OBJECTIVES: In the last years controlling the budget resources of public health funds for medicines becomes a very important issue for the reimbursement decisions. International price referencing (IPR) is the most used cost containment measure, especially in Central and Eastern European countries (CEEC). Nevertheless with the development of biotechnology and personalized medicine, IPR becomes more insufficient to control pharmaceutical expenditure. Therefore Health technology assessment (HTA) of medicines has been introduced within the decision making processes for reimbursement of new molecules in many CEEC.

METHODS: Review of the legislation and selected ISPOR pharmacoeconomic guidelines in Bulgaria and 9 CEEC (Latvia, Lithuania, Estonia, Croatia, Slovakia, Slovenia, Hungary, Poland, Romania). Reference pricing and HTA in Bulgaria in comparison to nine CEEC have analyzed different country policies and approaches.

RESULTS: All of the selected CEEC (100%) use IPR and HTA within the decision making processes for reimbursement of new molecules. 90% of the countries (excl. Poland) use IPR as main criterion for pricing. Seven countries use IRP towards reimbursed products - excluding Bulgaria and Romania (used for all prescription medicines), and Hungary (for innovative products). Only 40% of the surveyed CEEC have independent HTA body, where two of the countries (Croatia and Poland) use more than 30 countries for IPR. Bulgaria and Romania (20%) use selected reference countries for HTA.

CONCLUSIONS: The results of our review would contribute to assess the benefits of usage of external referencing both for pricing and HTA in Bulgaria and the rest of the CEEC in terms of patients' access to innovative medicines on the one hand, and on the other - control of public funds.