Fixed Doses Combinations Acting on Cardiovascular System - Utilization and Generic Competition

Aims: To analyze the impact of introduction of new fixed dose combinations (FDCs) in the Positive drug list on both the reference price and the utilization of reimbursed cardiovascular (CV) medicines.

Study Design: It is a retrospective and observational analysis of the changes in reimbursed fixed dose combinations (FDCs) acting on cardiovascular system (CVS).

Place and Duration of Study: Medical University of Sofia, Faculty of Pharmacy for the period 2009-2013.

Methodology: On total 18 INNs (international nonproprietary name) in different combinations belonging to 6 anatomic therapeutic chemical (ATC) groups (ACE-inhibitor and diuretic, Ca-antagonists and ACE-inhibitors, sartan and diuretics, Ca-antagonist and statin, two diuretics, b-blocker and diuretic); 60 dosage forms, and 104 trademarks were analyzed for changes in the prices and utilization after the inclusion in the Positive drug list (PDL).

Results: The number of the new generic medicines included in PDL is highest for the group of ACE -inhibitors and diuretics, angiotensin receptor blockers (AT receptor blockers, ARBs, sartans) and diuretics. Many new generic molecules as FDCs enter the PDL, thus leading to decrease in the reference price, because of generic competition. The decrease is significant in the new therapeutic groups. The changes in utilization calculated as defined daily dose (DDD)/1000 inhabitants/day show higher utilization in 2013 for the groups of ACE inhibitors and diuretics and AT receptor blockers and diuretics (Enalapril/ Hydrochlorthiazide (HCTZ), Perindopril/ Indapamide, Valsartan/HCTZ, Losartan/ HCTZ).

Conclusion: The study confirms that in Bulgaria the generic and therapeutic competition has increased during 2009-2013. It leads to significant price decrease and changes in the trends in utilization of the FDC in cardiology.