Co-authored by Smita Sealey and Laura Savi.

Key takeaways

• The U.S.’s Most Favored Nation (MFN) drug pricing remains unresolved, but biopharma companies are already changing how they think about pricing, access and launch strategy.
• Waiting for policy clarity may create risk; organizations that build decision-ready scenarios and governance now will be better positioned to move quickly.
• Europe’s role in global launch sequencing is under pressure, making resilient access models and market-specific strategies more important.
• Access teams need to move beyond analysis and become orchestrators of enterprise-level trade-offs across markets, functions and time horizons.

Over the past several months, MFN drug pricing has moved from a policy rumor to a signed executive order. It has been announced, challenged, revised and debated, yet it remains unresolved. In the middle of that uncertainty, the industry has been left in an uncomfortable position: one foot on the accelerator and one on the brake.

Some organizations are still watching closely, waiting for more clarity before making significant decisions. Others are preparing differently. They’re not trying to predict exactly how the policy lands, but they’re building the ability to move quickly once greater clarity emerges. Increasingly, speed to act will be the real differentiator.

ZS hosted a webinar, led by Laura Savi, that dove into this topic with experts Bill Coyle, Barry Farrimond, Smita Sealey and Stefan Kloss. Watch the webinar to get the full insights from the conversation.

Laura Savi (LS): Let’s get into it. Bill, walk us through some of the key uncertainties that remain today.

Bill Coyle (BC): I want to talk a little bit about what’s not completely clear. And of course, in this case, there’s quite a bit that’s not completely clear.

The first key consideration is how broadly MFN might expand across reimbursement channels and therefore affect the U.S. commercial book of business. Medicare is a big driver, but commercial is a very large driver. So how could MFN leak over to those commercial channels?

In public pronouncements, it seems like it could or might, based on the announcements that have been made by some manufacturers. However, it’s not completely clear. And when we think about TrumpRx.gov, you could imagine a way commercial patients might be able to pay for product cash through TrumpRx.gov and then get reimbursed through their payer.

How would it operationalize if it was commercial? Would it be through TrumpRx.gov? Would it be through prices that are made available to commercial payers? It’s not clear how it would operationalize. Even elements around price reporting and net price reporting by manufacturers, when they have confidential prices outside the U.S., how do they operationalize the reporting of that and honor the private contracts they have outside the U.S.?

The enforceability becomes a question as well. A lot of this was done by executive order. Some companies have created agreements with the U.S. government. It’s not clear always what’s in those agreements. And at the beginning, the Trump administration was seeking to codify MFN into law. It seems unlikely, at least in the coming legislative sessions, that you’d have legislation that puts MFN into a durable legislative construct.

So lots remains unclear, but this is the context in which we all need to operate to make the best decisions from the manufacturer side.

LS: Since the MFN announcement, what are you observing across companies, markets or behaviors that signal how seriously this is being taken?

BC: What we’re seeing across organizations is three groups evolving. There’s a wait-and-see group, a hedge-and-adjust group and a group that’s really preparedness-focused.

In the wait-and-see group, companies are monitoring developments and understanding what’s going on, but not necessarily changing what’s happening internally or some of the planning processes or governance processes that are in place. There’s risk for those companies that if they don’t have their plans lined up and then a trigger happens—or decisions come out of the administration, or things are codified—they need to scramble a bit to move forward.

The second group is more forward-focused. These are the hedge-and-adjust companies. They’ve started making tactical adjustments to what they do every day: scenario modeling to understand exposure, cross-functional conversations to pressure test launch strategies and sequencing, contracting assumptions, and go and no-go pricing points. They’re starting to look at decision-making or governance structures, but those structures largely remain unchanged.

The preparedness-focused group is taking a different approach. Rather than trying to predict a single outcome, we’re seeing a lot of capability building around how to respond quickly as things evolve. These companies are creating organizational structures, governance structures, cross-functional alignment and coordination that allow them to have dynamic planning around launch and pricing.

These organizations don’t have any more certainty than the rest of us. But organizationally, they’re looking to be better positioned to move quickly every time some element of clarity emerges.

LS: Looking slightly ahead, if we think about the post-2029 environment, how do you see international reference pricing mechanisms evolving in response?

BC: The particular challenge for most manufacturers, and even countries that are referenced by MFN, is secondary and tertiary referencing. Markets may be creating some liabilities for themselves by whom they reference or if they’re being referenced.

You might see some push among markets to clean that up. Even countries that aren’t directly targeted by MFN policy coming from the U.S. might be held back. Even if they’re not a wealthy enough country, they may hold back because a wealthy country references them. So I imagine you could see some shakeout there, or some working among these markets to take themselves out of the implied target list through secondary and tertiary referencing.

And then there’s IRP [international reference pricing] in the U.S. MFN is essentially an IRP, so that could continue to evolve as well. But that’s the big uncertainty we’re dealing with.

LS: One question we’ve heard consistently from our clients is whether Europe risks becoming a secondary launch market in this environment. Barry, what is your perspective on this point? Are we seeing shifts in Europe’s attractiveness? And if so, what does that mean for access and launch planning teams?

Barry Farrimond (BF): I think it’s more than a risk. It’s something that’s actually playing out right now. The bigger risk is that we’re not talking about it loudly enough, and we’re not acting quickly enough to counter the delays, the reconsiderations of launch sequence and the other things you mentioned.

At the same time, we need to continue to contextualize this discussion because if we focus just on MFN, it potentially becomes too narrow. What we’ve been navigating for the last five years are a series of structural shifts, both convergence and divergence within the regulatory and payer landscapes. MFN is absolutely one, but so is the JCA. Pick any major global economy, and even most of the minor ones, they will have gone through some kind of seismic change in that period.

We’re in a period of uncertainty where we don’t know what will come next because it has become so hard to predict the policy environment. It’s not just one thing. We’re now dealing with a period of compounding, directionally uncertain disruption. That’s the real challenge that launch teams and organizations are struggling with.

The rational short-term approach is to sequence Europe later, think about launching selectively or, in some cases, not launching at all. But if that becomes structurally ingrained in launch strategies and launch planning, and we’re not deliberate in resisting it, then once that pattern sets in, it’s going to be very hard for us to reverse.

So the corrective action is not to double down on classic approaches, but instead to think about how we build increasingly resilient access ecosystems. Precision access, if you will: finding the right product for the right country through the right access channel at the right time, and finding ways to pilot and scale.

LS: How will Europe adapt to MFN, given how important it is to stay relevant and be able to offer innovative drugs to patients?

BF: I’m going to borrow a phrase from Stefan and one of our other colleagues: The systems will bend, but they will not break. Things in Europe have always evolved, and they will continue to evolve, but they will do so slowly.

You are seeing some movements, maybe baby steps, in both the U.K. and Germany, where we’ve seen increases in prescription charges or a nominal increase in the overall cost and threshold. Others are continuing to hold the line more strongly. So the classic systems are not going away, and we have to work out how we can continue to develop those.

In terms of what Europe can do to stay relevant, there’s a level-up discussion that needs to happen. Policies need to be thought about at a European and country level to make it more, not less, attractive. That was already happening before MFN with some of the new legislation, and MFN has magnified the challenges we all knew were present.

That means reimagining tax incentives, science and innovation incentives, conditional agreements, affordability models—all of the really difficult things that have been avoided for far too long but are now coming into sharp focus.

LS: Let’s shift now from what’s happening to how organizations are actually responding. Smita, what are you seeing in terms of how organizations are trying to navigate this uncertainty? How are teams quantifying it, and how are they moving from analysis to action when triggers are activated?

Smita Sealey (SS): The honest answer is most organizations aren’t yet navigating the uncertainty. They’re still trying to quantify it.

There has been a huge amount of effort over the last six to 12 months to understand what MFN would look like. Is it going to be a light version, a codified version, a hybrid? How might it evolve across channels, and what does it mean for pricing corridors and portfolio value?

But a lot of teams are still at that diagnostic phase: running scenarios, refining assumptions and pressure testing models. And the pharma model simply wasn’t built for something this interconnected and this fast paced.

What’s emerging now is a real chicken-and-egg tension. On one hand, companies are trying to push the external environment, particularly in Europe, to fully recognize innovation. On the other hand, companies are also asking: What if that shift doesn’t happen fast enough? Do we adapt internally even if that means making very difficult trade-offs today?

Teams are caught between shaping the system and preparing for it if it doesn’t change. That’s where real discomfort emerges because preparing for that scenario means making tangible trade-offs today on where to launch, what your evidence strategy should be and what pricing discipline needs to look like.

I don’t think the challenge is just uncertainty. It’s moving from analyzing it to actually acting within it.

LS: Building on that, there is clearly a spectrum in how organizations are responding. Stefan, what differentiates companies that are getting ahead versus those that are a bit behind? What does proactive preparation actually look like in practice?

Stefan Kloss (SK): There are a few ways in which leading companies prepare. The first is about modeling MFN implications around GENEROUS, GUARD and GLOBE, depending on the manufacturer’s inclusion in these models. The next three are about execution.

There’s a dialogue with EU policymakers around funding and pricing models to shape that environment in order to get EU pricing closer to that of the U.S. Then there’s the shaping of a value strategy that can enable us to obtain higher reimbursement rates if necessary, even for a more narrow reimbursed target population. And last, there’s the equipping of country organizations with last-mile enablers to achieve those desired reimbursement outcomes.

On the modeling side, a good MFN model highlights the trade-off between generating revenue in MFN reference markets at specific price points and the MFN rebate implications on the U.S. side. These models need to take into account all the key markets. At a minimum, that includes Japan, the EU5, Canada, Brazil and China. For these, you need to build out expected price, market access and volume over the entire course of the asset’s life cycle.

When it comes to market shaping, expectations in the short term are mixed, as the majority of payers outside the U.S. are beginning to understand the implications of MFN trade policy. That said, public health priorities are not going away. I see two avenues of opportunity emerging here.

First, therapies of the highest therapeutic value could be put on a priority list where reimbursement outside the U.S. looks a lot more like U.S. pricing. Second, I anticipate alternative funding pathways stepping in to fund innovation. Patients will likely have the opportunity for private supplemental insurance, and certain employers might also step up and offer nonreimbursed services to their employees.

LS: What capabilities do companies need to start building now, not just to respond to MFN, but to operate more effectively in this kind of environment?

SS: The gap isn’t just that access strategy isn’t seen as enterprise strategy in most organizations. Access as a function clearly has a seat at the table. The difference is that it hasn’t been executed as an enterprise strategy.

Until now, if those trade-offs weren’t existential, you could pretty much launch broadly, accept a little bit of price erosion and still protect overall value because the world wasn’t like a giant domino board. MFN changes that. Now you’re making much harder calls: delay a launch, hold price, accept lower access. Those are enterprise bets. They’re not local optimizations.

Access needs to be an orchestrator of enterprise trade-offs, not just explaining implications, but helping drive decisions across markets, functions and time horizons.

If we translate that into capabilities, three things matter. The first is decision-ready scenarios, not just modeling. The gap isn’t quantifying uncertainty or generating insights. It’s agreeing upfront on what we’ll do under different conditions. Will we launch? How will we launch? What capabilities need to be true for those options to work?

The second is enterprise-level pricing and launch governance. In an MFN world, one country’s decision can shape global value. That requires much tighter price control and clear decision rights, and a willingness to override local optimization.

The third piece is data, analytics and tech. You need a much better single view of global price exposure, dynamic scenario testing across markets and the ability to track signals and trigger decisions in real time.

LS: Bringing it down to practical action, Bill, this one is for you. What are the two or three things organizations should start doing differently today to be ready? And how should we think about development and trial design moving forward from a U.S. and ex-U.S. perspective?

BC: In the short and near term, it’s really about being prepared. Clear, specific, ready-to-action scenario plans based on key triggers.

That key trigger could be that we decide to launch and take some risk in how we might be referenced. If we decide to launch outside the U.S., that key trigger could be seeing what a competitor does: What’s the public response? How does the administration respond? If we’re going first, what’s our PR plan?

So, it’s really about having ready-to-action scenario plans. Know how you’ll launch, if you’ll launch and where you’ll launch outside the U.S. if you feel this continued risk of MFN affecting the full U.S. book of business. Know how and where you’ll launch if there are triggers showing you can insulate parts of the business and limit your exposure.

Second, it means rapidly building organizational capabilities that support nonstandard access models outside the U.S. Depending on the category or the asset, it could be full or partial self-pay. It could be private insurance. It could be employer-mediated funding. It could be restricted public access. In the near term, strategic problem-solving and creativity among access professionals will really need to be paired with the classic focus on technical access expertise.

Finally, longer term, if you carry this to the extreme, you could imagine that if MFN really holds and exposes the entire U.S. book of business, you may need to be prepared for a dual-asset or dual-path world. Manufacturers, especially larger ones that have the scale, could consider dual-asset strategies once they’ve derisked an underlying mechanism of action and its likelihood to be successful.

In the pre-MFN context, this is not at all economically prudent. But it may be a path going forward if MFN is really here to stay and affects the entire U.S. book of business.

LS: If there’s one theme that stands out, it’s that while MFN introduces a great deal of uncertainty, it also creates an opportunity as a forcing mechanism for organizations to rethink how they make decisions across pricing, access and beyond.

As you think about what this means for your organization, here are a few questions worth carrying forward:

• Are we still treating MFN as something to monitor, or as something that requires a different way of making decisions today?
• When we say we’re doing scenario planning, are we genuinely exploring multiple futures, or are we quietly anchoring to one specific future?
• And do our current governance and global-to-local coordination mechanisms create speed and alignment, or slow us down when conditions change?