What is an Early Access Program (EAP)?
Early access programs (EAPs) provide an alternative regulatory pathway for existing therapies and new medicines to more efficiently meet patient needs. Prior to market approval, promising new drugs can be made available outside of the clinical trial space to individuals with life threatening or chronic, debilitating diseases. Likewise, an existing medicine which has shown potential to treat a currently off-label use can be made available more quickly to treat these life-threatening or chronic diseases.
While usually implemented by pharmaceutical companies based on patient therapeutic need, in France in late 2015, an EAP was also used by the social system as a means to control exorbitant drug costs – high premiums for two approved medicines for Age Related Macular Degeneration led to a Temporary Authorization for Use (ATU) of the significantly cheaper Avastin, which, off label, had shown efficacy in this therapeutic area.