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.


Companies are not going to be represented anymore at Transparency Commission and CNEDiMTS meetings…

This is a surprising decision that has been published last week at the French Journal Officiel.
Until now the TC was composed of 20 members with possibility to vote and 8 members (amongst which the representative of the French pharma companies association – the LEEM) with only a consultative role. Now the commission will be made of 21 voting members, including a representative of patients' association and the consultative members will only be 7, as the LEEM representative will now be excluded from the commission.

The situation is exactly the same with the CNEDiMTS (the commission in charge of reimbursement decisions for devices) as the representatives of the devices manufacturers and of the homecare providers associations are also going to be excluded from the commission.

According to the LEEM, this decision is an « inappropriate » one.

It is indeed surprising to see that, even if they hadn't any possibility to vote, companies associations representatives are now going to be purely excluded from reimbursement discussions! Maybe the message the HAS would like to send to the public opinion is that the reimbursement discussions are now going to be totally independent and absolutely not influenced by companies...

That wouldn't be in fact a very positive message and it might, in the end, lead to a certain mistrust of the French population against healthcare companies...

To be followed...


France : a new guide for the Medical Devices reimbursement dossier

This new version of the guide is available on the HAS website. The main modification when compared to the former version of the guide is that now, it is possible for manufacturers to submit a « light » (instead of a "complete") version of the reimbursement dossier in some specific situations. The situations where such a "light" dossier can be submitted are : when the device is to be registered on the basis of technical specifications described in the reimbursement list (LPPR), when the dossier is related to the registration of new references of an already registered device, when the dossier is related to an incremental evolution of an already registered device or when the dossier is related to a renewal of registration.
Of course each of these situations are conditioned by specifications that have to be fulfilled in order to consider the submission of such a "light" dossier.

Do not hesitate to contact me for any further precision about this new process.


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