2025 was a year of transformative change across the global healthcare landscape. From landmark policy developments in the US to the formal implementation of the new European Regulation on Health Technology Assessment (HTA) in the EU, in 2025 the pressures on pharmaceutical and medical device manufacturers had never been greater.
At Lumanity, throughout 2025 we explored the challenges and opportunities arising from this new reality. Our thought leadership and conference insights consistently pointed to the same emerging themes: the critical need for robust, early, and strategic evidence generation; the rising importance of proactive, cross-functional collaboration; and the necessity of adapting to evolving regulatory and pricing frameworks. Looking back at the year the key topics that shaped our conversations were these:
The US Market: Adapting to Unprecedented Policy Shifts
Evidence Generation: The Foundation of Modern Market Access
Embracing New Methodologies and Cross-Functional Ways of Working
The US Market: Adapting to Unprecedented Policy Shifts
The Inflation Reduction Act (IRA) has profoundly reshaped the US market. The volatility it created, combined with new payment models and calls for greater price transparency means manufacturers must be more focused than ever before. Following the release of information from the first round of Maximum Fair Price (MFP) negotiations, we examined the initial outcomes and raised key questions about how the Centers for Medicare & Medicaid Services (CMS) weighed therapeutic alternatives and patient perspectives.
Our white paper, “Learnings and Advice From the First Two Rounds of Medicare Drug Price Negotiations” provided actionable insights from our experience on the frontlines of these negotiations. A central learning was that success in the Medicare Drug Price Negotiation (MDPN) process hinges on early and continuous preparation. Manufacturers should begin preparing no later than 3–5 years before an asset is expected to be selected, focusing on identifying and addressing evidence gaps while there is still time. This requires a robust evidence base that goes beyond pivotal trials to include published network meta-analyses and real-world evidence studies. That advice still holds true today as we look ahead to 2026.
We also highlighted the growing strategic value of Pre-Approval Information Exchange (PIE). As we discussed in “Transforming IRA Pressures into Opportunities with PIE” early engagement with payers is no longer just a best practice but a crucial tool for moderating IRA pressures. With payers facing increased financial liability under the Medicare Part D redesign, PIE offers a vital channel to communicate a product’s holistic value, influence coverage decisions, and justify a launch price that reflects its true worth.
Adding another layer of complexity, in summer 2025 President Trump’s Most Favored Nation (MFN) Executive Order introduced further uncertainty. In our analysis, “US Drug Pricing: Navigating Pressures on Multiple Fronts”, we advised clients to avoid overreacting and to focus instead on building a deep, nuanced understanding of the entire pricing ecosystem; thinking creatively about how to demonstrate value.
You can find more insights on our IRA page.
A New Chapter in Europe
While there was plenty for us to report on and assess in the US, we also scrutinized events in Europe which entered a new chapter in its harmonization of HTA. On January 12, 2025, the European Regulation on Health Technology Assessment (EU HTAR) officially began to apply, bringing the era of Joint Clinical Assessments (JCAs) for new oncology drugs, advanced therapy medicinal products (ATMPs), and certain medical devices.
To mark this milestone, we launched a JCA video series where our experts shared timely insights and guidance. In our first installment, “EU HTA Regulation January 2025: Are you ready?”, Suzette Matthijsse reflected on the journey to implementation and our commitment to helping clients navigate this new journey. The series continued by exploring the practical impact of the JCA on developers, particularly for medical devices. A key theme was the value of participating in Joint Scientific Consultations (JSCs) to gain early insights into what assessors expect.
For medical device developers, this transition to JCA is a paradigm shift. In our article “JCA Dossier vs CEAR for Medical Device Developers”, we outlined how the new JCA dossier demands a far more comprehensive evidence package than the familiar Clinical Evaluation Assessment Report (CEAR). A significant new hurdle is the need to address multiple Populations, Interventions, Comparators, and Outcomes (PICOs) to satisfy the diverse requirements of all EU Member States.
You can find more articles on our EU HTAR page.
Evidence Generation: The Foundation of Modern Market Access
A consistent theme across all our work in 2025 was the paramount importance of strategic and rigorous evidence generation. Our popular “How To” series, launched in 2024, provided practical guidance on foundational health economics and outcomes research (HEOR) activities. To bring this series to life, we also launched an interactive graphic that visually outlined our step-by-step guides to building a robust HEOR strategy.
- In 2025, the series continued with a guide on “How to: Undertake a Literature Review,” clarifying the distinct roles of Systematic and Targeted Literature Reviews
- We followed this with guides on “How to: Perform a Feasibility Assessment” for indirect treatment comparisons and “How to: Develop an Early Cost-Effectiveness Model,” emphasizing how early modeling can identify key value drivers and prioritize evidence generation
- Our series culminated with “How to: Undertake an Evidence Gap Analysis and Evidence Generation Strategy,” which ties these concepts together. This strategic process, ideally started before a pivotal trial, ensures that a company’s evidence base is aligned with HTA requirements from the start
Embracing New Methodologies and Cross-Functional Ways of Working
During 2025 we also explored how to manage the increased uncertainty of modern HTA and drug development, a key focus of our presentations at ISPOR 2025, AMCP 2025, and HTAi 2025 conferences. Likewise, in Ireland the NCPE Annual Symposium 2025 called for a more agile, evidence‑driven and collaborative HTA system in Ireland — one that balances rising costs with proven patient benefit, prepares for new EU regulations, and accelerates access through real‑world data, pragmatic trials, and strong partnerships across policy, industry, and clinical care.
In “Recommendations for Managing Challenges in Using SEE in HTA Submissions,” we shared our experiences with Structured Expert Elicitation (SEE) – a valuable method for quantifying uncertainty when data are sparse, which has gained official backing from ISPOR and major HTA bodies. We provided practical recommendations for ensuring SEE studies are robust, from getting early alignment on the quantities of interest to careful management of timelines.
This need for new methods also applies to rare diseases. Our article “Rare Diseases Challenge Modelers to Deliver Equity” examined the unique difficulties modelers face when working with small patient populations and underscored the need to adapt established techniques to achieve more equitable access.
Across nearly every topic the need for deep, proactive, cross-functional collaboration emerged as a prerequisite for success. Whether preparing for an MDPN submission in the US or a JCA dossier in the EU, teams from market access, HEOR, medical, regulatory, and finance must work in close alignment from the very beginning.
Conclusion
As we look ahead to 2026, it is clear to us that these trends will only accelerate. A willingness to plan early, to generate robust and comparative evidence, and to collaborate effectively will be the defining features of successful organizations. We look forward to continuing the conversation as 2026 unfolds.
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If you would like to find out more about any of the topics covered in this article, please contact us.
