Makarova Elena Ivanovna

Arinina E.E., Makarova E.I., Tolordava G.A. 1207

For many years antiplatelet therapy is the basis for the prevention of cardiovascular diseases. Acetylsalicylic acid is the “gold standard” among all antiplatelet drugs. However, ASA administration has an adverse effect in the form of development of NSAID-induced gastropathy To reduce this effect various forms of production of medicines ASA are used. In this study the pharmacoeconomic assessment of drugs Thrombo ASS, Cardiomagnyl and Aspirin Cardio in patients with previous cardiovascular diseases was conducted. According to the results of conducted cost-minimization analysis determined that the treatment scheme with the use of Thrombo ASS is characterized by the lowest cost compared with Cardiomagnyl and Aspirin Cardio. The results of the budget impact analysis suggest that therapy drugs Thrombo ASS leads to budget savings up to 33 million rubles calculated for all patients with cardiovascular diseases in Moscow compared with alternatives.

Abdrashitova G.T., Makarova E.I., Rybchenko Y.V., Ugrekhelidze D.T. 1085

Abstract: Main presentations and educational seminars which took place during Annual European congress of International Society For Pharmacoeconomics and Outcomes Research (ISPOR) are covered.

Kulikov A.Y., Makarova E.I. 597

The treatment of multiple sclerosis (MS) is a formidable healthcare challenge the world over. Because MS is a progressive chronic disease, patients living with this diagnosis require treatment for life. The high prevalence of the disease among young people significantly affects patients’ quality of life and exacerbates the socioeconomic burden of the disease. Glatiramer acetate (Copaxone) is a synthetic analogue of the myelin protein that can influence MS pathogenesis with its immunomodulatory and neuroprotective effect. Copaxone has been continuously, safely used in clinical practice for more than 20 years. In terms of tolerance of Copaxone, the main challenge has been the adverse injection reactions associated with daily subcutaneous injection of a 20 mg/mL dose of the drug. To address this, a new pharmaceutical form was developed – Copaxone 40 mg/mL, which requires subcutaneous injection only three times a week. Both dosage regimens have comparable clinical efficacy, but differ in tolerance. Use of Copaxone 40 versus Copaxone 20 was associated with 50% fewer adverse injection reactions [11]. This suggested a need to conduct pharmacoeconomic research with the goal of producing a pharmacoeconomic assessment of Copaxone 40 versus Copaxone 20. The analysis that was conducted using the “cost minimization” analysis determined that the Copaxone 40 treatment method had lower associated costs than did the Copaxone 20 treatment method. The results of a budget impact analysis indicated that, if all patients in the RF [Russian Federation] currently receiving Copaxone 20 were to switch to therapy using the drug Copaxone 40, a cost savings of 812 million roubles would result in lower adverse reaction treatment costs. These savings would be due to the 209 fewer injections per patient per year that would be achieved by prescribing Copaxone 40, and consequently, the lower number of injection reactions.

Kulikov A.Y., Makarova E.I. 281

Psoriatic arthritis (PsA) can develop at any age and often affects the workingage population. In the course of the disease, physical activity of patients decreases, which leads to a drop in performance and absence from work due to treatment. If untreated, this can lead to disability and loss of function of the locomotive system structures. Strategy to combat PsA requires focus on the most effective prevention and control of both the progression of psoriasis, and arthritis associated therewith. It is equally important to minimize the risks associated with major organ toxicity and the development of side effects. In this context, the emergence of drugs for the treatment of psoriasis belonging to a new class of signaling pathways inhibitors seems to be highly relevant both from scientific and practical points of view. In general, biological products, which are antibodies that selectively bind to receptors or proteins on the extracellular membrane, block one biological marker (e.g., TNF-a, IL-17) participating in the immunopathogenesis of psoriasis, thus interrupting further inflammatory cascade of pathological processes leading to the formation of psoriatic efflorescence. Apremilast, which belongs to a new group of drugs - selective inhibitors of signaling pathways - has a fundamentally different mechanism of action. With targeted effect, the drug modulates intracellular signaling, eventually corresponding to the control of the expression of genes mediating key pro- and anti-inflammatory factors (e.g., release of cytokines) in myeloid, lymphoid and other cells involved in the “orchestration” of epidermis inflammation and hyperproliferation. The drug is administered orally, which eliminates additional costs for administering an injection, as is the case with biological drugs. The emergence of a new drug for the treatment of psoriatic arthritis, lack of proper control over the course of the disease, as well as limited healthcare system resources resulted in the pharmacoeconomic assessment of the priority drugs Apremilast compared to ustekinumab, adalimumab and infliximab using cost, cost-effectiveness and budget influence analysis methods. The cost analysis results showed that Apremilast treatment costs for the entire study period - 2 years - are on average 27% lower than the cost of treatment with ustekinumab, adalimumab and infliximab. Otezla treatment is characterized by a lower cost per unit of effectiveness - QALY, when considering the cost for the entire time horizon, as compared to Humira, Stelara and Remicade. Furthermore, the use of Apremilast leads to cost savings if administered for either 2 years or 1 year, in comparison with the alternative regimens.

Kulikov A.Y., Makarova E.I., Novikov I.V. 109

The most dangerous consequences of the global diabetes epidemic are diabetes-related complications. A wide variety of treatment options is currently available for patients with type 2 diabetes mellitus. However, the existing treatments have proven effective for no more than half of diabetic patients who managed to compensate the occurring complications, which is the reason for introducing novel glucose-lowering medicines into practice. Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of innovative medicines. Dapagliflozin was the first medicine in this group to be registered on the territory of Russia. Numerous trials have confirmed the efficacy of dapagliflozin at any stage of type 2 diabetes mellitus, both as monotherapy and in combination with metformin, sulfonylureas, dipeptidyl peptidase 4 inhibitors (iDPP-4) and insulin. Thus, the wide range of available glucose-lowering drugs, lack of adequate control over the disease and introduction of novel medicines warrant a new pharmacoeconomic study. The purpose of this study was to perform a pharmacoeconomic evaluation of dapagliflozin as a preferential medicine used to treat patients with type 2 diabetes mellitus, as compared to monotherapy or combined use of medicines of the sulfonylureas, metformin, glyptins, glyflozins and insulin group, by means of a cost analysis, and cost-effectiveness and budget impact analysis. Based on the results of the cost-effectiveness analysis, the dapagliflozin treatment scheme was reported to have the lowest cost of type 2 diabetes therapy to quality adjusted life-year (QALY) ratio compared to therapy regimens involving metformin, sulfonylureas, iDPP-4, basal and bolus insulins. The budget impact analysis demonstrated that treatment using Forxiga would result in budget savings of 31 million rubles over five years, if 1000 patients were to hypothetically switch over from other treatment regimens.

Kulikov A.Y., Makarova E.I. 111

The correct treatment of bronchial asthma is a difficult task not only for patients and healthcare professionals but for healthcare authorities as well. The economic burden of the disease is equal to the burden of diabetes mellitus and arterial hypertension. Nearly all indirect costs and not less than a third of direct costs of the treatment of the disease are related to management of exacerbations and poor asthma control. In recent years, there has been a considerable improvement in the treatment of asthma associated with emergence of new medicinal products and delivery devices. Unfortunately, not every patient is able to achieve the optimal disease management level. For this reason, technologies for creation of an effective treatment method for bronchial asthma are undergoing continual improvement nowadays. One of the solutions in this field was the development of inhaler devices producing extrafine aerosol with particle diameter under 2 µm. Such aerosols make it possible for inhalation medicines to reach the small airways, which are the principal site of inflammation in a number of bronchial asthma phenotypes (including bronchial asthma in smokers). The objective of this study was to determine the advantageous medicinal product for bronchial asthma using pharmacoeconomic analysis, on the basis of comparison between costs and effectiveness, safety, and quality of life in treatment with fixed combinations of inhaled glucocorticosteroids and long-acting β2agonists: medicinal products (MP) Foster®, Symbicort® Turbuhaler®, Seretide®, and Seretide® Multidisk. According to the results of the cost-utility analysis, it was determined that the therapy with Foster® is dominant and characterized by the lowest costs with reference to QALY compared to Symbicort® Turbuhaler® and is cost-effective compared to Seretide® and Seretide® Multidisk, on the basis of the obtained values of the incremental cost-utility analysis, which are significantly lower than the willingness-to-pay threshold in the Russian Federation. The budget impact analysis demonstrated that using Foster® for therapy results in budget savings compared to Symbicort® Turbuhaler®, Seretide®, and Seretide® Multidisk when transferring an additional number of patients (21 %) to Foster®.

Kulikov A.Y., Makarova E.I. 110

Control of bronchial asthma (BA) is a key principle of disease treatment. One of the factors resulting in uncontrolled BA is incorrect use of an inhalation device and, as a consequence, low adherence to therapy. According to research data, up to 94% of patients, depending on the type of delivery system, make mistakes during application, resulting in inconsistent dosage and reduced efficacy. These factors may contribute toward an increase in costs of the healthcare system and decrease in the quality of life of patients. For example, an unapproved change of the inhaler may lead to reduced BA control and, as a result, growing expenses for medical services despite lower initial costs of pharmacotherapy. Availability of a wide range of medications and devices for delivering them, as well as limited financial resources of the healthcare system inspired a pharmacoeconomic assessment of various schemes of BA therapy. According to the cost analysis results, the provided amounts of direct and indirect costs for one-year therapy with Symbicort® Turbuhaler® as the sole inhaler is on average 4.5% lower than the costs of treatment with DuoResp Spiromax®, Formisonid-Nativ®, Foradil Combi®, Foster®, Seretide® and Seretide® Multidisk®. A budget impact analysis demonstrated that switching of patients from therapy with budesonis/formoterol Turbuhaler® as the sole inhaler to therapy with DuoResp Spiromax®, Formisonid-Nativ®, Foradil Combi®, Foster®, Seretide® and Seretide® Multidisk® entails additional average budget expenditures of RUB 4 mln per annum due to increased hospitalization frequency per 106 cases, more frequent calls for ambulance per 364 cases, more frequent visits to outpatient settings and polyclinics per 180 cases, as well as more days of temporary disability per 1 862 days - every figure given per 1,000 patients with BA. It is, therefore, clinically and economically reasonable that patients initially receiving Symbicort® Turbuhaler® as a support maintenance therapy to continue therapy using the same medication.

Arinina E.E., Makarova E.I., Tolordava G.A. 1207

For many years antiplatelet therapy is the basis for the prevention of cardiovascular diseases. Acetylsalicylic acid is the “gold standard” among all antiplatelet drugs. However, ASA administration has an adverse effect in the form of development of NSAID-induced gastropathy To reduce this effect various forms of production of medicines ASA are used. In this study the pharmacoeconomic assessment of drugs Thrombo ASS, Cardiomagnyl and Aspirin Cardio in patients with previous cardiovascular diseases was conducted. According to the results of conducted cost-minimization analysis determined that the treatment scheme with the use of Thrombo ASS is characterized by the lowest cost compared with Cardiomagnyl and Aspirin Cardio. The results of the budget impact analysis suggest that therapy drugs Thrombo ASS leads to budget savings up to 33 million rubles calculated for all patients with cardiovascular diseases in Moscow compared with alternatives.

Abdrashitova G.T., Makarova E.I., Rybchenko Y.V., Ugrekhelidze D.T. 1085

Abstract: Main presentations and educational seminars which took place during Annual European congress of International Society For Pharmacoeconomics and Outcomes Research (ISPOR) are covered.

Kulikov A.Y., Makarova E.I. 597

The treatment of multiple sclerosis (MS) is a formidable healthcare challenge the world over. Because MS is a progressive chronic disease, patients living with this diagnosis require treatment for life. The high prevalence of the disease among young people significantly affects patients’ quality of life and exacerbates the socioeconomic burden of the disease. Glatiramer acetate (Copaxone) is a synthetic analogue of the myelin protein that can influence MS pathogenesis with its immunomodulatory and neuroprotective effect. Copaxone has been continuously, safely used in clinical practice for more than 20 years. In terms of tolerance of Copaxone, the main challenge has been the adverse injection reactions associated with daily subcutaneous injection of a 20 mg/mL dose of the drug. To address this, a new pharmaceutical form was developed – Copaxone 40 mg/mL, which requires subcutaneous injection only three times a week. Both dosage regimens have comparable clinical efficacy, but differ in tolerance. Use of Copaxone 40 versus Copaxone 20 was associated with 50% fewer adverse injection reactions [11]. This suggested a need to conduct pharmacoeconomic research with the goal of producing a pharmacoeconomic assessment of Copaxone 40 versus Copaxone 20. The analysis that was conducted using the “cost minimization” analysis determined that the Copaxone 40 treatment method had lower associated costs than did the Copaxone 20 treatment method. The results of a budget impact analysis indicated that, if all patients in the RF [Russian Federation] currently receiving Copaxone 20 were to switch to therapy using the drug Copaxone 40, a cost savings of 812 million roubles would result in lower adverse reaction treatment costs. These savings would be due to the 209 fewer injections per patient per year that would be achieved by prescribing Copaxone 40, and consequently, the lower number of injection reactions.

Kulikov A.Y., Makarova E.I. 281

Psoriatic arthritis (PsA) can develop at any age and often affects the workingage population. In the course of the disease, physical activity of patients decreases, which leads to a drop in performance and absence from work due to treatment. If untreated, this can lead to disability and loss of function of the locomotive system structures. Strategy to combat PsA requires focus on the most effective prevention and control of both the progression of psoriasis, and arthritis associated therewith. It is equally important to minimize the risks associated with major organ toxicity and the development of side effects. In this context, the emergence of drugs for the treatment of psoriasis belonging to a new class of signaling pathways inhibitors seems to be highly relevant both from scientific and practical points of view. In general, biological products, which are antibodies that selectively bind to receptors or proteins on the extracellular membrane, block one biological marker (e.g., TNF-a, IL-17) participating in the immunopathogenesis of psoriasis, thus interrupting further inflammatory cascade of pathological processes leading to the formation of psoriatic efflorescence. Apremilast, which belongs to a new group of drugs - selective inhibitors of signaling pathways - has a fundamentally different mechanism of action. With targeted effect, the drug modulates intracellular signaling, eventually corresponding to the control of the expression of genes mediating key pro- and anti-inflammatory factors (e.g., release of cytokines) in myeloid, lymphoid and other cells involved in the “orchestration” of epidermis inflammation and hyperproliferation. The drug is administered orally, which eliminates additional costs for administering an injection, as is the case with biological drugs. The emergence of a new drug for the treatment of psoriatic arthritis, lack of proper control over the course of the disease, as well as limited healthcare system resources resulted in the pharmacoeconomic assessment of the priority drugs Apremilast compared to ustekinumab, adalimumab and infliximab using cost, cost-effectiveness and budget influence analysis methods. The cost analysis results showed that Apremilast treatment costs for the entire study period - 2 years - are on average 27% lower than the cost of treatment with ustekinumab, adalimumab and infliximab. Otezla treatment is characterized by a lower cost per unit of effectiveness - QALY, when considering the cost for the entire time horizon, as compared to Humira, Stelara and Remicade. Furthermore, the use of Apremilast leads to cost savings if administered for either 2 years or 1 year, in comparison with the alternative regimens.

Kulikov A.Y., Makarova E.I., Novikov I.V. 109

The most dangerous consequences of the global diabetes epidemic are diabetes-related complications. A wide variety of treatment options is currently available for patients with type 2 diabetes mellitus. However, the existing treatments have proven effective for no more than half of diabetic patients who managed to compensate the occurring complications, which is the reason for introducing novel glucose-lowering medicines into practice. Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of innovative medicines. Dapagliflozin was the first medicine in this group to be registered on the territory of Russia. Numerous trials have confirmed the efficacy of dapagliflozin at any stage of type 2 diabetes mellitus, both as monotherapy and in combination with metformin, sulfonylureas, dipeptidyl peptidase 4 inhibitors (iDPP-4) and insulin. Thus, the wide range of available glucose-lowering drugs, lack of adequate control over the disease and introduction of novel medicines warrant a new pharmacoeconomic study. The purpose of this study was to perform a pharmacoeconomic evaluation of dapagliflozin as a preferential medicine used to treat patients with type 2 diabetes mellitus, as compared to monotherapy or combined use of medicines of the sulfonylureas, metformin, glyptins, glyflozins and insulin group, by means of a cost analysis, and cost-effectiveness and budget impact analysis. Based on the results of the cost-effectiveness analysis, the dapagliflozin treatment scheme was reported to have the lowest cost of type 2 diabetes therapy to quality adjusted life-year (QALY) ratio compared to therapy regimens involving metformin, sulfonylureas, iDPP-4, basal and bolus insulins. The budget impact analysis demonstrated that treatment using Forxiga would result in budget savings of 31 million rubles over five years, if 1000 patients were to hypothetically switch over from other treatment regimens.

Kulikov A.Y., Makarova E.I. 110

Control of bronchial asthma (BA) is a key principle of disease treatment. One of the factors resulting in uncontrolled BA is incorrect use of an inhalation device and, as a consequence, low adherence to therapy. According to research data, up to 94% of patients, depending on the type of delivery system, make mistakes during application, resulting in inconsistent dosage and reduced efficacy. These factors may contribute toward an increase in costs of the healthcare system and decrease in the quality of life of patients. For example, an unapproved change of the inhaler may lead to reduced BA control and, as a result, growing expenses for medical services despite lower initial costs of pharmacotherapy. Availability of a wide range of medications and devices for delivering them, as well as limited financial resources of the healthcare system inspired a pharmacoeconomic assessment of various schemes of BA therapy. According to the cost analysis results, the provided amounts of direct and indirect costs for one-year therapy with Symbicort® Turbuhaler® as the sole inhaler is on average 4.5% lower than the costs of treatment with DuoResp Spiromax®, Formisonid-Nativ®, Foradil Combi®, Foster®, Seretide® and Seretide® Multidisk®. A budget impact analysis demonstrated that switching of patients from therapy with budesonis/formoterol Turbuhaler® as the sole inhaler to therapy with DuoResp Spiromax®, Formisonid-Nativ®, Foradil Combi®, Foster®, Seretide® and Seretide® Multidisk® entails additional average budget expenditures of RUB 4 mln per annum due to increased hospitalization frequency per 106 cases, more frequent calls for ambulance per 364 cases, more frequent visits to outpatient settings and polyclinics per 180 cases, as well as more days of temporary disability per 1 862 days - every figure given per 1,000 patients with BA. It is, therefore, clinically and economically reasonable that patients initially receiving Symbicort® Turbuhaler® as a support maintenance therapy to continue therapy using the same medication.

Kulikov A.Y., Makarova E.I. 111

The correct treatment of bronchial asthma is a difficult task not only for patients and healthcare professionals but for healthcare authorities as well. The economic burden of the disease is equal to the burden of diabetes mellitus and arterial hypertension. Nearly all indirect costs and not less than a third of direct costs of the treatment of the disease are related to management of exacerbations and poor asthma control. In recent years, there has been a considerable improvement in the treatment of asthma associated with emergence of new medicinal products and delivery devices. Unfortunately, not every patient is able to achieve the optimal disease management level. For this reason, technologies for creation of an effective treatment method for bronchial asthma are undergoing continual improvement nowadays. One of the solutions in this field was the development of inhaler devices producing extrafine aerosol with particle diameter under 2 µm. Such aerosols make it possible for inhalation medicines to reach the small airways, which are the principal site of inflammation in a number of bronchial asthma phenotypes (including bronchial asthma in smokers). The objective of this study was to determine the advantageous medicinal product for bronchial asthma using pharmacoeconomic analysis, on the basis of comparison between costs and effectiveness, safety, and quality of life in treatment with fixed combinations of inhaled glucocorticosteroids and long-acting β2agonists: medicinal products (MP) Foster®, Symbicort® Turbuhaler®, Seretide®, and Seretide® Multidisk. According to the results of the cost-utility analysis, it was determined that the therapy with Foster® is dominant and characterized by the lowest costs with reference to QALY compared to Symbicort® Turbuhaler® and is cost-effective compared to Seretide® and Seretide® Multidisk, on the basis of the obtained values of the incremental cost-utility analysis, which are significantly lower than the willingness-to-pay threshold in the Russian Federation. The budget impact analysis demonstrated that using Foster® for therapy results in budget savings compared to Symbicort® Turbuhaler®, Seretide®, and Seretide® Multidisk when transferring an additional number of patients (21 %) to Foster®.