The Joint Clinical Assessment (JCA) came into force in January 2025. It begins with oncology and advanced therapies and will expand: orphan drugs in 2028 and all centrally authorised medicines by 2030.
This is a major change in how new medicines are assessed across Europe. For sponsors, it is not optional and preparation now will save both time and money later.
Why preparation matters
Many sponsors underestimate JCA until late in development. The result? Costly protocol amendments, duplication of work, and delayed reimbursement. Months lost in access means lost revenue and, more importantly, lost time for patients.
A simple readiness check can flag these risks early. The sooner you align your trial design with JCA expectations, the less rework you face downstream.
What sponsors are struggling with
- Comparators and endpoints
Standards of care vary by country. One HTA may expect physiotherapy, another supportive care. Without justification, evidence risks rejection.
Patients also highlight fatigue, daily functioning, and caregiver burden…yet these remain under-measured. - Compressed timelines
EMA and JCA run in parallel. Preparing dossiers within 100 days stretches teams thin, especially for smaller sponsors. - Local teams unprepared
Affiliates are vital for national HTA, but many lack JCA experience. Without clear tools, outputs become inconsistent. - Compliance and firewalls
Engaging patients is sensitive. Pharma faces conflict-of-interest risks, and strict firewalls between medical, commercial, and access functions mean insights often fail to reach the right teams. - Public scrutiny
JCA reports are published openly. Weaknesses in evidence will be visible to patients, clinicians, and payers.
Why patient evidence is central
In early JCA pilots, patients raised fatigue, cognitive functioning, and caregiver burden as critical. Yet these outcomes were often missing from endpoints.
Structured evidence — surveys, interviews, literature reviews — gives patients a visible role. But best practice goes further: closing the loop by showing how input shaped the PICO, endpoints, and access communication.
Groups such as the Acute Leukemia Advocates Network (ALAN) a global patient advocacy organisation working to embed patient perspectives into HTA and international EU HTA pilots are calling for this kind of traceability. Sponsors who can demonstrate it will stand out with regulators and payers alike.
How sponsors should respond
- Start early → build JCA into trial design before Phase III.
- Integrate regulatory and access → treat EMA and JCA as one process, not sequential.
- Equip affiliates → provide templates, training, and aligned narratives.
- Capture patient input properly → regulator-ready and compliant.
- Close the loop → show explicitly how patient input feeds into decisions.
- Bridge compliance walls → ensure insights flow across medical, commercial, and access teams safely.
- Use technology → AI can track comparator risks, monitor evolving HTA guidance, and generate draft payer language from patient insights.
Closing thought
The JCA is here, and with it comes compressed timelines, compliance scrutiny, and public visibility. Sponsors who prepare now will not only reduce risk but also save time and money…and bring patients faster access to new therapies.
Learn how our RAREready™ framework helps close evidence gaps, support affiliates, and provide compliant, closed-loop patient insights: RAREready.health