The Evidence Base Post 09 November 2026

ISPOR Europe 2026 daily round-ups: Insights from Day 1

Joanne Walker, Katie McCool & Laura Dormer

ISPOR Europe 2026 opens in Vienna with value, JCA, RWE, AI and global pricing all firmly on the agenda. With The Evidence Base team on site, we highlight some of the key discussions shaping Day 1 of the meeting.

ISPOR Europe 2026 is underway in Vienna, bringing together over 6,200 attendees across the global health economics and outcomes research (HEOR) community under the theme “Shaping the Future of Access Through Science and Policy.”

Hosted by ISPOR—The Professional Society for Health Economics and Outcomes Research, the opening day sets out many of the questions that will run through the meeting: how value should be defined, what the first year of Joint Clinical Assessment (JCA) is teaching us, where real-world evidence (RWE) and AI can strengthen decision-making, and how pricing and access policies are evolving across markets.

The opening plenary, “The Science of What Matters: Rethinking Value in Healthcare,” starts that discussion by asking whether current approaches to value assessment capture what really matters to patients, societies and health systems. Elsewhere across the multi-track program, sessions turn to JCA, cross-border collaborations, AI-enabled evidence generation, patient-centered research and the changing global pricing environment.

With The Evidence Base team on site at the Austria Center Vienna, we’ll be following these discussions throughout the day. Here are some of the highlights from Day 1.

ISPOR Welcome Remarks and Special Address

Opening ISPOR Europe 2026, Rob Abbott (ISPOR) challenged the HEOR community to help shape the future of access through science and policy. Drawing on his experience as an adventure motorcyclist, he introduced IPSGA – information, position, speed, gear and acceleration – as a framework for navigating a changing healthcare landscape.

For HEOR, that means gathering current evidence, communicating clearly with stakeholders, adapting the pace of work and ensuring methods and partnerships remain fit for purpose. Against a backdrop of technological advances and policy change, Rob asked whether the community was relying on information that was already outdated. Continuing the motorcycling analogy, he cautioned:

“In times of rapid change, moving too slowly can be just as dangerous as moving too fast.”

His message was a call to lead conversations about future healthcare systems and use the community’s collective reach to help turn those ambitions into policy and practice.

In the following video address, Olivér Várhelyi (European Commissioner for Health and Animal Welfare) framed access to valuable innovation as both a technical and a political challenge. Patients expect effective new treatments, while public authorities must make careful decisions about limited resources. As he explained:

“[HTA] helps us identify where innovation adds real value and where it would make the greatest difference for patients and society.”

The Commissioner highlighted progress under the EU Health Technology Assessment Regulation (EU HTAR), reporting five published Joint Clinical Assessment (JCA) reports and around 18 ongoing assessments. Shared European assessments offer opportunities to reduce duplication and support faster national decisions, but their impact depends on how they are used.

He called on Member States to make full use of joint assessments and accelerate national pricing and reimbursement decisions, emphasizing that European cooperation must translate into faster access for patients.

Plenary 1: The Science of What Matters: Rethinking Value in Healthcare

The opening plenary challenged delegates to reconsider both the foundations of medicine and how healthcare is delivered. Moderated by Sandra Nestler-Parr (BioCryst Pharmaceuticals), the discussion brought together Harald Schmidt (Maastricht University), who advocated systems medicine, network pharmacology and more precise prevention, and Sally Lewis (Kintsugi International), who argued that demonstrating a technology’s potential benefit does not ensure its value is realized in practice. Sally called for standardized outcome measurement within routine care, illustrating how clinical and patient-reported data can support service redesign and resource allocation. Across the discussion, the message was that broader value assessment must extend beyond new technologies to existing treatments and whole care pathways, with incentives and infrastructure that enable healthcare systems to act on the evidence.

Read our in-depth summary of Plenary 1 here >>>

Spotlight: Humans at the Helm: Navigating Increasing AI Autonomy in HEOR and HTA

As AI capabilities advance, the HEOR and HTA community is increasingly having to decide how much autonomy to give AI within evidence-generation and assessment workflows. The panel explored where greater autonomy may add value, where human judgment and accountability need to remain central, and what governance and validation are needed to support responsible use.

Moderator Bill Malcolm (Bristol Myers Squibb) highlighted traceability, reproducibility, validation and task decomposition as key safeguards for AI use in HEOR, with complex workflows broken into smaller, more controllable tasks. He argued that autonomy should be determined case by case rather than assumed. Using a scale ranging from no autonomy to systems setting their own goals, Bill suggested level three, where AI operates within predefined boundaries, as the appropriate upper threshold for HTA at present.

Dalia Dawoud (Cytel) considered the developing regulatory and HTA landscape. She highlighted the risk-based approach in FDA draft guidance and the joint FDA–EMA principles for good AI practice, where scrutiny reflects both the influence of an AI model and the consequences of the decisions it informs.

She also pointed to positions from the UK’s NICE, Canada’s CDA-AMC and the European HTA Coordination Group. While these organizations recognize the potential for AI to improve efficiency, human accountability remains central. She noted that the HTA Coordination Group has taken a particularly clear position that dossier preparation and analysis should not become fully automated without a person remaining responsible.

Other initiatives discussed include the emerging Cochrane-led framework for responsible AI use and reporting, alongside the ISPOR Special Task Force good-practice recommendations for generative AI in systematic literature reviews. Building on points she has made previously, as Dalia summarized, “the principle is augmentation, not automation,” with transparency and accountability remaining central to how AI is introduced into HTA workflows.

J. Jaime Caro (Thermo Fisher Scientific) used an analogy from his sailing experience to distinguish system capability from human responsibility. Modern navigation systems can perform much of the work once undertaken manually, he explained, but the captain remains accountable:

“Capability is not the same thing as responsibility. So the boat and the systems are very capable, and I still wear the captain’s hat.”

For HEOR, he extended the sailing analogy to explain how autonomy should be judged. A modern navigation system may be able to plot and follow a route, but that does not mean it should always be left to steer. He argued that the decision depends on both the level of judgment required and the consequences of getting it wrong. Low-judgment, low-consequence tasks may be suitable for automation, while higher-judgment tasks are better suited to AI-supported decision-making. Where both judgment and consequences are high, the human should still take the helm.

He illustrated this again with an example from sailing, where an automated route might be technically valid but fail to account for currents, shipping traffic or other contextual factors that an experienced sailor would recognize. The same principle applies in HEOR: an AI system may be capable of producing an answer, but professional expertise is still needed to know when that answer should be questioned.

Siguroli Teitsson (Bristol Myers Squibb) focused on practical implementation within industry. Rather than building AI systems and retrospectively inserting them into existing processes, he recommended beginning with the problem the workflow needs to solve, determining how value will be measured and then asking whether AI has a useful role. As he put it: “Greater autonomy should be earned and not assumed.”

Sig emphasized that speed and scientific quality should be considered together. AI may accelerate evidence generation, but poorly designed deployment can create additional questions and rework during HTA review, ultimately delaying decisions.

Using survival analysis for economic evaluation as an example, Sig showed how AI could support lower-risk tasks while expert checkpoints remain around consequential analytical decisions. Outputs would be validated before further steps, with supervised human–AI cycles supporting report updates. The aim, he argued, is faster evidence generation without compromising scientific quality or creating additional scrutiny during HTA review.

Audience discussion returned repeatedly to how trust should be established and where human attention should be concentrated. Speakers discussed using validation to build confidence over time and directing expert review toward ambiguous or higher-risk tasks rather than checking every AI output equally.

Questions also remain around how risk frameworks should adapt as model capabilities change, how organizations can provide sufficient transparency while protecting intellectual property, and how universities should prepare future HEOR professionals. The panel emphasized the continuing importance of subject-matter expertise and the need to teach students how to use AI while recognizing when its outputs should be challenged.

Concurrent sessions

Issue Panel: When Global Policy Agendas Collide – Evidence, Value, and Pricing Tensions at the Intersection of EU and US Reform

Moderated by Oliver Staples, the session examined how evolving EU and US pharmaceutical policies are creating competing pressures on evidence generation, pricing, innovation and patient access. Discussions focused on growing tensions between the EU’s JCA framework, US most-Favored-Nation (MFN) pricing reforms and wider European pharmaceutical policy developments.

Providing an industry perspective, Aodan Tynan contrasted the structured implementation of JCA with the uncertainty surrounding MFN pricing, warning that potential financial exposure in the US could discourage investment in European evidence generation and market launches. He also highlighted how fragmented national policy responses complicate industry decision-making, potentially encouraging more selective launch strategies and a shift towards alternative markets. Reflecting on the lasting implications of international price referencing, he stated:

“The genie is out of the bottle. The world is never going to go back to a stage where there isn't a level of price matching between the US and Europe. Those days are gone.”

Niklas Hedberg (TLV) stressed the importance of maintaining Europe’s commitment to coordinated HTA and improving patient access, while acknowledging concerns that changing pricing policies could reduce pharmaceutical launches across the region. However, he noted that MFN had yet to be codified and that widespread reductions in launches had not been observed, cautioning against assuming that increased pharmaceutical spending alone would resolve these challenges. Instead, he called for greater European collaboration, more efficient processes and stronger support for early-stage innovation, emphasizing that “we need to do more in Europe, and we need to do together.”

Duane Schulthess (VitalTransformation BVBA) argued that Europe cannot wait until the phased implementation of the EU HTAR is complete before responding to changing market conditions. Referring to historical differences in pharmaceutical pricing between Europe and the US, he highlighted the potential implications of international price referencing for investment, research pipelines, launch strategies and patient access, citing research suggesting that US pricing reforms are already influencing follow-on drug development. Schulthess also discussed the growing importance of markets beyond Europe and the US, describing global pharmaceutical dynamics as a “three-player game” in which China’s expanding role in innovation, alongside its reliance on international investment, introduces further complexity to pharmaceutical policy and market access decisions.

Forum: ISPOR Strategic Dialogues: Integrated Evidence Generation Across the Product Lifecycle

Realizing healthcare value also depends on whether evidence anticipates the decisions that follow regulatory approval. This was the focus of the Forum moderated by Finn Børlum Kristensen (Danish Centre for Health Economics, University of Southern Denmark), where panelists examined how earlier planning could reduce fragmentation without overlooking distinct decision-making needs.

Antonella Cardone (Cancer Patients Europe) called for “the right evidence at the right time to support the decision-making.” Cardone argued that patient involvement throughout development could connect evidence planning across stakeholders, but cautioned that silos persist within companies as well as between institutions. Evidence on outcomes important to patients should be collected from the outset, rather than sought when assessment submissions approach.

Beate Wieseler (IQWiG) distinguished longitudinal integration across successive decisions from vertical integration of different evidence requirements within a development program, potentially even within one study. Regulatory benefit–risk and comparative effectiveness questions need not be answered simultaneously, but both should inform study design. Beate identified protocols incorporating regulatory and HTA questions through the estimand framework as a practical near-term step, alongside access to individual patient data from trials.

Carlos Martin Saborido (Roche) cautioned against creating a combined regulatory and HTA silo that leaves pricing and reimbursement needs unresolved. Non-clinical uncertainties, such as whether a technology adds to or replaces existing treatment and its implications for resource use, can delay access. Carlos emphasized the importance of identifying these questions earlier and testing approaches through pilots using existing structures.

Maya Matthews (European Commission) described horizon scanning, joint scientific consultations and public joint clinical assessment reports as foundations for lifecycle planning. Maya also outlined the European Health Data Space’s intended contribution to secure research access, while noting interoperability and consultation-capacity requirements.

Michael Berntgen (European Medicines Agency) emphasized that different decision-making perspectives “are not necessarily disagreements”. Michael encouraged developers to bring concrete development programs into parallel joint scientific consultations. For conditional marketing authorizations, post-licensing evidence plans should anticipate HTA uncertainties alongside regulatory obligations.

Issue Panel: Are Patient Values Genuinely Shaping Value Assessment, or Do They Remain Acknowledged but Underutilized?

Despite growing recognition of patient perspectives in HTA, their influence on evidence interpretation and decision-making remains inconsistent. Kicking off the discussion, moderator Ramiro Gilardino (Insights & Impact) distinguished between broader elements of value, patient values and patient voice, questioning whether greater patient involvement is leading to meaningful changes in HTA decisions.

Dan Ollendorf (Institute for Clinical and Economic Review; ICER) described three pilot projects that incorporated patient feedback into economic models for rare and autoimmune diseases. He explained how patient input had informed revisions to disease states, quality-of-life assumptions and caregiver impacts, demonstrating its potential to shape quantitative analyses. He also emphasized the importance of qualitative evidence, arguing that “there should always be a role for qualitative and structured deliberative elements to augment what's coming out of the quantitative analysis.”

Chris Skedgel (Office of Health Economics) explored the distinction between patient-centered research and patient voice, highlighting the difficulty of balancing individual experiences with statistical evidence and wider societal priorities. He also raised concerns about the “eloquence trap”, where more articulate contributors may have greater influence on decisions, and questioned whether patient involvement should strengthen evidence, the legitimacy of HTA decisions, or both. He explained that:

“We're struggling to incorporate the patient voice in HTA because we're not quite sure what it is that we want patients to tell us.”

A recuring discussant during Day 1, Antonella Cardone argued that while overall survival remains important, complementary oncology endpoints can capture meaningful benefits for patients, including disease control, daily functioning and caregiver impacts. Drawing on examples involving metastasis-free survival, disease-free survival and treatment response, she highlighted how inconsistent HTA assessments can contribute to unequal access across Europe. She also outlined an emerging framework for evaluating patient-relevant endpoints.

The discussion highlighted the need for earlier agreement between developers, regulators and HTA bodies on acceptable evidence, meaningful patient involvement throughout development and greater transparency about how patient perspectives influence decisions.

Issue Panel: First Wave, First Lessons: Multi-Stakeholder Insights from the Initial Joint Clinical Assessments Under the European Regulation on Health Technology Assessment

The first completed JCAs are beginning to show how the new system is working in practice, where pressures are emerging and what may need to change as volumes increase. Suzette Matthijsse (Lumanity) set the context by noting that 27 JCAs have been initiated, with five published, 18 ongoing and four discontinued. She also stressed that JCA remains a non-binding clinical assessment, with national bodies retaining responsibility for value judgments and reimbursement decisions.

Anne Willemsen (Zorginstituut Nederland) reflected on the scale of collaboration already required, with 16 Member States taking assessor or co-assessor roles and 79 experts selected across the assessments. As she remarked, “It is incredible that we have managed to deliver these JCA reports.” She highlighted demanding timelines, indication changes and variable PICO requirements among the main early challenges, alongside the need for developers to plan evidence generation early, resource submissions appropriately and strengthen coordination between regulatory and market access teams.

James Ryan (AstraZeneca) described JCA as a “team sport,” arguing that developers need to anticipate likely PICOs and prepare analyses well before the final scope is issued. He also questioned whether early assessments risk placing too much emphasis on uncertainty and bias when evidence is judged against an idealized “mythical” randomized controlled trial.

“If every piece of evidence is implicitly compared against this perfect trial, we already know what we’re going to find. We’ll find uncertainty, risk of bias, missing evidence, confounding, more uncertainty, and then we’ll probably have some uncertainty about the uncertainty.”

Ryan argued that the value of JCA lies not simply in cataloguing limitations, but in explaining what the available evidence can support, where uncertainty matters and why.

Niklas Hedberg, who had earlier reflected on JCA from his European role as co-chair of the HTA Coordination Group, returned here to offer a national perspective from Sweden. He outlined how TLV and SBU are adapting existing processes, including through a dedicated HTA secretariat, and how Sweden has begun using three of the first four JCA reports. From that national perspective, he expects the shared assessment to reduce duplication and support faster work, although he cautioned that it is still too early to judge the full impact.

Discussion then shifted to scalability, discontinued assessments and the forthcoming evaluation of the Regulation. The panel highlighted the need to understand how JCA reports are being used nationally, how better to manage the parallel EMA and JCA processes, and whether evidence expectations remain proportionate across different technologies and disease areas.

Educational Symposia: One Assessment, Many Decisions: The Future of Country-Level HTA After JCA

With the first five JCA reports now public, attention is beginning to shift from how the process works at European level to what happens next within national HTA systems. Moderator Ruairi O'Donnell (Cencora) highlighted early signs of change in national templates, processes and timelines, while noting that countries are already using JCA differently. Some are referencing it alongside national submissions, while others are using it to replace parts of existing clinical assessment processes.

Anna Shopova (Amgen), whose company was among the first to receive a published JCA report, emphasized that JCA should be treated as one step within a broader access strategy rather than an endpoint. For industry, she argued, its value will depend on whether evidence can be reused across markets, national pathways become more predictable and the process ultimately supports faster access. She observed:

“The JCA is not the goal; it’s a step in the process, and how you are prepared internally, how you consider the JCA having impact on your strategy to your overall HTA and reimbursement strategy is one of the key things that we learned.”

Anne Willemsen (Zorginstituut Nederland [ZIN]) returned to the discussion after outlining the European experience in an earlier session, this time focusing on how the Netherlands is adapting. The Dutch HTA body has brought PICO scoping forward, updated its national submission template to avoid requesting evidence already provided at European level, and will require companies to reference the JCA dossier and report directly. National reports will then be shorter, adding the Dutch appraisal and therapeutic value conclusion rather than duplicating the European assessment.

Returning to the podium following her previous sessions, Antonella Cardone welcomed the formal involvement of patients in JCA but highlighted remaining gaps, including earlier involvement in PICO development, better feedback on how patient input has been used and stronger continuity between European and national processes. Clearer language, including through plain language summaries of JCA dossiers and reports, could also help patients engage more meaningfully with the evidence and provide informed input throughout the process.

Neil Grubert (Neil Grubert Consulting) placed JCA within a wider cross-border context, pointing to Beneluxa and the Joint Nordic HTA Bodies as examples of how shared European clinical assessment could support further collaboration. He also cautioned that JCA will evolve alongside wider pressures, including MFN pricing and broader pharmaceutical policy changes.

The discussion suggested that convergence will be gradual rather than uniform. JCA may provide a common clinical starting point, but national appraisal, pricing and reimbursement will remain distinct. This was captured by Anna’s remark:

“Evidence does not exist in vacuum. It is not just a set of numbers and tables, and it’s, in my opinion, quite important for a decision-maker to know in what context is this evidence presented. What does it actually mean?”

The next test will be whether Member States can use that common evidence base to reduce duplication, improve predictability and accelerate decision-making without losing the context needed for national judgments.

Forum: The HEMA Debate: The Value Judgements Involved in Deciding How “Value” Is Measured: A Value in Health Forum

Who should determine how healthcare benefits are measured and valued? This question was central to a Value in Health Forum debate moderated by Alistair McGuire, which examined the different principles guiding economic evaluation in HTA.

Introducing the session, Nancy J Devlin (University of Melbourne and Editor-In Chief of Value in Health) outlined the findings of the 2026 Health Economics Methods Advisory (HEMA) report, including its recommendation against routinely incorporating additional benefits into economic evaluations without accounting for their opportunity costs. She discussed the disagreement this recommendation had prompted, particularly around the principles that should guide decisions about expanding the benefits considered in HTA, and how they should be valued.

Darius Lakdawalla (University of Southern California) advocated a welfare economics approach grounded in individual preferences, maintaining that “the job of the economist is to measure individual preferences”, while policymakers should determine how those preferences inform decisions. He also challenged the use of a single opportunity cost threshold, arguing that inefficient resource allocation makes such a threshold conceptually difficult to define and measure.

Mark Sculpher (University of York) argued that opportunity costs are unavoidable when funding new interventions displaces existing healthcare services, maintaining that decisions about which benefits society should prioritize require legitimate social and political judgement. He acknowledged that broader benefits could be included in economic evaluations, provided there was a clear normative justification, while stressing that “benefits and opportunity costs need to be assessed symmetrically.”

McGuire examined a common challenge facing both approaches: how individual preferences or opportunity costs could be aggregated without introducing contested judgements about their relative importance. The subsequent discussion addressed healthcare inefficiencies, innovation, equity and the need for improved measurement, highlighting continuing disagreements over how healthcare benefits should be valued while identifying areas for further methodological development.

Forum: Shaping the Future of HEOR: A Special Preview of ISPOR's Updated Science Strategy

How should HEOR evolve when decision makers need evidence on broader outcomes, affordability and the delivery of care? In this session, ISPOR leaders outlined emerging priorities and the methodological work needed to support them.

Laura Pizzi (ISPOR) situated the updated Science Strategy within ISPOR’s Strategic Plan 2030, which calls for a broader definition of value and greater integration of affordability, accessibility and equity into healthcare decisions. Laura identified five scientific priorities: RWE, AI, patient-centered research, value-based healthcare and whole health. These would guide resource allocation, with a detailed report planned for next year.

Laura described plans to design an AI collaborative spanning methods, workforce training and principles for responsible use. On RWE, updates to ISPOR’s free protocol registry include results reporting and information on AI use and patient involvement, extending its role in research transparency.

Deborah Marshall (University of Calgary) explained how a working group is reviewing task-force processes to strengthen scientific rigor, delivery and relevance. Proposed changes cover systematic literature reviews, consensus methods, membership, governance and funding. Deborah emphasized evaluating reports’ influence on decisions and scientific practice, alongside existing citation measures, while acknowledging that improvements would require resources.

The whole-health initiative brings a related challenge: translating broader concepts of value into usable methods. Zsombor Zrubka (Initium Zrt.) presented a proposed definition of whole health, open for member feedback until the end of December 2026. The definition encompasses interacting physical, mental, behavioral, socioeconomic and environmental domains, considering outcomes and costs across sectors and emphasizing outcomes that matter to patients. Two workstreams are addressing definitions and terminology, and appropriate measurement tools.

Zsombor argued that implementation, rather than a lack of interest, is the immediate obstacle: “the bottleneck is on the operational level”. The initiative seeks to consolidate existing approaches and clarify their application, rather than replace established methods.

During the discussion led by Peter Neumann (Tufts Medical Center), Deborah cautioned against overly rigid measurement standards, advocating “standardizing, but with some flexibility” across cultures and health systems. Laura identified provider medical societies as an important partnership gap as HEOR increasingly examines value within care delivery. The discussion left a practical methodological question: how to make broader value assessment consistent enough to guide decisions while remaining responsive to different contexts.

Issue Panel: Whole Health at Risk: Does EU Joint Clinical Assessment Conflict with Europe’s Antimicrobial Resistance Ambitions?

Could the EU’s JCA framework undermine Europe’s ambitions to tackle antimicrobial resistance (AMR)? This question framed a debate moderated by Matthias Hofer (Office of Health Economics), examining whether JCA can adequately capture the patient- and population-level benefits of novel antimicrobials when its scope expands in 2030.

Introducing the session, Matthias outlined the growing burden of AMR and the wider benefits of antimicrobials, including reduced transmission, greater treatment diversity and protection against future health threats.

Anja Schiel (Norwegian Medical Products Agency) explained that JCA assesses relative clinical effectiveness and safety, while broader HTA appraisals and reimbursement decisions remain national responsibilities. However, she argued that tackling AMR requires greater coordination across borders, including shared evidence, specialist expertise, and a clearer political mandate. She also noted that antimicrobial stewardship creates challenges for evidence generation, as restricting the use of new treatments can limit opportunities to collect post-approval evidence.

Libby Hamson (GSK) identified a disconnect between EU policies intended to incentivize antimicrobial innovation and the lack of antimicrobial-specific JCA methodology. She explained that responsible stewardship limits commercial returns, while assessment challenges include the use of non-inferiority trials, limited evidence in resistant infections and difficulties capturing wider population-level benefits within JCA. To address these issues, she called for methodological guidance tailored to the assessment of antimicrobials.

Patrick Hopkinson (Independent Consultant) explored how the STEADI framework could support the assessment of wider antimicrobial benefits, while acknowledging difficulties in establishing causality, extrapolating evidence and measuring population-level effects. He called for collaboration to develop and potentially pilot tailored assessment methods before 2030.

The debate also considered temporarily exempting antimicrobials from JCA. Anja argued that the legislation does not provide for such an exemption, while Hamson maintained that retaining them could encourage methodological improvements. Anja stated that “the only way we can improve systems is if we challenge them”, while Patrick cautioned that “there's quite a lot of work to do to make everything fit for purpose.”

Looking ahead to Day 2

Tomorrow, the conversations will continue across another full day of sessions, posters and research presentations. The Evidence Base will be back on site following the discussions and bringing together the key takeaways from Day 2.