Early access to certain drugs before final reimbursement decision
Early Access (AP) is a mechanism that allows patients to obtain innovative treatments before reimbursement approval.
It applies to medicines addressing serious, unmet medical needs and helps reduce the gap between clinical development and effective patient access.
The framework is strictly regulated and requires real-world data collection, providing valuable evidence for future assessment and reimbursement decisions.
It ensures timely patient benefit while maintaining safety and regulatory oversight.
