It can concern medical devices (MD), in-vitro diagnostic medical device (IVDMD) or an innovative act defined by the article R. 165-63 of the code of the social security.
Payment request concerning an innovative MD or act, are examined by the high health authority which published in April 2015 a document relating to the innovation refund assessment process.
What changes :
To benefit from the refund assessment process, the MD or innovative act must demonstrate that it is technologically interesting and reasonably feasible.
Two ways are possible :
- A comparative clinical study to demonstrate the clinical benefit of the new technology to the patient.
- A cost minimization study after clinical demonstration of equivalence between the new technology and the other products already marketed.
The decree n° 2015-179 of the 16th of February 2015 relating to the applicable process and which modifies the article L. 165-1-1 of the code of the social security, details :
The eligibility conditions of the products or acts concerned
The request conditions and their assessment.
The health insurance payback’s condition relating to innovative products or acts.
The decree’s purpose is to implement the Social Security Financing Act of 2015 which makes easier the derogatory payment request.
The derogatory refund request can be submitted if the manufacturer :
- Justifies compliance with the eligibility criteria (technological interest and feasibility)
- Establishes a complete dossier for the technology evaluation
- Establishes a comprehensive draft study protocol
- Provides the estimated cost of the new technology
- Engages himself to communicate the study results and to make data access possible easily.
The request must be sent to this address :
Haute Autorité de santé,
Secrétariat DEMESP – forfait innovation,
Impasse de la Cokerie,
93218 Saint-Denis La Plaine Cedex
Or e-mailing to : secretariat-innovation(arobase)has-sante(point)fr
3 documents are available on the high authority website to help manufacturers in the request process :
- Guidance « Dépôt Dossier Demandeur Forfait Innovation »: relating to the request process.
- Trame type dossier Forfait Innovation: To build the innovation refund file.
- Bordereau de dépôt dossier innovation: To prove that the innovation refund file has been sent to the high health authority.