从孤岛到整合：2026 年及以后有效的场景建模该怎么做

International reference pricing has been a talking point for elected officials and Department of Health and Human Services leaders in the U.S. for nearly a decade, but President Donald Trump’s May 2025 executive order pushed for broader and faster adoption than many industry experts anticipated.

By the end of 2025, 14 of the 17 large drugmakers addressed by the White House had signed voluntary agreements to offer newly launched medicines in the U.S. at prices comparable to those in other high-income countries and make existing drugs available to Medicaid patients at most-favored-nation (MFN) prices. The three remaining manufacturers soon followed, along with nine other companies, bringing participation up to approximately 89% of the branded market in just over a year of the executive order’s publication. An early signal of MFN’s impact is an apparent decrease in new drug launches in EU markets, with one source estimating that launches declined roughly 35% year over year during that time period.

The introduction of MFN pricing represents one of the most consequential changes to pricing and access policies the U.S. pharmaceutical market has seen in years, but it is by no means the only major shift across the commercialization landscape. The EU’s Joint Clinical Assessment (JCA) process is raising the bar for comparative evidence standards, while national Health Technology Assessment (HTA) bodies such as NICE and Germany’s G-BA are scrutinizing evidence more closely and making greater use of real-world evidence (RWE) to supplement clinical trial data. Around the globe, market forces and supply chains are becoming increasingly volatile and interdependent. As they do, pharmaceutical decision-makers must navigate increasingly complex trade-offs with significant downside risk.

“Today’s complexity means that pharmaceutical leaders can no longer think in terms of sequential steps when they’re planning a launch strategy,” said Michael Day, Ph.D., senior director of regulatory strategy and CMC at Cencora. “You can’t optimize your regulatory path and then product safety and then market access and commercialization and expect the best possible global outcome. Sometimes the best regulatory path is not the best path to the market. In this world, all the different disciplines need to work together for a common cause.”

Scenario modeling — the practice of building and testing multiple forecasts based on a variety of assumptions about policies, competition and global markets — is an essential tool for decision-makers tasked with charting a course through these kinds of uncertainties. But most pharmaceutical companies still model scenarios using a single-threaded approach — that is, one function at a time — with each department working in isolation, using its own model and assumptions.

What’s needed for success is an integrated approach to scenario modeling and analysis, one that incorporates data gathered across the entire organization, breaks down the silos between departments and disciplines, and leverages newer technologies such as AI to manage the additional complexity.

Planning for commercialization in a borderless global market

JCA provides a joint scientific assessment of the relative clinical effectiveness and safety of a medicine compared with alternatives, but it does not determine pricing, reimbursement or overall value. National HTA bodies are required to give the JCA due consideration during their own country-specific assessments, alongside economic, healthcare-system and other concerns. A JCA report showing uncertainty about comparators, endpoints or generalizability can make payers more cautious and weaken your value story. Manufacturers need to consider this interdependency from the earliest phases of development.

They should also design an evidence plan that will satisfy both national payers and regulators. A clinical development program may be sufficient to support regulatory approval but still leave gaps for JCA or national HTA if it does not generate the comparative evidence needed against relevant standards of care. And because JCA is now conducted in parallel with EMA review, that evidence must be ready at the time of submission.

“In the past, manufacturers could choose which countries to make HTA submissions in, and they could base this decision on what kinds of data they had available,” explained Casper Paardekooper, vice president for health policy and strategy at Cencora. “Now, when they take part in the European clinical assessment process, as many as 27 different countries can have input into the PICOs (Population, Intervention, Comparator and Outcome) that serve as evidence in the JCA. To be successful in this process, you have to plan to include an array of comparators, endpoints and subpopulations in your research, and you need to have the evidence ready early on.”

In the current climate, European national pricing outcomes can not only sway other EU countries’ HTA bodies but also influence negotiations elsewhere, including the U.S. Prices in other parts of the world are interconnected, too. Several countries in Southeast Asia use reference pricing based on prices in European countries, while Australia is a major reference input for Canada.

“MFN and international reference pricing mean that what we do in one local market no longer only has local consequences,” Day said.

Reimagining scenario modeling for this new era

Many drugmakers still maintain separate U.S. and European launch teams, with each conducting its own pricing research and payer intelligence. In today’s world, the potential trade-offs involved in launch sequencing make this traditional approach untenable.

In integrated scenario modeling, policy, regulatory and CMC, market access, medical, clinical, and pharmacovigilance teams all provide input, making it possible to test scenarios that no single function could evaluate on its own:

• If you launch first in the U.S., should you still launch in Europe, Japan and Canada?
• If so, in what order?
• How much U.S. pricing risk can you accept in exchange for greater volume in Europe?

AI-enabled analytics can help make integrated scenario modeling more scalable by synthesizing large amounts of data and evidence, allowing teams to interrogate a broader range of scenarios than would be practical manually. It can also help teams update those scenarios more efficiently as assumptions, evidence and market conditions change.

AI doesn’t replace expert judgment, though. “AI can generate a plethora of different scenarios, but human experts still need to understand what those scenarios mean,” Day said. “The greater the uncertainty, the greater the diversity of thinking that’s required. Pharmaceutical companies will need to become increasingly agile and able to pivot quickly as soon as regulatory requirements or markets change.”

“Increasingly, strategic foresight is becoming the most critical capability within a pharmaceutical company,” Paardekooper added.

Start early

Integrated planning is best initiated in the earliest stages of product development. By launch day, it’s far too late to make critical changes in endpoint selection or clinical data strategies. Maximizing the return on your investments in R&D requires getting new treatments to patients as soon as possible. Without an interdisciplinary, connected strategy, there’s a risk of delay — or even that patients will not have access to the new therapy at all.

“The earlier you think about these things, and put them together, the more flexibility you can build into your development program,” Day added. “This flexibility enables drugmakers to make critical decisions with greater visibility into their downstream consequences. This is the foundation of success.”

Learn more about the market forces reshaping global launch strategies in Cencora’s latest report.