France’s Reimbursed Early Access Programs (EAPs) allow for reimbursement of new medicines before traditional reimbursement and even before Marketing Authorization. Given that it may take more than 9 months after Marketing Authorization for regular reimbursement to start in the traditional Market Access pathway, France’s Reimbursed Early Access Programs make it a very attractive market to enter for pharma and biotech companies with drugs in the early stages.
THE 2021 ATU REFORM
In 2021, a reform of the early access system changed the early access landscape. Up to 2021, the so called ‘ATU’ early access program was in place. It had two variants – the nominative ATU and cohort ATU, both of which were applicable to medicines whose clinical profile suggested that they would be beneficial for individual or groups of patients and for which a marketing authorization request had been filed, or would be filed, within a set period of time.
The key changes in the 2021 Early Access reform included the reorganization of the ATU program into AAP (Autorisation d’accès précoce, replacement for the cohort ATU) and AAC (autorisation d’accès compassionel, replacement for the nominal ATU). The AAP and AAC are primarily designed for patients with severe or rare diseases for which there are no existing suitable treatments available in the market. The AAP grants reimbursement to innovative medicines before marketing authorization (MA) has been granted and between MA and reimbursement decision for a cohort of patients. The AAC is aimed at non-innovative medicines or for medicines that are not initially intended for marketing authorization, allowing the drug’s use on a named-patient basis in a limited number of cases. However, it is also common for innovative medicines to start out with AAC requests and later file for an AAP.
Another attractive feature of the early access programs is that manufacturers can set prices freely in the AAC and AAP. However, rebates are applicable depending on the annual sales and once the final reimbursement price has been negotiated.
SPECIALISED FRENCH EARLY ACCESS PROGRAMMES FOR MEDICAL DEVICES
The ‘Forfait innovation’ allows companies to provide to patients early access to innovative health technologies (excluding medicines) in the early phases of clinical development. For a medical technology to qualify, it must be innovative, and its use must provide substantial health benefit or must reduce healthcare costs.
The request submission process is conducted through the Sesame platform and requires companies to provide a set of documents, including:
- A detailed description of the health technology, its clinical development status, justifications for compliance with the criteria (allowing the authorities’ evaluation of the technology)
- Estimated budget
- Commitment of the applicant to communicate the results of the study and access to the data
LET JUSTIN STINDT CONSULTANTS BE THE AGENCY TO FACILITATE YOUR FRENCH EARLY ACCESS
Justin Stindt Consultants is a market access consulting firm and your dedicated partner for market access services. Our team of experts have extensive experience in AAP and AAC feasibility assessments and dossier preparation, ensuring that our clients are well-prepared for seamless application submissions for their company. Our experts have assisted numerous clients in establishing early access programs in France, including the former ATU and the current AAP and AAC programs. Our agency has been the preferred service provider for many pharmaceutical and biotechnology companies seeking assistance with crafting French early access applications. We employ French native speakers with extensive experience in the industry and consulting agencies, and we have a proven track record of delivering successful dossiers that pave the way for early access in France.
