France

In September 2019, the French High Authority for Health (HAS) has released an assessment report regarding the evaluation of total or partial robotic-assisted nephrectomy, compared to open surgery and conventional laparoscopic surgery. Due to the lack of any prospective comparative studies reporting robust results with relevant judgment criteria and collected with appropriate follow-up time, HAS could not comment on the expected service or the expected service improvement of robot-assisted nephrectomy compared to open surgery or conventional laparoscopic surgery.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in July and August 2019 concern various types of devices, including orthopedic, cardiovascular, and blood glucose meters. A total of 29 decisions were made.

We have released the second part of the interview on the Market Access Insider channel on Youtube. The interview covered key stakeholders, procedure coding, principles of functioning of DRG system and add-on reimbursement for medical devices via LPPR List. Reimbursement pathways for devices, evidence requirements, pricing considerations, innovation funding (PHRC, PRME, forfeit innovation, Article 51, ETAPES program) were also discussed.

In late June 2019, the Committee on Evaluation and Public Health (CEESP) of the French High Authority for Health (HAS) validated a second, provisional version, updating the methodological guide for the evaluation of effectiveness at the HAS.

The French High Authority for Health (HAS) develops clinical guidelines and recommendations whose objective is to guarantee the quality and safety of care delivery within the French setting. In the second quarter of 2019, clinical guidelines/recommendations have been developed for 16 topics.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in June 2019 concern various types of devices, including orthopedic, cardiovascular and diabetes devices, and cochlear implants. A total of 32 decisions were made.

After having identified the eligibility conditions for teleconsultation and teleexpertise in 2018, the French High Authority for Health (HAS) published a series of documents in late June 2019, for the operational deployment of eHealth services. Each of the new modalities of practice is discussed: teleconsultation, teleexpertise, and teleimaging. Also, the HAS proposed an information document to be given to patients before a teleconsultation.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in May 2019 concern various types of devices, including orthopedic, cardiovascular and diabetes devices.

On the 24th of April 2019, the French Technical Agency for Hospital Information (ATIH) has released a technical note in connection with the 2019 DRG changes. Several key updates in relation to the financing of hospitalization benefits as a change of DRGs for fractional flow reserve, package to finance the rehabilitation and infusion costs of the pulmonary system and implementation of two innovative packages for PULSANTE and WISE CRT devices were outlined.

In France, there is a fast-track pathway, which provides reimbursement within the framework of the prospective medico-economic study, aiming at demonstrating benefits to patients or reduction of expenditure of health care system. On the 19th of April, the French National Authority for Health published two opinions regarding the inclusion of two devices into innovation package - eCLIPS: for treatment of cerebral aneurysm, Nuvaira™ Lung Denervation System for chronic obstructive pulmonary disease and asthma.

The report includes all published reimbursement decisions for IVD tests in 2018 in European countries with established frameworks for out-patient reimbursement laboratory tests (Belgium, France, Germany, Netherlands, Switzerland).

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in April 2019 concern orthopedic devices, coronary stents, ventricular assist devices, remote monitoring systems in cardiovascular field, cochlear implants, bronchial thermoplasty device.