France has a long history of testing different programs to include digital health in the healthcare.
Inspired by the German DiGA solution, they are in the process to introduce a pathway for conditional reimbursement (PECA) while the missing evidence is generated. The plan is that this will be available in2023.
The scope of this is either:
- Remote monitoring solutions where there is no existing ‘generic line’ for the specific indication.
- Any solution involving the patient that can show a therapeutic benefit (DTx)
The criteria to be eligible for this pathway is:
- Potential of a meaningful clinical benefit.
- Ability to develop to close the evidence gap during the period of conditional reimbursement.
The reimbursement will cover a 12-months period and is conditioned by a sustainable reimbursement dossier submission within 6 months of the start of the PECA for digital therapeutic devices (DTx) and within 9 months for remote monitoring solutions.
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