OBJECTIVES: The purpose of this study is to gather information on reimbursement policies regarding rare diseases in Central and Eastern European (CEE) countries. The aim is also to demonstrate whether there are separate reimbursement requirements for therapies used in the treatment of rare diseases.

METHODS: The interviews among HTA and Market Access experts from 19 CEE countries: Albania, Bosnia and Hercegovina, Bulgaria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Moldova, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia, Slovenia, and Ukraine were conducted. The requirements for reimbursement and health policy in rare diseases were examined and compared among all specified countries.

RESULTS: In most of the CEE countries, there is no clear policy related to rare diseases. Uncommon disorders are neither specifically recognized nor treated in legislation and reimbursement decisions. Drugs for rare diseases usually do not have unique requirements for reimbursement application. Only a few countries have a separate process with specific criteria for rare disease treatment, here and there the treatment decisions refer to a particular patient.

CONCLUSIONS: Rare diseases for which diagnosis and treatment methods are often lacking, and access to data is limited due to small populations, are treated equally with common diseases in the area of pricing and reimbursement in most CEE countries. In most countries, there is no specific approach to orphan drugs or other therapies dedicated to the treatment of rare diseases.