Joint Clinical Assessment (JCA) aims to harmonise HTA processes across the EU
The JCA, according to Regulation (EU) 2021/2282 (EU HTA), will initially be implemented for oncology drugs and ATMPs in January 2025 and evolve to include rare disease therapies in 2028, with a full roll-out by 2030.
It aims to harmonise processes and evidence requirements, avoid duplication of dossier development for manufacturers, accelerate patient access and focus on comparative effectiveness.The research question for each country will be scoped using a PICO (Population, Intervention, Comparator, Outcomes) survey which will be distributed for completion by all member states. Following confirmation of the PICOs, companies will have 90 days to dossier submission, emphasising the importance of precision planning and operational readiness efforts.
Aside from the ambitious timelines, additional challenges for JCA include
unclear details and rules leaving companies unsure about resource allocation, approval timelines and distribution of responsibilities.
Staged implementation requiring companies and agencies to manage two systems simultaneously for 5 years impacting diverse portfolios and requiring complex resource management
JCA updates are continuously published and Team DC is closely monitoring and evaluating the developments. You can stay informed on the subject by following us on LinkedIn.
We aim to help you navigate the complexity and breadth of information relating to the JCA to be best informed and prepared for the upcoming changes
Learn about JCA
An overview of JCA timelines
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What you need to know about PICO’s
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FAQ’s with Esther and Kevin
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Esther: Today, HTA is not a European discipline. Health technology assessment (HTA) is routinely conducted at a national level by each of the individual countries as they decide on the coverage of a new medicine or technology.
With the introduction of Joint Clinical Assessment, the clinical review of a new medicine, therapy or technology will be lifted to a European level and considered jointly on behalf of the 27 Member States.
That health technology appraisal process will aim to address as many policy questions as defined by the PICOs (population, intervention, comparator and outcomes). With PICOs being sourced and consolidated across the 27 Member States.
The process will run in harmony with the European Medicines Agency review of any new medicine, and the two processes will be closely tied together with some exchange of information and a tight exchange of subjects of scientific interest. The parameters for this are still under discussion.
As you can see, this is a real shift from a national assessment of new medicines and technologies to a joint clinical assessment at a pan-European level, which will then inform and form the basis for value-based assessments that will take place in each country around particular coverage.
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Esther: JCA is going to be introduced in phases.
We see at the moment that the Joint Clinical Assessment will apply for oncology medicines and ATMPs from January 2025. But anything that's already licenced, for example, that's seeking a new indication, would be covered presently by the existing national systems.
What this means for manufacturers is they're likely to need parallel work streams for many years to come.
The JCA process won't cover all medicines until after 2030.
So for the next five years at least, companies are likely to need parallel processes and parallel teams to address the needs of the Joint Clinical Assessment process relative to the existing national model of HTA as part of a value assessment at a country level.
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Esther: Any significant change will have challenges in terms of implementation for joint clinical assessment.
One of the biggest challenges right now is that the rule book, the implementing Acts, has not yet been fully published. So there's still some uncertainty facing manufacturers as they plan ahead for what it will require to traverse the Joint Clinical Assessment process which comes into effect for ATMPs and oncology medicines from January of 2025.
Some of the biggest challenges beyond that relate to the planning of evidence needs.
The concept of the Joint Clinical Assessment is that it will cover as many of the policy questions, the PICO questions (population, intervention, comparator, outcome) for the member states as possible.
But looking across 27 member states that may have very divergent existing practices, we could be looking at a relatively high number of different PICO questions that need to be addressed.
Putting a lot of emphasis on manufacturers to think carefully about evidence synthesis, indirect treatment comparisons and the way that things like systematic literature reviews are planned and conducted. And all of this in a very short time.
The tying of the process to the EMA process means that after confirmation of the consolidated PICOs, manufacturers will only actually have 100 days to finalise their submissions.
So pre pre-planning and prediction of PICO requirements and evidence needs will be really important.
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Kevin: So the first thing companies should be thinking about is really building awareness. This isn't just the groups working only on HD that need to be aware of JCA coming in. It's really broader than that. Talking to your regulatory colleagues, talking to clinical development, and making sure your leaders within the organisation are aware that this is a fundamental change if you're wishing to bring medicines to Europe.
It's also really important to do a full portfolio assessment. Not only assets in phase 3, but looking back at those products that are still in phase two to make an assessment across the whole of them. When will JCA become applicable to your products and what actions can you start to take now so that you are JCA ready, even if your products aren't coming until 2028 or 2030?
The other thing that you should be thinking about now is doing your own assessment of what the possible PICOs could be. As mentioned, there can be many from all of the different authorities. So start to have a look at this and run a simulation yourself to see what the possible consolidated PICOs might be.
The other thing you should be considering is around JSC.Is the joint scientific consultation right for your product? Would it get into that and is that going to be a valuable add?