When patients have a life threatening or debilitating illness, their physicians have exhausted current treatment options or there simply aren’t any treatment options available or they are unable to enter a clinical trial, mechanisms exist across the globe to enable access to pre-approval or unlicensed medicines. Healthcare professionals often seek to access these medicines for their patients and biopharmaceutical companies developing innovative medicines are increasingly making these medicines available to patients through pre-approval and unlicensed medicines access programs.
‘Pre-approval access’ is an umbrella terminology that is becoming more commonly used to describe the process of making a medicine available to a patient (or group of patients), when it is unlicensed in the country of intended use. A number of other terms for this process are in use, including: ‘expanded access’, ‘early access’, ‘compassionate use’, ‘named patient supply’, and ‘managed access’. These terms are used interchangeably, which can cause confusion, so Inceptua prefer the use of the ‘pre-approval access’ terminology