France launches fast-track process for reimbursement of digital solutions
08 Dec 2022

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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