Makarova Elena Ivanovna

Arinina E.E., Makarova E.I., Tolordava G.A. 977

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. 849

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. 391

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. 46

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.

Arinina E.E., Makarova E.I., Tolordava G.A. 977

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. 849

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. 391

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. 46

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.