Written by Sneha Bhadti, David Pritchett, & Susan O’Connell
The implementation of the European Union (EU) joint clinical assessment (JCA) process is fast approaching. In January 2025, the JCA will be rolled out for new oncology and orphan medications. Source has already published a blog introducing the EU JCA framework.
Crucially, JCA submissions will involve consolidated population, intervention, comparator, outcome, and study design (PICOS) criteria for all EU member states. These will be finalised 90 days prior to the submission. Since PICOS criteria are pivotal in structuring the research question and methodology for systematic literature reviews (SLRs), the introduction of the JCA process will have a major impact on how clinical SLRs are performed.
More PICOS criteria and shorter timelines
Diversity in the management of specific diseases across EU member states will result in multiple discrete PICOS criteria for a single JCA submission. The EUNet21 have already published two JCAs for medical devices: one for the Optilume® urethral drug-coated balloon, and another for the Evoke® Spinal Cord Stimulation System. The consolidated PICOS criteria for both assessments were composed of three discrete PICOS criteria, while research from the European Federation of Pharmaceutical Industries and Associations (EFPIA) suggests there is the potential for many more PICOS criteria for other technologies and indications. Using anonymised interventions, an orphan medication for a solid metastatic tumour indication required 16 discrete PICOS criteria involving 2 populations and 15 comparators, while a haematological cancer indication in the first‑line setting required 57 separate PICOS criteria involving 6 populations and 23 comparators. Hence, depending on the disease in question, the number of discrete PICOS criteria could be very high, introducing considerable complexity to the clinical SLR. Combined with the 90-day timeframe between finalisation of the PICOS criteria and the submission deadline, the best approach to performing an SLR for a JCA submission requires careful consideration.
The importance of planning
Multiple approaches could be considered when approaching the SLR for a JCA submission, each of which has advantages and disadvantages (Table 1).
One approach would be to perform the SLR in advance of PICOS consolidation, after conducting rigorous desk research to predict the final PICOS criteria. The aim of this research would be to establish how the disease in question is currently managed across each of the 27 EU member states.
An alternative approach would be to perform the SLR in advance of PICOS consolidation, adopting broad PICOS criteria to minimise risk and cover all possible bases in the consolidated PICOS. These broad criteria are likely to include items that ultimately do not feature in the final PICOS, so during the 90-day period prior to submission, the included publications would need to be filtered down to those aligned with the consolidated PICOS. This method could avoid a last-minute scramble to update the SLR with additional PICOS items in the final three months before submission. Moreover, there is the potential for sufficiently broad SLRs to be re-used across multiple submissions in the same disease area.
A third option would be to perform the SLR from start to finish during the 90-day pre-submission period. This approach would ensure the SLR is completely aligned with the consolidated PICOS criteria, but is only likely to be feasible for very small SLRs, for example those for rare diseases or indications for which very few treatments are available. Even in this scenario, extensive planning and discussion of the SLR protocol would be required in advance of PICOS consolidation, such that screening could begin as soon as the PICOS is finalised.
Each of the methods described here has its own advantages and disadvantages. In practice, the most appropriate approach to the SLR may vary based on the indication, budget, and time and resources available, and should therefore be determined on a project-by-project basis. Given the extremely tight timelines, artificial intelligence (AI)/machine learning (ML) tools may prove particularly useful during the scoping, screening and/or data extraction stages of SLRs for JCA submissions; however, further optimisation and validation of these tools is still required, as is clear guidance that AI/ML tools would be accepted by JCA assessors. Regardless of which approach is selected, early planning and discussion of the SLR will be absolutely essential given the very limited time available between PICOS consolidation and submission.
If you would like to learn more about systematic literature reviews, please contact Source Health Economics, an HEOR consultancy specialising in evidence generation, health economics, and communication.
