What the JCA changes
Under Regulation (EU) 2021/2282, new medicines in scope receive one joint clinical assessment of relative clinical effectiveness for all member states. Member states first agree the assessment scope, expressed as PICOs (population, intervention, comparators and outcomes). The company then has a short window to submit a dossier that answers every PICO, with literature searches that must be recent at the time of submission.
The JCA does not decide price or reimbursement. Cost-effectiveness, budget impact and the final decision stay national, so companies still need national submissions afterwards.
Track every EU joint clinical assessment, its trials and national status in JCA Pulse.
What we deliver
- PICO simulation: anticipating the comparators and populations member states are likely to request
- Evidence gap analysis against the expected scope
- Systematic literature reviews designed to JCA standards
- Indirect treatment comparisons, network meta-analysis and population-adjusted methods such as MAIC
- Dossier writing and quality review
- Responses to requests for additional information
- National follow-on submissions that reuse the JCA evidence
Plan backwards from the scope
The scoping step tends to produce more comparators and subpopulations than a single national submission, and the time to respond is short once the scope is confirmed. The evidence work therefore has to start before scoping begins. We help teams run the analysis early, so that the dossier is assembled rather than invented under deadline.
Our JCA Readiness Index scores every EU member state on readiness for joint clinical assessment.
Why Evidaxia
We have developed EU JCA dossiers for several companies, including PICO scoping, indirect treatment comparisons and network meta-analyses. Our HTA background means we also plan for what happens next in each national system.
How a joint clinical assessment starts
The process begins with the marketing authorisation application. When a developer submits an application to the EMA for a medicine in scope, it submits the summary of product characteristics and the clinical overview to the HTA secretariat at the same time, and this information is used to establish the scope. The JCA formally begins when an assessor and a co-assessor are appointed.
Scoping follows the HTA Coordination Group's guidance on the scoping process. The assessor and co-assessor draft an assessment scope proposal, Member States set out their needs through a PICO survey, and the assessor and co-assessor then consolidate the requested PICOs as far as possible. For medicines, the scoping process has to be completed before the opinion of the Committee for Medicinal Products for Human Use (CHMP). Our analysis of JCA PICO scoping explores what this means for evidence planning.
The guidance that shapes the dossier
The HTA Coordination Group has adopted a set of methodological and procedural guidance documents under Article 3(7)(d) of Regulation (EU) 2021/2282. Those most relevant to the dossier are:
| Guidance | Adopted | What it covers |
|---|---|---|
| Methodological and practical guidelines for quantitative evidence synthesis: direct and indirect comparisons | 8 March 2024 | Methods and reporting for meta-analysis, network meta-analysis and population-adjusted comparisons |
| Guidance on outcomes for joint clinical assessments | 10 June 2024 | How outcomes are selected, defined and interpreted |
| Guidance on validity of clinical studies | 19 September 2024 | How the validity of the clinical studies is assessed |
| Guidance on the scoping process | 28 November 2024 | The PICO survey and consolidation of PICOs |
| Guidance on filling in the JCA dossier template for medicinal products | 28 November 2024 | Dossier structure, information retrieval and table templates |
The dossier template guidance sets clear expectations for information retrieval. Searches should at least cover MEDLINE and Cochrane CENTRAL, alongside study registries, relevant HTA reports and the clinical data in the EMA submission, with a search cut-off date no more than three months before the dossier is submitted. See systematic literature reviews, SLR updates and indirect treatment comparisons.
From the JCA to national decisions
A JCA report provides a scientific analysis of relative clinical effects. Value, price and reimbursement are decided nationally, so the same evidence base also has to support cost-effectiveness models, budget impact analyses and national dossiers. Designing the review, the comparisons and the model together lets one package serve the JCA and the national submissions that follow. Read our analysis of one evidence plan for NICE and the JCA, explore early advice through joint scientific consultation, and compare national systems in our HTA requirements comparison.