Recommendations about inclusion of two devices into French innovation package in April 2019

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. It is determined in the article L.165-1-1 of the Social Security Code and driven by the manufacturer. The manufacturer includes a protocol of the study in the submission dossier for authorities.

On the 19th of April, the French National Authority for Health (HAS) published two opinions regarding the inclusion of two devices into innovation package in France:

• eCLIPS: a medical device for treatment of cerebral aneurysm
• Nuvaira™ Lung Denervation System: a catheter-based system used to address chronic obstructive pulmonary disease (COPD) and asthma

Decisions should be made jointly by Ministry of Health and HAS. Innovation funding is granted on the basis of publication in the Official French Gazette (Journal Officiel de la République Française).

See the full information in French here.

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