Early meeting with HAS: companies in the MedTech sector have every reason to consider an early meeting with the French National Authority for Health (Haute Autorité de Santé – HAS) at the initial stages of developing their medical devices. Although often underutilized, this process can play a crucial role in the success of clinical evaluation and reimbursement access.
What Is an Early Meeting with HAS?
It is a confidential and free exchange between a health industry company and HAS experts. This meeting allows the company to receive recommendations on the methodology of its study protocol, the relevance of selected clinical comparators, the primary endpoints to prioritize, and even the health economic evaluation strategy.
These discussions can concern:
- The inclusion of a device on the List of Reimbursable Products and Services (LPPR);
- Medical telemonitoring activities (LATM);
- Or access to specific programs like the innovation package or the PECAN program (early digital health coverage).
📚 Reference: Haute Autorité de Santé (HAS), Early Dialogues for Medical Devices [SESAME Practical Guide – https://urlz.fr/rbZb]; Article L161-37 of the French Social Security Code.
Why Request an Early Meeting?
Anticipating the expectations of health authorities is a proactive approach that can help avoid costly strategic adjustments to clinical development.
An early meeting will help clarify methodological requirements, better target expected data (clinical benefit, organizational impact, quality of life), strengthen the credibility of the submission with CNEDiMTS, and improve efficiency in preparing the reimbursement application file.
📚 Reference: Fabre C. and Bagot d’Arc M., Requesting an Early Meeting with HAS: A Strategic Asset for Manufacturers, AFCROs-DM, 2024.
When and How to Apply?
The request must be submitted via the HAS SESAME platform. It is eligible as soon as a clinical or health-economic study synopsis is available.
The required documentation includes: the application form, a product description and questions to be addressed to HAS, one or more protocols (or alternatively, a synopsis), any available publications or study results, and an outline of the intended health-economic strategy.
📚 Reference: HAS – SESAME Medical Device Guide, Annexes 1 and 2; AFCROs-DM, 2024.
What Experts Say
Recommendations provided during these meetings do not constitute formal approval of the project, but they offer valuable guidance for refining clinical strategy. They are based on the expertise of HAS methodologists and clinicians, as well as international standards.
📚 Reference: National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), HAS.
Early dialogues can also be conducted at the European level via EUnetHTA (European Network for Health Technology Assessment), particularly for high-impact devices (Class IIb and III, connected devices, etc.).
📚 Reference: EUnetHTA, Early Dialogues for Medical Devices (EDMD) – Joint Action 3, https://www.eunethta.eu/
In Conclusion
An early meeting with HAS is a key step to consider in planning clinical development. It represents a long-term strategic investment for any medical device manufacturer seeking to optimize their chances of market access and reimbursement.
