Research output: Contribution to journal › Article › peer-review
Фармакоэкономический анализ применения гилтеритиниба в лечении взрослых пациентов с рецидивами и рефрактерным течением острых миелоидных лейкозов с мутацией гена FLT3. / Колбин, Алексей Сергеевич; Гомон, Юлия Михайловна; Балыкина, Юлия Ефимовна; Проскурин, М. А.
In: Klinicheskaya Onkogematologiya/Clinical Oncohematology, Vol. 15, No. 1, 2022, p. 85-96.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Фармакоэкономический анализ применения гилтеритиниба в лечении взрослых пациентов с рецидивами и рефрактерным течением острых миелоидных лейкозов с мутацией гена FLT3
AU - Колбин, Алексей Сергеевич
AU - Гомон, Юлия Михайловна
AU - Балыкина, Юлия Ефимовна
AU - Проскурин, М. А.
N1 - Funding Information: 6. Центр экспертизы контроля качества медицинской помощи. Методи-ческие рекомендации по проведению сравнительной клинико-экономиче-ской оценки лекарственного препарата (электронный документ). М., 2018. Доступно по: https://rosmedex.ru/wp-content/uploads/2019/06/MR-KE%60I_ novaya-redaktsiya_2018-g.pdf. Ссылка активна на 16.06.2021. [Tsentr ekspertizy kontrolya kachestva meditsinskoi pomoshchi. Metodi-cheskie rekomendatsii po provedeniyu sravnitel’noi kliniko-ekonomicheskoi otsenki lekarstvennogo preparate. (Center for Expertise of Healthcare Quality Control. Methodological guidelines for comparative clinical and economic evaluation of drugs.) (Internet) Available fro m: https://rosmedex.ru/wp-content/ uploads/2019/06/MR-KE%60I_novaya-redaktsiya_2018-g.pdf. (accessed 16.06.2021) (In Russ)] 7. Государственный реестр лекарственных средств (электронный доку-мент). Доступно по: http://grls.rosminzdrav.ru/default.aspx. Ссылка активна на 16.06.2021. [Gosudarstvennyi reestr lekarstvennykh sredstv. (State Register of Drugs.) (Internet) Available from: http://grls.rosminzdrav.ru/default.aspx. (accessed 16.06.2021) (In Russ)] 8. Российский фармацевтический портал (электронный документ). До-ступно по: https://www.pharmindex.ru/ Ссылка активна на 16.06.2021. [Rossiyskiy farmacevticheskiy portal. (Russian Pharmaceutics Portal.) (Internet) Available from: https://www.pharmindex.ru/ (accessed 16.06.2021) (In Russ)] 9. Постановление Правительства от 07.12.2019 № 1610 «О программе государственных гарантий бесплатного оказания гражданам медицинской помощи на 2020 г. и на плановый период 2021 и 2022 гг.». [Government decree No. 1610 dated 07.12.2019. On the program of state guarantees of free healthcare provision for 2020 and for the planning period of 2021 and 2022. (In Russ)] 10. Методические рекомендации по способам оплаты медицинской помощи за счет средств обязательного медицинского страхования (электронный документ). Доступно по: https://rosmedex.ru/wp-content/ uploads/2019/07/Metod-rekomendatsii-red.ot-02.07.2019.pdf. Ссылка активна на 16.06.2021. [Metodicheskie rekomendacii po sposobam oplaty medicinskoy pomoschi za schet sredstv obyazatelnogo strahovaniya. (Methodological guidelines for methods of medical care payment covered by compulsory health insurance.) (Internet) Available from: https://rosmedex.ru/wp-content/uploads/2019/07/ Metod-rekomendatsii-red.ot-02.07.2019.pdf. (accessed 16.06.2021) (In Russ)] 11. Приказ Министерства здравоохранения и социального развития РФ «Об утверждении стандарта медицинской помощи больным миелоидным лей-козом (миелолейкозом), лейкозом уточненного клеточного типа». М., 2006. [Decree of the Ministry of Health and Social Development of the Russian Federation. On the approval of the medical care standard for patients with myeloid leukemia and leukemia of a specified cell type. Moscow; 2006. (In Russ)] 12. Прейскурант платных медицинских услуг ФГБУ РосНИИГТ ФМБА России (электронный документ). Доступно по: http://www.bloodscience. ru/patient/price/ Ссылка активна на 16.06.2021. [Preiskurant platnykh meditsinskikh uslug FGBU RosNIIGT FMBA Rossii. (Price list for paid medical services of the Russian Research Institute of Hematology and Transfusiology.) (Internet) Available from: http://www.bloodscience.ru/patient/ price/ (accessed 16.06.2021) (In Russ)] 13. Приказ Минздрава № 345н и Минтруда № 372н «Положение об ор-ганизации оказания паллиативной медицинской помощи, включая порядок взаимодействия медицинских организаций, организаций социального обслу-живания и общественных объединений, иных некоммерческих организаций, осуществляющих свою деятельность в сфере охраны здоровья». М., 2019. [Decree No. 345n of the Ministry of Health and No. 372n of the Ministry of Labor of the Russian Federation. On the organization of palliative services with interaction of healthcare providers, social services, non-governmental associations, and other non-commercial organizations involved in healthcare. Moscow; 2019. (In Russ)] 14. Федеральный закон от 24.11.1995 № 181 «О социальной защите инва-лидов в Российской Федерации». [Federal Law No. 181 dated 24.11.1995. On social protection of people with disabilities in the Russian Federation. (In Russ)] 15. Joshi N, Hensen M, Patel S et al. Health State Utilities for Acute Myeloid Leukaemia: A Time Trade-off Study. PharmacoEconomics. 2019;37(1):85–92. doi: 10.1007/s40273-018-0704-8. Publisher Copyright: © 2022 Practical Medicine Publishing House. All rights reserved.
PY - 2022
Y1 - 2022
N2 - Background. The implementation of new FLT3-targeted drugs in clinical practice has changed the approaches to the management of patients with acute myeloid leukemias (AML) with FLT3 mutation. One of these drugs is gilteritinib, approved by FDA in 2018 as a drug of choice in the therapy of adult patients with relapsed/refractory AML with FLT3 mutation. Aim. To assess the economic feasibility of gilteritinib in the therapy of adult patients with relapsed/refractory AML with FLT3 mutation. Materials & Methods. Pharmacoeconomic modelling was based on Markov and decision-tree models. Incremental cost-effectiveness ratio (ICER) was calculated relative to the efficiency indicator “overall survival”. Its values were compared with those calculated for venetoclax as reference drug, which has been already included in Essential Drug List and used as a first-line drug in this population if high-dose chemotherapy therapy is contraindicated. A Budget Impact Analysis has been made. Results. Gilteritinib proved to be not only more effective in terms of overall survival (median 9.3 vs. 5.6 months), but also more cost-intensive (7,408,108 vs. 1,685,356 rubles a year) compared to the currently used polychemotherapy regimens. However, the difference of ICER with venetoclax was +4.89 % of total costs. The Budget Impact Analysis showed that the total economic load of implementing gilteritinib in clinical practice throughout 3 years will be 8,628,658,505 rubles. Conclusion. Gilteritinib therapy is economically feasible and viable for adult patients with relapsed/refractory AML with FLT3 mutation.
AB - Background. The implementation of new FLT3-targeted drugs in clinical practice has changed the approaches to the management of patients with acute myeloid leukemias (AML) with FLT3 mutation. One of these drugs is gilteritinib, approved by FDA in 2018 as a drug of choice in the therapy of adult patients with relapsed/refractory AML with FLT3 mutation. Aim. To assess the economic feasibility of gilteritinib in the therapy of adult patients with relapsed/refractory AML with FLT3 mutation. Materials & Methods. Pharmacoeconomic modelling was based on Markov and decision-tree models. Incremental cost-effectiveness ratio (ICER) was calculated relative to the efficiency indicator “overall survival”. Its values were compared with those calculated for venetoclax as reference drug, which has been already included in Essential Drug List and used as a first-line drug in this population if high-dose chemotherapy therapy is contraindicated. A Budget Impact Analysis has been made. Results. Gilteritinib proved to be not only more effective in terms of overall survival (median 9.3 vs. 5.6 months), but also more cost-intensive (7,408,108 vs. 1,685,356 rubles a year) compared to the currently used polychemotherapy regimens. However, the difference of ICER with venetoclax was +4.89 % of total costs. The Budget Impact Analysis showed that the total economic load of implementing gilteritinib in clinical practice throughout 3 years will be 8,628,658,505 rubles. Conclusion. Gilteritinib therapy is economically feasible and viable for adult patients with relapsed/refractory AML with FLT3 mutation.
KW - acute myeloid leukemias
KW - FLT3 mutation
KW - gilteritinib
KW - incremental cost-effectiveness ratio
KW - pharmacoeconomics
KW - FLT3 mutation
KW - acute myeloid leukemias
KW - gilteritinib
KW - incremental cost-effectiveness ratio
KW - pharmacoeconomics
UR - http://www.scopus.com/inward/record.url?scp=85126586910&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/a69ee1a7-8723-30fb-ac6f-debc0eefd36d/
U2 - 10.21320/2500-2139-2022-15-1-85-96
DO - 10.21320/2500-2139-2022-15-1-85-96
M3 - статья
AN - SCOPUS:85126586910
VL - 15
SP - 85
EP - 96
JO - Klinicheskaya Onkogematologiya/Clinical Oncohematology
JF - Klinicheskaya Onkogematologiya/Clinical Oncohematology
SN - 1997-6933
IS - 1
ER -
ID: 93827395