FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

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Vol 10, No 2 (2017)
View or download the full issue PDF (Russian)

Original Article 

3-11 733

A survey conducted in four hospitals located in the city of St. Petersburg revealed that the commonly used perioperative antibiotic prophylaxis (PAP) did not follow (in 88% of cases) the guidelines approved for national clinical practice.

Aim. To perform a cost-effectiveness analysis of the commonly practiced PAP among patients with clean, clean-contaminated and contaminated surgical wounds in a multidisciplinary hospital.

Materials and methods. The PAP cost-effectiveness analysis was performed using the data from a multicenter epidemiological survey and previously conducted studies. The Markov model was used to compare the effectiveness and safety of the commonly used PAP with that recommended by the clinical practice guidelines. The rate of surgical site infection (SSI) and antibiotic-associated diarrhea (AAD) were chosen for the endpoints.

Results. The costs associated with a single case of PAP according to the clinical practice guidelines was 3.5 times less than that associated with the PAP used in the common practice (RUB 4913,67 and 17837,71 respectively). The present analysis demonstrates that the PAP recommended by the clinical practice guidelines was more cost-effective as compared with the commonly practiced PAP.

Conclusion. Regular epidemiological monitoring is required to improve effectiveness and safety of the existing PAP practice. 

12-21 1078

Comparative pharmacoeconomic analysis of fixed-dose combinations (FDC) vilanterol / fluticasone furoate vs budesonide / formoterol was needed to identify the preferable FDC for asthma management.

Study objective: to identify the preferable FDC of inhaled corticosteroid/ longacting beta agonist combinations (ICS/LABA) for the treatment of moderate or severe asthma in Russia. Materials and

Methods. Retrospective comparative pharmacoeconomic study; cost-minimization analysis and budget-impact analysis.

Results. The present analysis shows that the 12-month direct medical costs for the treatment of asthma using vilanterol / fluticasone furoate and budesonide / formoterol are 29,276 and 40,447 RUR per patient, respectively. The direct costs of treatment with vilanterol / fluticasone furoate are less than those for budesonide / formoterol by 28%. The annual health budget savings that result from replacing budesonide / formoterol by vilanterol / fluticasone furoate are 1,151,512,731 RUR per 100,000 patients.

Conclusion. The present results indicate that the vilanterol / fluticasone furoate FDC is preferable (more beneficial) as compared with the budesonide / formoterol FDC. 

22-30 1098

The recently introduced novel drug combinations for the treatment of COPD are based on long-acting beta-agonists (vilantererol / umeclidinum bromide) and long-acting anticholinergics (olodaterol / tiotropium bromide). In addition to their beneficial clinical effects, these medications have an impact on COPD treatment costs. Minimizing the costs of highly effective medications is necessary to improve the public medical care and drug supply.

Objective: to identify the key differences between vilantererol / umeclidinum bromide and olodaterol / tiotropium bromide, and evaluate the ways of minimizing health budget expenditures.

Materials and methods. We used the available information from research, clinical trials, and instructions for medical use to conduct a cost analysis that was based on the prices for these medications at different levels of drug supply. As a result, the impact on the healthcare budget was determined under conditions of choosing the least expansive medication and adding vilantererol / umeclidinum bromide in the list of VED.

Results. According to the network meta-analysis, when compared with mono-component drugs, vilantererol / umeclidinum bromide showed a more favorable effect on cardiovascular events, as well as a more pronounced effect on the volume of forced exhalation in the first second (FEV1). For the olodaterol / tiotropium bromide combination, no such trend was seen. The costs of 12-month therapy with vilantererol / umeclidinum bromide and with olodaterol / tiotropium bromide were 27,541 and 36,120 rubles, respectively (a difference of 24%). The average direct medical costs were 32,753 and 41,333 rubles per patient per year, respectively. If the vilantererol / umeclidinum bromide combination is added to the VED list and the manufacturer’s maximum selling price is registered at the level of the reference countries, the savings can reach 3-5%.

Conclusion. In patients with severe and extremely severe COPD, and also when COPD monotherapy in patients without severe symptoms (FEV1 ≥50%, CAT <10 scores, mMRC <2) or with mild to moderate symptoms (FEV1 ≥50%) is not effective, the use of vilantererol / umeclidinum bromide in place of olodaterol / tiotropium bromide is more promising in terms of minimizing health budget spending. 

31-40 800

In accordance with currently accepted recommendations for the diagnosis and treatment of chronic obstructive pulmonary disease (COPD), both monotherapy with long-acting anticholinergics (LAAC) or combined therapy (LAAC / long-acting beta-agonists, LABA) can be used. To justify a rational choice between these two medications, we used the methodology of clinical/economic analysis.

Objective: to assess possible financial and clinical/economic consequences of replacing monotherapy based on LAAC (tiotropium bromide) by the fixed combination of LAAC / LABA (vilantererol / umeclidinum bromide) in patients with severe and extremely severe COPD.

Materials and methods. The target population included patients with severe and extremely severe COPD (FEV1 <50%, CAT ≥10, mMRC ≥2, with severe symptoms). QALY (quality-adjusted life-year) was used as the main criterion of effectiveness. Direct medical costs of drug therapy, and the costs of management of adverse events and/or COPD exacerbations were calculated. The costs of these two therapeutic regimens were calculated from the registered data on the maximum selling prices of VED drugs or from the prices expected if/when the given drugs are registered in the VED list (+ VAT + weighted average wholesale premium). Other direct medical costs were calculated in accordance with the Federal program of free medical care, as well as the cost-effectiveness factors recommended by the FFOMS. The obtained values of savings in direct medical costs and the cost-effectiveness ratio (CER) were evaluated for their sensitivity to changes in basic prices of the compared medications.

Results. The use of vilantererol / umeclidinum bromide resulted in improved lung function (an increase in FEV1 by 120% on the 169th day, 0.205 vs 0.093), improved quality of life and reduced symptoms, as well as a 63%-lower need for urgent drugs as compared to the tiotropium bromide monotherapy. The quality of life was 0.752 and 0.732 QALY in the group of vilantererol / umeclidinum bromide and tiotropium bromide, respectively. The direct medical costs in these two groups amounted to 32,753 rubles and 37,641 rubles, respectively. Thus, the savings of using the combined medication reached 4,888 rubles, which is 13% less than that with the mono-component drug. If the current practice of treating COPD with tiotropium bromide is replaced by the combined vilantererol / umeclidinum therapy, the total budget savings can reach more than 327 million rubles.

Conclusion. The use of vilantererol/umeclidinum for the treatment of severe and extremely severe COPD is strongly preferred over tiotropium bromide, as it leads to significantly better clinical outcomes and provides savings for the health care budget. 

41-43 947

The aim of our study was to conduct a pharmacoeconomic and cost analysis of the therapeutic use of anti-HIV drugs.

Material and methods. The study was based on the documented medical histories of HIV-infected patients; it also incorporated the data from the state-sponsored auctions and contracts for drug purchase, as well as the information from the website with recommendations for Moscow pharmacies. Both statistical and analytical approaches were used.

Results. We found that all drugs needed for the treatment of patients with HIV infection are available in Russia. These drugs appear in the updated list of the treatment standards approved for domestic use in Russia.

Conclusion. The difference between the government-sponsored prices and the retail prices of these medications has an impact on the costs of ant-HIV therapy.

44-52 681

The article presents the results of traditional pharmaco-economic analysis (the “cost-effectiveness” method) and socio-economic analysis of pharmaco-therapeutic regimens in a chronic disease.

The specific aim was to compare the methods of pharmaco-economic and socioeconomic analyses when applied to the treatment of children with chronic asthma exacerbations.

Materials and methods. The data on basic therapy of asthma exacerbations in children hospitalized in 2014-2015 were used (total 608 cases).

Results. The combination of an inhaled glucocorticosteroid and long-acting β2-agonists proved to be the most optimal therapy as far as pharmaco-economics is concerned. The ways to calculate the coefficient of incremental costs of therapeutic regimens are shown. The discrepancy between the results of pharmacoeconomic analysis, on the one hand, and the data on socio-economic losses, on the other hand, was documented. The addition of montelukast (a leukotriene receptor antagonist) in the treatment regimen leads to an increase in medical costs from 873.00 rubles to 1515.39 rubles, and to a decrease in the average number of hospitalizations per year. In this case, the number of days of absence from work for a parent also decreases, which contributes to a higher GDP. As exemplified in this model group of 1000 patients, an increase in the direct medical costs by 734 thousand rubles leads to a decrease in the socio-economic losses (saving 34 million rubles.)

Сonclusion. The traditional pharmacoeconomic analysis is the ideal instrument to compare between the original and generic drugs, and to evaluate the treatment of acute diseases. With respect to chronic diseases, this pharmaco-economic analysis should be used with caution. Without taking into account the effectiveness of the analyzed pharmacotherapy in treating possible exacerbations, or the transition to a more severe / mild form of the disease, the clinical component of the pharmaco-economic analysis may be missed. And if so, only the economic component of the selected therapy will play the major role in the final assessment. In this case, the results of the entire pharmaco-economic analysis may become less significant as they will reflect the least expensive treatment only, leaving behind the clinical aspects, e. g. the number of positive outcomes. 

53-61 908

The aim of the study is to assess the economic feasibility of using pomalidomide in patients with recurrent and refractory multiple myeloma (MM), who had received previous 1st and 2nd (bortezomib and lenalidomide) line therapy.

Materials and Methods. In this study, the methods of cost analysis, cost – effectiveness analysis, budget impact analysis (in relation to the State Guarantees Program) as well as sensitivity-toprice-change analysis were used.

Results. The results indicate that the pomalidomide therapy in patients with recurrent and refractory MM who had previously received 1st and 2nd (bortezomib and lenalidomide) line therapy is clinically beneficial and also economically feasible in terms of public procurement. If introduced this program can save the Federal budget up to 232 785 963 rubles.

Conclusion. According to the budget impact analysis, if pomalidomide (Innovid) is included in the list of public procurement, then the Federal spending on the treatment of MM with pomalidomide, lenalidomide and bortezomib will be less by 12% compared to the MM treatment with bortezomib and lenalidomide only.

62-67 1100

Treatment of patients with non-small-cell lung cancer (NSCLC) is one of important problems of current oncology practice. The first-line NSCLC chemotherapy standards are based on the platinum-containing medications. Today, immunotherapy is considered to be the best option for the second-line NSCLC treatment after the platinum-based chemotherapy. In the Russian Federation, nivolumab and pembrolizumab are recommended to be used in such clinical situations.

The aim of the study was to estimate the costs of the immunotherapy when used for the second line NSCLC treatment.

Materials and methods. Direct comparative studies between nivolumab and pembolizumab have not been conducted, but in previously published studies, no statistically significant difference in efficacy between nivolumab and pembolizumab in second-line therapy of NSCLC was identified. With regards to this, the analysis from the stand point of the healthcare system, the research was carried out by using the method of cost minimization with the Markov model. The data on pricing entered with no discounts for a period of 1-5 years. The costs of the immunotherapeutic drugs were taken from the results of auctions current year. In the basic version, the calculations were made for a patient with a body weight of 70 kg. It was assumed that nivolumab is given at a dose of 3 mg/kg every 2 weeks, and pembrolizumab – at a dose of 2 mg/kg every 3 weeks. Only the costs of the immunotherapeutic drugs and the expenses for their administration were taken into account. In the sensitivity analysis, the impact of cost changes within reasonable limits, on the total expenses were analyzed for patients of 60-80 kg body weight.

Results. The costs of the immunotherapy during the first year of treatment are maximal and amount to 84% of the total expenses. At the same time, the cost of pembrolizumab for 5 years of treatment (in the basic version) is 5.7% lower than that for nivolumab. When prices vary within reasonable limits, the use of each of these two drugs may become economically justified. If the patient body weight ranges from 67 to 80 kg, the use of pembrolizumab is economically more beneficial.

Conclusions. As nivolumab and pembrolyzumab used for the second line therapy of NSCLC in this study are similar in terms of the treatment costs. Depending on the price variations within reasonable limits and the patient body weight changes, each of these drugs can be economically preferable. 


69-74 667
Among the most important aspects of the health policy are the methods for pricing of medicines, especially of innovative medicines. In many countries, the “therapeutic value” of a medicine is commonly used as a major criterion in negotiations on medicine prices. The existing tools for assessing the therapeutic value of medicines are not used in the Russian Federation. Here we propose a method for estimating the therapeutic value of innovative medicines based on the multi-criterial analysis.

ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)