Coverage with Evidence Development in France

France has a well-developed system to provide solutions for Coverage with Evidence (CED)/Managed introduction.

The first solution which has been set up in 2010 with the Article 165.1.1 is the “Forfait Innovation”, which third version will be released soon. The Article 165.1.1 is a conditional reimbursement with a clinical study, which aims at improving the medical devices’ clinical evidence, until its final reimbursement either in a DRG (T2A), Act classification (CCAM) or on the reimbursement list (LPPR).

More recently, Organizational innovation and e-health / connected health has been incorporated into a new experimentation, with the 2018 regulation (Article 51).

Michel, who has already brought to the market 3 “Forfait Innovation” and is currently working on several projects under the new Article 51 regulation, will develop these new CED solutions in the webinar.

Speaker

Michel Verhasselt CEO and founder of Meditech Access, which he founded 2012. He holds a master's degree in business administration and health economics from the Catholic University of Lille. He has 25 years experience in the field of health economics, HTA, DRG coding and reimbursement, especially for the medical device industry, make him an expert. He conducts public affairs and market access activities for France, Belgium and Switzerland. Michel has successfully established CED arrangements for several companies.