The Innovation Package is a temporary funding mechanism for a technology contingent on carrying out a study to provide clinical or cost-effectiveness data to prove its efficacy.

• It enables a manufacturer to obtain funding for its technology in order to support the implementation of the pivotal study that will establish its usefulness.
• It combines the early availability of a health technology to patients and the collection of the clinical or cost-effectiveness data necessary to demonstrate its value with a view to its long-term financial coverage.

Is this scheme suitable for my project?

Intended for technologies with high clinical or economic stakes, applying for the Innovation Package is a preferred way to access the market

• A technology that is included in the innovation package is released onto the French market via the enrollment of patients in the study, with the possibility of additional patients being taken on between the end of enrollment and standard care in order to ensure continuity of the technology between the clinical study and standard care.

The innovation package is granted by the Ministers of Health and Social Security, who examine the budgetary aspects, after receiving the opinion of the HAS, whose role is to establish the eligibility of the request in terms of:

• the innovative nature of the technology
• and the relevance of the proposed study.

• Prise en charge dérogatoire et temporaire de la technologie et des soins associés à son utilisation : pour les patients de l’étude et pour une cohorte additionnelle afin d’éviter une rupture d’accès jusqu’à la prise en charge de droit commun ;
• Coût de l’étude clinique à la charge du promoteur.

Permanent access. The company submits its application when it is ready to do so, based on the maturity of its technology, the first available data, and when the protocol of the pivotal study behind its application has been established.

Response times are limited by regulatory deadlines for each stage. Those deadlines are now capped at 75 days for the two parties responsible for examining the files, the HAS and the Ministry, which is responsible for evaluating the provisional budget for the study and giving an opinion on the overall cost of the planned treatment.

• A distributor, a manufacturer of innovative health products (medical device, in vivo diagnostic medical device)
• A National Professional Council (CMP) in a professional capacity.
• In association, where appropriate, with a company providing a service or with a healthcare facility

Vous devez avoir déjà construit le protocole de l’étude qui permettra de collecter les données nécessaires à la prise en charge de droit commun. Ce protocole fait partie du dossier à déposer.

Applications for reimbursement must be sent simultaneously to the DGOS (Ministry of Health) and to the HAS.

A guide describing the application and the practicalities of filing is available to help you apply.