Early Access Programs in France (ex ATU)
#PreApprovalPrograms #CompassionateUse #EarlyAccess
Cevidra offers services for Early Access Programs in France for your medicinal products in France before the commercial launch.
What is an early access program?
Early access programs (previously named Cohort ATU) is a scheme that allows patients who have reached a therapeutic impasse to benefit, on an exceptional and temporary basis, from certain medicinal products that are not authorised in a specific therapeutic indication. It is a Temporary Authorization for Use.
The early access authorisation (also called expanded access) is granted by the HAS on a derogatory basis and for a renewable period of one year. It applies either to a medicinal product:
Which does not yet have a Marketing Authorisation for the specific indication but for which the company undertakes to submit it within 2 years, called pre-MA early access (AP1);
- Or to a medicinal product which already has a Marketing Authorisation in the indication but has not yet been accepted for reimbursement by Social Security, called post-MA early access (AP2).
The early access program is intended for innovative products and access is subject to various criteria, as defined in Article L.5121-12 of the Public Health Code:
The medicinal product must be intended for the treatment of serious, rare or debilitating diseases
There is no suitable treatment available
The implementation of the treatment cannot be delayed
The medicinal product is presumed to be innovative, in particular with regard to a possible clinically relevant comparator
How to apply for an early access?
Early Access (EA) applications are made to the HAS through a dematerialized procedure, at the initiative of the pharmaceutical company. The evaluation period can last 3 months after the validation of the administrative application. At the time of the request, the pharmaceutical company has to appoint a local representative, named “exploitant”.
Cevidra has a strong expertise in early access programs and can support you in the following steps:
Clinical Data due diligence to assess eligibility to an EA
Definition of the EA strategy and timelines
Review of the Protocol of Therapeutic Use (PTU)
Labelling preparation
Support in early access request: Application preparation, Pre-submission meeting preparation, Submission of the application through the e-platform (Sesame), Follow-up on the exchanges with the HAS
How to manage an early access?
The management of early access starts when the EA is granted by the HAS, and requires the involvement of the exploitant at different levels.
How to distribute products under early access?
Once early access is granted, products should be made available within 2 months. Products can be delivered to hospitals when the treatment access form has been fully validated since certain inclusion criteria must be fulfilled, as defined in the PTU.
Early Access products are for hospital use only. The ordering process may require the signature of a price offer or a specific contract. This step is a prerequisite to the reception of orders.
Cevidra has its own logistics platform to offer product storage, stock monitoring, delivery from its warehouse, order management, invoicing and cash collection.
How is the early access program funded ?
The granting of an early access by the HAS opens the rights to health insurance coverage. This means that a selling price is freely defined by the company (MAH), and that this price is fully reimbursed to hospitals.
Following the reform of Early Access Programs in July 2021, two systems of rebates have been implemented and correspond to fees paid by the company (MAH):
An annual rebate based on the turnover with a progressive rate
A rebate paid retrospectively at the end of the scheme which corresponds to a payback if the final price of the commercial product is below the price defined during the EA (overpayments are refunded)