JCA creates a common EU-level clinical assessment, but it does not harmonise all the evidence and assessments required to secure national access. Differences in national treatment pathways, the relevance of populations and comparators, approaches to determining clinical added value, and requirements for economic evidence and budget impact can therefore create gaps between the JCA evidence package and national HTA requirements
JCA standardises the clinical assessment, not the national value question
The JCA is a streamlined process that involves a single EU-level submission of evidence, providing a common comparative assessment of clinical effectiveness and safety. 2
During JCA scoping, Member State requirements are consolidated into an assessment scope covering relevant populations, comparators and outcomes. The resulting PICOs may therefore expose evidence gaps early, before manufacturers address the requirements of individual national pricing and reimbursement processes.3
However, harmonisation stops at the clinical assessment. The JCA does not determine added clinical value, pricing or reimbursement, which remain the responsibility of individual EU Member States.2 Manufacturers must therefore continue to navigate distinct national value frameworks and access processes after the JCA is completed. This distinction is important because the time to patient availability can vary substantially across European markets.4
Where the evidence gaps emerge
National EU authorities assess the common clinical output from the JCA in accordance with their own HTA and reimbursement frameworks; however, due to differing reimbursement requirements, evidence gaps may emerge.5 The table below summarises key areas where this may occur and potential mitigating actions that manufacturers should consider:
| JCA | Potential national implication | Potential action | |
| Comparator | Considers several comparators and accepts indirect-treatment comparison | Local standard of care may not be adequately addressed by JCA analysis due to the relevance of the selected comparator in local clinical practice, or due to diverging methodological criteria | Validate clinical pathway assumptions, and explore ITC methodology requirements and feasibility if direct comparative data is not available |
| Population | National assessment may focus on the population covered in the regulatory label or trial population or specific subgroups, with implications for price benchmarks further down the line | Understand the impact of target population on comparator expectations, making a clear distinction between clinical versus economic comparators; then explore evidence requirements to demonstrate payer-relevant incremental value and a strategy to avoid price anchoring to low-cost standard of care | |
| Outcomes | Beyond efficacy and safety assessment, additional outcomes to support the case for adoption into local care pathways may also be needed | Understanding how different national HTA assessments will value specific endpoints, e.g., HR-QoL, caregiver impact, patient preferences, route of administration, shifting patients from one care setting or level of care to another, etc. Also, manufacturers need to consider the implications of orphan drug designation for evidence needs and potential methodological implications in each country | |
| Economic / value | Cost-effectiveness, budget impact and affordability invariably require local narrative and compelling evidence | Understand where the therapy can demonstrate payer-relevant cost-offsets or drive healthcare efficiency beyond clinical outcomes, to justify inclusion in budget-constrained systems |
Conclusion:
Once the JCA is complete, manufacturers are still required to translate the JCA evidence package into individual national-level value strategies adapted to the context of each healthcare system. This process can be split into three distinct phases:
- Diagnosis: mapping the JCA evidence package against local requirements in priority markets
- Prioritisation: determining which gaps are most likely to affect appraisal success, price potential or access, and which evidence requirements are just “nice-to-haves”
- Mitigation: deciding on how to resolve critical evidence gap, including additional analyses, indirect comparisons, economic modelling, local evidence generation – all supported by robust payer validation
In sum, the real challenge is ensuring that the evidence generated for JCA can be translated into compelling national value propositions across priority markets. Manufacturers should therefore assess national evidence requirements early, identify where the JCA package may fall short and prioritise the gaps most likely to affect appraisal outcomes, pricing potential or access.
A structured approach spanning diagnosis, prioritisation and mitigation can help teams focus evidence generation where it matters most, reduce avoidable surprises during national HTA and strengthen the pathway from EU-level assessment to patient access.
Remap is well-positioned to help market access teams plan for JCA and national access as a single connected evidence strategy, rather than as sequential exercises.
Questions market access teams should ask now:
- Which evidence gaps are likely to have the most significant implications for P&MA at national level assessments in priority markets?
- What gaps can be mitigated without significant additional evidence generation e.g. subgroup analysis, different data cuts, ITCs, SLRs, NMAs?
- If significant new evidence generation is needed, what are the launch strategy trade-offs?
Wondering how to turn JCA evidence gaps into a clear national action plan: speak to Remap to explore our approach for diagnosing, prioritising and mitigating national evidence gaps.
Bibliography:
- 1. European Union. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Published online December 22, 2021. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32021R2282
- 2. Remap Consulting. What is the joint clinical assessment and what does it entail? April 3, 2023. https://remapconsulting.com/hta/what-is-the-joint-clinical-assessment-and-what-does-it-entail/
- 3. HEOR. The EU Joint Clinical Assessment: A harmonised approach to clinical assessments across the European Union. https://heor.co.uk/wp-content/uploads/2023/11/EU-Joint-Clinical-Assessment-1-HT.pdf
4. Forest T. The why, what and when of the Joint Clinical Assessment. Idea Regulatory. October 14, 2025. https://idearegulatory.com/the-why-what-and-when-of-the-joint-clinical-assessment/
5. European Commission. Questions and Answers on general methodological and procedural issues for joint clinical assessments. Published online May 18, 2026. https://health.ec.europa.eu/publications/questions-and-answers-general-methodological-and-procedural-issues-joint-clinical-assessments_en
6. AIFA. Guidelines for compiling the dossier of a medicinal product for pricing and reimbursement borne by the NHS. December 24, 2025. https://www.aifa.gov.it/en/-/linee-guida-compilazione-dossier-medicinale-rimborsabilita-prezzo-ssn
7. HTACG. Joint Clinical Assessment Report Tovorafenib. Published online June 9, 2026. https://health.ec.europa.eu/document/download/395c2ba0-849a-4f3b-9251-aa2495b3efd7_en?filename=hta_jca_mp_202406_tovorafenib_report_en.pdf