Real World Evidence (RWE) and Orphan drug policies in selected Central and Eastern European (CEE) Countries

Abstract

The rationale for the initial project performed in the Central and Eastern European countries (CEE) was to assess and to share information from the region regarding drug policies. With this special cross countries comparison we aimed to analyze the significance of real world data (RWD) and real world evidence (RWE) for access to new therapies decisions and orphan drugs policies. We focused our comparison on the selected CEE countries (Poland, Estonia, Latvia, Croatia, Czech Republic and Hungary). It shows that although all of those countries are using HTA during reimbursement process, the approach towards RWD is different. In most of the cases RWD are not mandatory for reimbursement decisions, however in all the countries RWD can be submitted as supportive information for the decision making process.