France’s Reimbursed Early Access Programs (EAP) provide opportunities for reimbursement of new and innovative drugs that treat serious diseases before traditional reimbursement starts. This makes it a very attractive option for pharma and biotech companies with pipelines in early stages.
366 products and 236 unique active substances (INNs) reimbursed
In April 2025, HAS published the new list of maximum compensation amounts for products reimbursed under the AAP/ex-ATU program. There are 366 products covered in the early access scheme list, of which there are 236 unique INNs. This are 18 more products and 10 more INNs compared to the previous September 2024 AP reimbursement list.
Some of the newly added medicines include anti-cancer drugs (elranatamab, zolbetuximab) and rare disease drugs (beremagene geperpavec, maralixibat). This broad selection highlights continuous efforts to provide innovative treatments to patients in need while also emphasizing the appeal of the French market for pharma and biotech firms.
| Drug name | INN | Indication |
|---|---|---|
| Vyjuvek | beremagene geperpavec | Epidermolysis bullosa dystrophica with mutation(s) of the collagen type VII alpha 1 chain gene |
| Livmarli | maralixibat | Familial progressive intrahepatic cholestasis |
| Winrevair | sotatercept | Pulmonary arterial hypertension |
| Elrexfio | elranatamab | Relapsed and refractory multiple myeloma |
| Jakavi | ruxolitinib | Acute or chronic graft-versus-host disease |
| Adzynma | ADAMTS13r | Congenital thrombotic thrombocytopenic purpura due to ADAMTS13 deficiency |
| Elahere | mirvetuximab soravtansine | Folate receptor alpha-positive high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer |
| Spevigo | spesolimab | Prevention of flare-ups of generalised pustular psoriasis |
| Kayfanda | odevixibat | Cholestatic pruritus associated with Alagille syndrome |
| Vylov | zolbetuximab | HER-2-negative, unresectable or metastatic locally advanced adenocarcinoma of the gastric or oesogastric junction |
French reimbursement is possible even for medicines costing millions
The most expensive therapy reimbursed by the AP early access program in 2025 is still Upstaza, a gene therapy medicine for a rare disease. The price of Upstaza is €3,500,000. However, Upstaza is not an isolated case, the top 10 most expensive reimbursed products are all cell and gene therapies, indicating a potential shift towards personalized and precision medicine that shows promising outcomes for patients with complex and/or rare conditions.
French reimbursement option for gene therapies, cancer therapies and innovative treatments
The 2025 list includes innovative treatments, including cell and gene therapies such as PTC Therapeutics’ Upstaza (eladocagen exuparvovec), cancer therapies like AstraZeneca’s Imjudo (tremelimumab), and other innovative treatments. Justin Stindt Consultants has compiled and translated to English the complete list of the products reimbursed under the ATU/AAP scheme, please contact us for a free copy.
JSC Expertise
Justin Stindt Consultants is a specialized market access consulting firm offering bespoke market access services. Our team of experts has extensive experience in AAP and AAC feasibility assessments and dossier preparation, ensuring that our clients are well-prepared for seamless application submissions. 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.
Stay updated
We are closely monitoring the ATU-AAP tables of maximum compensation which are updated typically three times a year and will keep our clients informed of the latest changes. For more detailed insights and updates, visit our blog regularly.
Why choose us?
- Proven Expertise: With years of experience in global pricing and reimbursement, our team offers unparalleled expertise and strategic insights.
- Tailored Solutions: We understand that each client and market is unique, and we provide customized solutions that address specific needs and challenges.
- Comprehensive Support: From initial strategic advice to implementation and beyond, we offer end-to-end support to ensure your success.
- Regulatory Mastery: Our deep understanding of regulations, requirements and processes, including extensive experience with HAS, positions us to effectively advocate for your products.
Partner with Justin Stindt Consultants to leverage our expertise and achieve your market access goals with confidence.
