The Joint Clinical Assessment (JCA), a core feature of the Regulation (EU) 2021/2282, aims to streamline and harmonise health technology assessments (HTAs) across Europe. A critical step in this process is the scoping phase, during which the Coordination Group defines the key research questions manufacturers must address in their submission using the PICO framework – Population, Intervention, Comparator, Outcome. These PICOs, informed by clinical guidelines of the Member States (MS), establish the evidence requirements that the manufacturers must meet.
However, national variations in clinical practice make PICO consolidation difficult. An ISPOR analysis of 45 HTAs for five oncology drugs across five MS showed that none of the product had a uniform PICO, with the number of distinct PICO combinations ranging from 4–8 per product.1 Similarly, a hypothetical JCA case study in first-line non-small cell lung cancer across six MS, estimated 10 relevant PICO. The inclusion of additional MS would likely further increase the number and complexity of PICOs.2
Early experience shows that a comprehensive and well-prepared PICO strategy, in preparation of the scoping process, will be key determinant of JCA success. Accurately forecasting how assessors will delineate the PICOs can streamline evidence generation, while misaligned expectations risk unexpected evidence requirements, unanticipated analyses, and delays in patient access. In cases of misalignment, the manufacturer may be required to submit an updated JCA dossier, with timelines of 7–30 days.3 This combination of unpredictability and tight timelines has raised concerns across the industry about the potential impact on market access in Europe. Therefore, early precision in PICO planning, alongside strategic foresight, is essential to mitigate submission delays and support timely reimbursement.
Crafting a winning PICO strategy
Creating a successful PICO strategy requires early integration into clinical development, beginning in Phase II. By proactively identifying likely comparators and outcomes at this stage, manufacturers can design pivotal Phase III trials that are strategically aligned with anticipated PICOs, thereby minimising the risk of evidence gaps and unplanned post-hoc analyses.
Manufacturers should consider the following to ensure an effective PICO strategy:
- Competitor horizon scanning: Perform an in-depth review of clinical guidelines and existing HTA reports to understand the available treatment options across key markets and proactively anticipate evolving practice patterns to remain aligned with a shifting therapeutic landscape.
- Payer/clinician validation: Collaborate with payers across Europe to validate relevant PICOs, clarify uncertainties and capture any misalignment between clinical practice and reimbursement that may impact the PICOs.
- Joint Scientific Consultations (JSC): Leverage the JSC early in development to cocreate and validate draft PICOs, gain critical insights into the anticipated JCA requirements and to ensure the clinical development programme is strategically aligned with HTA expectations across MS.
In the JCA era, a proactive and well-informed PICO strategy is essential for ensuring timely, successful market access across Europe. To support your organisation in navigating this evolving landscape, Remap Consulting offers tailored PICO readiness diagnostics to help anticipate challenges, align evidence generation, and optimise your strategy ahead of the scoping phase.
Contact us to discuss how we can support your team in building a PICO strategy that sets the foundation for JCA success.