Davydovskaya Maria Vafaefna

Vinogradova I.A., Davydovskaya M.V., Kokushkin K.A., Lobanova N.A., .., Markarjan V.G., .., Nikitin E.A., .., Ptushkin V.V., .., Sharkunov N.N., .., Shihbabaeva D.I., .. 670

1 City clinical hospital named afer S.P. Botkin, Moscow, Russia 2 Clinical Trials and Healthcare Technology Assessment Centre of Moscow Department of Healthcare, Moscow, Russia

Davydovskaya M.V., Ermolaeva T.N., Kokushkin K.A., Tolkushin A.G., Yagudina R.I. 612

1 Clinical Trials and Healthcare Technology Assessment Centre of Moscow Department of Healthcare, Moscow, Russia 2 First Moscow State Medical University I.M. Sechenov (Sechenov University), Moscow, Russia

Andreev D.A., Davydovskaya M.V., Ermolaeva T.N., Kokushkin K.A., Tolkushin A.G. 322

OBJECTIVE: To compare and identify differences in the economic burden of multiple sclerosis amount and structure in European countries and in Russia. MATERIALS AND METHODS: The results of the cross-sectional observational retrospective study of the socio-economic burden of multiple sclerosis “New insights into the burden and costs of multiple sclerosis in Europe” were taken as an input data for the current article. The study was held in 16 European countries: Austria, Belgium, Hungary, Great Britain, Germany, Denmark, Spain, Italy, Netherlands, Poland, Portugal, Russia, France, Czech Republic, Switzerland, Sweden. The study reported data was divided by the following groups: direct costs (healthcare costs: inpatient care, day admission, consultations, tests, medication, disease-modifying treatments (DMTs), services and informal care costs) and indirect (short-term absence, long-term absence, invalidity, early retirement). We conducted an in-depth comparative cost structure analysis in the countries examined. As the costs were presented in terms of severity according to the EDSS scale, the average weighted cost was calculated considering the proportion of patients with different severity. We analyzed costs per patient, including direct medical costs, costs of DMTs, as well as indirect costs, and besides that the total cost for each country (total damage) based on the prevalence of multiple sclerosis was calculated. To describe the cost structure, the following ratios were developed: DMTs share of total cost, total cost to GDP per capita. With the help of the range ranking minimum, maximum, average, median, and also standard (mean square) deviation values were determined. RESULTS: The total average cost per patient with multiple sclerosis per year for any European country examined was about 2 million rubles. ± 882 thousand rubles, for Russia - 671 thousand rubles. (minimum value). The average direct costs per patient reaches 949 ± 370 thousand rubles in general, in Russia it is 464 thousand rubles (the minimum value). The DMTs costs in the structure of total costs were highest in Russia (57.16%) with an average value of 30.97% ± 14.36%. The lowest DMTs costs were in the UK (11.49%), Netherlands (10.07%) and Sweden (10.04%). The total multiple sclerosis burden for the country with an allowance for the prevalence of the disease, ranged from 393 billion rubles in Germany to 8.8 billion rubles in Hungary (in Russia - 78.8 billion rubles). The average of total costs to GDP per capita ratio for all countries was 84.64% ± 23.06%, for Russia - 41.05% (minimum value). CONCLUSION: In Russia, the economic burden of multiple sclerosis (including direct and indirect costs) is relatively small in comparison with European countries; while the share of DMTs costs in Russia is the highest among the countries surveyed.

Davydovskaya M.V., Ermolaeva T.N., Klabukova D.., Kokushkin K.A., Krysanova V.S., .. 29

Introduction. Therapeutic options for the management of patients with multiple myeloma include innovative drugs. One of the therapeutic approaches is the use of new proteasome inhibitors – Ixazomib and Carfilzomib – which have similar indications for use in combination with lenalidomide and dexamethasone. In conditions of limited funding, one of the determining factors is the cost of therapy, thus, it is necessary to conduct a clinical and economic analysis of the use of these drugs to determine the most economically viable treatment option. Materials and methods. The study design is an analysis of the impact on the budget of using the drug Ixazomib (Ninlaro®) in combination with lenalidomide and dexamethasone compared with carfilzomib in combination with lenalidomide and dexamethasone in the city of Moscow. Target population: adult patients with recurrent and / or refractory multiple myeloma after at least one line of previous therapy. The modeling time horizon is 3 years. Two scenarios for treating patients were considered: current medical practice (without using Ixazomiba) – basic, simulated medical practice (using Ixazomiba) – alternative. The assessment of the cost of patient care was based on direct medical costs. Results. The total direct costs when using the combination with ixazazomib for 1 year amounted to about 7.1 million rubles, when using the combination with carfilzomib – more than 9.5 million rubles, while using lenalidomide with dexamethasone – more than 3.5 million rub. The use of the combination with Ixazomib is associated with lower costs for medicinal preparations, correction of undesirable effects, as well as with the absence of costs for the administration of the drug as compared with the use of the regimen with carfillosome. A gradual increase in the use of Ixazomib in combination with lenalidomide and dexamethasone during the 1st year will save more than 3.1 million rubles for the Moscow health care budget, about 5.7 million rubles for the 2nd year, during the 3rd year - about 9.9 million rubles. Conclusion The use of Ixazomib in combination with lenalidomide and dexamethasone in the treatment of patients with recurrent and / or refractory multiple myeloma after at least one therapy line is clinically effective and cost-effective within the framework of preferential drug supply in the city of Moscow.

Vinogradova I.A., Davydovskaya M.V., Kokushkin K.A., Lobanova N.A., .., Markarjan V.G., .., Nikitin E.A., .., Ptushkin V.V., .., Sharkunov N.N., .., Shihbabaeva D.I., .. 670

1 City clinical hospital named afer S.P. Botkin, Moscow, Russia 2 Clinical Trials and Healthcare Technology Assessment Centre of Moscow Department of Healthcare, Moscow, Russia

Davydovskaya M.V., Ermolaeva T.N., Kokushkin K.A., Tolkushin A.G., Yagudina R.I. 612

1 Clinical Trials and Healthcare Technology Assessment Centre of Moscow Department of Healthcare, Moscow, Russia 2 First Moscow State Medical University I.M. Sechenov (Sechenov University), Moscow, Russia

Andreev D.A., Davydovskaya M.V., Ermolaeva T.N., Kokushkin K.A., Tolkushin A.G. 322

OBJECTIVE: To compare and identify differences in the economic burden of multiple sclerosis amount and structure in European countries and in Russia. MATERIALS AND METHODS: The results of the cross-sectional observational retrospective study of the socio-economic burden of multiple sclerosis “New insights into the burden and costs of multiple sclerosis in Europe” were taken as an input data for the current article. The study was held in 16 European countries: Austria, Belgium, Hungary, Great Britain, Germany, Denmark, Spain, Italy, Netherlands, Poland, Portugal, Russia, France, Czech Republic, Switzerland, Sweden. The study reported data was divided by the following groups: direct costs (healthcare costs: inpatient care, day admission, consultations, tests, medication, disease-modifying treatments (DMTs), services and informal care costs) and indirect (short-term absence, long-term absence, invalidity, early retirement). We conducted an in-depth comparative cost structure analysis in the countries examined. As the costs were presented in terms of severity according to the EDSS scale, the average weighted cost was calculated considering the proportion of patients with different severity. We analyzed costs per patient, including direct medical costs, costs of DMTs, as well as indirect costs, and besides that the total cost for each country (total damage) based on the prevalence of multiple sclerosis was calculated. To describe the cost structure, the following ratios were developed: DMTs share of total cost, total cost to GDP per capita. With the help of the range ranking minimum, maximum, average, median, and also standard (mean square) deviation values were determined. RESULTS: The total average cost per patient with multiple sclerosis per year for any European country examined was about 2 million rubles. ± 882 thousand rubles, for Russia - 671 thousand rubles. (minimum value). The average direct costs per patient reaches 949 ± 370 thousand rubles in general, in Russia it is 464 thousand rubles (the minimum value). The DMTs costs in the structure of total costs were highest in Russia (57.16%) with an average value of 30.97% ± 14.36%. The lowest DMTs costs were in the UK (11.49%), Netherlands (10.07%) and Sweden (10.04%). The total multiple sclerosis burden for the country with an allowance for the prevalence of the disease, ranged from 393 billion rubles in Germany to 8.8 billion rubles in Hungary (in Russia - 78.8 billion rubles). The average of total costs to GDP per capita ratio for all countries was 84.64% ± 23.06%, for Russia - 41.05% (minimum value). CONCLUSION: In Russia, the economic burden of multiple sclerosis (including direct and indirect costs) is relatively small in comparison with European countries; while the share of DMTs costs in Russia is the highest among the countries surveyed.

Davydovskaya M.V., Ermolaeva T.N., Klabukova D.., Kokushkin K.A., Krysanova V.S., .. 29

Introduction. Therapeutic options for the management of patients with multiple myeloma include innovative drugs. One of the therapeutic approaches is the use of new proteasome inhibitors – Ixazomib and Carfilzomib – which have similar indications for use in combination with lenalidomide and dexamethasone. In conditions of limited funding, one of the determining factors is the cost of therapy, thus, it is necessary to conduct a clinical and economic analysis of the use of these drugs to determine the most economically viable treatment option. Materials and methods. The study design is an analysis of the impact on the budget of using the drug Ixazomib (Ninlaro®) in combination with lenalidomide and dexamethasone compared with carfilzomib in combination with lenalidomide and dexamethasone in the city of Moscow. Target population: adult patients with recurrent and / or refractory multiple myeloma after at least one line of previous therapy. The modeling time horizon is 3 years. Two scenarios for treating patients were considered: current medical practice (without using Ixazomiba) – basic, simulated medical practice (using Ixazomiba) – alternative. The assessment of the cost of patient care was based on direct medical costs. Results. The total direct costs when using the combination with ixazazomib for 1 year amounted to about 7.1 million rubles, when using the combination with carfilzomib – more than 9.5 million rubles, while using lenalidomide with dexamethasone – more than 3.5 million rub. The use of the combination with Ixazomib is associated with lower costs for medicinal preparations, correction of undesirable effects, as well as with the absence of costs for the administration of the drug as compared with the use of the regimen with carfillosome. A gradual increase in the use of Ixazomib in combination with lenalidomide and dexamethasone during the 1st year will save more than 3.1 million rubles for the Moscow health care budget, about 5.7 million rubles for the 2nd year, during the 3rd year - about 9.9 million rubles. Conclusion The use of Ixazomib in combination with lenalidomide and dexamethasone in the treatment of patients with recurrent and / or refractory multiple myeloma after at least one therapy line is clinically effective and cost-effective within the framework of preferential drug supply in the city of Moscow.