One year of JCA: Key learnings and recommendations for 2026

When the EU JCA came into force on January 2025, expectations ranged from hopes of true harmonisation across the EU to concerns about added complexity and duplication of effort. After the first wave of assessments in 2025, early insights into how JCA process are beginning to emerge, but the lack of final decisions means it is still premature to draw firm conclusions. As we move into 2026, the JCA assessment reports for medicines currently under review are expected in the second and third quarters of the year,¹ enabling end-to-end visibility of the JCA and its real impact on evidence generation, regulatory alignment, and market access strategy.

Drawing on our experience supporting manufacturers across therapy areas, in this article Dr Bhakti Dhingra, explores what key lesson can be determined at this stage, from the first year of implementation in 2025 as well as practical, actionable recommendations manufacturers can take to further strengthen their readiness.

A rapidly expanding scope

In 2025, the JCA applied to new cancer medicines and advanced therapy medicinal products (ATMPs). In 2026 we will see the introduction of the first JCAs for selected high-risk medical devices. From January 2028, the process will extend to orphan medicinal products, and by 2030 it will encompass all new medicines authorised in the EU.²

Implementation is accelerating. 13 JCAs have been initiated to date³ and the Member HTACG’s 2026 Annual HTA Work Programme, signals major increase in activity. Around 50 JCAs will be initiated in 2026 for medicines containing new active substances for the treatment of cancer and for advanced therapy medicinal products. In addition, approximately five JCAs for selected high-risk medical devices are expected to commence from June 2026. Alongside assessments, early dialogue is set to increase as well and the HTACG plans to initiate 8-12 JSCs for medicinal products and 2-5 JSCs for medical devices.⁴

What Year One of JCA has taught us:

1.    Fewer JCAs than expected: The number of products entering JCA in 2025 was below initial forecasts (25 JCAs in 2025). This can be potentially attributed to many manufacturers appear to have taken a cautious “wait-and-see” approach, reluctant to be among the first to navigate an untested system.

2. Broader evidence within compressed timelines: Compared with most national HTAs, the JCA demands a wider evidence package including multiple comparators, subpopulations, and often patient-reported outcomes, all within tighter timelines. This has challenged traditional development and submission planning.

3. PICO complexity is a key challenge: Diverse standards of care across Member States are translating into numerous PICOs per product. Aligning evidence synthesis and narrative across these scenarios has proven far more demanding than many anticipated.

4. Limited transparency: Industry feedback highlights uncertainty around how initial PICO proposals are formulated and consolidated. Limited opportunities for structured manufacturer input increase the risk of misalignment with feasible evidence generation.

5. Relevance of the final JCA scope: As PICOs increase, dossiers grow larger and more complex. This can dilute the clarity of conclusions and their applicability to individual national HTA processes, the very decisions that ultimately determine access as JCA is non-binding.

Manufacturers that adapt development planning, evidence generation, and cross-functional collaboration now will be best placed to turn this evolving framework into a competitive advantage.

Lightning Health recommends the following practical steps manufacturers should take:

1. Design for multiple PICOs early: Evidence plans and statistical analysis strategies must anticipate a range of comparators and subpopulations before Phase III finalisation.

2. Pressure-test assumptions: Pre JCA PICO simulation workshops with ex-HTA experts from key markets can identify gaps long before formal scoping.

3. Start indirect comparisons early: Work on ITCs and endpoint strategy should begin ahead of consolidated PICO release to mitigate the post-scope time squeeze.

4. Use JSCs strategically: With limited slots and rising demand, early applications for Joint Scientific Consultation are becoming essential especially for comparator selection and endpoint alignment.

5. Plan for compressed timelines: 2025 experience shows dossiers must be largely drafted before final PICOs and often in parallel with EMA milestones. Pre-populate reusable modules disease background, pathways, trial methods well in advance.

6. Enhance cross functional collaboration: As the JCA spans across a multitude of functions, establish robust matrix working across  departments to enable early alignment on scope, evidence, minimise duplication and manage compressed timelines.

7. Prepare JCA-to-local translation: Develop structured plans to translate JCA clinical outputs into national HTA submissions, alongside integrated HEOR activities to address country specific gaps.

8. Learn from early JCA outcomes: Systematic monitoring of published JCAs will be critical to refine evidence strategy and avoid repeating early pitfalls. Conducting educational workshops to align and update the wider team on JCA is critical.

The JCA process demands earlier cross-functional alignment, deeper anticipation of PICO diversity, and far greater integration between regulatory and access strategies. Manufacturers that treat JCA as a late-stage submission exercise risk misaligned trials, unfeasible comparators, and dossiers that struggle to translate into national decisions. 2026 will be pivotal. With activity scaling rapidly and the first device JCAs beginning, the learning curve will steepen. Success will depend not only on understanding the regulation, but on operational readiness, scenario planning, and the ability to convert a single European assessment into meaningful local value stories

Lightning Health help manufacturers turn JCA requirements into clear, executable access strategies. From early PICO scenario planning to evidence gap assessment, we combine HTA expertise with practical implementation to keep programmes on track within compressed timelines. Get in touch to learn more enquiries@lightning.health.

References:

1.    IQWIG (2025). Available at: https://www.iqwig.de/en/presse/press-releases/press-releases-detailpage_158016.html

2.    EC (2025). Available at: https://ec.europa.eu/commission/presscorner/detail/en/ip_25_226

3.    EC: List of ongoing JCA (2025). Available at: https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en

4.    HTA CG Annual Work Programme 2026 (2025). Available at: https://health.ec.europa.eu/document/download/81db097f-a9cb-4404-837c-115b4289321d_en?filename=hta_hatcg_2026-awp_en.pdf

‍