clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИ10.24411/2588-0519-2019-10061clinvest-436Research ArticleФАРМАКОЭКОНОМИКАPHARMACOECONOMICSФармакоэкономический анализ применения меполизумаба у омализумаб-резистентных пациентов с тяжёлой бронхиальной астмойCost-effectiveness analysis of the use of mepolizumab in omalizumab-resistant patients with severe asthmahttps://orcid.org/0000-0002-6803-4763ТолкушинА. Г.TolkushinA. G.

к. ф. н., ведущий научный сотрудник

Москва

Candidate of Pharmaceutical Sciences, Senior scientifi cresearcher

Moscow

tolkushin@inbox.ruРоговВ. А.RogovV. A.

к. ф. н., старший преподаватель, кафедра управления и экономики фармации

 Волгоград

Candidate of Pharmaceutical Sciences, senior lecturer,Department of management and Economics of pharmacy

https://orcid.org/0000-0001-7527-5840ИвановД. А.IvanovD. A.

аспирант кафедры клинической фармакологии

Москва

Post-graduate student

Moscow

ivanov.dm.and@gmail.comПогудинаН. Л.PogudinaN. L.

к. э. н., генеральный директор

Москва

Candidate of economical sciences

Moscow

ГБУ «НПЦ КИОМТ» ДЗМРоссияPBI «SPC CTAMT DZM»Russian FederationФГБОУ ВО «Волгоградский государственный медицинский университет» Минздрава РоссииРоссияVSMURussian FederationФГАОУ ВО РУДН МОН РФРоссияRUDNRussian FederationНИК «Разумный выбор»РоссияCEO, Smart Choice independent research companyRussian Federation201921072019011926Copyright © Толкушин А.Г., Рогов В.А., Иванов Д.А., Погудина Н.Л., 20192019Толкушин А.Г., Рогов В.А., Иванов Д.А., Погудина Н.Л.Tolkushin A.G., Rogov V.A., Ivanov D.A., Pogudina N.L.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/436

Цель. Определить клинические и экономических последствия применения лекарственного препарата меполизумаб у пациентов с тяжёлой бронхиальной астмой (ТБА) и неэффективностью терапии лекарственным препаратом омализумаб. Методы. Было проведено сравнительное клинико-экономическое исследование и анализ «влияния на бюджет» использования меполизумаба или омализумаба у омализумаб-рефрактерных пациентов с ТБА. Источником информации об эффективности служили результаты опубликованных клинических исследований, о стоимости лекарственных препаратов — предельные отпускные цены производителей жизненно необходимых и важнейших лекарственных препаратов и инструкции по применению лекарственных препаратов, о стоимости медицинских услуг — нормативы финансовых затрат на единицу оказания медицинской помощи, указанные в программе государственных гарантий оказания бесплатной медицинской помощи на территории Российской Федерации, а также коэффициенты относительной затратоёмкости по клинико-статистическим группам. Результаты. По результатам многоцентрового открытого исследования OSMO применение меполизумаба у пациентов с неэффективностью терапии омализумабом приводило к снижению частоты клинически значимых обострений и обострений, требующих госпитализации (1,18 и 0,19 случая/год соответственно) по сравнению с 12 месяцами до скрининга (3,26 и 0,63 события/год соответственно). В результате анализа затрат выявлено, что переключение на меполизумаб приводит к существенной экономии: сумма прямых медицинских затрат составила 865 217 и 1 666 401 руб. на одного пациента в год. Анализ «влияния на бюджет» продемонстрировал экономию средств системы ОМС при лечении с применением меполизумаба в рамках анализируемой когорты пациентов (n=18) на 2,8 млн рублей в первый год и 12,7 млн рублей через 5 лет. Анализ «упущённых возможностей» показал, что использование меполизумаба может позволить пролечить дополнительно 3 человека за 1 год терапии и 15 человек за пять лет внедрения анализируемого ЛП. Заключение. Применение меполизумаба у пациентов с ТБА, резистентной к применению омализумаба, позволит сократить расходы бюджета и приведёт к увеличению эффективности проводимого лечения.

Objective. To determine the clinical and economic consequences of the drug mepolizumab in patients with severe bronchial asthma (SBA) and the ineff ectiveness of omalizumab. Methods. We conducted cost-eff ectiveness and budget impact analysis of the use of mepolizumab or omalizumab in omalizumab-refractory patients with SBA. Source of information about the eff ectiveness were the results of published clinical studies; the cost of drugs — maximum ex-works prices of manufacturers of vital and essential medicinal products and instructions for use of drugs; the cost of medical services — program of state guarantees of free medical assistance on the territory of the Russian Federation, as well as the coeffi cients of relative cost intensity for clinicalstatistical groups. Results. According to the results of a multicenter open study OSMO, the use of mepolizumab in patients with ineff ective omalizumab therapy led to a decrease in the frequency of clinically signifi cant exacerbations and exacerbations requiring hospitalization (1.18 and 0.19 cases / year, respectively) compared to 12 months before screening (3.26 and 0.63 events / year, respectively). Result of the cost analysis showed that switching to mepolizumab leads to signifi cant savings: the sum of direct medical costs was 865 217 and 1 666 401 RUB per patient per year, respectively. Budget impact analysis demonstrated savings in the CHI system in the treatment with mepolizumab within the analyzed cohort of patients (n=18) by 2.8 million rubles in the fi rst year and 12.7 million rubles in 5 years. Analysis of «missed opportunities» showed that the use of mepolizumab can allow to treat an additional 3 people for 1 year of therapy and 15 people for fi ve years of implementation of the analyzed drug. Conclusion. The use of mepolizumab in patients with SBA resistant to omalizumab, will reduce budget costs and will increase the eff ectiveness of treatment.

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The authors declare that there are no conflicts of interest present.