Skip to main content

Early value dossiers for medical technologies

The essential tool to understand the value proposition for your product and position it well with reimbursement/HTA stakeholders

Learn more
See details

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.
See details

Recommendations about add-on reimbursement for medical devices in France in January 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 January 2023. Twenty-four 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 and peripheral vascular, neurovascular, and orthopedic devices, in-vitro diagnostics, 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.

Recommendations for cardiovascular and peripheral vascular devices:

  • Coronary stent coated with sirolimus VIVO ISAR by TRANSLUMINA (application for registration; sufficient actual benefit; level V of clinical added value compared to other active coronary stents listed on the LPPR and already covered in the selected indications);
  • Fenestrated aortic stent graft ANACONDA CUSTOM FENESTRATED by VASCUTEK (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value compared to ZENITH FENESTRATED).

Recommendations for orthopedic devices:

  • Magnetic intramedullary lengthening nail PRECICE IMLL by NuVasive (application for registration; sufficient actual benefit; level II of clinical added value compared to external fixators).

Recommendations for neurovascular devices:

  • Self-expanding intracranial stent with controlled release p48 MW by PHENOX (application for registration; sufficient actual benefit; level V of clinical added value compared to the flow diverter of the previous range, p64).

Also, recommendations were made in relation to in-vitro diagnostics 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.