Economic aspects of application of the russian biosimilar omalizumab in patients with atopic bronchial asthma of moderate to severe clinical courses

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Abstract

A certain success in the treatment of bronchial asthma is associated with the introduction of monoclonal antibodies into the treatment process. They made it possible to improve the control of the disease. A number of original genetically engineered biological drugs, such as benralizumab, reslizumab, dupilumab, mepolizumab and omalizumab, are currently registered in Russia. In 2020, this list was supplemented by the first Russian biosimilar drug omalizumab – Genolar® (JSC Generium, Russia). High rates of the development of modern medicine are closely related to the use of biosimilars. The prescription of biosimilars today often makes it possible to provide a larger number of patients with modern drugs at lower costs.

The aim of the study was a comprehensive pharmacoeconomic assessment of the application of the domestic biosimilar drug omalizumab in the treatment of patients suffering from moderate and severe atopic bronchial asthma.

Materials and methods. At the first stage, an information search in the available databases (Cochrane Library, MedLine, Embase, eLIBRARY) was carried out. According to the results obtained, a meta-analysis (Agache I. et al.) was found out; within its framework, the efficacy and safety of the use of several monoclonal antibodies was assessed. Dupilumab was chosen as the reference drug. Pharmacoeconomic analyses were carried out using a “Cost-Minimization Analysis” (CMA) and a “Budget Impact Analysis” (BIA). Taking into account various options of bronchial asthma, the developed algorithm for providing medical care to adult patients with atopic asthma made it possible to assess the costs, including direct medical and indirect costs.

Results. The cost analysis demonstrated the advantage of using the Russian biosimilar omalizumab in patients with atopic asthma compared to dupilumab due to financial savings of up to 40%. The Budget Impact Analysis showed that the use of the domestic biosimilar omalizumab, even taking into account the annual increase in the number of patients (8%), will save up to 109,641,409.64 rubles (or 3%) compared to the current practice.

Conclusion. The use of the domestic biosimilar omalizumab in patients with moderate to severe atopic bronchial asthma is a clinically effective and economically justified approach to organizing medical care for adult patients in Russia.

About the authors

Vera S. Krysanova

Scientific and Practical Center for Clinical and Economic Analysis, the Ministry of Health of Moscow Region; Sechenov First Moscow State Medical University; Medical Institute of Continuing Education, Moscow State University of Food Production

Email: v.krysanova@mail.ru
ORCID iD: 0000-0002-0547-2088

Researcher of the Department of Clinical and Economic Analysis; post-graduate student of the Department of Clinical Pharmacology and Propedeutics of Internal Diseases; Lecturer at the Department of Therapy with a course in Pharmacology and Pharmacy

Russian Federation, 4A, Karbyshev Str., Krasnogorsk, Moscow Reg., Russia, 143403; 4A, Karbyshev Str., Krasnogorsk, Moscow Reg., Russia, 143403; 11, Volokolamsk Hwy., Moscow, Russia, 125080

Alina D. Ermolaeva

Scientific and Practical Center for Clinical and Economic Analysis, the Ministry of Health of Moscow Region; Sechenov First Moscow State Medical University

Email: aluska.ru@mail.ru
ORCID iD: 0000-0001-9082-1010

Candidate of Sciences (Pharmacy), Senior Researcher of the Department for Monitoring and Analysis of Medicinal Supply; Assistant of the Department of Organization and Economics of Pharmacy at the Institute of Pharmacy n. a. A.P. Nelyubin

Russian Federation, 4A, Karbyshev Str., Krasnogorsk, Moscow Reg., Russia, 143403; 8, Trubetskaya Str., Moscow, Russia, 119991

Tatyana N. Ermolaeva

Scientific and Practical Center for Clinical and Economic Analysis, the Ministry of Health of Moscow Region

Email: ermolaeva_mzmo@mail.ru
ORCID iD: 0000-0002-3615-0292

Head of the Department of Clinical and Economic Analysis of Scientific

Russian Federation, 4A, Karbyshev Str., Krasnogorsk, Moscow Reg., Russia, 143403

Maria V. Davydovskaya

Scientific and Practical Center for Clinical and Economic Analysis, the Ministry of Health of Moscow Region; Pirogov Russian National Research Medical University

Email: mdavydovskaya@gmail.com
ORCID iD: 0000-0002-8294-0893

Doctor of Sciences (Medi- cine), Deputy Director for Research; Professor of the Department of Neurology, Neurosurgery and Medical Genetics

Russian Federation, 4A, Karbyshev Str., Krasnogorsk, Moscow Reg., Russia, 143403; 1, Ostrovityanov Str., Moscow, Russia, 117997

Konstantin A. Kokushkin

Scientific and Practical Center for Clinical and Economic Analysis, the Ministry of Health of Moscow Region; Sechenov First Moscow State Medical University

Author for correspondence.
Email: kokushkinka@gmail.com
ORCID iD: 0000-0002-6758-2389

Director; Applicant for the Department of Clinical Pharmacology and Propedeutics of Internal Diseases

Russian Federation, 4A, Karbyshev Str., Krasnogorsk, Moscow Reg., Russia, 143403; 8, Trubetskaya Str., Moscow, Russia, 119991

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3. Figure 2 – Results of assessing costs for providing medical care per patient with atopic BA per year

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Copyright (c) 2021 Krysanova V.S., Ermolaeva E.D., Ermolaeva T.N., Davydovskaya M.V., Kokushkin K.A.

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