Innovation Package
Type of financing
Experimentation
Beneficiary
Medical device manufacturer
Context of use
Facility
Objective
This package has multiple benefits:
- patients get to enjoy a promising technology
- public authorities get to ensure that the implementation of a clinical or cost-effectiveness study will make it possible to confirm the benefit to patients or effectiveness in terms of reducing the costs of care.
- the company gets financial support for the technology as soon as the clinical study is set up to establish the proof of its efficacy.
Issue
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.
Description
Type of financing
- Temporary special reimbursement of the technology and the care associated with its use: For the patients in the study and for an additional cohort in order to avoid a break in access to standard care.
- Cost of the clinical study to be borne by the sponsor
Amount of funding
The allocated fee is paid to the institution for each patient included in the study. It takes into account the technology as well as the associated care costs.
Its amount is defined for each eligible technology after analysis of the provisional budget drawn up by the applicant according to the model defined by the Ministry. Depending on the technology, the cost can be partial or total.
For more information, please visit the DGSO website.
Schedule/frequency
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.
Type of project leader
- 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
Who is it intended for?
Project maturity
You must have already created the study protocol that will allow the collection of the data necessary for standard care. This protocol is part of the application to be submitted.
Conditions to be met
Eligible innovative technologies are those for which, at the time the application is submitted, there is evidence that they are likely to have a significant benefit for health or to reduce health care costs, but which are not sufficient to be covered by the public purse under standard reimbursement rules.
In short, the eligibility of a request for this special reimbursement is assessed by the HAS with regard to three criteria taken together:
- the type of technology involved with regard to the categories of health technologies eligible for the innovation package, i.e. medical devices (MDs), in vitro diagnostic medical devices (IVD-MDs), professional duties.
- the innovative nature of the technology (4 conditions defined in article R.165-63 of the Social Security Code);
- the relevance of the clinical or cost-effectiveness study proposed by the applicant (conditions defined in article R.165-63 of the Social Security Code)
How to apply
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.
Frequently Asked Questions
Find out more
For more information, see:
The DGOS also offers meetings, before the application is submitted, to discuss the general framework, the functioning of innovation support mechanisms, and the interaction with other financing tools
The HAS offers appointments (free and confidential) to manufacturers who wish to have one before they file the application: