[Clinical and economic analysis of Reslizumab use in the treatment of patients with severe allergic eosinophilic asthma].

Asthma is a heterogeneous chronic disease of airways. One of its endotypes is eosinophilic asthma, accompanied by both peripheral blood and airway eosinophilia, where severe eosinophilia is usually associated with more severe asthma. Anti - interleukin-5 (IL-5) monoclonal antibodies (MAb) can reduce eosinophil counts in peripheral blood and tissues in asthma patients. The first drug of this class registered in Russia was reslizumab. AIM: Comparative clinical and economic analysis of reslizumab use in patients with allergic asthma and eosinophilia. MATERIALS AND METHODS: Omalizumab was chosen as a reference drug, because until now it was the only MAb for the treatment of severe asthma in Russia. The study population included patients with allergic asthma with both high levels of IgE and high eosinophil counts in peripheral blood, i.e. individuals eligible for both omalizumab and reslizumab treatment. A decrease in the number of exacerbations requiring prescription of systemic corticosteroids and an increase in QALY index was used as efficacy criteria. An indirect comparative study was used, because no direct comparison has been conducted to date. As a result, reslizumab demonstrated a statistically significant reduction in the frequency of clinically significant asthma exacerbations compared with omalizumab. The utility of the both asthma treatment strategies was compared using Markov models, taking into account the frequency of exacerbations, their severity, as well as decrease in QALYs due to exacerbations. The time horizon was 12 months. RESULTS: Reslizumab treatment was 37.2% less expensive compared with omalizumab for the patients who are equally eligible for the both drugs. The calculated cost - effectiveness and cost - utility ratios were in favor of reslizumab. Budget impact analysis showed a significant effect of reslizumab on reducing budget costs. If reslizumab is used in 4250 patients (an estimated number of patients with severe allergic asthma and eosinophilia in Russia), this would reduce the costs for their treatment by up to 4896 million rubles per year. CONCLUSIONS: For patients with severe allergic eosinophilic asthma who are equally eligible for the both drugs, reslizumab can be considered a more reasonable medical technology in terms of pharmacoeconomics when compared with omalizumab.

Optimization Approach for Estimating the Required Amount of Pharmaceuticals in the Russian Federation.

OBJECTIVES: To propose an algorithm that relates the effectiveness of drugs for a wide range of diseases with the financial capabilities of patients. METHODS: Estimates of the volume of pharmaceuticals that are consumed in the Russian Federation by all segments of the population regardless of household income were considered. These were calculated using statistically valid probabilities of the appearance of various diseases, official state data on the structure of expenditures of various strata of the population, and the optimal choice of the most effective medicines with income restrictions taken into account. The main idea was to introduce the utility function of the drug and the cost of treatment. For each disease, its own set of drugs was selected. RESULTS: On the basis of the real-world data for several diseases, optimal estimates were calculated using the proposed algorithm. In the process of approbation, some weak points of the algorithm were found, such as the methods of packaging pharmaceuticals and associated cost of a packaging unit. These characteristics should be discussed separately, introducing conventional units of drug volumes. A unit of quantity corresponding to the maximum effect of the drug in question is proposed in the work. CONCLUSIONS: The proposed algorithm for estimating the amount of medicines can be successfully used by both pharmaceutical (or dealer) companies and government agencies for objective population provision. The usual sources of such estimates are based either on market surveys or on pharmacy network data. Both ways are very expensive and do not allow predicting mass demand in the future, for example, with an unexpected epidemic or the emergence of new medicines. In addition, the proposed algorithm can be successfully applied to the pricing problem: a variation in price may show a change in the volume of use.

A mathematical model for predicting the development of bacterial resistance based on the relationship between the level of antimicrobial resistance and the volume of antibiotic consumption.

OBJECTIVES: Infections that are inadequately treated owing to acquired bacterial resistance are a leading cause of mortality. Rates of multidrug-resistant bacteria are rising, resulting in increased antibiotic failures and worsening patient outcomes. Mathematical modelling makes it possible to predict the future spread of bacterial antimicrobial resistance. The aim of this study was to construct a mathematical model that can describe the dependency between the level of antimicrobial resistance and the amount of antibiotic usage. METHODS: After reviewing existing mathematical models, a cross-sectional, retrospective study was carried out to collect clinical and microbiological data across 3000 patients for the construction of the mathematical model. Based on these data, a model was developed and tested to determine the dependency between antibiotic usage and resistance. RESULTS: Consumption of inhibitor/cephalosporins and fluoroquinolones increases inhibitor/penicillin resistance. Consumption of inhibitor/penicillins increases cephalosporin resistance. Consumption of inhibitor/penicillins increases inhibitor/cephalosporin resistance. CONCLUSIONS: It was demonstrated that in some antibiotic-micro-organism pairs, the level of antibiotic usage significantly influences the level of resistance. The model makes it possible to predict the change in resistance and also shows the quantitative effect of antibiotic consumption on the level of bacterial resistance.

[Pharmacoeconomic analysis of using mirabegron to treat overactive bladder in the setting of the Russian Federation health care].

RELEVANCE: The present paper presents, for the first time in Russia, a comparative pharmacoeconomic analysis of using mirabegron (Betmiga) to treat overactive bladder (OAB). MATERIALS AND METHODS: Three medical technologies were evaluated: treatment of OAB with mirabegron 50 mg/day, solifenacin 5 mg/day and solifenacin 10 mg/day. In addition, the strategies of mirabegron and botulinum toxin type A were analyzed as a result of simulating the second-line treatment. RESULTS: When modeling for 1-year horizon, the lowest cost was found in mirabegron strategy, which was 16% lower than with solifenacin. When comparing the second line strategies using mirabegron and botulinum toxin type A, costs of mirabegron group were 61% lower. According to the selected performance criteria, mirabegron was more effective in comparison with other strategies. The findings of the budget impact analysis revealed that using mirabegron was preferable compared with solifenacin as the first line treatment, and compared with botulinum toxin type A as the second-line treatment. The analysis of cost-effectiveness and availability of technology showed growth when using mirabegron strategy; there was an increase in the efficiency of mirabegron strategy relative to solifenacin strategy, accompanied by cost reduction and, as a consequence, reducing the burden on the budget. CONCLUSIONS: Thus, using mirabegron to treat OAB both as the first and the second line treatment is absolutely cost-effective and profitable medical technology.

[Invasive mucormycosis in patients with hemoblastosis in St.-Petersburg].

Thirty four patients with mucormycosis in 10 hospitals of St. Petersburg were observed in 2004-2013. The most frequent underlying diseases of mucormycosis were acute leukoses (64%). In 100% of the patients mucormycosis developed as a nosocomial infection. The risk factors, etiology, basic clinical signs and strategy in the treatment of mucormycosis were analyzed.

[Clinical and economic expedience of ertapenem therapy of complicated urinary tract infection].

Clinical and economic investigation of various antibiotics use in the treatment of complicated urinary tract infection (CUTI) was performed under the Russian economic environment. The drugs of comparison were ertapenem, ceftriaxone and levofloxacin. Direct costs and their structure were shown, and the cost efficiency was calculated. Alternative analysis and one-side susceptibility analysis were performed. In complicated urinary tract infections when the major pathogens were Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis it was clinically and economically reasonable to start the treatment with ceftriaxone or ertapenem, while levofloxacin could be an alternative strategy. When the effects of the acquired resistance on the treatment effectiveness were evaluated (SIS model) it was shown that the pathogens susceptibility to ertapenem was preserved for a significantly longer time than that to ceftriaxone or levofloxacin (60 months). Such a parameter may serve as an additional evidence of the reasonable use of ertapenem as the starting treatment of CUTI.