What 3 Rounds of IRA Negotiations Have Taught Manufacturers About Readiness

With 22 manufacturers and 40 products now having navigated the Medicare Drug Price Negotiation Program across 3 rounds—the class of 2026 having completed effectuation, the class of 2027 in deep implementation planning, and the class of 2028 now in active negotiations—the industry has accumulated something it lacked at the outset: genuine institutional experience.¹

In a session at Asembia’s AXS26 Summit, Brian Corvino, principal value and access practice leader, Deloitte Consulting; Ritesh Parekh, vice president of US market access and channel strategy, Takeda Pharmaceuticals; and Shaili Shah, US Ibrance lead, Pfizer; translated that experience into actionable guidance for manufacturers who have not yet been selected—and who almost certainly will be.

The urgency is not hypothetical. When Corvino asked each panelist the most common question he receives—once a manufacturer believes its product will be selected, how soon should it activate?—the answers were unambiguous.

“You should be planning for it now,” said Shah. “If you're scoping talent from across the globe, that takes a really long time. Leadership alignment takes a very long time making sure you have resources. This is not our day jobs, and so how to get yourself prepared is to start as early as humanly possible. And remember, it's a good problem to have to be selective.”

Building the Enterprise Program: Structure Before Submission

Readiness for the Inflation Reduction Act (IRA) is not a market access exercise. It is, in Corvino’s framing, the ultimate matrix organization challenge—one that requires executive sponsorship, cross-functional coordination across virtually every department, and a degree of structural discipline that most pharmaceutical organizations do not have a prebuilt muscle for.

Valenta, whose organization navigated negotiations for both rivaroxaban (Xarelto; Johnson & Johnson) and ustekinumab (Stelara; Johnson & Johnson) as part of the first 2 rounds, described the critical importance of centralized accountability. The scope of activities required during a compressed timeline—financial analytics, real-world evidence development, regulatory review, alliance management, and CMS engagement preparation—demands a single individual responsible for ensuring everything gets done, even if that individual is not the ultimate decision-maker on any single workstream.

Shah built on this with a 3-tier staffing model refined through the Ibrance negotiation process. The first tier is what she called the “pilot in command”: a senior leader with the rare combination of clinical fluency, real-world evidence literacy, and commercial acumen—someone who can speak credibly across all stakeholder groups without needing an intermediary. The second tier is subject matter experts selected for their ability to execute independently, not for their seniority. The third, and frequently undervalued, is a dedicated project manager.

“You need somebody that's really responsible for driving forward things like needing advice, sending emails, reviewing decks, and it sounds really basic, but you need the right infrastructure to get things done, and that really frees up capacity for some of the senior leaders to do some of the other things that were mentioned,” said Shah.

Parekh added 2 dimensions that apply with particular force at large, globally distributed organizations: the importance of proactive, structured internal communications—up, down, and across the enterprise—and the need to establish foundational organizational understanding of what IRA selection actually means before the work begins. Both become much harder once a selection announcement triggers a cascade of questions from business units that have not been prepared.

The 5D Framework

Corvino organized the session’s substantive content around what Deloitte has termed the “5D framework” for IRA readiness:

• Diagnose (portfolio impact assessment)
• Deploy (organizational readiness)
• Develop (information collection and manufacturing dossier)
• Defend (value of the drug through the negotiation process)
• Deliver (ensure compliant effectuation and execution)

On the diagnose phase, Valenta was emphatic that portfolio selection risk assessment is not only about products facing imminent selection. The real value of the exercise is in pipeline planning—specifically, in designing real-world evidence programs for assets years before they would theoretically be eligible, while there is still time to generate the data that will matter most to CMS.

“What I would recommend, or at least think through, is, as you're developing an asset, what is the long-term data plan for that asset, not just clinical data, but also, how are you thinking about the real world data that you're going to need at year 7, 8, 9, when you are selected, if you are selected by CMS?” said Valenta.

The diagnose phase also requires thinking beyond direct selection. Corvino identified indirect selection—where a competitor product’s negotiated price creates downstream pricing pressure on a related asset—as a frequently overlooked dimension, along with spillover effects into commercial payer contracting and the specific complexities introduced when a product is co-owned through an alliance. Several of the 40 products negotiated across the first 3 rounds have been alliance products, and Valenta noted that the governance complexity of an alliance effectively doubles the organizational challenge.

On the deploy phase, Shah identified finance as the most underutilized function in most organizations’ IRA submissions. The value dossier’s cost section—covering research and development allocation, therapeutic area cost attribution, and historic cost of goods—requires a level of financial precision that market access teams are not positioned to provide alone, and that must be established with methodological rigor across multiple years of data.

“What’s better than to bring in the individuals that really understand the costs, both from a historic perspective as well from a current perspective,” said Shah. “I think that's really important in a lot of organizations, at least those that I've spoken to.”

Parekh emphasized the strategic approach to the clinical value submission: the entire framing must be built around the Medicare population specifically, not the broader labeled population, and not the commercial payer audience that most organizations have spent years cultivating their value story for. He also stressed the nonnegotiable importance of challenge sessions—structured internal reviews in which the submission is pressure-tested from a CMS perspective, by individuals who do not share the team’s deep disease-state familiarity.

“You can't just think from an internal standpoint,” said Parekh. “You got to think from a CMS standpoint, those that are going to be in the room that don't know the space and the marketplace and the actual disease state as well as you do.”

Defending the Value Story: Preparing for the Room at CMS

The defend phase—the structured series of meetings with CMS during the negotiation window—received some of the session’s most practically granular guidance. Manufacturers are permitted 6 individuals in the room for CMS meetings. The panelists’ collective advice: maximize that number, maintain consistency across meetings, and prepare for an audience whose expertise lies in program administration and cost analysis, not in the clinical and market access details that manufacturers spend years developing.

“I think the one thing that was learned early on was, how do you write it in a very simplistic way, in like a third grade level?” said Valenta. “I hate to say that, but it makes it so easy, so people can truly understand it that aren't in our shoes, day in and day out.”

Shah returned to the theme of internal communication: before and after each CMS meeting, brief updates to senior leadership are essential to maintaining organizational alignment and preventing the information vacuum that can generate damaging internal narratives during a high-stakes negotiation process.

“If you don’t let people know, they’re going to create a story,” said Shah. “And that’s the worst thing that can happen in a negotiation process.”

Effectuation and the Part B Frontier

The session’s final segment addressed effectuation—the operational process of making negotiated Maximum Fair Prices (MFPs) available in the market. With the class of 2026 having navigated effectuation for the first time and the class of 2027 now in deep operational planning, the industry has moved from theoretical concern to real-world execution. Valenta framed effectuation as a people-process-technology challenge requiring the same structural discipline as the preparation phase, with the added complication that pharmacy and claims systems may require parallel builds to accommodate the new pricing architecture without disrupting existing workflows.

The more significant inflection point, however, is IPAY 2028—the first round to include Medicare Part B products, which are physician-administered and reimbursed on an average sales price (ASP) basis. This distinction, Parekh argued, introduces a fundamentally different set of stakeholder dynamics and patient access risks. Unlike Part D, which is highly concentrated at the dispensing level, Part B effectuation touches every provider office and infusion center that administers the affected products.

“There are nuances in Part B that are different in Part D,” explained Parekh. “D is very concentrated in terms of where the dispenses happens, [in] at least the top 50% or so. You have the provider office economics and buy-and-bill, and you don't just think about it from a Medicare standpoint, but also with ASP, how that's going to impact commercial patients as well. You’ve got a little bit more of a burden on the on the duplication of discounts side, when we think about 340B as well.”

Additionally, Part B effectuation introduces risk of nonmedical switching, where a patient currently stable on a therapy may face formulary or site-of-care changes driven not by clinical factors but by the MFP mechanics. Parekh was careful to note that every stakeholder in the ecosystem shares an interest in avoiding this outcome, but that good intent does not substitute for operational specificity.

That operational specificity is now taking shape. In Milliman’s analysis of the IPAY 2028 selection list published in February 2026, 5 of the 15 selected products are covered under Medicare Part B, and eight of the 14 manufacturers involved in IPAY 2028 negotiations have prior experience from earlier rounds—experience the panelists argued will meaningfully advantage those organizations in building effectuation plans that protect both access and patient continuity.²

The Playbook That Must Be Written Before It Is Needed

Corvino closed the session with a frame that tied together everything the panelists had shared: the muscle required for IRA readiness does not naturally exist in most pharmaceutical organizations, and the window to build it before being called upon to use it is finite and shrinking.¹ Three rounds in, the organizations that have been through this process have a structural advantage—but only if they have done the after-action work to memorialize what they learned.

“You're never guaranteed to be selected for IRA, which is a good thing, but you can be selected in year 1 and then not be selected for until year 3,” said Valenta. “Because of that, what's important is to make sure that you're memorializing or building a playbook for how does it actually work.”

For manufacturers not yet selected, the panelists’ message was equally direct: use the time that others did not have. Build the real-world evidence plan now. Establish the cost allocation methodology now. Identify the pilot-in-command now. The IRA negotiation process is not one that rewards reactive preparation—and with 20 additional products set for selection annually beginning in 2029, the organizations that have not yet been through the process are not waiting for an unlikely event. They are counting down to an inevitable one.

References

1. Parekh R, Shah S, Valenta M, et al. IRA readiness and lessons learned from rounds 1, 2, and 3. Presented at: AXS26; April 27-30, 2026; Las Vegas, NV.

2. Bott C, Johnson S, Dawson L, et al. 4 key takeaways from the third round of drugs selected for Medicare drug price negotiation. Milliman. February 20, 2026. Accessed April 30, 2026. https://www.milliman.com/en/insight/key-takeaways-third-medicare-drug-price-negotiation