Conversations we’re expecting to hear at ISPOR Europe 2025: Will the EU HTA Regulation deliver harmonization or create new complexity?
ISPOR Europe 2025, the leading conference for health economics and outcomes research (HEOR) organized by ISPOR — The Professional Society for Health Economics and Outcomes Research, will take place in Glasgow (November 9–12, 2025) under the theme “Powering Value and Access Through Patient-Centered Collaboration.” The meeting comes at a time of significant change across the evidence and access landscape, as developments such as the EU HTA Regulation and the growing use of AI in evidence generation reshape how value is assessed and decisions are made amid ongoing geopolitical and economic pressures.
In this “Conversations we’re expecting to hear at ISPOR Europe 2025” series, The Evidence Base explores several key themes likely to feature prominently throughout the meeting – each reflecting an evolving dialogue among researchers, policymakers, payers, and patients.
Few topics are likely to dominate ISPOR Europe 2025 as much as the implementation of the EU HTA Regulation (EU HTAR). With the first joint clinical assessments (JCAs) and joint scientific consultations (JSCs) now underway, this year’s meeting offers a timely opportunity to assess early experiences from the Regulation’s first operational year. Sessions across the program will examine its impact on rare diseases, orphan products, and vaccines, alongside methodological challenges such as data transportability, patient involvement, and managing missing data in submissions.
Why these sessions matter: Since the EU HTAR came into effect in January 2025, much discussion has focused on how effectively it is being implemented across Member States. The next phase will determine whether JCAs achieve the intended goal of harmonization or introduce new layers of complexity. For industry, patients, and HTA bodies, the first year has already provided valuable lessons on evidence planning, coordination with the EMA, and opportunities for more transparent, collaborative assessment. The discussions at ISPOR Europe 2025 will help shape how the Regulation evolves from framework to function.
Selected sessions
Date and time: Monday November 10, 2025, 11:45am – 12:45pm
Moderator: Caroline Delaitre-Bonnin (Thermo Fisher Scientific, France)
Speakers: Samantha James (Thermo Fisher Scientific, France), Ruth Chapman (Thermo Fisher Scientific, UK) and Martin Parkinson (Thermo Fisher Scientific, UK)
Opening the conference’s discussion on capacity building for JCA implementation, this session draws on the speakers’ direct experience supporting oncology and advanced therapy medicinal product assessments to inform preparations for future waves of the EU HTAR. They will share insights on developing integrated evidence plans and preparing JCA submissions ahead of orphan medicines and vaccines entering scope in 2028 and 2030. Through real-world case studies, the panel will highlight lessons learned, recurring challenges, and emerging opportunities to streamline processes, reduce duplication, and accelerate patient access under the evolving European HTA framework.
Date and time: Monday November 10, 2025, 1:45pm – 2:45pm
Moderator: Grammati Sarri (Cytel, UK)
Speakers: Blythe Adamson (Flatiron Health, USA), Stephen Duffield (NICE, UK) and Antonio Remiro Azócar (Novo Nordisk, Spain)
Building on the need for efficiency and consistency, this workshop will explore how transportability analyses can enhance evidence generation under the EU HTAR. Although not yet formally integrated into JCAs, these methods, used to evaluate whether data from one context can apply to another, offer potential to improve external validity and support decision-making across diverse EU health systems. Speakers will present a practical framework, a hypothetical JCA case study, and advanced analytic approaches, including estimands and covariate adjustment. Through role play, audience participation, and live polling, attendees will examine real-world challenges, methodological solutions, and opportunities for integrating transportability analyses into future EU JCAs.
Challenges and methods for JCA in orphan indications - applying early learnings
Date and time: Monday November 10, 2025, 3:15pm – 3:45pm
Moderator: Caroline Ling (RTI Health Solutions, UK)
Speakers: Patrick K Hopkinson (PHTA Consulting) and Sorrel Wolowacz (RTI Health Solutions, UK)
Developing therapies for rare diseases presents unique challenges under the JCA framework, where limited evidence and complex endpoints often test traditional evaluation methods. This session will guide attendees through a structured approach to overcoming these hurdles. Experts will outline a five-step methodological framework, from PICO prediction to submission development, and share case studies demonstrating how these strategies have supported successful assessments across Europe.
Embedding effective patient involvement in EU joint clinical assessments
Date and time: Monday November 10, 2025, 5:00pm – 6:00pm
Moderator: Antonella M Cardone (Cancer Patients Europe, Belgium)
Speakers: Julie Spony (European Commission, Belgium), Margaret Galbraith (French National Authority for Health [HAS], France) and Jose Diaz (Bristol Myers Squibb, UK)
In this issue panel, speakers will debate practical solutions to ensure patient engagement in JCAs becomes both timely and impactful. The discussion will explore four concrete upgrade options designed to strengthen transparency and influence: an EU-wide patient-led PICO (Population, Intervention, Comparator, Outcome) survey to capture key outcomes early in the process; compulsory multilingual lay and plain language summaries of manufacturer dossiers and JCA reports to enhance accessibility; patient co-authorship of contextual domains such as unmet need and treatment acceptability; and adoption of a NICE-style patient and carer involvement policy.
Outcome assessment in rare diseases: is JCA breaking the silos or perpetuating the chaos?
Date and time: Tuesday November 11, 2025, 10:15am – 11:15am
Moderator: Laura Sawyer (Symmetron, UK)
Speakers: Milad Karimi (BioMarin, UK), Steffen Thirstrup (European Medicines Agency, The Netherlands) and Olivier Chassany (Assistance Publique–Hôpitaux de Paris – AP-HP, France)
Reinforcing earlier discussions, as orphan drugs enter the JCA process from 2028, limited data, small patient populations, and symptom variability will make it increasingly difficult to define outcomes that meaningfully reflect patient experience. At the same time, differing priorities among regulators, HTA bodies, and patient organizations risk creating additional barriers to access. This session will explore whether harmonizing outcome assessment strategies across stakeholders with distinct objectives is feasible—or even appropriate. Speakers representing regulatory, HTA, and industry perspectives will discuss how mechanisms such as parallel scientific advice and refined JCA guidance could support greater consistency while maintaining the flexibility needed to foster innovation.
Date and time: Tuesday November 11, 2025, 11:15am – 12:15pm
Moderator: Maciej Niewada (ISPOR Poland Chapter)
Speakers: Anna Kowalczuk (Agency for Health Technology Assessment and Tariff System, Poland), Martin Visnansky (University of Veterinary Medicine and Human Pharmacy, Slovakia)and Bertalan Németh (Syreon Research Institute, Hungary)
This panel will bring together national HTA agencies and patient representatives from Central and Eastern Europe (CEE) to share early experiences and highlight the region’s valuable contributions to the evolving European HTA landscape under the EU HTAR. Featuring insights from the Polish HTA agency, which serves as co-assessor in the first JCA process, the discussion will explore coordination challenges, capacity building, and opportunities to enhance patient engagement. Speakers will examine how CEE expertise in cost-effectiveness, affordability, and sustainability can help strengthen the legitimacy and practical value of JCAs across Member States.
EMA vs. JCA vs. HTA: navigating evidence requirements and simultaneous interactions
Date and time: Tuesday November 11, 2025, 12:45pm – 1:15pm
Moderator: Sangeeta Budhia (Parexel International, UK)
Speakers: Emtiyaz Chowdhury (Parexel, UK)
In this sponsored session, the speakers will focus on how the introduction of the JCA is reshaping evidence planning and reimbursement evaluation across Europe. Discussion will center on how health technology developers (HTDs) can prepare for simultaneous launches, adapt clinical trial designs, and align RWE strategies to meet both JCA and national HTA requirements. Key topics include whether greater data transparency through the JCA could reduce divergence among HTA agencies, how evidence transferability will be managed across markets, and the role of early stakeholder engagement in developing integrated, efficient, and patient-focused market access strategies.
Date and time: Tuesday November 11, 2025, 1:45pm – 2:45pm
Moderator: Ruairi O'Donnell (Cencora, UK)
Speakers: Anja E Schiel (Norwegian Medicines Agency, Norway), James Ryan (AstraZeneca, UK) and Rod Taylor (UK)
Despite the EU HTAR taking effect in early 2025, several critical questions remain about how JCA outputs will align with national HTA processes. This session will explore whether Member State-specific PICOs can be harmonized without undermining local decision-making, how JCA findings can inform cost-effectiveness analyses, and how to balance patient-reported outcomes (PROs) with the technical requirements of economic modeling. Speakers representing HTA agencies, industry, and academia will share early experiences, methodological insights, and practical recommendations to help both assessors and developers navigate the evolving interface between European and national HTA evaluations.
Optimal strategies for predicting and consolidating PICOs: one best method or a blended approach?
Date and time: Tuesday November 11, 2025, 5:00pm – 6:00pm
Moderator: Pamela Vo (EVERSANA, Switzerland)
Speakers: Michal Stanák (National Institute for Value and Technologies in Health Care, Slovakia), Zsombor Zrubka (Óbuda University, Hungary) and Michael Happich (Eli Lilly, Germany)
Defining PICOs for JCAs under the EU HTAR presents significant challenges. Incorporating input from 27 Member States can lead to numerous research questions and extensive systematic literature reviews (SLRs), stretching time and resources. To improve efficiency, alternative methods such as country surveys and AI-driven PICO prediction are being explored. Panelists from HTA agencies, academia, and industry will compare these approaches, discussing whether a unified or blended strategy can best streamline PICO development, reduce duplication, and support more coordinated evidence generation across Member States.
A new era for EU HTA: what can the EU HTAR learn from the EMA’s path to harmonization?
Date and time: Tuesday November 11, 2025, 5:00pm – 6:00pm
Moderator: Wim Goettsch (Utrecht University; Zorginstituut Nederland, The Netherlands)
Speakers: Anja E Schiel (Norwegian Medicines Agency, Norway), Ansgar Hebborn (Roche Products Ltd, Switzerland) and Tina Wang (CIRS, UK)
The session will open with a comparative analysis examining how the EU HTAR is developing in relation to the European Medicines Agency’s (EMA) evolution. Both initiatives were established to strengthen EU-level coordination but differ in mandate, authority, and integration with national systems. Drawing on these parallels, panelists providing policy, regulatory, and industry perspectives will discuss which lessons from the EMA’s experience can inform HTAR implementation, which pitfalls to avoid, and where HTA may require a distinct approach. The interactive debate will include audience polling and discussion on how today’s political and technological contexts shape HTA harmonization and the future role of JCAs.
Mind the gaps: managing missing PRO data in the era of JCA for HTA submissions
Date and time: Tuesday November 11, 2025, 5:00pm – 6:00pm
Moderator: Miranda Cooper (AstraZeneca, Spain)
Speakers: Neil Hawkins (University of Glasgow, UK), Olivier Chassany (Assistance Publique–Hôpitaux de Paris – AP-HP, France) and Gianluca Baio (University College London, UK)
This session will explore the issue of how missing PRO data should be handled to ensure that patients’ experiences are accurately represented in treatment evaluation. PROs provide vital insights into patient needs and quality of life, but collecting them, especially as illness progresses, can be burdensome, often leading to incomplete data and potential bias. The panel will discuss analytic and practical approaches for addressing missing PRO data, the need for clearer methodological guidance in HTA and the JCA, and how greater consistency could improve the reliability and impact of patient-centered evidence.
Date and time: Wednesday November 12, 2025, 10:00am – 11:00am
Moderator: Ruairi O'Donnell (Cencora, UK)
Speakers: Matteo Scarabelli (EFPIA, Belgium), Antonella M Cardone (Cancer Patients Europe, Belgium) and Justin Doan (Pfizer, USA)
This issue panel will examine how patient involvement can be structured to ensure transparency, representativeness, and meaningful impact. The discussion will address practical questions on managing confidentiality, handling conflicts of interest, and improving access to understandable information through plain language summaries. Speakers representing policy, patient organizations, and industry will share insights on integrating patient-relevant outcomes and experiences into HTA procedures, offering concrete recommendations to strengthen the legitimacy and inclusiveness of patient engagement under the new EU HTA framework.
Coverage by The Evidence Base
Our editorial team will be on site in Glasgow to cover some of these key sessions, share daily highlights and speak with presenters and partners. Follow The Evidence Base on LinkedIn for live updates throughout the meeting. For exclusive post-event analysis and session round-ups, register on our site to receive regular updates.
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