France

22

Feb 2021

On February 5, 2021, the French Ministry of Solidarity and Health published the results of the pre-selection of applications submitted in 2020 for participating in the coverage with evidence development programs. Regarding the Health Economic Research Program (PRME), 20 applications regarding various medical technologies were selected, including high throughput genome sequencing analysis in pediatric diagnostics, robotic thoracic surgery during lobectomy or segmentectomy in lung cancer, robotic gastric bypass for morbid obesity, mechanical thrombectomy techniques in the treatment of ischemic stroke, CAR-T cell therapy in the treatment of diffuse large B-cell lymphomas, creation of arteriovenous accesses for hemodialysis - the surgical technique and the endovascular technique, etc. Regarding the national Hospital Program of Clinical Research (PHRC-N), 205 applications were pre-selected. Read more

03

Feb 2021

On January 11, 2021, a new version of the Nomenclature of Medical Biology Acts (NABM068) was released. One new code for detecting the genome of the influenza A and B viruses by RT-PCR was introduced. Read more

29

Jan 2021

The French Ministry of Solidarity and Health constantly announces the new experiments initiated under Article 51 of the Social Security Financing Act. These experiments are focused on various topics concerning medical technologies and organization of care. Eleven new experiments were initiated in the fourth quarter of 2020. The experiments concern areas of diabetes, nutrition, home monitoring of patients on oral cancer drugs, bariatric surgery, and others. More details about each of the experiments initiated in the fourth quarter of 2020 is provided in this article. Read more

26

Jan 2021

On January 18, 2021, a new version of the List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in November-December 2020, as well as other modifications made during this period. Newly-introduced devices belong to the cardiovascular (coronary stents), orthopedic, neuromodulation (deep brain stimulation), peripheral vascular (stent-grafts to treat aortic abdominal aneurysm), and other areas of care. Read more

22

Jan 2021

On December 30, 2020, the French National Authority for Health (HAS) published a report "Economic evaluation of telemonitoring to inform public decision-making", based on the systematic literature review. According to the results of the review, telemonitoring can be considered as a way to improve the organization of care and reduce care costs. Read more

18

Jan 2021

On December 31, 2020, the French National Authority for Health (HAS) published a methodological guide clarifying aspects related to the organizational impact of health technologies under the evaluation. As the organizational impact can be documented when submitting an evaluation file for a drug, medical device, or a procedure, the guide aims to define the types of organizational impact and to propose criteria to measure these effects. Read more

08

Jan 2021

On December 16, 2020, the Ministry of Solidarity and Health issued a few Orders on the registration of certain endoprostheses by Cook Medical in the List of Reimbursable Products and Services (LPPR) for add-on reimbursement. Conditions of reimbursement for vascular endoprostheses were specified. Read more

09

Dec 2020

On November 27, 2020, the National Committee for the evaluation of medical devices and health technologies (CNEDiMTS) at the French National Authority for Health (HAS) released a recommendation about the registration of flash self-monitoring glucose system FREESTYLE LIBRE 2 in the LPPR list. Read more

16

Nov 2020

In November 2020, the new intra-DRG was published on the website of the French Ministry of Solidarity and Health. A new chapter was added for urogenital implants - “Implantable devices for the treatment of female stress urinary incontinence.” Read more

11

Nov 2020

On October 16, 2020, the Order of the Ministry of Solidarity and Health in relation to the new experiment on reinforced support for the elderly people (DRAD) was published in the Official Journal of the French Republic. The experiment offers a solution to elderly people with loss of autonomy who wish to stay at home, for whom "classic" support from home services is not more sufficient. Read more

30

Oct 2020

On October 14, 2020, the French National Authority for Health (HAS) announced the ongoing update of the submission file guides to support companies who requested reimbursement for medical devices with a system of machine learning (artificial intelligence). Read more

26

Oct 2020

On October 15, 2020, the French National Authority for Health (HAS) published the report “New techniques of bariatric surgery: identification, the status of advancement and opportunities to evaluate,” in which they outlined three techniques currently diffusing in France (SADI-Sleeve, Endosleeve, and Sleeve Gastrectomy with Transit Bipartition). All three methods are the subject of ongoing clinical studies, and the evaluation will be initiated at the end of these studies. Read more