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Evidence gap analysis

Strategic analysis of the sufficiency of evidence to obtain reimbursement and HTA approval in Europe and recommendations about evidence generation

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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 August 2024

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2024. Five recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, peripheral vascular, neuromodulation, orthopedic, and spine devices.

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:

  • Implantable heart monitor LUX-DX by Boston Scientific (application for registration; insufficient actual benefit);
  • Iliac bifurcation vascular endoprosthesis E-LIAC by CryoLife (application for registration; sufficient actual benefit; level V of clinical added value compared to other iliac bifurcation stents listed on the LPPR);
  • Rechargeable dual channel deep brain stimulation system PERCEPT RC by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value compared to the ACTIVA RC dual channel rechargeable system).

Recommendations were also made regarding spine and orthopedic devices.

See the details in French here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.