Preparing for the Second Wave of IRA Implementation
By Chris Stewart, PharmD
The first ten drugs selected for IRA negotiation hit pharmacy counters in January. The headlines moved on by February. And somewhere around March, market access teams realized the hard part hadn’t even started yet.
I was on a call recently with a former Part D plan executive, someone I’ve known since my own days closer to the payer side, and she said something that stuck with me. “Everyone’s still talking about the negotiation like it’s the finish line. It’s the starting gun.” She’s right. The Maximum Fair Price (MFP) taking effect was the easy, visible milestone. What’s happening underneath, in plan design, in pharmacy operations, in the quiet repositioning of competitor products, is where 2027 and 2028 are going to be won or lost.
What 2028 Planning Should Already Be Wrestling With
The 2028 negotiation list expanded into Part B for the first time. That changes everything for buy-and-bill products. Infused biologics, provider-administered therapies, oncology assets that have lived comfortably in the medical benefit world, all of them are now playing by rules that were designed with retail pharmacy in mind. The operational lift on physician practices, hospital outpatient departments, and 340B covered entities is going to be significant, and manufacturers who haven’t mapped the downstream channel implications are going to be reacting instead of leading.
A few things for 2027 that should already be on the 2028 planning agenda:
- Channel strategy reassessment. If your product will be subject to MFP on the 2028 list, your buy-and-bill economics are about to shift. Site of care decisions, GPO contracting, and 340B exposure all need fresh modeling.
- Competitive repositioning scenarios. When a competitor’s MFP hits, payers don’t always prefer the lower-net-price product. Sometimes they double down on the non-negotiated alternative because the rebate math is better. Have you modeled both directions?
- Plan design intelligence. Part D plans are restructuring formularies in ways CMS didn’t entirely anticipate. Some negotiated drugs are landing on tiers that were not anticipated or with utilization management that wasn’t there before. The “win” of a lower price can be quietly offset by access friction.
- Patient support program redesign. Copay dynamics changed under the redesigned Part D benefit. Your hub, your PAP, your adherence programs, all of them need to be re-examined for a world where the patient out-of-pocket experience looks fundamentally different.
Why 2028 Planning Needs to Start Now
2028 is when the cumulative effect really lands. By then, we’ll have three cohorts of negotiated drugs in market, the Part B expansion will be fully operational, and the small molecule cliff (the 9-year vs. 13-year negotiation eligibility gap) will be reshaping pipeline decisions in ways that ripple all the way back to development strategy.
The manufacturers who are doing the following three things are the ones that will be most likely to succeed in this evolving access landscape:
- Building integrated forecast models that treat IRA exposure as a portfolio variable, not a single-asset problem.
- Rethinking launch sequencing for assets approaching the 9-year mark, with real urgency around indication expansion and patient capture.
- Investing in policy intelligence as an ongoing capability, because the IRA implementation is still being written in guidance documents, not just statute.
One Last Thought
The reality is that the second wave of IRA implementation will not reward reactive organizations. It will favor those who can anticipate how policy, economics, and channel dynamics converge, and translate that into actionable strategy. This is where Petauri can play a critical role, helping manufacturers move beyond static planning into integrated, scenario-based decision making that connects policy insight to real-world execution across payers, providers, and patients. As the stakes rise in 2027 and 2028, the advantage will belong to those who are not just tracking the shift, but actively building for it.
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