Early access authorisation for innovative medicines prior to reimbursement
The Early Access Authorisation (AAP) applies to innovative medicines for severe or rare diseases addressing unmet medical needs. Managed by HAS and ANSM, it enables patients to access treatment before official reimbursement.
This framework ensures strict supervision, including a data collection protocol and continuous assessment of the benefit-risk balance.
It is designed to provide patients with faster access to innovative therapies while supporting the generation of robust evidence for subsequent market and reimbursement decisions.
