ISPOR Glasgow with EVERSANA: Perspectives on JCA, PICO, and HTA

At ISPOR EU in Glasgow, a cross-stakeholder panel – ‘Optimal Strategies for Predicting and Consolidating PICOs: One Best Method or a Blended Approach?’ – tackled one of the most pressing topics for HEOR and market access teams in 2025: how Joint Clinical Assessment (JCA) under the EU HTA Regulation is reshaping evidence strategies – and how best to anticipate and consolidate PICO (Population, Intervention, Comparator, outcomes) across diverse Member State contexts, thereby harmonising evidence requirements, as well as the operational realities for HTA bodies and industry.

To find out more, pharmaphorum spoke with that panel: Niklas Hedberg, Chief Pharmacist at the Dental and Pharmaceutical Benefits Agency (TLV) in Sweden; Michael Happich, Senior Director, International Value & Access, at Eli Lilly and Company; Dr Zsombor Zrubka, Associate Professor and General Director of the University Research and Innovation Center, and Director of the Health Economics Research Center at Obuda University, Budapest, Hungary; and moderator Pamela Vo, VP HEOR at EVERSANA.

Despite a late afternoon slot competing with five parallel sessions, attendance exceeded 300: a testament to the importance and immediacy of the topic. The discussion was balanced, well received, and highlighted a sustained appetite for methodological and operational clarity around PICO scoping and consolidation in the year ahead.

The panellists’ perspectives converged on a hopeful trajectory for JCA’s potential to streamline assessments, tempered by pragmatic recognition of transitional challenges, capacity needs, and the realities of national appraisal and affordability.

JCA: Promise, process, and pragmatism

The EU HTA Regulation (2021/2282) establishes a permanent framework for joint clinical assessments (JCAs), starting with oncology and Advanced Therapy Medicinal Products (ATMPs) in 2025, extending to orphan medicines in 2028, and all new medicinal products by 2030. A single EU-level submission could reduce duplication, align evidence expectations, and initiate national appraisal phases earlier – thereby supporting faster, wider patient access, if executed as intended.

Hedberg urged collaborative confidence through the early hurdles to build a more predictable, convergent system, while Happich stressed the need to embrace a truly European perspective – anchoring scoping in European guidelines to avoid fragmentation and realise “win‑win‑win” benefits for HTA bodies, industry, and patients once first reports arrive.

Meanwhile, Vo observed mixed reactions among sponsors: some see expansion potential; others experience JCA as “an additional dossier.” Nonetheless, the common goal remains wider, faster access, dependent on transparent collaboration and process learning. "If all stakeholders collaborate and remain open, JCA can succeed and deliver wider, faster access across Europe,” she said.

Additionally, Zrubka highlighted a structural shift: JCA advances evidence generation earlier, increasing organisational demands and skill requirements across stakeholders – and it brings regulatory timing risks when assessments precede final EU authorisation.

Overall, the panel acknowledged heavy resource intensity on all sides, the ambiguity of a new process, and the fact that JCA addresses clinical evidence, but cannot alone overcome affordability and willingness to pay constraints at the national level.

PICO: The common language, and how to predict it

PICO provides the standard format to define research questions and data needs for assessment, structuring population/subpopulations, intervention, comparators (with EU-wide hierarchy and clinical practice fallbacks), and patient‑centred outcomes, including when surrogates are justified.

Three complementary approaches to predicting PICO for JCA were discussed:

1. Systematic Literature Review (SLR): Traditional, robust, and comprehensive, but time intensive and human resource heavy, with JCA-compatible SLRs often compressed into ≈3 months.
2. Country/affiliate surveys: Closest to real JCA scoping dynamics; enables interaction with national HTA bodies, yet, demands high coordination and effort to consolidate divergent inputs.
3. AI-based tools (e.g., NAVLIN’s PICO Planner): Rapid, consistent, and broad coverage across guidelines and prior HTA decisions, especially when hybrid validated by experts. Limitations include retrospective bias (less capture of emerging evidence) and interpretability/transparency concerns.

Panel consensus: Blend, don’t bet on one

While Vo framed the heart of the issue panel, Happich argued against “either/or”: start with an HTA landscape assessment (AI/SLR), then validate with country surveys, he advised, noting a structural oddity that industry is outside formal PICO scoping, and that greater stakeholder inclusion could enhance predictability.

Hedberg also signalled public side willingness to consolidate PICOs across Member States and to expand informal training/exchange even if formal interaction is constrained at present.

HTA operations and the Coordination Group: Where consolidation happens

The Member State Coordination Group on HTA (HTA CG) serves as the joint configuration and first point of contact for ongoing JCAs, with public information on the EU platform.

A shared European lens (guidelines, comparators, outcomes) increases the odds that JCA becomes a genuine work sharing platform, rather than 27 parallel exercises, so to speak.

Access depends on more than clinical assessment. JCA clarifies the clinical side but national appraisal, pricing, and affordability remain decisive – and may become more visible once clinical uncertainties are reduced.

The ISPOR Glasgow panel conveyed a constructive, forward looking mood: JCA can work – and work better over time – if stakeholders commit to a European level mindset, invest in blended PICO prediction methods, and build capacity for fast, harmonised evidence synthesis.

The first waves of JCAs are already testing processes in oncology and ATMPs – and lessons from these cases will inform how sponsors, HTA bodies, and researchers converge on practical solutions. As the panel put it, JCA won’t eliminate national economic constraints, but it can streamline clinical assessment and make real differences in timing, consistency, and clarity, thereby bringing forwards earlier appraisal starts and, ultimately, faster patient access where budgets allow.

The task now is to keep talking, keep learning, and keep building the tools and relationships that turn the regulation’s promise into routine, reliable practice across Europe.

About the interviewees

Niklas Hedberg is Chief Pharmacist at the Dental and Pharmaceutical Benefits Agency (TLV) in Sweden. He is the HTAR Coordination Group co-chair for medicinal products. Hedberg was the Chair of the Executive Board for EUnetHTA21 (2021-2023) and for EUnetHTA JA 3 (2018- 2021). He has been working with HTA and pricing and reimbursement since 2001.

Michael Happich is Senior Director, International Value & Access, at Eli Lilly and Company, where he leads strategic application of Artificial Intelligence in Health Technology Assessment (HTA) and EU HTA Policy. He has been 20 years in the pharmaceutical industry, leading HTA and Real-World Evidence (RWE) teams across international markets.

Zsombor Zrubka is an HEOR expert with a background as a physician. Currently, he is Associate Professor and General Director of the University Research and Innovation Center, and Director of the Health Economics Research Center at Obuda University, Budapest, Hungary.

Pamela Vo is VP HEOR at EVERSANA with 20+ years of global experience in pharma and consulting sectors specialising in evidence generation, HTA strategy, and shaping value propositions that support market access and reimbursement worldwide.