Regulation (EU) 2021/2282 promised one clinical assessment in place of twenty-seven. Since the Joint Clinical Assessment (JCA) began in January 2025, the initial reports, scopes, and discontinued procedures show how this promise is being fulfilled in practice. For decision-makers in the pharmaceutical and medtech sectors, the JCA is an operational procedure that affects the design of trials, the way teams are organized, and the development of national market access plans.
Is the Joint Clinical Assessment Delivering on Its Promise?
The whitepaper entitled “The PICO Problem: Europe’s Joint Clinical Assessment in its First Twenty Months” by Ingenious e-Brain evaluates the JCA against what has actually happened since it came into effect. The insightful paper centers on PICO (Population, Intervention, Comparator, Outcomes), the framework that forms the basis of every JCA. Twenty-seven health systems do not agree on the correct comparator or outcome measure, and it is at the PICO stage that these disagreements have to be resolved. The first published reports show how varied the scopes already are, with the number of PICOs per assessment ranging from one to seven.
The paper also examines how the Joint Clinical Assessment relates to national processes such as AMNOG and HAS, at the fact that its scope will be expanding to include orphan medicines in 2028 and all new medicines by 2030, and what that means for evidence planning. It closes with some practical advice on how to develop PICO readiness before the pivotal trial design is finally determined.
What Can Readers Expect in This Whitepaper?
- JCA rollout: The staged timeline, starting with oncology medicines and ATMPs in January 2025, followed by medical devices and IVDs in January 2026, then orphan medicines in 2028, and all other new medicines that are authorised centrally in 2030.
- JCA’s role: What the Joint Clinical Assessment covers, the kinds of decisions that remain the responsibility of the national pricing and reimbursement bodies, and how the Member States are expected to make use of its reports.
- PICO scoping: How the PICO is drafted, how Member State input is consolidated, and the 100-day (or 60-day) dossier window that follows.
- First JCA outcomes: Published reports, including tovorafenib, the range of one to seven PICOs per assessment, and the procedures discontinued because dossiers did not meet requirements.
- Capacity vs. demand: There are about 25 assessments planned for 2025 compared with around 10 that have already been started, alongside the target of about 55 for 2026 and the limited number of joint scientific consultation opportunities.
- Impact on pharma companies: Why trial endpoints and comparators are usually decided before a PICO exists, and how the JCA shifts timelines and responsibilities inside organizations.
- Medical devices and diagnostics: The process of selecting devices and in vitro diagnostics, the difference between the evidence obtained during conformity assessment and JCA evidence, and the role of companion diagnostics in medicine JCAs.
- Recommendations: Six practical steps for pharma companies, starting with incorporating PICO considerations into the decision moving from Phase II to Phase III and ending with the creation of an internal PICO options library.
Understand how the Joint Clinical Assessment is working in practice and what the PICO actually means for your evidence strategy.
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