With the Joint Clinical Assessment (JCA) now underway for oncology products and advanced therapy medicinal products (ATMPs), stakeholders are keenly observing how this process will impact national health technology assessments (HTAs). While Germany has already published updated guidance on its HTA framework incorporating JCA findings1-2, France has provided limited insights into how it will integrate JCA outcomes into its national process. However, in late 2024, the French National Health Authority, HAS (Haute Autorité de Santé), hosted a webinar shedding light on these anticipated changes3.
What Has Changed in France?
Minimal Structural Changes
The core HTA process in France remains largely unchanged. Manufacturers must still submit a reimbursement request to HAS, and the evaluation criteria will continue to follow the doctrines of the Commission de la Transparence (TC) and the Commission d’évaluation économique et de santé publique (CEESP). HAS retains the authority to make the final reimbursement decision, ensuring national specificity in the assessment process.
Availability of the JCA Outcome
One notable update is that HAS assessors will now have access to the JCA outcome when evaluating a medicinal product. However, this does not replace the national assessment but serves as an additional reference point.
Changes in Early Scientific Advice
Introduction of Joint Scientific Consultation (JSC)
The availability of early scientific advice in France has evolved with the prioritization of JSC at the European Union (EU) level. Medicines that have undergone or plan to undergo JSC will not be eligible for early scientific advice at the national level. Despite this shift, national early scientific advice remains available but is now exclusively provided in written format, with meetings no longer an option. Submissions for early scientific advice will continue to be accepted quarterly.
Impact on Early Access Programs
The implications of the JCA on France’s early access programs depend on the timing of the program:
- Pre-Marketing Authorization (pré-AMM): Data generated from early access must be included in the national reimbursement dossier.
- Post-Marketing Authorization (post-AMM): Data previously submitted in the EU evaluation (Marketing Authorization Application (MAA) and JCA) cannot be reused in the national reimbursement dossier. However, supplementary data from the early access program that was not included at the EU level may still be incorporated into the national application.
Data Submission and HTA Report Structure
A key principle of the JCA implementation is that any data submitted at the EU level cannot be duplicated or requested at the national level for HTA purposes. However, if new data becomes available after the JCA publication, it should be included in the national reimbursement dossier. Additionally, HAS retains the right to request supplementary data from the manufacturer.
While the overall structure of the HTA report remains the same, new sections will be added to account for the integration of JCA outcomes.
Looking Ahead
At this stage, the JCA’s implementation has had minimal impact on the core structure of France’s HTA process. However, its true influence on pricing, reimbursement, and market access (PRMA) will only become clear once real-world cases emerge.
P4A is closely monitoring developments in JCAs and their impact on PRMA in France, ensuring you stay ahead with the latest insights. Get in touch to explore how we can help you navigate JCAs, subsequent HTA submissions, and optimize your PRMA strategies.
Written by Johann Sanseau, Senior Analyst
