MFN Pricing, IRA Negotiation, PBM Scrutiny, and 340B Remain Top Market Access Concerns

Key Takeaways

• MFN-related policy remains a major strategic issue, with panelists describing implications for Medicare, Medicaid, launch pricing, tariffs, and ex-US commercialization decisions.
• Global pricing decisions are becoming more tightly linked to US market access strategy, particularly as the US is discussed more directly as a reference market.
• IRA negotiation is now an operational reality, and panelists said manufacturers are preparing earlier and more intensively for government pricing discussions.
• Comparative evidence and value messaging appear central to IRA negotiations, with strong emphasis on preparation, competitor framing, and health economic support.
• Patient out-of-pocket savings under IRA implementation may not be uniform, according to discussion during the panel, despite negotiated pricing and list price changes.
• Part B drug price implementation remains an unresolved concern, especially in provider buy-and-bill settings.
• PBM and 340B issues remain major market access priorities, even though the session excerpt focused most heavily on MFN and IRA.

At a Asembia 2026, market access leaders discussed four of the most consequential policy issues affecting manufacturers and payers: most favored nation (MFN) drug pricing and tariffs, Inflation Reduction Act (IRA) drug price negotiation, pharmacy benefit manager (PBM) reform, and the 340B drug discount program in a session titled "Evolving US Policy and Value Economics Shaping the Future of Specialty."

The panel featured Lindsay Bealor Greenleaf, Head of MAPS, ADVI Health; Sabrina Aery, Founder and Principal, Aery Policy & Access Partners; Chris Mancill, SVP and Head, US Market Access, AstraZeneca; and Annette Powers, Senior Vice President and Head, Global Market Access and Public Affairs, Astellas Pharma.

Across the discussion, panelists emphasized that market access strategy is becoming more interconnected across US and ex-US pricing, product launch sequencing, government negotiation, and payer dynamics. For payer stakeholders, the session underscored how policy shifts are increasingly influencing pricing benchmarks, formulary strategy, patient affordability, and long-term market behavior.

MFN Policy Continues to Shape Pricing and Launch Strategy

A major focus of the panel was MFN pricing and the growing number of related policy mechanisms now under discussion.

Greenleaf opened by outlining the current landscape, including proposals related to MFN pricing in Medicare Part B and Part D, a Medicaid MFN pathway for participating manufacturers, tariff policy, and the existence of White House agreements with multiple companies. She said key themes attached to those agreements included Medicaid MFN, new launch MFN, product placement in Trump Rx where appropriate, and exemptions from certain Medicare MFN requirements and tariffs.

From a payer perspective, panelists described MFN as more than a standalone pricing proposal. They framed it as a policy development with implications for launch planning, global price corridors, product sequencing, and manufacturer portfolio strategy.

Mancill said the issue resonates because of longstanding concerns over pricing differences between the US and other countries. Powers added that companies not directly involved in recent agreements still need to conduct internal analytics and assess what type of MFN-related approach might make the most sense for their own portfolios, manufacturing footprints, and future pipeline plans.

Aery said smaller companies and companies with limited portfolios may face particularly difficult decisions, especially if they are preparing for launch and do not have the same flexibility or leverage as larger manufacturers. She noted that some companies are rethinking or pausing ex-US launch plans while they model the implications of MFN proposals.

Panelists Urged a Global View of Pricing Strategy

One recurring theme was the need for broader coordination between US and global pricing functions.

Powers said companies increasingly need a unified global pricing perspective because MFN changes the way US and ex-US pricing interact. She noted that companies may need to revisit not just current products, but manufacturing and pricing strategies for future launches as well.

Greenleaf echoed that view, saying each company’s response depends on its own gross-to-net modeling, current portfolio, and pipeline. She added that some smaller companies that recently launched in the US are currently deferring ex-US launch activity while they evaluate whether they can achieve acceptable prices under the policy environment being discussed.

For payers, the conversation suggested that changes in manufacturer launch strategy, international pricing behavior, or product sequencing could eventually influence the timing and economics of US market entry and contracting.

IRA Negotiation Is Becoming More Structured and More Immediate

The second major area of discussion was IRA drug price negotiation.

Greenleaf noted that 10 drugs are already subject to negotiated pricing and that the next cycle is underway. She asked panelists how the process is evolving and whether there were notable changes under current leadership.

Mancill said manufacturers should invest early in a strong value narrative, including a clear explanation of the patient population, the product’s contribution to the healthcare system, and the available health economic evidence. He described the negotiation process as highly intensive and said companies should prepare for detailed questions not only about the product itself, but also about the competitive landscape and implications for broader access negotiations.

He also emphasized the importance of anticipating when a product may enter negotiation and ensuring that internal leadership is prepared well before selection occurs.

Powers similarly stressed preparation, saying manufacturers need to educate decision-makers on their products and make thoughtful decisions about what distinguishes them from competitors. She also noted that on the global side, IRA planning now intersects with launch sequencing, orphan strategy, MFN implications, and competitor timelines.

Aery added that, based on her review of published CMS justifications, comparative evidence appears to play a prominent role in the process. She also said that although manufacturers initially had significant uncertainty about how CMS would approach negotiation, especially in the first round, she has not observed a major difference between administrations in the overall structure of decision-making based on the exercise she described.

Comparative Evidence and Competitor Framing May Be Especially Important

A notable theme in the IRA discussion was the role of comparative evidence.

Aery said CMS appears to conduct literature reviews, identify comparators, and build pricing justifications using several categories of information, including comparative clinical evidence and patient and provider listening sessions. She suggested that manufacturers may spend considerable effort trying to influence how CMS defines the relevant comparator and how the product’s unmet-need story is understood.

Panelists described this as part of a broader shift in which manufacturers must be ready much earlier and with more robust evidence packages than in previous pricing or access discussions.

That emphasis could become increasingly relevant as negotiated prices influence broader market expectations and as manufacturers adjust their value arguments in both public and private channels.

Patient Out-of-Pocket Relief May Be Uneven

The panel also discussed whether negotiated pricing is translating into lower patient out-of-pocket costs.

Greenleaf shared an example involving patients taking Eliquis who reportedly faced higher out-of-pocket costs in 2026 despite negotiated pricing and a list price cut. She said internal analysis across the 10 drugs in the first IRA cycle suggested that patients were, on average, somewhat better off, but that the improvement was modest and not consistent across all products. She specifically noted one example in which average patient out-of-pocket costs were reportedly higher.

Mancill responded that while the out-of-pocket cap under Part D has generally been viewed positively, other changes to the benefit design may mean that not all patients experience savings in the same way. He suggested that patients who do not reach the annual cap may still experience higher costs earlier in the benefit year if plans move from flat copays toward coinsurance.

Powers added that continued monitoring is important to understand how these changes are affecting patients in practice. She said that while implementation at the pharmacy level may have gone more smoothly than expected, questions remain about whether the overall design is improving access and affordability as intended.

The discussion highlighted a key tension: negotiated prices and list price changes do not necessarily translate directly into lower patient cost sharing, depending on how benefit design and other supply chain decisions are structured.

Part B Effectuation Remains a Significant Open Question

The panel concluded the IRA discussion by turning to physician-administered Part B drugs and the ongoing concern over how maximum fair prices will be operationalized in buy-and-bill settings.

Aery said this remains a closely watched issue and referenced ongoing stakeholder work related to Medicare Part B effectuation. She noted that CMS had not finalized a Part B effectuation approach last year and that the market is awaiting updated guidance.

She characterized effectuation as potentially very complex, particularly because of the differences between pharmacy channels and physician buy-and-bill environments.

Although the session excerpt ended before a fuller discussion of solutions, the issue was presented as a major unresolved operational challenge with implications for providers, manufacturers, and downstream reimbursement.

Broader Market Access Pressure Extends Beyond IRA Alone

Although the session focused most heavily on MFN and IRA, the panel was framed around 4 major policy issues: MFN and tariffs, IRA negotiation, PBMs, and 340B.

That framing itself was telling. Panelists described the current market access environment as unusually dynamic, with multiple policy fronts moving at once and creating overlapping implications for pricing, access, reimbursement, and product strategy.

The broader message was that federal pricing policy, supply chain pressure, benefit design, and access infrastructure are becoming more tightly linked. Decisions made in one policy domain may increasingly influence others, whether through pricing benchmarks, rebate structures, affordability outcomes, or provider reimbursement.

Reference

Greenleaf LB, Aery S, Mancill C, Powers A. Evolving US policy and value economics shaping the future of specialty. Asembia. 2026. Las Vegas, NV.