The Joint Clinical Assessment (JCA) is a significant initiative within the European Union’s Health Technology Assessment (HTA) framework, designed to harmonise the evaluation of new health technologies across EU member states. The JCA was defined under the EU Regulation on Health Technology Assessment (EU HTA), specifically Regulation (EU) 2021/2282, which was adopted to improve the availability of innovative technologies for EU patients and increase efficiency through joint clinical assessments. This regulation entered into force in January 2022 and will be applicable from January 2025 onwards [1].
The Joint Clinical Assessment (JCA) will be applicable from January 12, 2025, as per the EU Regulation on Health Technology Assessment (HTA) [2]. This means that any new oncology or advanced therapy medicinal product (ATMP) application submitted to the European Medicines Agency (EMA) starting from January 12, 2025, will trigger the JCA process [3]. Drugs submitted before this date but assessed after January 12, 2025, will not be subject to the JCA process.
The JCA process is managed by the HTA Coordination Group (HTACG), which comprises representatives from the HTA bodies of each member state. The process begins with the appointment of two rapporteurs from different member states’ HTA bodies, who are responsible for conducting a scoping process to define the research question and scope of the assessment using the PICO framework (Population, Intervention, Comparator, Outcomes) [4]. The PICO framework is a structured approach that provides clarity, transparency, and robustness to the assessment process, allowing for a systematic evaluation of the relative clinical effectiveness and safety of emerging health technologies [5].
The PICO framework is central to the JCA process, as it underpins the appraisal of evidence submitted by health technology developers (HTDs). The framework involves defining the population that will benefit from the technology, the intervention being assessed, the comparator(s) against which the intervention is evaluated, and the outcomes that will be measured to determine the intervention’s effectiveness and safety [6]. This structured approach enhances the reproducibility of the JCA, allowing for easier replication of the assessment by other researchers or healthcare institutions [5].
Despite its advantages, implementing the PICO framework within the JCA presents several challenges. One major challenge is the lack of alignment in PICO criteria across different EU countries, as each member state may have specific national requirements for the PICO scheme. This can lead to a high number of PICO parameters, complicating the scoping phase of the JCA process and making it difficult to reach a consensus on the research questions [5]. Additionally, the narrow timeframe for the JCA process, which runs parallel to the European Medicines Agency (EMA) approval process, poses a challenge for manufacturers who must generate extensive data within a short period [1].
To address these challenges, it is crucial for pharmaceutical companies to align their pivotal clinical trials with the PICO framework from the beginning, ensuring that they gather the most relevant data required for a successful JCA. This proactive approach minimises the need for additional data collection during the JCA stage, saving time and resources for both companies and regulatory bodies [5]. Furthermore, early engagement with stakeholders, including healthcare professionals, patient cohorts, and technology manufacturers, is essential to ensure a comprehensive understanding of healthcare needs and to align the assessment with industry expectations [5].
Moreover, the JCA process is designed to run concurrently with the EMA marketing authorisation process, which requires careful coordination to ensure that the timelines align, and that the necessary data is available when needed [7]. The scoping phase of the JCA involves a PICO survey sent to all 27 EU countries, with the results consolidated by an assessor and co-assessor to form the scope for the JCA [7]. This consolidation aims to address the diverse informational requirements of member states while minimising the number of PICO parameters to ensure a focused and efficient assessment process.
Time will tell whether the JCA and use of the PICO framework will offer real opportunities for more efficient and harmonised health technology assessments across the EU, ultimately improving patient access to innovative treatments across Europe.
We have to hope!
Bibliography
- Gallinger P. Overlaps and differences in the PICO criteria between the different EU countries. 2022 September 2024]; Available from: https://www.ispor.org/docs/default-source/euro2022/2022-10-21ispor-poster-eu-hta-picov2-0-pdf.pdf?sfvrsn=8d04c843_0.
- EU Commission, The EU regulation on health technology assessment: what’s in it and why it matters?”. 2023.
- O’Donnell, R. From PICO anxiety to PICO strategy: planning for EU HTA success. 2024 September 2024]; Available from: https://www.amerisourcebergen.com/manufacturer-solutions/global-market-access-international-consulting/eu-jca/resources.
- Schuster, V., EU HTA Regulation and Joint Clinical Assessment-Threat or Opportunity? J Mark Access Health Policy, 2024. 12(2): p. 100-104.
- Marksmann Healthcare. The Role of PICOS Framework in EuNetHTA’s Joint Clinical
Assessment. 2024 September 2024]; Available from: https://marksmanhealthcare.com/2024/05/29/the-role-of-picos-framework-in-eunethtas-joint-clinical-assessment/.
- Caroline Delaitre-Bonnin. Navigating the Challenges and Opportunities of the PICO Framework in the New EU HTA Regulation. 2024 September 2024]; Available from: https://www.ppd.com/blog/navigating-challenges-opportunities-pico-framework-new-eu-hta-regulation/.
- Aitken, D., The EU Joint Clinical Assessment: A harmonised approach to clinical assessments across the European Union. 2023.
