France: Temporary reimbursement pending results from clinical trial
18 Jul 2023

France offers a pathway called PECT (The Prise en Charge Transitoire ) for temporary reimbursement off valuable and innovative medical devices and services pending completion of ongoing clinical trial.

The aim is to support the introduction of medical devices with a high value within the scope of the LPPR process (brand specific reimbursement).

Since the launch 2021, 6 products have been granted a positive evaluation. Four of these have been managed by our sister company Meditech Access!

The assessment by HAS is based on 7 criteria:

  1. Used in the treatment of a serious or rare disease or to compensate for a disability
  2. Not have a relevant comparator, meaning that they address a medical need that is not, or is poorly, covered.
  3. Be likely to bring a significant improvement in the patient's health or to compensate for a disability.
  4. Be likely to be innovative, i.e. have a novel character other than a simple technical development with regard to the healthcare technologies used in the claimed indication.
  5. Be likely, based on the results of clinical trials, to have clinically relevant efficacy and a significant effect with potential acceptable undesirable effects.
  6. Be the subject of studies currently in progress which will provide, within 12 months of the application, sufficient data for the CNEDiMTS to be able to give an opinion on the application for registration on the LPPR listing.
  7. Not be a digital medical device with a therapeutic purpose or used for remote medical monitoring.

The most frequent criteria leading to a negative decision (based on 4  rejected applications):

Successful PECT (all) applications:

Positive HAS opinion without publication in Official Journal:

  • PICSO, Intermittent coronary venous sinus occlusion system (MIRACOR) - 20 December 2022
  • FLOWTRIEVER SYSTEM composed of TRIEVER catheter and FLOWTRIEVER catheter, Aspiration/extraction system (INARI MEDICAL) - 20 December 2022
  • WISE CRT SYSTEM, Cardiac Resynchronisation System (EBR System) - 27 July 2022

PECT published in the Official Journal :

  • THE INSIDES SYSTEM, Chyme reinstillation system (THE INSIDES COMPANY) - 8 June 2023
  • SYMPLICITY SPYRAL, Renal denervation catheter (MEDTRONICS) - 14 December 2022
  • NEOVASC REDUCER SYSTEM, Coronary sinus reduction system (NEOVASC) - 7 mars 2022

Don’t miss this opportunity to have reimbursement 12 months before.