Ready for EU Joint Clinical Assessment (JCA): Key Reflections from 2024 & Important Unknowns
The European Health Technology Assessment (HTA) landscape is undergoing a significant shift, with the introduction of the Joint Clinical Assessment (JCA) on 12th January 2025, initially for oncology products and advanced therapy medicinal products (ATMPs).
Over the past year or so, the Costello Medical team has been actively preparing for the introduction of the EU JCA; given its imminent launch, we have been reflecting on our key takeaways, and what we hope to find out as the JCA gets underway.
Value of Early Preparation
Early strategy development and planning from manufacturers will be crucial to meet the tough evidence requirements and timelines of the JCA:
- Manufacturers of oncology products or ATMPs may face large numbers of PICOs due to dense treatment landscapes or variations in standard of care across member states
- Our PICO simulation exercise found that consulting clinical and HTA guidelines can help with PICO prediction, enabling the tailoring of clinical evidence generation and systematic reviews
- We also recommend that manufacturers engage in early payer and clinician discussions to scope, validate and consolidate PICOs
- Manufacturers may also benefit from engaging early with the Joint Scientific Consultation (JSC) process, though we appreciate that spaces are currently limited
- Developing integrated evidence generation plans to solve the challenges that are so commonly seen with ATMPs will be crucial to ensure that future clinical evidence will meet the rigorous requirements of JCA
- Using technology to aid productivity will help all, but especially small biotechs, to meet the needs of the parallel regulatory and JCA processes, including the 100-day JCA dossier development timeline
Keeping Up to Date With JCA Methods and Processes
- Additional methodological guidance and process details for the JSC and JCA were published at various times during 2024
- The HTA CG anticipates making further updates to JCS and JCA methodological guidance based on lessons learnt as the processes get underway. A formal review of how JCA is working is scheduled for 2028
- Manufacturers will need to remain flexible, keeping up with and adapting to the quickly evolving JCA methodological guidance and processes
- Manufacturers may also wish to monitor for opportunities to make their voice heard, such as during future potential public consultations
National HTA Processes Remain Largely Unchanged
- Some European HTA bodies have released statements about how their HTA evaluations will change considering the JCA
- In France and Ireland, major changes to national HTA processes are not expected, with key changes relating only to the clinical evidence section in the national HTA submission dossier template
- The majority of EU member states have not indicated how JCA will affect their national HTA evaluations
Wish List: What We Hope to Learn
As JSC and JCA get underway, we hope to gain clarity on the following questions:
- How will the HTA CG prioritise 5–7 medicines for Joint Scientific Consultation (JSC) in 2025?
- How much variability will there be in the approach that individual member states take to inform their input into the PICO scoping process?
- What would be the consequences of a given PICO not being addressed by the JCA dossier?
- To what extent will the factors that influence level of evidence for rare disease indications be taken under consideration in the assessment of ATMPs?
- How will real-world evidence be assessed, and to what extent will it be accepted?
- How transparently will patient expert input be considered in JCA reports?
- How will national HTA bodies view the usefulness of the JCA report in cases where it doesn’t contain the latest trial data cut (e.g. for overall survival data for oncology products)?
- Is there an expiration date for the JCA report?
- Will JCA translate into efficiency for manufacturers and HTA bodies, and accelerated patient access?
