Pharmacoeconomics: theory and practice
№3, 2018, Vol.6
Pharmacoeconomical analysis of adverse reactions caused by investigational medical products in russian clinical trials
In recent years, amid the rapid development of the pharmaceutical market, the introduction of new drugs, there has been a trend towards an increase in the number of reports of adverse drug reactions (ADR) sent to Federal Service for Surveillance in Healthcare (Roszdravnadzor). The enhancement of adverse drug reactions is an important additional factor in increasing the direct costs of treating a particular disease and can even out the difference in the cost of drug therapy when conducting comparative clinical and economic research. The aim of our study was to conduct an economic assessment of the costs of adverse drug reactions during the drug therapy using the examples (или based on the examples) of domestic clinical and economic research. The search for clinical and economic studies was carried out on the basis of the eLIBRARY. RU database. The key words of the search were: “side effect”, “adverse drug reaction”, “adverse event”, “costs”. Clinical, economic and pharmacoeconomic studies conducted in the territory of the Russian Federation from 2014 to 2017 were selected for the analysis. A total of 44 papers from 754 publications found were selected for the further analysis. Among the main nosologies, the 1st place in the number of studies containing information about ADR was taken by Oncology (16 publications), the 2nd place - “Rheumatology (8 publications), the 3rd place - “Cardiology” (5 publications). When analyzing the costs of correction of the adverse drug reactions, it was revealed that the total costs for the Oncology profile for 1 year amounted to 943,928 rubles, and for the Rheumatology profile - 145,976 rubles. At the same time, the relative costs of correcting such adverse drug reactions amount to only 2-10% of total costs. The cost of the correction of the adverse drug reaction of profile "Cardiology" for 1 year amounted to 76,981 rubles. The conducted literature review demonstrates the importance of estimating the cost of correcting side-effects of adverse drug reactions during drug therapy, since they make a significant contribution to the structure of the direct costs of therapy for various diseases.
Currently, there are more and more cases of switching between drugs belonging to the same pharmacological group in favor of a drug with a lower cost. However, it is important to note that from the point of view of the overall economic effect of the use of a medicinal product, its market value may not be the main cost driver. Against this background, for rational prescribing of drugs and efficient use of resources of the health care system, first of all, attention should be paid to other factors characterizing medicines. In order to examine the actualized problem on a practical example, we carried out pharmacoeconomic research of two drugs for the treatment of type 2 diabetes from the group of selective inhibitors of dipeptypeptidase (DPP-4) - alogliptin and vildagliptin. The aim of the study was to establish whether the transition to an alternative, characterized by a lower cost, will be accompanied by savings in the health care system. The results of the pharmacoeconomic analysis obtained by the authors showed that “switching” patients from the drug vildagliptin to the medicinal drug alogliptin in order to save the health budget is an erroneous strategy, since according to the meta-analysis based on the Juan Ling et all, 2018. As result are total costs higher, increased complications and worse control of diabetes.
Pharmacoeconomic evaluation of the drug follitropin- alpha+lutropin-alpha (Pergoveris) using in treatment of infertile women with suboptimal ovarian response in the Russian Federation
Infertility is successfully treated by IVF and ICSI methods. One of the most important stages in IVF protocol is control ovarian stimulation (COS). There are recombinant and menopausal drugs to develop and mature oocyte. In this article was compared the economic efficiency of follitropin-alpha+lutropin-alpha vs follitropin-alpa+menotropin vs menotropin based on cost-effectiveness, budget impact analysis. Folliropin-alpha+lutropin-alpha cost of treating per one patient estimate 51 520 rubles, menotropin – 49 104 rubles, follitropin- alpa+menotropin - 61 298 rubles. Cost-effectiveness analysis, provided on the number of retrieved oocytes, rate of implantation and rate of clinical pregnancy, shown that follitropin-alpha+lutropin-alpha is dominant therapy. According to the results of the budget impact analysis, the increasing use of follitropin- alpha+lutropin-alpha on the market to 51.5% will save 29.2 million rubles.