The evolving landscape of health technology assessment (HTA) in the European Union (EU) is characterised by a significant development: the introduction of joint clinical assessments (JCA) in 2025.
This initiative, part of the new HTA regulation, aims to enhance efficiency, improve the quality of evaluations, and ultimately ensure that patients gain quicker access to innovative medicinal products and medical technologies.
In this article, we will delve into what the JCA entails and its implications for pharmaceutical companies engaged in clinical trials.
What is a Joint Clinical Assessment?
JCA is a process designed to evaluate the clinical benefits, i.e. relative effectiveness and relative safety, of new medicinal products or medical technologies in a more collaborative and harmonised manner across EU member states. The JCA will be conducted in parallel with the European Medicines Agency (EMA) procedure by the Member States, in a joint effort to provide a comprehensive analysis that aids national authorities in their decision-making processes.
Thus, the aim of JCA is not to replace the national reimbursement process or pricing negotiations currently performed by the individual EU Member States but to add/ improve existing procedures by creating a way for pan-European collaboration and information sharing across Europe.
The role of PICO in JCA
In order to create this collaboration, each Member State’s needs should be reflected, and this should be achieved through the provided input on the PICO parameters:
POPULATION
INTERVENTION
COMPARATOR
OUTCOMES
These elements will form the research question to be answered during the assessment by the companies. It is crucial to understand that the JCA report will be non-binding and will not draw any conclusions, as it is an assessment of the clinical data rather than an appraisal. Thus, only at the national level, when local considerations and the non-clinical domains are taking into context can a value be determined, and a pricing & reimbursement decision/recommendation made.
Timelines for JCA procedures
The JCA process unfolds in a strict timeline. A Joint Scientific Consultation would take place years before the JCA procedure starts.
Day 1
EMA filing
The JCA process begins when the Health Technology Developer files for assessment. This is the starting point of the PICO scoping process.
Day 130
PICO information to HTD
The HTD receives the PICO information after 130 days.
Day 230
JCA dossier deadline
The standard EMA procedure allows a maximum of 100 days for compilation of the JCA dossier. (60 days for the accelerated process)
Day 369
EC decision
Following a period including delivery of CHMP opinion to the HTD, and a 7 days window for the HTD to conduct fact checking, the EC gives their decision.
Day 399
Final JCA report
The HTD receives the final JCA report, endorsed by coordination group, no later than 30 days after the EC decision.
Implications for Health Technology Developers
- Early planning: Companies should initiate thinking and strategic palling around the clinical study and comparators early. Predict the potential PICO’s 3-4 years before regulatory submission.
- Early Engagement: It’s advisable for companies to engage early with the HTA bodies (early scientific advice) to understand the data requirements and align clinical trial designs with these expectations. Early dialogue can help mitigate risks related to regulatory delays.
- Collaboration and Transparency: The collaborative nature of the JCA will require companies to be transparent in sharing data and insights. Also, internal collaboration between regulatory and market access/HEOR teams is becoming extremely important.
Reflections on JCA from the life science industry
The implementation of the JCA was a hot topic during the European ISPOR 2024 held in Barcelona. Delays and issues are expected in the short term. However, opportunities are seen in the long term.
- Readiness: there are large differences across Europe in how ready the Member States are, with the more established countries being further along (e.g. France, Germany, the Netherlands) versus the Central Eastern European (CEE) states (e.g. Poland, Estonia, Romania).
- Tight timelines: manufacturers are concerned on the short timelines during the process, with only having 100 days between the PICO confirmation and the JCA dossier submission deadline in a standard procedure. For the accelerated route at EMA, this is reduced to only 60 days.
- Limited opportunity for industry engagement: the manufacturers will not be involved in the PICO scoping process, however at the scoping explanation meeting they will have the opportunity to engage with the HTA commissioning group.
- Uncertainty in national implementation:
- No set limit on the maximum number of PICO combinations for the assessment.
Are you looking for JCA support?
Arex can support with PICO simulations from an early stage. Our early development team has the expertise and experience to support from both a regulatory perspective and a market access point of view. While going through the JCA, Arex can also support local submissions to gain access for the patients.
Our Market Access team and Regulatory Affairs team have the skills and experience to support your JCA.
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