JCA: what we do and don’t know less than 1 month from launch
The Joint Clinical Assessment (JCA) will commence on 12 January 2025, but how prepared are countries and manufacturing companies for the new process? It is estimated that 25 medicinal products will undergo JCA next year alone [1] however, some aspects of the process remain unclear less than a month ahead of launch.
Limited early advice may impact JCA success
Joint scientific consultation (JSC) enables companies to obtain early advice on evidence needs for subsequent JCA [2]. The latest guidance indicates that next year, only 5–7 JSCs for medicinal products and 1–3 for medical devices are expected [1], which is fewer than half of the planned JCAs for 2025 [1]. This raises questions about whether the provision for JSC is adequate, as advice will not be available to all companies and the JCA will need to prioritize which products/devices will receive JSC [3]. While there is the aim to increase JSC capacity in the coming year [1], early advice will be extremely limited in the first year of the JCA, and it is currently unclear what impact this will have on products for which advice cannot be received.
Scoping process clarified, but workload still unclear
New guidance confirms that the relevant population, intervention, comparator(s) and outcomes (PICOs) will be defined during the scoping phase, which includes a survey to collect information from the 27 EU member states [4]. PICOs will be generated based on the situation at the time of the survey, with member states asked to limit their requests to what is necessary for national decision making. The population is based on the claimed therapeutic indication, and subpopulations can be defined to address different questions (eg if different comparators are available for subpopulations). Comparator treatments may or may not be licensed for the indication in the EU, meaning that off-label treatments can be requested as comparators. Companies will have the opportunity to request a scope-explanation meeting, which will only clarify (not modify) the scope. These meetings will be held on fixed dates, with a maximum duration of 60 minutes. The company will need to provide justification and rationale if any PICOs are unanswered. The appropriateness of the rationale will be reviewed by the assessors, with overall acceptability decided at national level. While additional detail on process and what is/isn’t accepted is welcome, companies still do not know how many PICOs they can expect, which will have a significant impact on their resource needs.
Dossier check is an additional step in an already busy process
We now know that the Commission will consult with assessors and confirm whether the dossier meets requirements within 15 working days of submission [5]; however, there is a lack of information on how this completeness check will be conducted. Furthermore, timelines for the company to submit any requested information (data, analyses and/or other evidence) are short, with a response required within 15 days [5]. Companies will need to ensure that adequate resources are available to respond to requests. To minimize the risk of potential issues with the dossier, companies may seek early advice through JSC. However, as discussed above, the provision for JSC is limited and may not be available to all companies.
领英推荐
No clock stops, even for major changes
Despite changes to the expected duration of some elements of the JCA process in guidance published in November 2024 [5], there is no change to the overall length of the process (406 days). Companies will have 100 days for dossier preparation after confirmation of the final scope, and there will be no clock stops, even in the event of changes to the indication. Assessors will review whether any changes to the indication affect the assessment scope, and the JCA subgroup will decide whether the JCA continues. If a new assessment scope is prepared, the company will be requested to submit an updated dossier within 30 days [6]. Therefore, companies will need to liaise closely with their regulatory affairs department to anticipate whether there may be indication changes and the potential impact. With only 100 days for companies to prepare the dossier and several pressure points during the JCA process, early and thorough preparation is essential.
Contact us to discuss how our market access specialists can support you with JCA preparation.
Read our blog post on opportunities for the use of AI in JCA here and follow the AMICULUM LinkedIn page for regular updates.
References