Early Access Management
" Early access " is a system that allows patients who have reached an impasse in their treatment to benefit, exceptionally and temporarily, from certain drugs not authorized for a specific therapeutic indication.
The provision of these treatments considered as innovative are conditioned to specific situations and should be collected from physicians and patients for regular evaluation by the authorities.
KAPPA SANTÉ'S EXPERTISE
The health authorities offer early access to innovative therapies that are in the process of being approved for a specific therapeutic indication.
As of July 1, 2021, Early Access and Compassionate Access (AP/AC) have taken over from the Temporary Use Authorizations (ATU and RTU).
This reform allows patients to benefit from the latest innovative therapies, particularly in oncology and hematology. However, the implementation of this early access remains complex with the organization of a data collection and the drafting of therapeutic use protocols. Completeness rates for these data are still insufficient today.
Kappa Santé can help you with all aspects of setting up and monitoring these early accesses, where data collection is central.