ISPOR Europe 2025: Trends and Talking Points

ISPOR delivered a panoramic view of health technology landscape change

Hosted in Glasglow, Scotland, ISPOR Europe 2025 gave us a panoramic view of how quickly the health technology landscape is changing – and the change is global. Whether in Europe or the US, health technology development is both more cost-conscious, and more focused on the patient voice and patient outcomes than it has ever been. There are also policy and funding shifts with healthcare systems tying reimbursement to patient outcomes and value-based healthcare models. Pharmaceutical price negotiations too are transitioning in ways that will have global impact. The EU has adopted coordinated drug price bargaining to reduce disparities between member states, and in the US since May 12, an executive order from President Donald Trump has tailored the Most Favored Nation (MFN) policy – normally applied to international trade – to fit US pharmaceutical pricing negotiations.

The European Union Health Technology Assessment Regulation (HTAR) – its Joint Clinical Assessment (JCA) policy, launched last January – is already having a massive impact on health technology assessment in Europe and elsewhere. ISPOR focus points included member states’ preparedness for JCA, population(s), intervention(s), comparator and outcome(s) (PICO) simulation, and early learnings from different stakeholders’ perspectives. The shifting assessment landscape generated lots of discussion about how to stimulate deeper engagement with the patient perspective – grounding our understanding of unmet need and the true value of a novel therapy’s benefit.

Joint Clinical Assessment for Orphan Drugs

It was also no surprise that the focus of JCA is moving toward orphan drugs, as these will be eligible for JCA in 2028. Panellists reinforced our position on the need for special strategic considerations for rare diseases. These considerations cover disease characteristics, evidence generation challenges and outcome definition/assessment challenges. It will be essential to embed JCA requirements into the product development process through early PICO scenario planning, evidence planning and gap analysis, and stakeholder mapping and engagement. Alongside strategies such as conducting de novo real-world evidence (RWE) studies and market research, collaborating with patient advocacy groups and registries, and engaging early with clinical experts before the JCA invitation, the panellists highlighted considerations we also regard as essential. Notably, the risk of strong conflicts of interest remains particularly challenging in the context of orphan diseases.

JCA, PICOs, and manufacturers

Another JCA update session, titled “Optimal Strategies for Predicting and Consolidating PICOs: One Best Method or a Blended Approach,” emphasized the importance of predicting PICOs accurately and long before the JCA process even begins. To achieve this we should aim to combine several approaches – literature reviews, clinician surveys, and Generative AI. These steps are in-line with our PICO Framework and PICO simulation commentaries:

• Navigating EH HTA – Your Roadmap to Success
• Joint Clinical Assessment – Anticipating Your PICOs

If an outcome is prioritized it should be priority for each patient/comparator combination – or have a justification as to why this is not possible.

For manufacturers, as we anticipated, the JCA is proving to be a resource intensive process. One especially challenging for small biotech companies. This is an important consideration when it comes to European patients’ access to novel therapies given emerging biotech companies are increasingly taking their therapies to market rather than partnering with a larger manufacturer. If the burden of the JCA is too high – given the wider pricing pressures induced by the MFN policy – there is a risk that emerging biotechs will choose not to launch in Europe.

President Trump’s “Most Favored Nation” Policy

Turning to the implications of developments in the US, ISPOR left us with a snapshot of the changing landscape heralded by President Trump’s MFN policy.

Signed as an executive order in May, President Trump’s MFN aims to combat high drug prices in the US by benchmarking drug prices against those used in countries with similar economic standing. The MFN policy urges pharmaceutical companies to offer US patients the lowest price based on a basket of drug prices in reference countries. At ISPOR, this basket included 16 countries, but this number could well change in the future. Countries in the reference basket are reported to be Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Iceland, Ireland, Israel, Luxembourg, the Netherlands, Norway, Sweden, Switzerland and the UK.

This approach reflects a broader shift toward international reference pricing, which is the most widely used mechanism for controlling European drug prices. Currently, it is implemented by numerous European countries to reduce drug prices. The US may follow common practice adopted by these European countries – typically referencing prices from five to seven countries and setting the referrer drug price to the median price of these countries.

By linking US drug prices to those in lower-cost countries, the MFN policy could erode margins in the commercially crucial US market. This pressure on profitability could impact investment, with a ripple effect across the broader economy. The risk of policy spillover is also likely to be considerable. The MFN policy draws on diverse HTA systems, and this could trigger shifts in global pricing strategies as manufacturers work to preserve return on their investment in a technology research and development. Possible outcomes include a pivot toward high list price – high discount models aimed at protecting US margins, as well as restructuring of global access and pricing dynamics. Over time these shifts could influence innovation, encourage international pricing convergence and lead to policy decisions that are increasingly informed by cost-effectiveness and value-based assessments.

Artificial Intelligence

Much has been said about AI and the conversation continued at ISPOR Europe 2025. Globally, AI’s potential to reduce time to insight across the evidence base was a talking point. Crucial given the ever increasing complexity of the HTA submission roll-out process (e.g. JCA), the increasingly interconnected nature of pricing decisions (e.g. MFN) and therefore the need to identify as early as possible the crucial levers to effectively demonstrate value.

Of course, carefully integrating RWE into value demonstration activities is critical. One conference session, titled “Generative AI: Driving the Next Era of Medicine,” suggested that Generative AI (GenAI) is accelerating and enhancing HEOR and RWE work by enabling advanced analysis of disease progression, treatment response, and evidence-based decision making using electronic health records, claims, and scientific literature.​

Another session titled, “Survival Analysis in the Era of Generative AI,” confirmed that in principle it is possible to automate survival analysis and report writing with AI. There are reservations though, and these stem from AI’s results not always being accurate, resulting in errors that can cascade. The session confirmed it is essential for an expert human to lead, control and check the use of AI.

Conclusion

As we look forward to December and the end of the year, ISPOR’s sessions, posters, and conversations helped us to look back at the changes 2025 has brought. We left Glasgow better equipped to help manage the global healthcare challenges that will come in 2026.