Protsenko Marina Valeryevna

Kulikov A.Y., Protsenko M.V. 2951

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.

Zubarev P.D., Kulikov A.Y., Protsenko M.V., Telnova E.A., Ugrekhelidze D.T. 1929

To assess the level of development of pharmacoeconomics in the Russian Federation as a branch of science analysis of pharmacoeconomic and clinical economic studies published in the scientific electronic library “eLIBRARY.RU” (RSCI) for the period from 2005 through 2015 was performed. As a result, it was determined that the number of such studies from year to year is steadily increasing. The leader among the countries who publish their researches on the platform of the scientific electronic library “eLIBRARY. RU” was Russia, the second and the third places were shared by Ukraine and Belarus, respectively. The research was carried out in 52 subjects of the Russian Federation, which is represented by 63 Universities. Leader out of them was the I.M. Sechenov First Moscow State Medical University. It turned out that most pharmacoeconomic and clinical-economic research during the specified time interval was devoted to cardiovascular, pulmonary, oncological and endocrinological diseases. As a result of analysis, it was found that among pharmacoeconomic research methods most commonly used “cost– effectiveness” analysis (45,1%). In addition, on the basis of the analyzed data of Russian science citation index and the total number of published works, the rating of the authors who conducted research in the field of pharmacoeconomics in the country.

Kulikov A.Y., Protsenko M.V. 1033

First Moscow State Medical University I.M. Sechenov (Sechenov University), Moscow, Russia

Kulikov A.Y., Protsenko M.V., Serpik V.G. 828

The article presents updated and advanced results of a pharmacoeconomic study conducted in 2016 on the treatment of patients with pulmonary arterial hypertension II and III functional classes with ambrisentan and bosentan preparations in Russia. The evaluation was provided through cost analysis, “cost minimization” analysis, “cost-utility” analysis, “budget impact” analysis. Еhe cost of pharmacotherapy with Volibrys (ambrisentan) of arterial pulmonary hypertension, regardless of the functional class, was 1 200 000 rubles. and 1 300 000 rubles. respectively, with the need for 12 and 13 packs of the drug per year. The average annual cost of treatment with bosentan ranges from 1 368 900 rubles. up to 1 471 644 rubles. respectively, with the need for 13 and 14 packs of the drug. The results of the “cost minimization” analysis, carried out on the assumption of equal effectiveness of ambrisentan and bosentan, showed that per one patient for one year, the preparation of Volibris (ambrisentan) in comparison with the preparations of bosentan (Traklir and Bozeneks) 175 760 to 178 504 rubles. The values of the “cost-utility” coefficient for ambrisentan in the treatment of pulmonary arterial hypertension II and III of the functional class varied depending on the dosage (5 or 10 mg) from 1,831,563 rubles. up to 2 012 040 rubles for QALY and 2 667 711 rubles up to 2 787 728 rubles. for QALY. At the same time, similar averaged values for bosentan amounted to 2 480 073 rubles and 3 271 174 rubles for QALY for II and III functional class pulmonary arterial hypertension, respectively. The “budget impact” analysis based on the estimated number of patients with pulmonary arterial hypertension in the Russian Federation, which is 2936 people, showed that the transfer of this number of patients treated with the bosentan in the form of original (Tracler) and reproduced (Bozeneks) 1: 1, for treatment with the drug ambrisentan (Volibris), will allow for 2 years to save 853.2 million rubles, which is 9.7% of the budget required for the treatment of bosentan.

Goloenko N.G., Evstigneeva L.., Zhilyaev E.., Korotaeva T.., Kulikov A.Y., Logvinuk P.A., Lytkina K.., Protsenko M.V., Serpik V.G., Yagudina R.I. 517

Possessing a high prevalence and disability, psoriatic arthritis (PsA) is a serious socio-economic burden for the patient and for society. Therefore, the choice of the PsA treatment strategy requires focusing on not only the prevention and control of the disease but also the effective allocation of the available resources of the healthcare system. Objective. In this regard, the purpose of this study was to conduct a comparative pharmacoeconomic evaluation of biologics: secukinumab (Cosentyx), golimumab (Simponi®), certolizumab pegol (Cimzia®), Ustekinumab (Stelara®), adalimumab (Humira®), etanercept (Enbrel®) and infliximab (Remicade®, Flammegis®, Infliximab produced by local BIOCAD company). Materials and methods. Based on data on the effectiveness of compared treatment regimens, data on the cost of drugs and medical services, as well as the frequency of their provision, an analysis of direct costs, cost-effectiveness analysis, as well as budget impact analysis were carried out. Results. The cost analysis educed that the amount of direct costs for treatment with secukinumab 150 mg for ‘biologic-naive’ patients with active PsA is on average 28% and 40% lower than the cost of treatment with certolizumab pegol, golimumab, ustekinumab, adalimumab, etanercept and infliximab in the first and subsequent years of therapy, in accordance. Estimation of costs and efficacy showed that treatment of PsA with secukinumab 150 mg is characterized by lower costs per unit of effectiveness (ACR 20/50/70 response), relative to the indicators of the compared drugs in the first and subsequent years of therapy. The assumed prescription of secukinumab instead of certolizumab pegol, golimumab, ustekinumab, adalimumab, etanercept, and infliximab (including biosimilar) 19% of patients with active PsA leads to budget savings of 468 million rubles and 1.5 billion rubles for the first and three years of treatment, in accordance, on the calculated patient population. Conclusion. According to the results of the study, the pharmacoeconomic feasibility of using secukinumab 150 mg as a first-line line biologic for the treatment of active PsA has been established.

Kulikov A.Y., Protsenko M.V., Serpik V.G., Sobolev N.P. 20

Wide range of available platforms for phacoemulsification of cataracts and limited financing of the health care system make crucial of optimal decisions in choosing specific models of platforms. In this regard, for the first time in Russia and in the world, an assessment of healthcare technology (HTA) of 6 platforms for cataract phacoemulsification was carried out - Centurion, Infiniti, Stellaris, Stellaris PC, Whitestar Signature, Visalis 500. Our study revealed the limitations of the existing evidence base for comparative purposes evaluations of various phacoemulsification platforms from a health system perspective. Due to this we made an assumption of the use expert assessment of the analized platforms in terms of ultrasound time and the volume of aspirated liquid allowed us to provide HTA, the results of which on the one hand confirm the applicability of the HTA methodology itself for the analysis of the type of medical device under consideration, and with available cost data demonstrated «cost-effectiveness ”of the Centurion platform and its advantage in terms of budget impact analysis among other platforms of the latest generation. The full use of HTA for cataract phacoemulsification platforms requires the creation of an evidence base, taking into account perspective of organizational decision-making process.

Protsenko M.V., Serpik V.G. 20

Pharmacoeconomic assessment is an obligate element for including a drug in the reimbursement lists – EDL and state federal reimbursement drug list, which in turn represents an important step in ensuring the availability of drug therapy. In this regard, the registration of a new drug of the group of janus kinase inhibitors, baricitinib in Russia, used in the treatment of rheumatoid arthritis in patients with moderate and severe degree of intolerance or lack of adequate treatment for one or more basic antirheumatic drugs, actualized the task of its pharmacoeconomic assessment. The pharmacoeconomic analysis of baricitinib by the cost-effectiveness methods compared with adalimumab and the “budget impact” compared with the entire group of genetically engineered biological products showed that, from the point of view of the cost-effectiveness evaluation, baricitinib is characterized as a dominant alternative, and with the position of the “budget impact” evaluation, the use of baricitinib is accompanied by budget savings. In accordance with the current rules of pharmacoeconomic assessment, the drug baricitinib gains + 9 points and, by decision of the Commission of Ministry of Health, was included in the lists of EDL and state federal reimbursement drug list, approved by Order of the Government of the Russian Federation 2406-R of October 12, 2019.

Kulikov A.Y., Protsenko M.V. 2951

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.

Zubarev P.D., Kulikov A.Y., Protsenko M.V., Telnova E.A., Ugrekhelidze D.T. 1929

To assess the level of development of pharmacoeconomics in the Russian Federation as a branch of science analysis of pharmacoeconomic and clinical economic studies published in the scientific electronic library “eLIBRARY.RU” (RSCI) for the period from 2005 through 2015 was performed. As a result, it was determined that the number of such studies from year to year is steadily increasing. The leader among the countries who publish their researches on the platform of the scientific electronic library “eLIBRARY. RU” was Russia, the second and the third places were shared by Ukraine and Belarus, respectively. The research was carried out in 52 subjects of the Russian Federation, which is represented by 63 Universities. Leader out of them was the I.M. Sechenov First Moscow State Medical University. It turned out that most pharmacoeconomic and clinical-economic research during the specified time interval was devoted to cardiovascular, pulmonary, oncological and endocrinological diseases. As a result of analysis, it was found that among pharmacoeconomic research methods most commonly used “cost– effectiveness” analysis (45,1%). In addition, on the basis of the analyzed data of Russian science citation index and the total number of published works, the rating of the authors who conducted research in the field of pharmacoeconomics in the country.

Kulikov A.Y., Protsenko M.V. 1033

First Moscow State Medical University I.M. Sechenov (Sechenov University), Moscow, Russia

Kulikov A.Y., Protsenko M.V., Serpik V.G. 828

The article presents updated and advanced results of a pharmacoeconomic study conducted in 2016 on the treatment of patients with pulmonary arterial hypertension II and III functional classes with ambrisentan and bosentan preparations in Russia. The evaluation was provided through cost analysis, “cost minimization” analysis, “cost-utility” analysis, “budget impact” analysis. Еhe cost of pharmacotherapy with Volibrys (ambrisentan) of arterial pulmonary hypertension, regardless of the functional class, was 1 200 000 rubles. and 1 300 000 rubles. respectively, with the need for 12 and 13 packs of the drug per year. The average annual cost of treatment with bosentan ranges from 1 368 900 rubles. up to 1 471 644 rubles. respectively, with the need for 13 and 14 packs of the drug. The results of the “cost minimization” analysis, carried out on the assumption of equal effectiveness of ambrisentan and bosentan, showed that per one patient for one year, the preparation of Volibris (ambrisentan) in comparison with the preparations of bosentan (Traklir and Bozeneks) 175 760 to 178 504 rubles. The values of the “cost-utility” coefficient for ambrisentan in the treatment of pulmonary arterial hypertension II and III of the functional class varied depending on the dosage (5 or 10 mg) from 1,831,563 rubles. up to 2 012 040 rubles for QALY and 2 667 711 rubles up to 2 787 728 rubles. for QALY. At the same time, similar averaged values for bosentan amounted to 2 480 073 rubles and 3 271 174 rubles for QALY for II and III functional class pulmonary arterial hypertension, respectively. The “budget impact” analysis based on the estimated number of patients with pulmonary arterial hypertension in the Russian Federation, which is 2936 people, showed that the transfer of this number of patients treated with the bosentan in the form of original (Tracler) and reproduced (Bozeneks) 1: 1, for treatment with the drug ambrisentan (Volibris), will allow for 2 years to save 853.2 million rubles, which is 9.7% of the budget required for the treatment of bosentan.

Goloenko N.G., Evstigneeva L.., Zhilyaev E.., Korotaeva T.., Kulikov A.Y., Logvinuk P.A., Lytkina K.., Protsenko M.V., Serpik V.G., Yagudina R.I. 517

Possessing a high prevalence and disability, psoriatic arthritis (PsA) is a serious socio-economic burden for the patient and for society. Therefore, the choice of the PsA treatment strategy requires focusing on not only the prevention and control of the disease but also the effective allocation of the available resources of the healthcare system. Objective. In this regard, the purpose of this study was to conduct a comparative pharmacoeconomic evaluation of biologics: secukinumab (Cosentyx), golimumab (Simponi®), certolizumab pegol (Cimzia®), Ustekinumab (Stelara®), adalimumab (Humira®), etanercept (Enbrel®) and infliximab (Remicade®, Flammegis®, Infliximab produced by local BIOCAD company). Materials and methods. Based on data on the effectiveness of compared treatment regimens, data on the cost of drugs and medical services, as well as the frequency of their provision, an analysis of direct costs, cost-effectiveness analysis, as well as budget impact analysis were carried out. Results. The cost analysis educed that the amount of direct costs for treatment with secukinumab 150 mg for ‘biologic-naive’ patients with active PsA is on average 28% and 40% lower than the cost of treatment with certolizumab pegol, golimumab, ustekinumab, adalimumab, etanercept and infliximab in the first and subsequent years of therapy, in accordance. Estimation of costs and efficacy showed that treatment of PsA with secukinumab 150 mg is characterized by lower costs per unit of effectiveness (ACR 20/50/70 response), relative to the indicators of the compared drugs in the first and subsequent years of therapy. The assumed prescription of secukinumab instead of certolizumab pegol, golimumab, ustekinumab, adalimumab, etanercept, and infliximab (including biosimilar) 19% of patients with active PsA leads to budget savings of 468 million rubles and 1.5 billion rubles for the first and three years of treatment, in accordance, on the calculated patient population. Conclusion. According to the results of the study, the pharmacoeconomic feasibility of using secukinumab 150 mg as a first-line line biologic for the treatment of active PsA has been established.

Kulikov A.Y., Protsenko M.V., Serpik V.G., Sobolev N.P. 20

Wide range of available platforms for phacoemulsification of cataracts and limited financing of the health care system make crucial of optimal decisions in choosing specific models of platforms. In this regard, for the first time in Russia and in the world, an assessment of healthcare technology (HTA) of 6 platforms for cataract phacoemulsification was carried out - Centurion, Infiniti, Stellaris, Stellaris PC, Whitestar Signature, Visalis 500. Our study revealed the limitations of the existing evidence base for comparative purposes evaluations of various phacoemulsification platforms from a health system perspective. Due to this we made an assumption of the use expert assessment of the analized platforms in terms of ultrasound time and the volume of aspirated liquid allowed us to provide HTA, the results of which on the one hand confirm the applicability of the HTA methodology itself for the analysis of the type of medical device under consideration, and with available cost data demonstrated «cost-effectiveness ”of the Centurion platform and its advantage in terms of budget impact analysis among other platforms of the latest generation. The full use of HTA for cataract phacoemulsification platforms requires the creation of an evidence base, taking into account perspective of organizational decision-making process.

Protsenko M.V., Serpik V.G. 20

Pharmacoeconomic assessment is an obligate element for including a drug in the reimbursement lists – EDL and state federal reimbursement drug list, which in turn represents an important step in ensuring the availability of drug therapy. In this regard, the registration of a new drug of the group of janus kinase inhibitors, baricitinib in Russia, used in the treatment of rheumatoid arthritis in patients with moderate and severe degree of intolerance or lack of adequate treatment for one or more basic antirheumatic drugs, actualized the task of its pharmacoeconomic assessment. The pharmacoeconomic analysis of baricitinib by the cost-effectiveness methods compared with adalimumab and the “budget impact” compared with the entire group of genetically engineered biological products showed that, from the point of view of the cost-effectiveness evaluation, baricitinib is characterized as a dominant alternative, and with the position of the “budget impact” evaluation, the use of baricitinib is accompanied by budget savings. In accordance with the current rules of pharmacoeconomic assessment, the drug baricitinib gains + 9 points and, by decision of the Commission of Ministry of Health, was included in the lists of EDL and state federal reimbursement drug list, approved by Order of the Government of the Russian Federation 2406-R of October 12, 2019.