An out-of-the-box solution to navigate regulation effectively
The Joint Clinical Assessment (JCA) is a pivotal component of the European Union’s Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR), aimed at harmonizing health technology assessments across member states. The JCA was implemented 12 January 2025 and “will initially apply to new active substances to treat cancer and to all advanced therapy medicinal products (ATMPs).” The rules will continue to encompass other therapeutic areas in the future.
While the JCA aims to reduce duplicative assessments and administrative burdens for health technology developers (HTDs), with the stringent timelines of JCA running parallel to marketing authorization (MA) applications, the demand for rapid and relevant evidence generation has become a critical need. Traditional evidence-generation methods often struggle to meet these accelerated requirements, emphasizing the need for smarter and more adaptive approaches.
One approach Catalyst Flex has taken is to look at the JCA from a health economics outcomes research (HEOR) service delivery perspective to drive an out-of-the-box solution to effectively address any complexities.
JCA processes from the HEOR industry lens
Navigating the JCA process under the HTAR requires niche expertise in value communications to ensure a health technology aligns with regulatory and HTAR requirements and is entitled for its early market access. An HEOR agency may support HTDs in either or a combination of these steps:
- Writing the Letter of Intent (LoI): A comprehensive LoI paves the way to the health technology’s consideration for the JCA process and expects to have a balanced tone blending research and advocacy.
- Scoping (PICO definition): The development and consolidation of the PICO survey ensures that the incorporating feedback from the JCA Subgroup to capture the most relevant population including a fit-for-purpose choice of subgroups, comparators from other member states, and patient-centric outcomes.
- Identifying Experts and Stakeholders: Relevant experts and stakeholder organizations are integral components of the JCA process and demand strategic choices to reflect apt representativeness in the JCA dossier with inclusivity and diversity.
- Developing and Submitting Dossiers: A robust clinical dossier is prepared, consolidating clinical trial data, real-world evidence, and necessary documentation, ensuring compliance with the JCA dossier submission template.
- Reviewing Dossier Factual checks, quality assurance, and editorial reviews are essential steps to ensure the completeness of the JCA dossier for its smooth processing and require vast quality control experience for handling such tasks.
Human-in-the-loop automation
The JCA process is inherently complex and time-sensitive, requiring meticulous attention to detail across various stages, from drafting the LoI to final report publication. Integrating a human-in-the-loop (HITL) AI/ML evidence synthesis automation tool into this process can significantly enhance both efficiency and accuracy. For instance, AI can assist in drafting the LoI by analyzing previous successful submissions and suggesting language that aligns with HTAR. This not only accelerates the drafting process but also ensures compliance with regulatory standards, reducing manual effort and time.
As the process advances into PICO scoping and evidence identification, HITL AI plays a key role in integrated evidence planning. It can automate the development of the PICO survey, efficiently processing input from the joint scientific consultation (JSC) and the JCA subgroup to map clinical outcomes, populations, and comparators to the most relevant evidence. This accelerates decision-making while ensuring alignment with evolving HTAR norms. Simultaneously, AI can quickly identify credible experts and stakeholder organizations from large datasets, streamlining the selection process and ensuring the dossier is informed by stakeholder voices appropriately.
When it comes to dossier development, AI plays a crucial role in synthesizing and consolidating clinical trial data, real-world evidence, and necessary documentation. The speed at which AI may process large volumes of data significantly reduces the time spent on manual compilation.
On the other hand, the HITL feature still allows human experts to review and refine the outputs provided by the AI/ML algorithms. AI also helps identify gaps or inconsistencies during the dossier review and report preparation phases, ensuring timely and accurate finalization of the JCA report.
By combining AI’s efficiency with human oversight, the process is not only faster but also retains the necessary rigor for regulatory compliance. This hybrid approach empowers HTDs to meet the stringent timelines and complex requirements of the JCA with greater precision and confidence.
Functional services bring value to JCA processes
The Catalyst Flex medical writing and HEOR team leverages a robust global network of clinical, epidemiology, biotech, and medtech subject matter experts and adept researchers. Swiftly identifying and engaging the right assessors, co-assessors, experts, and other essential stakeholders, including patient advocates, ensures a comprehensive and credible dossier.
With the help of an experienced team of senior and principal HEOR analysts, we bring deep expertise in JCA submission requirements. Also, we support our clients through development of evidence-informed market access strategy with an understanding of pricing dynamics, within the EU and beyond.
Strategic consulting for your entire JCA submission process ensures seamless navigation through each stage of the JCA or JSC process and supports your success.
To learn more about JCA or discuss any kind of your HTAR or HEOR business needs, connect with Catalyst Flex.
