The EU Health Technology Assessment Regulation stopped being theoretical in 2026. The Member State Coordination Group on HTA endorsed the first Joint Clinical Assessment report in April 2026, and the European Commission published it in June. After a year of preparation on the basis of guidance and assumption, developers finally have a worked example of what a JCA looks like in practice — and a growing pipeline behind it.
Where the framework stands
Joint Clinical Assessment has applied since January 2025, initially to new oncology medicines and advanced therapy medicinal products. The scope widens on a phased timetable: orphan medicines join in January 2028, and all new medicinal products fall within scope from 2030.
The first completed assessment concerned tovorafenib, an orphan medicine for paediatric low-grade glioma. Notably, the first product through the process was an orphan medicine assessed under the ATMP and oncology scope rather than the orphan expansion — a reminder that category boundaries matter less than whether a product meets the current criteria. Beyond that first report, a substantial number of assessments are in progress, and at least one has been discontinued following withdrawal of the underlying marketing authorisation application.
What the early experience signals
- The PICO framework drives everything. The scope of a JCA is set by the populations, interventions, comparators and outcomes that Member States collectively consider relevant. Because national practice varies, the consolidated scope can be considerably broader than the evidence base a developer assembled for regulatory approval.
- Timelines run parallel to the regulatory review, not after it. The JCA dossier is prepared alongside the EMA assessment. Companies that treat market access as a post-approval activity are structurally late.
- A discontinued assessment is instructive. Where a marketing authorisation application is withdrawn, the JCA falls away with it — underlining that the two processes, while separate, are tightly coupled.
- The JCA does not decide reimbursement. It provides a common clinical evidence assessment; pricing and reimbursement decisions remain national. A JCA report is an input to the Greek process, not a substitute for it.
Preparing for a wider scope
For companies with orphan medicines in development, January 2028 is closer than it appears. Evidence generation decisions taken now — comparator selection, endpoint choice, subgroup planning — determine whether a future JCA dossier can answer the questions Member States will ask. Retrofitting a trial programme to a PICO scope after the fact is rarely possible.
Joint Scientific Consultations offer a route to test evidence plans against HTA expectations early, and are worth considering well before a dossier is due.
How PQRA helps
PQRA supports companies preparing for and responding to Joint Clinical Assessment. We assess whether a development programme will satisfy the likely PICO scope, help structure JCA dossiers alongside the regulatory submission, and translate JCA outputs into the evidence Greek payers require for pricing and reimbursement. For products approaching the 2028 orphan expansion, we help align evidence generation with HTA expectations while the trial programme can still accommodate them.
The framework is now operating, and the first reports are public. Speak to PQRA about what Joint Clinical Assessment means for your product and your access strategy.
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