The Evolving Landscape of Early Access Programmes: Comparisons and Implications for Market Access.

BACKGROUND • Early Access Programmes (EAPs) are country-specific regulatory processes which grant market access to unlicensed medical drugs to specific patients, under specific terms, provided that specific criteria are fulfilled • EAPs can be divided into two main types:  Nominative or Named-Patient Early Access Programmes are typically initiated by physicians for an individual patient in great need of a medicinal product, which will be administered under the physician's responsibility  Cohort Early Access Programmes are usually defined programmes initiated by the manufacturer to allow access for a group of patients to an unauthorised medicinal product • Early access to highly needed and innovative drugs is clearly valuable and benefits various healthcare stakeholders: