Abstract

INFLUENCE OF REGULATORY MEASURES AND MARKET POLICY FOR REIMBURSED MEDICINAL PRODUCTS ON THE VALUE, PAID WITH PUBLIC FUNDS IN BULGARIA IN 2015

Z. Mitkova*, M. Manova, M. Vasileva, B. Zidarova, D. Apostolova and A. Savova

ABSTRACT

In Bulgaria large number of medicines yearly are included and excluded from Positive Drug List (PDL). It leads to different changes in the value per DDD paid with public funds (reference value) and utilization of medicines. The goal of the study is to analyze the main results from market policy of inclusion and exclusion of medicines in PDL as well as other factors leading to changes in reference value per DDD for all reimbursed medicines. The study is retrospective and observational analysis of Annex 1 and Annex 2 of Positive Drug List (PDL) in 2015. The changes in reference value per DDD, the rate of the decreasing or increasing of value were observed for all therapeutic groups in Annex 1 and Annex 2, where new medicines are included or excluded. We found that 109 new trademarks (belonging to 53 INNs), as well as 15 fixed dose combinations (belonging to 7 INN) in 2015 were included in Annex 1. 149 new trademarks, belonging to 67 INNs, were included in Annex 2, along with 16 fixed dose combinations (belonging to 7 INN). The number of excluded medicines is 60, belonging to 57 INNs from Annex 1, and 90 trademarks belonging to 85 INNs from Annex 2. On total the number of medicines in which the reference value is reduced is higher than medicines with the unchanged prices. The leading factor for decreasing the reference value in 2015 is a change of the price of the medicinal product within the group. It is mainly due to external reference comparison but also to generic and therapeutic competition. The next reason leading to decreasing the value is inclusion in PDL of generic medicines with lower prices.

Keywords: pricing, reimbursement, reference value, generic competition.