The innovation package is a temporary financing scheme for a technology, conditional on the completion of a study that must provide clinical or medico-economic data proving its effectiveness.

• It enables a manufacturer to obtain financing for its technology in order to promote the implementation of the pivotal study that will establish its usefulness.
• It combines the early availability of a healthcare technology to patients with the collection of the clinical or medico-economic data needed to demonstrate its value with a view to its long-term financial coverage.

• Temporary, derogatory coverage of the technology and the care associated with its use: for study patients and for an additional cohort in order to avoid a break in access up to standard coverage;
• The cost of the clinical study to be borne by the sponsor.

The lump sum allocated is paid to the facility for each patient included in the study. It takes into account not only the technology but also the associated care costs.

Its amount is defined for each eligible technology after analysis of the projected budget drawn up by the applicant according to the model defined by the ministry. Depending on the technology, partial or total coverage is available.
For more information, visit site de la DGOS.

• A distributor, a manufacturer of innovative healthcare products (medical device, in vivo diagnostic medical device);
• A national professional council (CNP) in the context of a professional act;
• In association, where applicable, with a company providing a service or with a healthcare establishment.

You must have already built the study protocol that will enable you to collect the data needed for standard care. This protocol is part of the dossier to be submitted.

The innovative technologies concerned are those which, at the time of filing, have data establishing that they are likely to bring a significant benefit to health or to reduce healthcare expenditure, but which are not sufficient to claim reimbursement by the community according to the rules of ordinary law.

In short, the eligibility of a request for derogatory reimbursement is assessed by the HAS with regard to three cumulative criteria:

• the type of technology concerned with regard to the categories of healthcare technologies eligible for the innovation package, i.e. medical devices (DM), in vitro diagnostic medical devices (DM-DIV), professional acts;
• the innovative nature of the technology (4 conditions defined in article R.165-63 du code de la sécurité sociale);
• the relevance of the clinical or medico-economic study proposed by the applicant (conditions defined in article R.165-63 du code de la sécurité sociale).