This is the third and last post of the Conditional Reimbursement series focusing on Key European Markets.
To accelerate the entry of promising medical technologies, the French authorities implemented the first Coverage with Evidence Development (CED) mechanism in 2007. Although the initial reactions were enthusiastic, over time the momentum turned into disappointment with several technologies being declined reimbursement in what was considered a long and unclear process.
In general, the medical industry felt that France was lagging behind other markets in terms of innovation. Several companies abandoned the CED process while others preferred not even to launch their medical products in France.
According to Prof. Jacques Belghiti, President of the National committee for the evaluation of medical devices and health technologies (CNEDiMTS), “the main issue was that the process definition was too general and too broad, with no defined timeline, no clear definition of what innovation means and no guidelines on how to conduct clinical or economic studies”.
While there were a couple of positive examples of truly innovative technologies approved in the process, including the implantable visual prosthetics Argus II from Second Sight, there was a consensus among French authorities on the need to review the whole process.
Welcome to the (new) Forfait Innovation
In June 2015 a new decree described the changes to the Forfait Innovation (national innovation funding), which aimed to remove the major hurdles in the way of effective evaluations. Although the goal of the Forfait Innovation remained unchanged, to provide temporary funding of promising and innovative medical technologies to accelerate their introduction in France, it brought a defined application process with a clear description of which technologies could be candidates for the program.
In the new process, medical device manufacturers can apply independently or in partnership with Physician’s Associations to request temporary funding to conduct a study to collect the required data needed to validate the benefits of the related medical technology. The procedure is explained in details at the French National Authority for Health (HAS) website.
According to the latest timelines, the authorities have up to 45 days to check the applications and decide on its admissibility to the process. When taking into consideration other periods associated with the confirmation of suitability and the budget assessment by the Ministry of Health, the final Forfait Innovation decision should come within 120 days of initial application.
From bottom to top
The clarity and approach of the recent redesign of the Forfait Innovation and HAS have generated significant optimism on how France will look into promising medical technologies from now on.
Not long ago France was perceived as a complex and closed market to medical innovations. Nowadays companies are revisiting their strategies based on the concrete improvements in the Forfait Innovation program.
During a seminar organized by the Strategic Council of Health Industries in France (CSIS) in April 2016 it was mentioned that “the establishment of the innovation package for medical devices and innovative actions, as well as new support arrangements for certain technologies, have brought the first responses to the challenges of access to innovation from the medical device industry.”
We at ValueConnected also approached medical companies and asked for their opinion about the new Forfait Innovation and have learned that the process brought increased transparency and opportunity for market access. Therefore, we expect a significant increase in the number of applications.
France is definitely back on the list of top opportunities for Market Access and Reimbursement activities, and we strongly recommend medical companies to consider the Forfait Innovation as an extremely valuable mechanism for the introduction of medical innovations.
Are you looking into France as a potential market for your new product? Contact us today at [email protected] and we will help you assessing if and how the Forfait Innovation can accelerate your market access and commercial results.