Clinical Microbiology and Antimicrobial Chemotherapy. 2017; 19(3):260-264
To estimate proportion of hard and surrogate endpoints used as effectiveness criteria in pharmacoeconomic studies of antimicrobial drugs.
The pharmacoeconomic studies of 30 antimicrobial agents proposed for inclusion in the Russian essential drug list in the 2014-2016 were reviewed.
A total of 47 effectiveness criteria were analyzed, of them 40.4% were hard endpoints. Two studies of antifungal drugs used the hard endpoints only. The hard endpoints were used in 58.8% of studies involving antibacterial drugs. The lowest percentage of hard endpoints was observed in studies of antiviral agents (26%).
Overall, the hard endpoints comprised only 42.5% of effectiveness criteria used in pharmacoeconomic studies of antimicrobial agents, with antiviral agent studies having the lowest percentage. Antifungal therapy studies stood out due to exclusive use of hard endpoints. More than a half of effectiveness criteria used in antibacterial drug studies was the hard endpoints. Adverse events were used as the surrogate endpoints. Treatment-emergent resistance risk is an important outcome that can be used to guide decision-making process when listing pharmaceutical agents.