France

On February 4, 2021, the guide on dossier submission to the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) for the inclusion of the device in the List of Reimbursable Products and Services (LPPR) was published in English. Furthermore, the guide was recently updated with the information dedicated to the technologies falling within the scope of artificial intelligence.

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.

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.

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.

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.

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.

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.

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.

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.

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.”

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.

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).