Recommendations about add-on reimbursement for medical devices in France in October 2021

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 October 2021. More than 20 recommendations were published in relation to the registration, modification of registration conditions, renewal of registration of devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, peripheral vascular, neurovascular and neuromodulation, and other groups of 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.

Decisions for cardiovascular devices:

• Mechanical circulatory assistance device Heartware by Medtronic (application for renewal of registration; sufficient actual benefit; level I of clinical added value);
• Mechanical circulatory assistance device Excor by Berlin Heart GmbH (application for modification and renewal of registration; sufficient actual benefit; level I or level V of clinical added value depending on the indications);
• Mechanical circulatory assistance device Heartmate 3 by Abbott (application for modification and renewal of registration; sufficient actual benefit; level I of clinical added value);
• Mechanical circulatory assistance device Heartmate II V2 by Abbott (application for renewal of registration; sufficient actual benefit; level I of clinical added value).

Decisions for peripheral vascular devices:

• Self-expanding carotid endoprosthesis RX ACCULINK by Abbott (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Abdominal aortic endoprosthesis TREO by Vascutek (application for registration; sufficient actual benefit; level V of clinical added value);
• Paclitaxel-eluting balloon In.Pact Admiral by Medtronic (application for modification of registration conditions; sufficient actual benefit; level III of clinical added value).

Decisions for neuromodulation and neurovascular devices:

• Implantable non-rechargeable spinal cord stimulation system Vanta by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value);
• Directional electrodes and extensions for deep brain stimulation Sensight by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value);
• Non-rechargeable implantable system for spinal cord stimulation Precision Novi by Boston Scientific (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Non-rechargeable implantable spinal cord neurostimulation system Precision Novi (application for removal);
• Reperfusion catheters used in cerebral artery thromboaspiration systems Penumbra ACE 68 - Penumbra ACE 60, Penumbra Jet 7, Penumbra 3MAXC, Penumbra Jet D by Penumbra (applications for registration; sufficient actual benefit; level V of clinical added value).

Decisions related to different technology groups:

• Radiofrequency needle electrodes LEVEEN Lung by Boston Scientific (application for modification of registration conditions; sufficient actual benefit; level II and level IV of clinical added value depending on the indications);
• Urinary catheter Speedicath Compact Set by Coloplast Laboratories (application for renewal of registration; sufficient actual benefit; level IV of clinical added value);
• Protective coating for tibial prosthesis Aqualeg by Aqualeg SAS (application for renewal of registration; sufficient actual benefit; level V of clinical added value).

Decisions for medical aids:

• Solution for ophthalmic use ELIXYA by Laboratoire Chauvin (application for registration; sufficient actual benefit; level V of clinical added value);
• High absorption hydrocellular anatomical dressings Advazorb Sacral and Advazorb Heel by BRIGHTWAKE LTD t/a ADVANCIS MEDICAL (application for registration; sufficient actual benefit; level V of clinical added value);
• Anatomical hydrocellular dressings 3M TEGADERM SILICONE FOAM BORDER ANATOMIC FORMS by 3M France (application for registration; sufficient actual benefit; level V of clinical added value);
• Dual band venous compression system Coban 2 by 3M France (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
• Food for special medical purposes Dekas Plus Essential and Dekas Plus by Alveolus Biomedical BV (applications for registration; sufficient actual benefit; level V of clinical added value).

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). First EU issues of both newsletters are available for download free-of-charge.

Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).