Recommendations about add-on reimbursement for medical devices in France in January 2023

02

Feb 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). 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).

The latest related news

06

Jun 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 May 2023. Twenty-one 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, endocrine, ENT, gastrointestinal, and orthopedic devices, as well as medical aids.

Read more

01

Jun 2023

On May 23, 2023, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic setting the tariffs for the medical telemonitoring activities covered by social health insurance in the context of the new framework. The tariffs will differ whether they bring an organizational or clinical (improvement in quality of life, morbidity, or mortality) benefit.

Read more

30

May 2023

On April 5, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) announced the selection of thirty-five applications for Innovation Funding of healthcare research projects were accepted. A total of 231 applications were received in response to the funding announcement of June 27, 2022 (changed on September 20, 2022), and thirty-five of them were accepted.

Read more

29

May 2023

On May 17, 2023, the Ministry of Health and Prevention published the 2023-2027 Digital Health Roadmap. The new roadmap specifies the priorities and the projects to be carried out by 2027. One of the key objectives is to support the implementation and extension of telemonitoring to more chronic pathologies.

Read more

26

May 2023

In late May 2023, the Norwegian Directorate of e-Health released an updated version of the Norwegian Laboratory code (NLK) system to be implemented no later than July 1, 2023. A total of 142 new codes were added, 33 codes were terminated, and 122 codes were amended.

Read more