With the creation of the fast-track solution for digital health (PECA) and the permanent pathway for remote monitoring (TLS), France has also clarified that Digital solutions with a therapeutic benefit should follow the process for LPPR registration.
This allows for a very broad scope of digital solutions.
The LPPR process requires that the company to submit a dossier to demonstrate the value of the product. For medical devices with a de novo application (brand specific), the evidence requirements have been high compared to other countries. Even though randomized studies frequently are requested, it is not a default. The evidence should be appropriate for the decision question at hand. If it is possible to establish an important improvement without randomized studies, this may be accepted.
For product where the required evidence is not yet in place and there is sufficient evidence to suggest a meaningful potential improvement, the new FastTrack solution (PECA) can provide temporary reimbursement for up to 12 months.
Combined with the reimbursement pathway for remote monitoring (TLS), France offers the most comprehensive reimbursement pathway for digital health in Europe.
Want to understand more:
- Don’t miss the upcoming webinar on January 25.
- Other blogposts about digital health solutions in France.
- If you need help in France, don’t hesitate to reach out to our partner, Meditech Access