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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 May 2024

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 May 2024. Seven 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 neurovascular, neuromodulation, endocrine, ophthalmology, and orthopedic 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:

  • Self-expanding intracranial stent with controlled release DERIVO 2 by Acandis GmbH (application for registration; sufficient actual benefit; level V of clinical added value compared to the flow-diverters of the previous DERIVO and DERIVO MINI ranges);
  • Implantable and rechargeable spinal cord stimulation system INCEPTIV by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value compared to INTELLIS, a previous-generation implantable and rechargeable spinal cord stimulation system);
  • Dual mobility acetabulum consisting of a cement-free cup, a metal alloy insert, and a highly cross-linked polyethylene insert enriched with vitamin E, TRINITY DUAL MOBILITY SYSTEM, by Corin (application for registration; sufficient actual benefit; level V of clinical added value compared to single mobility cups with a conventional polyethylene insert).

Recommendations were also made regarding endocrine, ophthalmology devices, and 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 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.