intensive and cross-functional. Submissions require extensive clinical, economic, and operational data, including real-world evidence, patient access program participation, and research and development costs dating back to discovery. The speakers noted that government reviewers take a broad view of therapeutic alternatives and evidence sources, including international studies and multiple types of comparator data. Corvino highlighted that manufacturers in the 2026 negotiation cycle submitted up to 285 comparative references per product, and overlap with CMS-selected references was frequently limited.

Defend: Value of Drug Through Negotiation Process

Once selected, manufacturers move into the defend phase, which involves direct engagement with CMS. This includes the Value Communication Meeting and subsequent negotiation discussions. According to Corvino, these meetings are not simply administrative or technical—they are high-stakes opportunities to influence the agency’s perception of the product’s value.

Penkowski stressed the importance of choosing the right internal speakers for these engagements. Company representatives should be deeply knowledgeable, able to speak clearly and accessibly about clinical data, and familiar with the real-world treatment landscape. She recommended treating these meetings with the same preparation as a US Food and Drug Administration (FDA) advisory committee.

The speakers also encouraged the use of internal “red teams” to test value narratives, challenge assumptions, and simulate reviewer responses. This helps organizations develop objection-handling materials and refine their messages in advance of formal interaction with CMS. Given the volume and complexity of information, preparation is key to making these sessions productive and positioning the product favorably in CMS’s evaluation.

Deliver: Ensure Compliant Effectuation and Execution

The final phase, deliver—referred to throughout the session as “effectuation”—was described as particularly complex. Manufacturers are responsible for building new operational infrastructure to ensure negotiated prices reach patients at the pharmacy counter, across tens of thousands of dispensing entities, without existing “pipes” in place to support the required financial and data exchanges. The timeline is tight: manufacturers must submit plans by September 1 in advance of a January 1 go-live, even though some specifications are still evolving.

Corvino and Penkowski emphasized that the current implementation phase, particularly for the 2026 and 2027 negotiation classes, provides a narrow window for stakeholders to shape operational models and advocate for system fixes. Challenges already emerging include cash flow pressures on pharmacies, data delays (especially around 340B), and the need to de-duplicate overlapping rebates—issues that, if unaddressed, could have downstream effects on access and sustainability.

With Medicare Part B drugs coming into scope in 2028, both speakers urged proactive planning. The IRA, they noted, represents a foundational change in drug pricing and access—and organizations that treat it as a one-time compliance task risk falling behind.

“This is a magic moment for us as an industry to truly shape and build the machinery that we’re going to be living with in the ecosystem for at least the next decade,” Corvino concluded.

Reference

Corvino B, Penkowski B. What did the first round of IRA direct price negotiations teach us? Presented at: Asembia 2025; April 29, 2025; Las Vegas, NV.