A new “fast-track” reimbursement process for innovative devices and innovative surgical procedures !
Last week the French HAS published on its website a new reimbursement guide related to the "Forfait innovation".
Concretely, this new reimbursement process is dedicated to innovative devices (and to innovative surgical/medical procedures) which already obtained the CE mark but for which the clinical data are not robust enough to support a "standard" reimbursement dossier.
Under specific conditions to be fulfilled (for instance, the HAS will determine whether or not the device is "innovative") a specific dossier, that would be assessed by the HAS under a 45 days delay, can be submitted by manufacturers (or by professional physician associations for surgical procedures).
Under the light of this dossier, the HAS will decide whether or not the device can be temporarily reimbursed. Then the French Ministry of Health will make the final decision in which the temporary reimbursement tariff as well as the number of patients to be treated and the length of the temporary reimbursement will be indicated. This final decision should be published 120 days after the initial submission (a shorter delay than the 180 days delay usually seen for "standard" reimbursement dossiers)
It is more than important to note that when applying for that process, the applicant will mandatory be committed to presenting a concrete project of clinical trial or medico-economic study (with for instance a description of the budget which will be dedicated to the study), that will be conducted in order to produce the requested complementary data.
Dossiers for such innovative devices/procedures can be submitted as of August 17th , 2015.
Don't hesitate to contact me for any further information about this new process.