THE EU HTA REGULATION AND JOINT CLINICAL ASSESSMENT: Turning Regulatory Promise into Market Access Reality

Internal Analysis and Methodology

Executive Summary

The EU HTA Regulation (2021/2282) represents the most significant structural change to European market access in a generation. With Joint Clinical Assessments (JCAs) now live for oncology and ATMPs since January 2025, and the first JCA reports expected in Q2 2026, the window for reactive strategies has closed. This article examines the operational, evidentiary, and strategic implications of JCA and PICO consolidation for pharma and MedTech leaders, drawing on cross-stakeholder perspectives from ISPOR EU Glasgow 2025, the latest regulatory developments, and Alira Health’s direct experience supporting clients through active JCA processes, organizational readiness, and stakeholder engagement strategy.

A Watershed Moment for European Market Access

The European Union has long grappled with fragmented health technology assessment. Twenty-seven Member States, each conducting independent clinical evaluations, created duplicative processes, inconsistent outcomes, and significant delays in patient access to innovative therapies. With the application of the EU HTA Regulation from 12 January 2025, this landscape is fundamentally shifting.

The regulation introduces a permanent framework for Joint Clinical Assessments, beginning with oncology medicines and Advanced Therapy Medicinal Products (ATMPs), extending to high-risk medical devices in 2026, orphan medicines in 2028, and all centrally authorized products by 2030. The ambition is clear: a single EU-level clinical evidence submission that replaces up to 27 parallel national dossiers, enabling faster appraisal starts and, ultimately, wider patient access.

Yet ambition and execution are different things. As it was observed at the European Access Academy Meeting in Berlin in 2025 discussion on JCA and PICO strategies: “If all stakeholders collaborate and remain open, JCA can succeed and deliver wider, faster access across Europe.” The operative word is “if.”

The JCA in Practice: Where Things Stand

The first year of JCA implementation has yielded both progress and pragmatic recalibration. The HTA Coordination Group (HTACG) initially projected 17 JCAs for cancer medicines and 8 for ATMPs in 2025. In practice, approximately 10 products have entered the process, with the first JCA report now anticipated in Q2 2026. This lower-than-expected volume likely reflects manufacturers adopting a wait-and-see posture, choosing to learn from early precedents before committing their own submissions.

Nevertheless, meaningful operational milestones have been achieved. The HTA IT platform now provides a standardized digital submission route. Dossier templates, file-naming conventions, and guidance documents have been formalized, creating the procedural infrastructure that was absent under the voluntary EUnetHTA 21 framework. In October 2025, the European Commission adopted the final implementing regulation for medical devices and IVDs, completing the legal architecture for the full JCA rollout.

The 100-Day Reality

The operational challenge is stark. Once the consolidated PICO list is communicated, manufacturers have approximately 100 days to finalize and submit their JCA dossier. The scope is significantly broader than any single national HTA submission, covering multiple subpopulations, comparators, and outcomes designed to satisfy the evidentiary needs of all 27 Member States simultaneously.

This timeline makes one thing clear: evidence generation cannot begin at PICO confirmation. Companies must initiate work at risk, based on predicted PICOs, or face the prospect of public “no evidence” statements in the JCA report that will reverberate across every national negotiation in Europe.

Alira Health on the Front Line: Supporting a Live JCA in Oncology

This is not theoretical for us at Alira Health. We are currently supporting one of the 13 ongoing JCA processes in oncology, specifically in non-small cell lung cancer (NSCLC), from end to end, from early PICO prediction and evidence gap analysis through dossier preparation, submission, and interaction with assessors. This hands-on involvement gives us a front-row perspective on the practical realities of JCA execution: the compressed timelines, the breadth of comparator and subpopulation requirements, and the cross-functional coordination demands that the process imposes on sponsor organizations.

Our experience confirms what the ISPOR Glasgow panelists emphasized: the gap between regulatory design and operational reality is where success or failure is determined. Companies that engage early, invest in robust PICO prediction, and build dedicated JCA capabilities are navigating these first waves with confidence. Those that delayed preparation are now confronting the full weight of a 100-day submission window with insufficient evidence infrastructure.

PICO Prediction: The Strategic Imperative

PICO, the framework defining Population, Intervention, Comparator, and Outcomes, is the common language of JCA. Getting PICO prediction right is arguably the single most consequential strategic exercise in the new European access environment.

The ISPOR Glasgow panel, featuring perspectives from the Swedish TLV, Eli Lilly, and academic HEOR research, converged on a clear consensus: no single method is sufficient. The optimal approach blends three complementary methodologies.

Internal Aalysis

Michael Happich, Senior Director at Eli Lilly, captured the practical wisdom at ISPOR Glasgow: start with an HTA landscape assessment using AI or SLR tools, then validate with country-level surveys. He also noted a structural gap: industry is formally excluded from PICO scoping, and greater stakeholder inclusion would meaningfully improve predictability.

From the public side, Niklas Hedberg of Sweden’s TLV signaled willingness to expand informal PICO consolidation across Member States and to invest in training and exchange, even where formal interaction mechanisms remain constrained by the regulation’s design.

Beyond Clinical Assessment: The National Reality

A critical nuance often lost in JCA discussions is that the regulation addresses clinical evidence only. National appraisal, pricing, and reimbursement remain squarely within Member State competence. JCA does not, and cannot, overcome affordability constraints or willingness-to-pay thresholds at the national level.

This matters strategically. A favorable JCA report creates the clinical foundation for faster national appraisal starts, but it does not guarantee market access. Conversely, any evidence gap identified in the JCA becomes visible to every payer across Europe simultaneously. A weakness that one country might previously have overlooked now becomes an anchor point in 27 parallel negotiations.

Internal Analysis

The Organizational Challenge: A Mindset Shift, Not Just a Process Change

As Zsombor Zrubka of Obuda University highlighted at the ISPOR panel, JCA advances evidence generation earlier in the product lifecycle, increasing organizational demands and skill requirements across all stakeholders. The regulation introduces parallel timelines with EMA review, stretches cross-functional teams, and demands capabilities that many organizations have not yet built.

The readiness gap is real. Industry research from late 2024 suggests only about one-third of companies felt well-prepared for JCA. Those with near-term oncology or ATMP launches tended to be further ahead, while others adopted a watch-and-wait posture. With first JCA results imminent, that window of passive observation is closing.

What Leading Organizations Are Doing Now

1. Predicting PICOs at risk, initiating indirect treatment comparisons (ITCs) and real-world evidence (RWE) generation early in the development timeline
2. Building dedicated JCA workstreams separate from EMA submission teams to manage the parallel process demands
3. Training cross-functional teams (clinical, regulatory, market access, HEOR, and affiliate teams) on JCA-specific methodological standards
4. Engaging in Joint Scientific Consultations (JSCs) to align evidence development with both regulatory and HTA requirements before Phase III completion
5. Updating internal process maps to integrate PICO prediction, early ITCs, and scientific advice into the standard development timeline

How Alira Health Is Helping Companies Build JCA Readiness

Beyond our direct involvement in active JCA processes, Alira Health is working with several pharmaceutical and biotech companies to address the organizational foundations that JCA success depends on. Two areas of support have emerged as particularly critical.

First, organizational design, governance, and process optimization for JSC and JCA. Many companies have discovered that their existing market access and HEOR operating models were built for a world of sequential, country-by-country HTA submissions. The JCA demands a fundamentally different configuration: parallel workflows, earlier cross-functional integration, dedicated resourcing, and governance structures that enable rapid decision-making under compressed timelines. We are helping clients redesign their internal processes and governance frameworks to meet these requirements, ensuring that accountability, escalation pathways, and resource allocation are fit for a JCA-era operating model.

Second, optimizing external stakeholder engagement in line with the regulation. The EU HTA Regulation introduces new rules and boundaries around how health technology developers can interact with HTA bodies, assessors, clinical experts, and patient organizations throughout the JCA and JSC processes. Companies must navigate a more structured and transparent engagement environment, where informal channels that previously shaped national HTA outcomes are either unavailable or governed by new procedural constraints. Alira Health is supporting clients in designing compliant yet effective external engagement strategies, identifying the right moments, channels, and stakeholders for input while ensuring full alignment with the regulation’s interaction framework.

Internal Analysis

The Road Ahead: 2026 and Beyond

The next 18 months will be decisive. The first JCA reports, expected in Q2 2026, will establish precedents that shape how assessors evaluate evidence, how Member States interpret and apply JCA findings nationally, and how manufacturers calibrate their evidence strategies going forward.

Key Milestones to Watch

Source: HTA Coordination Group

Simultaneously, the convergence of JCA with other global access dynamics cannot be ignored. In the United States, the Inflation Reduction Act’s Medicare price negotiations are reshaping revenue expectations. GLP-1 competition is accelerating access timelines. AI-driven tools are being adopted for evidence synthesis, PICO simulation, and launch-sequence optimization. Companies that treat JCA as an isolated European compliance exercise, rather than as part of a global evidence and access strategy, will find themselves structurally disadvantaged.

Implications for Pharma and MedTech Leaders

The EU HTA Regulation is not merely an administrative reform. It is a structural shift in how clinical value is evaluated, communicated, and ultimately negotiated across the world’s largest single pharmaceutical market. The implications extend across the enterprise:

• For R&D leaders: Evidence generation planning must now begin at Phase II, not at launch readiness. Clinical trial design should anticipate JCA PICO requirements alongside regulatory endpoints.
• For Market Access and HEOR teams: The JCA dossier is the new baseline for European access. Building the capability to predict PICOs, execute blended methodological approaches, and prepare for 100-day submission timelines is no longer optional.
• For Commercial and Strategy leaders: Launch sequencing, pricing corridors, and value narratives must account for a world where a single clinical assessment is transparent to all 27 Member States. The strategic premium shifts from managing information asymmetry to building an evidence story that holds up under unified scrutiny.
• For MedTech companies: With JCA rules for medical devices taking effect in 2026, and implementation processes still being defined, early engagement through JSCs and proactive evidence planning is essential. The learning curve from the medicinal product experience should be studied carefully.

Conclusion: From Regulation to Routine

The panel at ISPOR Glasgow captured a constructive, forward-looking consensus: 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, harmonized evidence synthesis.

The task now is practical. The first wave of JCAs is testing processes in real time. Lessons from these cases will shape how the system matures. JCA will not eliminate national economic constraints, but it can streamline clinical assessment and make real differences in timing, consistency, and clarity, bringing forward earlier appraisal starts and faster patient access where budgets allow.

For leaders navigating this transition, the imperative is clear: invest now in the capabilities, processes, and cross-functional alignment that JCA demands. The organizations that treat this as a strategic transformation rather than a compliance obligation will be the ones that turn the regulation’s promise into competitive advantage and, most importantly, faster access for the patients who need it.

At Alira Health, we are not waiting for the system to mature before engaging. We are in the process today, supporting live JCA submissions, helping companies redesign their organizations for the JCA era, and guiding stakeholder engagement strategies that are both compliant and effective. We invite leaders across pharma and MedTech to connect with us and explore how we can accelerate your JCA readiness together.

What challenges are you seeing as your organization navigates EU HTA and evolving global pricing dynamics? I’d welcome your perspectives in the comments.

About the Author: Andrea Mantovani is a Senior Partner at Alira Health, specializing in commercial strategy, market access, and transaction support for pharmaceutical and biotechnology companies, with particular focus on oncology and rare diseases.

Sources and References

1. EU HTA Regulation (EU) 2021/2282;
2. ISPOR EU Glasgow 2025, “Optimal Strategies for Predicting and Consolidating PICOs” panel;
3. European Commission Joint Clinical Assessments portal;
4. EMA HTAR implementation guidance (January 2025);
5. Commission Implementing Regulation (EU) 2025/2086 on JCA for medical devices
6. EURORDIS HTA Regulation overview;
7. Alira Health Website and Publications.

Originally published at https://www.linkedin.com.