Kulikov Andrey Yurievich

professor of Department of organization of medical provision and pharmacoeconomics, I.M. Sechenov First Moscow State Medical University Moscow,Russia
Babiy V.V., Kulikov A.Y. 1791

The aim of this study was to determine the optimal medical technique of treatment of human immunodeficiency virus (HIV) infected adults with HIV-1 RNA<100 000 copies/ml by assessing costs and effectiveness of highly active antiretroviral therapy: rilpivirine/ tenofovir/ emtricitabine (single tablet regimen (STR)), efavirenz + tenofovir/ emtricitabine (multi-pill regimen), lopinavir + tenofovir/ emtricitabine (multi-pill regimen). The obtained results have demonstrated that prescription of rilpivirine-containing combined Highly Active Antiretroviral Therapy (HAART) (STR) is associated with additional costs on ambulatory treatment, that are overlaid by lower costs (direct and indirect) on new persons with HIV, infected by the analyzed group. Therefore, cost savings, as compared to mentioned schemes of HAART, accompany prescription of the scheme rilpivirine/ tenofovir/ emtricitabine (Eviplera), according to the «budget impact» analysis.

Kulikov A.Y., Novikov I.V. 1780

The goal of this analysis is to evaluate the incremental cost-utility of insulin degludec compared with glargine in patients with type 2 diabetes receiving basal-only therapy in addition to metformin as per prescribing conditions in the Russia. Total medical costs and effectiveness in terms of QALY were collected and analysed for insulin degludec and insulin glargine, both in combination with metformin. Sources of data: the effectiveness - the analysis of publications of clinical studies, drug prices - register for the prices of the VED, the cost of health care resources - standard providing outpatient services. Results: The analysis illustrates that insulin degludec for type 2 diabetes provides a significant health improvement expressed in quality adjusted lifeyears. The ICUR of insulin degludec in combination with metformin compared to insulin glargine, both added to metformin was estimated at 337 112 rub for QALY which demonstrates its cost-effectiveness.

Kulikov A.Y., Novikov I.V. 1715

Study purpose: To determine preferential medicinal products for the treatment of diabetes mellitus type 2 in terms of pharmacoeconomic analysis based on comparative cost and efficacy, safety and quality of life ratio between the modern insulin analogues.

Materials and methods: Study design – retrospective, modeling. Methods of pharmacoeconomic analysis - cost-effectiveness, costutility. Alternatives compared – insulin aspart (NovoRapid®), insulin lispro (Humalog®), insulin glulisine (Apidra®), premix insulin aspart 30/70 (NovoMix® 30), premix insulin lispro 25/75 (HumalogMix® 25), insulin detemir (Levemir®) and insulin glargine (Lantus®).

Data sources: efficacy – analysis of publications on clinical studies performed; medicinal product prices – registry of quoted prices for vital and essential medicines; cost of healthcare resources – outpatient and polyclinical assistance standards.

Study results: Among short-acting insulin analogues, CER value was 1091.84 rub.; 1133.55 rub. and 1175,27 rub. for NovoRapid®, Humalog® and Apidra®, respectively. Among premix insulin analogues, CER value was 1418.47 rub. for NovoMix® 30 and 1512.08 rub. for HumalogMix® 25. Among basal insulin analogues CER value was 2084.39 rub. for Levemir® and 2471.23 rub. – for Lantus®. Costutility analysis for NovoRapid®, Humalog®, Apidra®, NovoMix® 30, HumalogMix® 25, Levemir® and Lantus® CUR value was 84463.04 rub., 87689.69 rub., 90917.35 rub., 99573.21 rub., 106144.38 rub., 79269.45 rub. and 93981.16 rub. for 1 QALY, respectively. Therefore, in terms of costutility, when insulins were added to OAD treatment, NovoRapid® is the preferable drug because of the lowest CUR value. Among premix and basal insulin analogues, NovoMix® 30 and Levemir® were preferable drugs because of the lowest CUR values in their group.

Kulikov A.Y., Ugrekhelidze D.T. 1542

According to the World Health Organization, the prevalence of post-stroke spasticity is 200 people per 100 thousand inhabitants and the total number of patients in the world exceeds 12 million people. Approximately 450 000 people have a cerebrovascular accident (CVA) annually in the Russian Federation and the post-stroke spasticity is developed in about one third of the survivors. The main goal of this study is to conduct pharmacoeconomic analysis of three bestselling in the Russian Federation botulinum toxin type A preparations - Dysport®, Botox®, Xeomin compared with standard therapy without botulinum toxin type A. According to the conducted cost-effectiveness analysis where Modified Ashworth scale score is used as a main outcome Dysport® is a dominated alternative compared with other studied therapy schemes. What is more, budget impactanalysis shows that therapy with Dysport® during one year leads to the saving of 45 563 rubles compared with Botox® and saving of 44 408 rubles compared with Xeomin per one patient.

Arinina E.E., Kulikov A.Y., Novikov I.V., Tolkushin A.G. 1629

Study objective: To perform a comparative pharmacoeconomic analysis of the therapy combinations: sitagliptin with metformin, and sulfonylureas with metformin in patients with type 2 diabetes on metformin monotherapy whose target glycemic goal is not reached with diet and exercise.

Materials and methods: A time horizon of 10 years was used to conduct the comparative pharmacoeconomic analysis. The following were used as reference data for the calculations: drug prices, as registered in the VED [Vital Essential Drugs]; earlier publications on the cost of complications; and data on treatment outcomes and hypoglycaemia rates in comparator groups from the JADE modelling study, based upon the data from clinical study 024 for the Russian patient population.

Results: Total medical expenditures for one patient came to 449,927 rubles in the sitabliptin+metformin group, and 415,385 rubles in the sulfonylurea+metformin group – a difference of 7.7%. Within this, the share of costs for the actual drugs was 53% and 11%, respectively, indicating a greater burden due to longterm consequences (hypoglycaemia, complications from type 2 diabetes, transitioning to insulin) for the sulfonylurea group. When converted to 10,000 patients, the cost of the drugs in the sitagliptin group was 2,149 million rubles higher, and the expenditures for complications, including hypoglycaemia and insulin therapy, were 1,559 million rubles lower. Thus, in the sitagliptin group – unlike the sulfonylurea group – 410,000 cases of hypoglycaemia were prevented, as well as 40 cases of macro- and microvascular complications. Conclusion: the results suggest that the combination use of sitagliptin + metformin is pharmacoeconomically justified when compared to sulfonylurea + metformin to treat type 2 diabetes patients.

Kulikov A.Y. 1576

During the pharmacoeconomic analysis of axitinib use as a secondline therapy for mRCC, it was found that this target therapy regimen would significantly increase the time to progression, overall survival and annual survival rate. Despite the high cost of this treatment regimen at the horizon of ten year study, the treatment regimen including axitinib characterized by the lowest values of the cost-effectiveness ratio, reflecting the costs incurred by the health care system for patient’s life saving, and increme

Komarov E.A., Kulikov A.Y. 1590

Mantle cell lymphoma (MCL) accounts for approximately 2% to 10% of the total number of lymphatic system tumours, the incidence rate in Western Europe and Scandinavia is approximately 0,5/100 000 people. Most MCL cases are aggressive lymphomas, and overall survival is in the range of 3 to 5 years, while the disease is characterized by a short time to progression. The objective of this study was to determine the better treatment option between temsirolimus and ibrutinib in the treatment of MCL, in terms of pharmacoeconomic analysis, by means of comparative cost-effectiveness assessment. The cost-effectiveness results obtained in this temsirolimus versus ibrutinib comparative study demonstrated that ibrutinib therapy was associated with lower cost per effectiveness unit when life years gained and quality-adjusted life years were utilized as effectiveness criteria. Obtained budget impact analysis results revealed that ibrutinib therapy resulted in budget saving.

Kulikov A.Y., Serpik V.G., Yagudina R.I. 1506

Currently the health care system of the Russian Federation has gone through the stages of systematic changes to meet the modern requirements and realize the settled objectives. However, the mentioned changes are not only limited to the incorporation of innovative prophylactic, medical-diagnostic and rehabilitative technologies but they mainly affect the areas of management and decision-making in the health system. One of the most important tips in the health system management is the development of rules/algorithms including medical technologies in public health programs. Taking into account the ongoing public deliberations on the draft of the rules on forming the lists of medicines, it’s an actual point to submit to the professional community the author’s vision on the algorithm of decision-making in regard to the inclusion/exclusion of medicines in public programs/lists on the basis of pharmacoeconomic assessment. The offered algorithm of the article involves two stages. The goal of the first stage is the expertise on the pharmacoeconomic assessment of the considered medicament. The requirements applicable to the pharmacoeconomic research of the considered medicine are designed and introduced in the scopes of the expertise. The second stage applies to the actual decision-making algorithm based on the pharmacoeconomic assessment (in the case of the expertise is conducted). The algorithm is a list of strict formal rules interpreting the outcomes of pharmacoeconomic assessments. The rules are seen as sufficient conditions to deliver a recommendation for the approval or refusal on including/ leaving of the medicine in the public program of medicine supply.

Zinchuk I.Y., Kulikov A.Y., Pavlov P.V. 1519

During the pharmacoeconomic analysis of Crizotinib use as a firstline chemotherapy for ALK-positive non-small cell lung cancer (NSCLC), based on the results of Markov models, it was found that this chemotherapy regimen would significantly increase the time to progression and the overall survival, with an annual survival rate of 73%, 43% and 21% of patients following the first, second and third year of treatment, respectively. Despite the high cost of this treatment regimen, reaching 5,262,681 rubles at the horizon of ten year study, the treatment regimen including Crizotinib will be characterized by the lowest values of the cost-effectiveness ratio, reflecting the costs incurred by the health care system for patient’s life saving. Thus, Crizotinib use as firstline of chemotherapy in patients with ALK-positive NSCLC is the most preferable treatment regimen from a pharmacoeconomic point of view

Kulikov A.Y., Litvinenko M.M. 1439

Summary: Pharmacoeconomic analysis is a flexible tool for the decision-making on different levels in the healthcare system: from the individual patient level to the regional and federal levels. The actuality of such an analysis becomes more and more apparent in the healthcare marked by the annual increase in the implemented and published studies in this area. However, such an increase in evaluations doesn’t guarantee the proportional growth in terms of their quality and complexity. This article focuses on the opportunities of pharmacoeconomic researches, as well as on the usual inaccuracies in the pharmacoeconomic studies in Russia.

Kulikov A.Y., Ursu E.P. 1439

Main points on financing of healthcare at the regional level are presented, the interrelation between expenditures of regional budgets and the working-age mortality, between the average duration of one case of the temporary disability and the level of public satisfaction with the quality of healthcare is showed. A brief description of the analysis was performed, the types of behavior were highlighted, the results were presented and common trends were emphasized.

Kulikov A.Y., Rybchenko Y.V. 1380

Breast cancer is a global problem due to its wide prevalence which is increasing every year. The comparative pharmacoeconomic study of Herceptin in subcutaneous and intravenous formulations was conducted for optimization of drug supply for this nosology. Direct medical expenses without taking into account the drug price were compared. As a result of pharmacoeconomic evaluation of the alternative treatment options, it was established that subcutaneous Herceptin saves 39,806 roubles per patient during one treatment year due to the cost differences related to administration, medical staff, as well as hospitalization. Moreover, when IV formulation is used for one treatment year per patient, the medicinal substance is lost due to « throwing out» the remaining part of the drug in the vial, which may not be used in connection with breach of sterile dosage forms. The loss is as high as 166,208 roubles; this translates into 11% monetary loss from the whole treatment cycle.

Babiy V.V., Kulikov A.Y. 1401

In this study, a pharmacoeconomic analysis of chronic lymphocytic leukemia therapy in previously untreated patients was conducted, using treatment regimens obinutuzumab (Gazyva) + chlorambucil and rituximab +chlorambucil. The results of the study showed that though the costs of the first treatment course with obinutuzumab + chlorambucil are significantly higher, this regimen reduces the cumulative cost of subsequent therapy lines in patients with CLL (due to a longer progression-free survival). In the end of the third year of therapy, cumulative costs become relatively similar: with the use of the obinutuzumab + chlorambucil regimen, the cumulative cost per 1 patient/year will be 38,390 rubles higher compared to the rituximab + chlorambucil regimen. At the same time, the obinutuzumab regimen showed a lower cost-effectiveness ratio, i.e. it had an advantage over the alternative technology.

Kulikov A.Y., Pochuprina A.A. 1383

In this study we conducted pharmacoeconomic assessment of the use of canakinumab in patients with cryopyrin-associated periodic syndromes (CAPS) versus the symptomatic treatment alone. Incidence of remission in the treatment group was selected as the efficacy endpoint, and superior efficacy of canakinumab was demonstrated in the treatment group as compared to the symptomatic treatment. Based on cost-effectiveness analysis, it was determined that canakinumab treatment required considerable expenses; however, due to the small number of patients the impact on overall budget will be insignificant. It should also be noted that the treatment with this medicinal product will help reduce the costs of out-patient and policlinic care, in-patient medical care, as well as administration-related and complications management costs.

Kulikov A.Y., Rybchenko Y.V. 1350

A pharmacoeconomic study of the treatment of phenylketonuria (PHU) treatment using Kuvan drug product combined with the diet or dietary therapy alone has been conducted. It has been established that the therapy is dominant in the first case when compared to the second case because it shows better therapeutic effectiveness and is characterized by a lower cost–effectiveness ratio. It has also been determined that the addition of Kuvan to the dietary therapy requires additional costs of 11,569,761 RUB per one patient over 16 years. Despite the increase in the costs linked to the use of the new and only drug for the treatment of PKU, the overall effect on the budget will be decreased due to the low prevalence of the disease.

Komarov E.A., Kulikov A.Y. 1329

Although there have been improvements in the detection and treatment of breast cancer (BC) it remains the most common cancer in women and oneof the leading causes of death. In Western Europe and North America, breast cancer is the leading cause of death among women aged 35 to 54 years (20%), and the second leading cause of death in women aged over 55 years exceeded only by cardiovascular diseases. Breast cancer incidence increases with age, beginning from 40 years, with a peak at 60 to 65 years. The objective of this study was to determine, from the pharmacoeconomic point of view, the preferred treatment regimen (Kadcyla, lapatinib + capecitabine, trastuzumab + capecitabine, capecitabine), used in the treatment of HER2-positive breast cancer, on the basis of comparison of cost-effectiveness ratio, safety and life quality. The use of Kadcyla in the treatment of patients with HER2-positive breast cancer resulted in the highest values of life years gained and quality adjusted life years in comparison with lapatinib + capecitabine, trastuzumab + capecitabine, or capecitabine regimen. According to the results of the costeffectiveness analysis and cost-utility analysis it was found that the therapy with Kadcyla required higher costs to achieve LYG and QALY compared to those of the treatment regimens with the use of lapatinib + capecitabine, trastuzumab + capecitabine, and capecitabine, respectively. Incremental ratios in both analyses are higher than the willingness to pay threshold values for the Russian Federation.

Komarov E.A., Kulikov A.Y. 1280

Breast cancer (BC) is the most common type of cancer in women and one of the leading causes of death among women worldwide, including our country. According to the World Health Organization, over 11,000,000 women with diagnosed BC receive care and treatment worldwide. Each year approximately 1,200,000 new cases of breast cancer are registered and more than 500,000 women die, and it is estimated that the incidents will increase up to 1,450,000. The objective of this study was to determine a treatment regimen (pertuzumab+trastuzumab+docetaxel or placebo+trastuzumab+docetaxel) more advantageous from the pharmacoeconomic point of view, used in the treatment of HER2+ metastatic breast cancer (mBC), on the basis of comparison of costeffectiveness ratio, safety and life quality. The results of the cost-effectiveness analysis showed that cost-effectiveness ratios (effectiveness criterion – Life Years Gained, LYG) were as follows (over a period of 25 years: 1,823,530 rubles in the pertuzumab+trastuzumab+docetaxel group and 587,120 rubles in the placebo+trastuzumab+docetaxel group. The incremental costeffectiveness ratio for the health technologies compared was 8,150,535 rubles/LYG. The results of the cost-utility analysis showed that the cost-utility ratios (utility criterion – Quality Adjusted Life Years, QALY) were as follows (over a period of 25 years): 2,716,738 rubles in the pertuzumab+trastuzumab+docetaxel group and 908,787 rubles in the placebo+trastuzumab+docetaxel group. The incremental cost-effectiveness ratio for the health technologies compared was 10,187,748 rubles/QALY. The results of the budget impact analysis demonstrated that for the Perjeta-trastuzumab-docetaxel treatment regimen, the difference in the required budgetary funds was 5,711,668 rubles in comparison with the placebo-trastuzumab-docetaxel treatment regimen per treatment of one patient with BC (over a period of 25 years).

Kulikov A.Y., Protsenko M.V. 1299

Chronic myelogenous leukemia (CML) is among the nosologies included in the governmental program for supply of medicines to patients with hemophilia, mucoviscidosis, pituitary dwarfism, Gaucher disease, malignant neoplasms in lymphoid, hematopoietic and related tissues, multiple sclerosis, and also after organ and (or) tissue transplantation. Only one medicine, imatinib, is currently available to CML patients within this program. However, 20% to 35% of CML patients have intolerance or develop resistance to imatinib. Therefore, this patient group should receive treatment with the second-generation tyrosine-kinase inhibitors, in particular dasatinib. Pharmacoeconomic analysis is required for dasatinib to be included in the list of expensive medicinal products. This pharmacoeconomic study investigates the use of dasatinib as a second-line CML therapy, based on «cost-effectiveness» and «budget impact» analysis. The study demonstrated that in terms of cost-effectiveness analysis, dasatinib is a strictly preferred alternative as compared to the high doses of imatinib. Moreover, taking into account consumption rate of dasatinib in the real world settings, it is possible to provide treatment to 100% of patients with resistance and/or intolerance to imatinib without additional funding above the total federal budget for CML treatment in 2014.

Babiy V.V., Kulikov A.Y. 1301

The aim of this study was to determine optimal medical technique based on assessing cost and efficacy of treatment of von Willebrand disease using blood clotting factor concentrates (blood clotting factor VIII + von Willebrand factor): Wilate, Haemate P, Immunate. It was determined that in studies on assessing the efficiency of the concentrates more than 95% of patients rated hemostasis excellent/good. However, the studies were based on different scales of efficiency assessment, different vWF:RСo doses and different data for vWD patients (severity of the disease), therefore the efficiency of blood clotting factor concentrates might be not equal. Results of present study with the assumption about equality of groups, that were analyzed in studies on assessing the efficiency of the concentrates (although, studies on Wilate included more severe patients),evidence that prescribing blood clotting factor concentrate Wilate lead to cost savings compared to the older generation products.

Kulikov A.Y., Rybchenko Y.V. 1239

Follicular lymphoma is a disease requiring effective therapy that helps to improve a patient’s quality of life. In this study, a comparative analysis of subcutaneous administration of MabThera versus intravenous MabThera was performed. Considering that the formulations are equally effective, a cost minimization analysis was carried out, which showed that transition from intravenous to subcutaneous MabThera resulted in savings of 35,847 rubles per one patient during the treatment course due to the decreased drug administration expenses, medical staff costs, and expenses for hospitalization or day-time staying. The use of the subcutaneous formulation can also prevent economic damage caused by loss of the drug remaining in the vial with the use of the intravenous formulation where the dose depends on the body surface area.

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Kulikov A.Y., Serpik V.G., Yagudina R.I. 1506

Currently the health care system of the Russian Federation has gone through the stages of systematic changes to meet the modern requirements and realize the settled objectives. However, the mentioned changes are not only limited to the incorporation of innovative prophylactic, medical-diagnostic and rehabilitative technologies but they mainly affect the areas of management and decision-making in the health system. One of the most important tips in the health system management is the development of rules/algorithms including medical technologies in public health programs. Taking into account the ongoing public deliberations on the draft of the rules on forming the lists of medicines, it’s an actual point to submit to the professional community the author’s vision on the algorithm of decision-making in regard to the inclusion/exclusion of medicines in public programs/lists on the basis of pharmacoeconomic assessment. The offered algorithm of the article involves two stages. The goal of the first stage is the expertise on the pharmacoeconomic assessment of the considered medicament. The requirements applicable to the pharmacoeconomic research of the considered medicine are designed and introduced in the scopes of the expertise. The second stage applies to the actual decision-making algorithm based on the pharmacoeconomic assessment (in the case of the expertise is conducted). The algorithm is a list of strict formal rules interpreting the outcomes of pharmacoeconomic assessments. The rules are seen as sufficient conditions to deliver a recommendation for the approval or refusal on including/ leaving of the medicine in the public program of medicine supply.

Zinchuk I.Y., Kulikov A.Y., Pavlov P.V. 1519

During the pharmacoeconomic analysis of Crizotinib use as a firstline chemotherapy for ALK-positive non-small cell lung cancer (NSCLC), based on the results of Markov models, it was found that this chemotherapy regimen would significantly increase the time to progression and the overall survival, with an annual survival rate of 73%, 43% and 21% of patients following the first, second and third year of treatment, respectively. Despite the high cost of this treatment regimen, reaching 5,262,681 rubles at the horizon of ten year study, the treatment regimen including Crizotinib will be characterized by the lowest values of the cost-effectiveness ratio, reflecting the costs incurred by the health care system for patient’s life saving. Thus, Crizotinib use as firstline of chemotherapy in patients with ALK-positive NSCLC is the most preferable treatment regimen from a pharmacoeconomic point of view

Kulikov A.Y., Novikov I.V. 1780

The goal of this analysis is to evaluate the incremental cost-utility of insulin degludec compared with glargine in patients with type 2 diabetes receiving basal-only therapy in addition to metformin as per prescribing conditions in the Russia. Total medical costs and effectiveness in terms of QALY were collected and analysed for insulin degludec and insulin glargine, both in combination with metformin. Sources of data: the effectiveness - the analysis of publications of clinical studies, drug prices - register for the prices of the VED, the cost of health care resources - standard providing outpatient services. Results: The analysis illustrates that insulin degludec for type 2 diabetes provides a significant health improvement expressed in quality adjusted lifeyears. The ICUR of insulin degludec in combination with metformin compared to insulin glargine, both added to metformin was estimated at 337 112 rub for QALY which demonstrates its cost-effectiveness.

Kulikov A.Y., Litvinenko M.M. 1439

Summary: Pharmacoeconomic analysis is a flexible tool for the decision-making on different levels in the healthcare system: from the individual patient level to the regional and federal levels. The actuality of such an analysis becomes more and more apparent in the healthcare marked by the annual increase in the implemented and published studies in this area. However, such an increase in evaluations doesn’t guarantee the proportional growth in terms of their quality and complexity. This article focuses on the opportunities of pharmacoeconomic researches, as well as on the usual inaccuracies in the pharmacoeconomic studies in Russia.

Kulikov A.Y., Ugrekhelidze D.T. 1542

According to the World Health Organization, the prevalence of post-stroke spasticity is 200 people per 100 thousand inhabitants and the total number of patients in the world exceeds 12 million people. Approximately 450 000 people have a cerebrovascular accident (CVA) annually in the Russian Federation and the post-stroke spasticity is developed in about one third of the survivors. The main goal of this study is to conduct pharmacoeconomic analysis of three bestselling in the Russian Federation botulinum toxin type A preparations - Dysport®, Botox®, Xeomin compared with standard therapy without botulinum toxin type A. According to the conducted cost-effectiveness analysis where Modified Ashworth scale score is used as a main outcome Dysport® is a dominated alternative compared with other studied therapy schemes. What is more, budget impactanalysis shows that therapy with Dysport® during one year leads to the saving of 45 563 rubles compared with Botox® and saving of 44 408 rubles compared with Xeomin per one patient.

Arinina E.E., Kulikov A.Y., Novikov I.V., Tolkushin A.G. 1629

Study objective: To perform a comparative pharmacoeconomic analysis of the therapy combinations: sitagliptin with metformin, and sulfonylureas with metformin in patients with type 2 diabetes on metformin monotherapy whose target glycemic goal is not reached with diet and exercise.

Materials and methods: A time horizon of 10 years was used to conduct the comparative pharmacoeconomic analysis. The following were used as reference data for the calculations: drug prices, as registered in the VED [Vital Essential Drugs]; earlier publications on the cost of complications; and data on treatment outcomes and hypoglycaemia rates in comparator groups from the JADE modelling study, based upon the data from clinical study 024 for the Russian patient population.

Results: Total medical expenditures for one patient came to 449,927 rubles in the sitabliptin+metformin group, and 415,385 rubles in the sulfonylurea+metformin group – a difference of 7.7%. Within this, the share of costs for the actual drugs was 53% and 11%, respectively, indicating a greater burden due to longterm consequences (hypoglycaemia, complications from type 2 diabetes, transitioning to insulin) for the sulfonylurea group. When converted to 10,000 patients, the cost of the drugs in the sitagliptin group was 2,149 million rubles higher, and the expenditures for complications, including hypoglycaemia and insulin therapy, were 1,559 million rubles lower. Thus, in the sitagliptin group – unlike the sulfonylurea group – 410,000 cases of hypoglycaemia were prevented, as well as 40 cases of macro- and microvascular complications. Conclusion: the results suggest that the combination use of sitagliptin + metformin is pharmacoeconomically justified when compared to sulfonylurea + metformin to treat type 2 diabetes patients.

Kulikov A.Y., Novikov I.V. 1715

Study purpose: To determine preferential medicinal products for the treatment of diabetes mellitus type 2 in terms of pharmacoeconomic analysis based on comparative cost and efficacy, safety and quality of life ratio between the modern insulin analogues.

Materials and methods: Study design – retrospective, modeling. Methods of pharmacoeconomic analysis - cost-effectiveness, costutility. Alternatives compared – insulin aspart (NovoRapid®), insulin lispro (Humalog®), insulin glulisine (Apidra®), premix insulin aspart 30/70 (NovoMix® 30), premix insulin lispro 25/75 (HumalogMix® 25), insulin detemir (Levemir®) and insulin glargine (Lantus®).

Data sources: efficacy – analysis of publications on clinical studies performed; medicinal product prices – registry of quoted prices for vital and essential medicines; cost of healthcare resources – outpatient and polyclinical assistance standards.

Study results: Among short-acting insulin analogues, CER value was 1091.84 rub.; 1133.55 rub. and 1175,27 rub. for NovoRapid®, Humalog® and Apidra®, respectively. Among premix insulin analogues, CER value was 1418.47 rub. for NovoMix® 30 and 1512.08 rub. for HumalogMix® 25. Among basal insulin analogues CER value was 2084.39 rub. for Levemir® and 2471.23 rub. – for Lantus®. Costutility analysis for NovoRapid®, Humalog®, Apidra®, NovoMix® 30, HumalogMix® 25, Levemir® and Lantus® CUR value was 84463.04 rub., 87689.69 rub., 90917.35 rub., 99573.21 rub., 106144.38 rub., 79269.45 rub. and 93981.16 rub. for 1 QALY, respectively. Therefore, in terms of costutility, when insulins were added to OAD treatment, NovoRapid® is the preferable drug because of the lowest CUR value. Among premix and basal insulin analogues, NovoMix® 30 and Levemir® were preferable drugs because of the lowest CUR values in their group.

Kulikov A.Y. 1576

During the pharmacoeconomic analysis of axitinib use as a secondline therapy for mRCC, it was found that this target therapy regimen would significantly increase the time to progression, overall survival and annual survival rate. Despite the high cost of this treatment regimen at the horizon of ten year study, the treatment regimen including axitinib characterized by the lowest values of the cost-effectiveness ratio, reflecting the costs incurred by the health care system for patient’s life saving, and increme

Kulikov A.Y., Rybchenko Y.V. 1380

Breast cancer is a global problem due to its wide prevalence which is increasing every year. The comparative pharmacoeconomic study of Herceptin in subcutaneous and intravenous formulations was conducted for optimization of drug supply for this nosology. Direct medical expenses without taking into account the drug price were compared. As a result of pharmacoeconomic evaluation of the alternative treatment options, it was established that subcutaneous Herceptin saves 39,806 roubles per patient during one treatment year due to the cost differences related to administration, medical staff, as well as hospitalization. Moreover, when IV formulation is used for one treatment year per patient, the medicinal substance is lost due to « throwing out» the remaining part of the drug in the vial, which may not be used in connection with breach of sterile dosage forms. The loss is as high as 166,208 roubles; this translates into 11% monetary loss from the whole treatment cycle.

Kulikov A.Y., Ursu E.P. 1439

Main points on financing of healthcare at the regional level are presented, the interrelation between expenditures of regional budgets and the working-age mortality, between the average duration of one case of the temporary disability and the level of public satisfaction with the quality of healthcare is showed. A brief description of the analysis was performed, the types of behavior were highlighted, the results were presented and common trends were emphasized.

Kulikov A.Y., Rybchenko Y.V. 1350

A pharmacoeconomic study of the treatment of phenylketonuria (PHU) treatment using Kuvan drug product combined with the diet or dietary therapy alone has been conducted. It has been established that the therapy is dominant in the first case when compared to the second case because it shows better therapeutic effectiveness and is characterized by a lower cost–effectiveness ratio. It has also been determined that the addition of Kuvan to the dietary therapy requires additional costs of 11,569,761 RUB per one patient over 16 years. Despite the increase in the costs linked to the use of the new and only drug for the treatment of PKU, the overall effect on the budget will be decreased due to the low prevalence of the disease.

Komarov E.A., Kulikov A.Y. 1590

Mantle cell lymphoma (MCL) accounts for approximately 2% to 10% of the total number of lymphatic system tumours, the incidence rate in Western Europe and Scandinavia is approximately 0,5/100 000 people. Most MCL cases are aggressive lymphomas, and overall survival is in the range of 3 to 5 years, while the disease is characterized by a short time to progression. The objective of this study was to determine the better treatment option between temsirolimus and ibrutinib in the treatment of MCL, in terms of pharmacoeconomic analysis, by means of comparative cost-effectiveness assessment. The cost-effectiveness results obtained in this temsirolimus versus ibrutinib comparative study demonstrated that ibrutinib therapy was associated with lower cost per effectiveness unit when life years gained and quality-adjusted life years were utilized as effectiveness criteria. Obtained budget impact analysis results revealed that ibrutinib therapy resulted in budget saving.

Babiy V.V., Kulikov A.Y. 1791

The aim of this study was to determine the optimal medical technique of treatment of human immunodeficiency virus (HIV) infected adults with HIV-1 RNA<100 000 copies/ml by assessing costs and effectiveness of highly active antiretroviral therapy: rilpivirine/ tenofovir/ emtricitabine (single tablet regimen (STR)), efavirenz + tenofovir/ emtricitabine (multi-pill regimen), lopinavir + tenofovir/ emtricitabine (multi-pill regimen). The obtained results have demonstrated that prescription of rilpivirine-containing combined Highly Active Antiretroviral Therapy (HAART) (STR) is associated with additional costs on ambulatory treatment, that are overlaid by lower costs (direct and indirect) on new persons with HIV, infected by the analyzed group. Therefore, cost savings, as compared to mentioned schemes of HAART, accompany prescription of the scheme rilpivirine/ tenofovir/ emtricitabine (Eviplera), according to the «budget impact» analysis.

Kulikov A.Y., Rybchenko Y.V. 1239

Follicular lymphoma is a disease requiring effective therapy that helps to improve a patient’s quality of life. In this study, a comparative analysis of subcutaneous administration of MabThera versus intravenous MabThera was performed. Considering that the formulations are equally effective, a cost minimization analysis was carried out, which showed that transition from intravenous to subcutaneous MabThera resulted in savings of 35,847 rubles per one patient during the treatment course due to the decreased drug administration expenses, medical staff costs, and expenses for hospitalization or day-time staying. The use of the subcutaneous formulation can also prevent economic damage caused by loss of the drug remaining in the vial with the use of the intravenous formulation where the dose depends on the body surface area.

Komarov E.A., Kulikov A.Y. 1329

Although there have been improvements in the detection and treatment of breast cancer (BC) it remains the most common cancer in women and oneof the leading causes of death. In Western Europe and North America, breast cancer is the leading cause of death among women aged 35 to 54 years (20%), and the second leading cause of death in women aged over 55 years exceeded only by cardiovascular diseases. Breast cancer incidence increases with age, beginning from 40 years, with a peak at 60 to 65 years. The objective of this study was to determine, from the pharmacoeconomic point of view, the preferred treatment regimen (Kadcyla, lapatinib + capecitabine, trastuzumab + capecitabine, capecitabine), used in the treatment of HER2-positive breast cancer, on the basis of comparison of cost-effectiveness ratio, safety and life quality. The use of Kadcyla in the treatment of patients with HER2-positive breast cancer resulted in the highest values of life years gained and quality adjusted life years in comparison with lapatinib + capecitabine, trastuzumab + capecitabine, or capecitabine regimen. According to the results of the costeffectiveness analysis and cost-utility analysis it was found that the therapy with Kadcyla required higher costs to achieve LYG and QALY compared to those of the treatment regimens with the use of lapatinib + capecitabine, trastuzumab + capecitabine, and capecitabine, respectively. Incremental ratios in both analyses are higher than the willingness to pay threshold values for the Russian Federation.

Komarov E.A., Kulikov A.Y. 1280

Breast cancer (BC) is the most common type of cancer in women and one of the leading causes of death among women worldwide, including our country. According to the World Health Organization, over 11,000,000 women with diagnosed BC receive care and treatment worldwide. Each year approximately 1,200,000 new cases of breast cancer are registered and more than 500,000 women die, and it is estimated that the incidents will increase up to 1,450,000. The objective of this study was to determine a treatment regimen (pertuzumab+trastuzumab+docetaxel or placebo+trastuzumab+docetaxel) more advantageous from the pharmacoeconomic point of view, used in the treatment of HER2+ metastatic breast cancer (mBC), on the basis of comparison of costeffectiveness ratio, safety and life quality. The results of the cost-effectiveness analysis showed that cost-effectiveness ratios (effectiveness criterion – Life Years Gained, LYG) were as follows (over a period of 25 years: 1,823,530 rubles in the pertuzumab+trastuzumab+docetaxel group and 587,120 rubles in the placebo+trastuzumab+docetaxel group. The incremental costeffectiveness ratio for the health technologies compared was 8,150,535 rubles/LYG. The results of the cost-utility analysis showed that the cost-utility ratios (utility criterion – Quality Adjusted Life Years, QALY) were as follows (over a period of 25 years): 2,716,738 rubles in the pertuzumab+trastuzumab+docetaxel group and 908,787 rubles in the placebo+trastuzumab+docetaxel group. The incremental cost-effectiveness ratio for the health technologies compared was 10,187,748 rubles/QALY. The results of the budget impact analysis demonstrated that for the Perjeta-trastuzumab-docetaxel treatment regimen, the difference in the required budgetary funds was 5,711,668 rubles in comparison with the placebo-trastuzumab-docetaxel treatment regimen per treatment of one patient with BC (over a period of 25 years).

Kulikov A.Y., Serpik V.G. 1204

Pharmacoeconomic study comparing luteinizing hormonereleasing hormone agonists (LHRH-A), used for prostate cancer treatment was conducted. The study included drugs: buserelin, goserelin, triptorelin and leuprorelin. Pharmacoeconomic study included the following methods:cost analysis, cost-effectiveness analysis, cost minimization analysis and budget impact analysis. The time horizon for cost analysis, cost minimization analysis and budget impact analysis amounted to 1 year, whereas for costeffectiveness analysis it was equal to 6 months. Direct costs were taken into account. As a result, it was found that annual costs for the treatment of one patient for each of the considered drugs (buserelin, goserelin, triptorelin and leuprorelin) respectively accounted for 55 169 rubles, 90 130 rubles, 90 133 rubles и 94 599 rubles. Results of the budget impact analysis showed that the annual budget per patient using drug therapy buserelin, goserelin, triptorelin and leuprorelin respectively amounted to 129 545 rubles, 164 506 rubles, 164 509 rubles and 168 974 rubles. Cost minimization analysis demonstrated that under the assumption of equal clinical effectiveness review of medications, annual treatment of one patient using buserelin is characterized with 34 961 rubles compared with goserelin and 39 430 rubles compared with leuprorelin. Cost-effectiveness analysis using the criterion of decreasing the prostatespecific antigen (PSA) level, it was found that buserelin is characterized with the greatest rate of decrease in the PSA value, so it has the smallest value of the cost-effectiveness ratio and, thus, relative to the comparison drugs is strictly preferred drug.

Kulikov A.Y., Pochuprina A.A. 1383

In this study we conducted pharmacoeconomic assessment of the use of canakinumab in patients with cryopyrin-associated periodic syndromes (CAPS) versus the symptomatic treatment alone. Incidence of remission in the treatment group was selected as the efficacy endpoint, and superior efficacy of canakinumab was demonstrated in the treatment group as compared to the symptomatic treatment. Based on cost-effectiveness analysis, it was determined that canakinumab treatment required considerable expenses; however, due to the small number of patients the impact on overall budget will be insignificant. It should also be noted that the treatment with this medicinal product will help reduce the costs of out-patient and policlinic care, in-patient medical care, as well as administration-related and complications management costs.

Babiy V.V., Kulikov A.Y. 1401

In this study, a pharmacoeconomic analysis of chronic lymphocytic leukemia therapy in previously untreated patients was conducted, using treatment regimens obinutuzumab (Gazyva) + chlorambucil and rituximab +chlorambucil. The results of the study showed that though the costs of the first treatment course with obinutuzumab + chlorambucil are significantly higher, this regimen reduces the cumulative cost of subsequent therapy lines in patients with CLL (due to a longer progression-free survival). In the end of the third year of therapy, cumulative costs become relatively similar: with the use of the obinutuzumab + chlorambucil regimen, the cumulative cost per 1 patient/year will be 38,390 rubles higher compared to the rituximab + chlorambucil regimen. At the same time, the obinutuzumab regimen showed a lower cost-effectiveness ratio, i.e. it had an advantage over the alternative technology.

Babiy V.V., Kulikov A.Y. 1301

The aim of this study was to determine optimal medical technique based on assessing cost and efficacy of treatment of von Willebrand disease using blood clotting factor concentrates (blood clotting factor VIII + von Willebrand factor): Wilate, Haemate P, Immunate. It was determined that in studies on assessing the efficiency of the concentrates more than 95% of patients rated hemostasis excellent/good. However, the studies were based on different scales of efficiency assessment, different vWF:RСo doses and different data for vWD patients (severity of the disease), therefore the efficiency of blood clotting factor concentrates might be not equal. Results of present study with the assumption about equality of groups, that were analyzed in studies on assessing the efficiency of the concentrates (although, studies on Wilate included more severe patients),evidence that prescribing blood clotting factor concentrate Wilate lead to cost savings compared to the older generation products.

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Professor of the Department of organization of drug supply and pharmacoeconomics, leading researcher pharmacoeconomic studies of the Laboratory Research Institute of Pharmacy, First MGMU them. IM Sechenov. Moscow, Russia