OBJECTIVES: The health technology assessment (HTA) approach for assessment of medicinal product was introduced in Bulgaria in December 2015. HTA requirements for comparator, epidemiological data, budget impact analysis and pharmacoeconomic methods and the reimbursement process based on external and internal reference pricing have existed since 2013 in Bulgaria.

METHODS: Legislative analysis of HTA methodology have been performed and quantitatively descriptive analyses have been applied in evaluating the current HTA - process of the new molecules and level of reimbursement for five years period in Bulgaria. The Bulgarian process of new INN subject for reimbursement was reviewed and systematically analyzed due to several institution, involved in that complex and challenging process.

RESULTS: An HTA approach of medicines was introduced in Bulgaria in December 2015 with requirements for epidemiological data, source of cost, effectiveness over efficacy, modeling, sensitivity analysis, ICER, QALY, discounting cost, comparator, budget impact analysis and etc.

Totally 84 new INNs were submitted for HTA assessment, a step prior pricing and reimbursement of medicines in 2016 - 2017. Only n=32 (38% of all submitted) of novel molecules with positive HTA assessment were classified for reimbursement in 2016 - 2017. Contrary to the period 2013-2015, where only pharmacoeconomics data for reimbursement were required, almost all submitted 71 new INN were accepted for reimbursement.

CONCLUSIONS: The newly introduced HTA approach in Bulgaria in 2015 is more restrictive for reimbursement decisions than before. Harmonised HTA - evidence requirements among the competent national authorities involved in the reimbursement process need to be legally implemented in order to facilitate and increase the patient access to innovative medicines.