Summary:

In Bulgaria CV medicines utilization has changed the latest years. Previous studies show that the generic competition leads to change in the market. The goal of the study is to analyze the impact of introduction of new generic substances in the positive drug lists on the reference value of reimbursed cardiovascular (CV) medicines and changes in consumption.

It is a retrospective and observational analysis of the changes of monoproducts acting on cardiovascular system for the period 2009-2013 years. On total 48 INN out of 12 ATC groups were included in the analysis and 48 INN with the 595 trademarks available on the Bulgarian market were analyzed for the changes in utilization.

The changes within the therapeutic groups with new generic molecules entrance in Positive Drug List (PDL) are different but generally, the generic competition leads to decrease of reference price per DDD thus affecting positively the utilization. The decrease is more than two fold in the therapeutic groups of ACE inhibitors, AT angiotensin receptor blockers, and antihyperlipidemic. In the group of well-established cardiovascular glycosides and antiarrhythmic medicines’ prices remain stable. The number of the new generic medicines included in PDL is the highest for the group of ACE inhibitors, AT angiotensin receptor blockers, and statins. The changes in utilization as DDD/1000 inh/day follow the market rules and decrease of price of the products often leads to the higher utilization, especially for therapeutic groups ACE inhibitors, AT angiotensin receptor blockers, statins.

The study confirms that the generic and therapeutic competition lead to significant price decrease and change the trends in the CV medicines consumption.