Welcome to Justin Stindt Consultants, your agency adept in early access programmes France. The pathway to market access for drug reimbursement can be intricate. Yet, France offers unique opportunities through its Reimbursed Early Access Programs, enabling timely reimbursement even before Marketing Authorization. As an international consulting agency with a specialized focus on the French pharma, biotech and medtech landscape, our team of experts and consultants are well-versed in the nuances of the AAP (Autorisation d’accès précoce) and AAC (autorisation d’accès compassionel) programs. Trust in our expertise to navigate France’s early access initiatives, ensuring your applications align with the stringent criteria set by the ANSM and HAS. Rely on Justin Stindt Consultants as your partner in unlocking the potential of your innovative medical solutions in the French market.
Early Access Programmes in France: Unlocking Opportunities for Timely Reimbursement
In France, the traditional Market Access process for drug reimbursement involves an extensive appraisal by the Transparency Commission, followed by price negotiations with CEPS for retail drugs or drugs on the T2A exclusion list (liste en sus). As a result, it may take more than 9 months after Marketing Authorization for regular reimbursement to start.
France’s Reimbursed Early Access Programs make it a very attractive market to enter in the early stages of new medicines for pharma and biotech companies as it allows for fully reimbursed usage ahead of regular reimbursement, even prior to Marketing Authorization. They are also an opportunity for further evidence generation. Justin Stindt Consultants is an agency specialized in the French early access programs AAC and AAP. Our experienced team of Consultants and Experts will help you to assess the likelihood of success and build the dossiers to support your AAC / AAP applications.
French Early Access Programmes: AAP (Autorisation d’accès précoce) and AAC (autorisation d’accès compassionel)
The French early access programs are known as the AAP (Autorisation d’accès précoce) and AAC (autorisation d’accès compassionel) and are primarily directed towards severe or rare diseases that lack an existing suitable treatment in the market. The AAP allows the reimbursed use of an innovative medicine before marketing authorization (MA) has been granted and between MA and reimbursement decision for a group of patients. The AAC (or CPC cadre de prescription compassionnel) is intended for non-innovative medicines or for medicines that are not initially intended for marketing authorization that allows the use on a named-patient basis in a small number of cases.
French Early Access Programmes enable free pricing
While the ANSM is responsible of granting compassionate access authorizations (AAC), both ANSM and HAS hold the responsibility of granting early access authorizations (AAP). 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.
Justin Stindt Consultants is your agency to facilitate the French Early Access Programmes AAP and AAC
Justin Stindt Consultants is your market access service provider with the right experts with extensive experience in conducting feasibility assessments of AAP and AAC programs and writing successful dossiers, ensuring that our clients are well-prepared for successful application submissions. Justin Stindt Consultants has helped many clients set up early access programs in France including the formerly known ATU and the current AAP and AAC programs.
Our agency has been selected by many pharma and biotech companies as service provider of choice to write the French early access applications. Our company leverages French native speakers with extensive experience both in the industry and consulting agencies and a successful track record as a supplier of early access dossiers leading to early access in France.
Early Access Programmes in France for Medical Devices
The ‘Forfait innovation’ allows companies to provide patients with early access to innovative health technologies other than medicines in the early phase of clinical development. To be eligible, the health technology has to be innovative, and its use has to bring a significant benefit to health or reduce health expenses.
The request submission has to be done via the Sesame platform and the following documents are needed:
- Argument justifying compliance with the eligibility criteria
- Complete file allowing the evaluation of the technology
- Complete draft study protocol conditioning treatment
- Estimated budget
- Commitment of the applicant to communicate the results of the study and access to the data
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