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Early value dossiers for medical technologies

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Recommendations about add-on reimbursement for medical devices in France in April 2023

11 May 2023

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in April 2023. Twenty-three recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, orthopedic, nephrology and urology, and surgical devices, as well as medical aids.

The first step in the assessment is the clinical (actual) benefit (SA), which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value (ASA) is graded on a scale from I (major) to V (absent) for claimed indications, which supports the pricing decisions.

Some examples of the recommendations are provided below.

  • Transcatheter mitral valve repair system Edwards PASCAL Precision (mitral) by Edwards Lifesciences (application for registration; sufficient actual benefit; level V of clinical added value compared to other edge-to-edge mitral repair clips listed on the LPPR in the selected indications);
  • Bone substitute derived from derivatives of bovine origin Geistlich Bio-Oss Pen by Geistlich Pharma (application for registration; sufficient actual benefit; level V of clinical added value compared to synthetic bone substitutes and bone substitutes containing derivatives of animal origin already listed on the LPPR);
  • Modular system for massive pelvic reconstruction Mutars Lumic by Implantcast (application for modification and renewal of registration; sufficient actual benefit; level IV of clinical added value compared to custom-made pelvic reconstruction prostheses);
  • Copolymer ureteral implant Deflux by Kebomed (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to other implants for the treatment of vesicorenal reflux registered on the LPPR).

Also, recommendations were made in relation to other cardiovascular and orthopedic devices, surgical devices, and a number of medical aids.

See the details in French here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Contact us to get a free, three-month, no-obligation trial.