Following publication of the “accord cadre” between the CEPS and the LEEM at the end of last year, both parties have now signed an amendment aimed at better defining the pricing framework for orphan drugs. This will play a crucial part of any pricing negotiation between manufacturers and the CEPS, influencing pricing models and access agreements, and potentially have a knock-on effect on international reference pricing for orphan drugs in the future. It is hoped this will ensure faster access to innovative drugs in areas where no treatment is currently available. In this update, Yasmina Zegaoui, Senior Consultant outlines the key changes.