Critical Analysis of Pricing and Reimbursement Process on The Basis of New Indroduced Pharmacoeconomic Guidelines In Bulgaria.

INTRODUCTION The pricing and reimbursement process in Bulgaria is based on different approaches implemented by NCPR among which is external and internal reference pricing A pharmacoeconomic guidelines (PE) with a HTA approach for assessment of submitted dossiers was implemented y the competent authority (CA) in Bulgaria in April 2015. Requirements for efficacy, safety, benefits, adverse events, comparator, standard treatment, drug utilization, budget impact, patient population during the premarketing and postmarketing period are changed in order to provide high quality evidence the decision making process. The experience of other member states in that field is analysed and compared. (1)