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Клинико-экономическое исследование применения акалабрутиниба у пациентов с хроническим лимфолейкозом
Недогода С.В., Саласюк А.С., Барыкина И.Н., Лутова В.О., Попова Е.А. Клинико-экономическое исследование применения акалабрутиниба у пациентов с хроническим лимфолейкозом. Современная Онкология. 2021;23(4):612–620. DOI: 10.26442/18151434.2021.4.201339
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Nedogoda SV, Salasyuk AS, Barykina IN, Lutova VO, Popova EA. Pharmacoeconomic analysis of acalabrutinib in patients with chronic lymphocytic leukemia. Journal of Modern Oncology. 2021;23(4):612–620.
DOI: 10.26442/18151434.2021.4.201339
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Аннотация
Цель. Проведение оценки экономических последствий (клинико-экономический анализ и анализ влияния на бюджет – АВБ) при включении нового ингибитора тирозинкиназы Брутона акалабрутиниба в клиническую практику для терапии взрослых пациентов с хроническим лимфолейкозом (ХЛЛ) высокого риска в рамках льготного лекарственного обеспечения.
Материалы и методы. В ходе настоящего исследования построена аналитическая модель принятия решений в MS Excel, которая позволяет провести клинико-экономический анализ и АВБ при применении препарата акалабрутиниба в сравнении с ибрутинибом и комбинацией венетоклакса с обинутузумабом в 1-й линии терапии ХЛЛ высокого риска, а также акалабрутиниба, ибрутининба и комбинации венетоклакса с ритуксимабом в терапии рецидивов и рефрактерных форм ХЛЛ (рХЛЛ) высокого риска. В модели учтены только прямые медицинские затраты на 1 пациента (затраты на лекарственную терапию).
Результаты. Анализ минимизации затрат показал, что применение препарата акалабрутиниб в 1-й линии и при лечении рецидивов и рХЛЛ высокого риска относительно препаратов сравнения является предпочтительной опцией, обладая сопоставимой эффективностью и меньшей стоимостью. Снижение затрат в 1-й линии терапии ХЛЛ высокого риска и терапии рецидивов и рХЛЛ высокого риска по сравнению с ибрутинибом составило 0,8 млн руб., или 15,4%, в 1-й линии терапии ХЛЛ высокого риска по сравнению с комбинацией венетоклакс + обинутузумаб – 1,2 млн руб., или 21,4%, в терапии рецидивов и рХЛЛ высокого риска в сравнении с комбинацией венетоклакс + ритуксимаб – 0,9 млн руб., или 17,8%. АВБ показал, что в случае инициации акалабрутинибом 1-й линии и терапии рецидивов и рХЛЛ высокого риска нагрузку на бюджет системы здравоохранения удастся снизить на 0,813 млрд руб., или 16,0%, за 1 год терапии и на 1,219 млрд руб., или 9,1%, за 3 года терапии при учете только затрат на лекарственные препараты.
Ключевые слова: хронический лимфолейкоз, ингибитор тирозинкиназы Брутона, акалабрутиниб, ибрутиниб, обинутузумаб, венетоклакс, анализ минимизации затрат, анализ влияния на бюджет, фармакоэкономика
Материалы и методы. В ходе настоящего исследования построена аналитическая модель принятия решений в MS Excel, которая позволяет провести клинико-экономический анализ и АВБ при применении препарата акалабрутиниба в сравнении с ибрутинибом и комбинацией венетоклакса с обинутузумабом в 1-й линии терапии ХЛЛ высокого риска, а также акалабрутиниба, ибрутининба и комбинации венетоклакса с ритуксимабом в терапии рецидивов и рефрактерных форм ХЛЛ (рХЛЛ) высокого риска. В модели учтены только прямые медицинские затраты на 1 пациента (затраты на лекарственную терапию).
Результаты. Анализ минимизации затрат показал, что применение препарата акалабрутиниб в 1-й линии и при лечении рецидивов и рХЛЛ высокого риска относительно препаратов сравнения является предпочтительной опцией, обладая сопоставимой эффективностью и меньшей стоимостью. Снижение затрат в 1-й линии терапии ХЛЛ высокого риска и терапии рецидивов и рХЛЛ высокого риска по сравнению с ибрутинибом составило 0,8 млн руб., или 15,4%, в 1-й линии терапии ХЛЛ высокого риска по сравнению с комбинацией венетоклакс + обинутузумаб – 1,2 млн руб., или 21,4%, в терапии рецидивов и рХЛЛ высокого риска в сравнении с комбинацией венетоклакс + ритуксимаб – 0,9 млн руб., или 17,8%. АВБ показал, что в случае инициации акалабрутинибом 1-й линии и терапии рецидивов и рХЛЛ высокого риска нагрузку на бюджет системы здравоохранения удастся снизить на 0,813 млрд руб., или 16,0%, за 1 год терапии и на 1,219 млрд руб., или 9,1%, за 3 года терапии при учете только затрат на лекарственные препараты.
Ключевые слова: хронический лимфолейкоз, ингибитор тирозинкиназы Брутона, акалабрутиниб, ибрутиниб, обинутузумаб, венетоклакс, анализ минимизации затрат, анализ влияния на бюджет, фармакоэкономика
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Aim. Pharmacoeconomic analysis of new Bruton tyrosine kinase inhibitor for the treatment of high-risk adult patients with chronic lymphocytic leukemia (CLL) within the framework of health state budget.
Materials and methods. In the course of this study, an analytical decision-making model was built in MS Excel, which allows to provide pharmacoeconomic analysis and analysis of the budget impact of acalabrutinib in comparison with the combination of venetoclax with obinutuzumab in the first line of therapy for high-risk CLL, as well as acalabrutinib and the combination of venetoclax with rituximab in the treatment of high-risk relapses and refractory forms of CLL. The model took into account only direct medical costs per patient (drug therapy costs).
Results. The “cost minimization” analysis showed that the use of the drug acalabrutinib in the 1st line and for the treatment of relapses and refractory forms of high-risk CLL is the preferred option compared to comparators, having comparable efficacy and lower cost. The cost reduction in the first-line therapy of high-risk CLL and the treatment of relapses and refractory forms of high-risk CLL compared with ibrutinib amounted to 0.8 million rubles or 15.4%, in the first-line therapy of high-risk CLL compared with the combination of venetoclax + obinutuzumab – 1.2 million rubles or 21.0%, in the treatment of relapses and refractory forms of high-risk CLL in comparison with the combination of venetoclax + rituximab – 0.9 million rubles or 17.6%. Budget impact showed that in the case of initiation of first-line acalabrutinib and treatment of relapses and refractory forms in high-risk CLL patients, the burden on the health care system budget can be reduced by 0.813 billion rubles or 16.0% for 1 year of therapy and by 1.219 billion rubles or 9.1% over 3 years of therapy, taking into account only the costs of drugs.
Keywords: chronic lymphocytic leukemia, Bruton's tyrosine kinase inhibitor, acalabrutinib, ibrutinib, obinutuzumab, venetoclax, cost minimization analysis, budget impact analysis, pharmacoeconomics
Полный текст
Список литературы
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34. Jansen JP. Network meta-analysis of survival data with fractional polynomials. BMC Medl Res Methodol. 2011;11:61. DOI:10.1186/1471-2288-11-61
35. Phillippo DM, Ades AE, Dias S, et al. Methods for population-adjusted indirect comparisons in health technology appraisal. Med Decis Making. 2018;38(2):200‑11. DOI:10.1177/0272989X17725740
36. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Eng J Med. 2019;380(23):2225-36. DOI:10.1056/NEJMoa1815281
37. Al-Sawaf O, Zhang C, Lu T, et al. Venetoclax‐Obinutuzumab for previously untreated chronic lymphocytic leukemia: 4‐year follow‐up analysis of the randomized CLL14 study. J Clin Oncol. 2021;39(36):4049-60. DOI:10.1200/JCO.21.01181
38. Kater AP, Seymour JF, Hillmen P, et al. Fixed duration of venetoclax-rituximab in relapsed/refractory chronic lymphocytic leukemia eradicates minimal residual disease and prolongs survival: post-treatment follow-up of the MURANO phase III study. J Clin Oncol. 2019;37(4):269-77. DOI:10.1200/JCO.18.01580
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24. [A21-54] Acalabrutinib (pretreated chronic lymphocytic leukaemia). Available at: https://www.iqwig.de/en/projects/a21-54.html. Accessed: 02.11.2021.
25. [A21-52] Acalabrutinib (previously untreated chronic lymphocytic leukaemia). Available at: https://www.iqwig.de/en/projects/a21-52.html. Accessed: 02.11.2021.
26. Acalabrutinib (Calquence®) HTA ID: 20063. Available at: https://www.ncpe.ie/drugs/acalabrutinib-calquence-hta-id-20063/ Accessed: 02.11.2021.
27. Davids MS, Telford C, Abhyankar S, et al. Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naïve chronic lymphocytic leukemia. Leuk Lymphoma. 2021;62(10):2342-51. DOI:10.1080/10428194.2021.1913144
28. Matching-Adjusted Indirect Comparisons of Efficacy and Tolerability Outcomes with Acalabrutinib versus Selected Comparators for patients with Relapsed/Refractory Chronic Lymphocytic Leukemia. Study Report 4 October 2019.
29. Zlokachestvennye novoobrazovaniia v Rossii v 2019 godu (zabolevaemost' i smertnost'). Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. P.A. Gertsena − filial FGBU “NMITs radiologii” Minzdrava Rossii, 2020 (in Russian).
30. Rossi D, Cerri M, Deambrogi C, et al. The Prognostic Value of TP53 Mutations in Chronic Lymphocytic Leukemia Is Independent of Del17p13: Implications for Overall Survival and Chemorefractoriness. Clin Cancer Res. 2009;15(3):995-1004. DOI:10.1158/1078-0432.CCR-08-1630
31. Mikhailova NB, Kalashnikova OB, et al. Vedenie patsientov s khronicheskim limfoleikozom. Opyt PSPbGMU (poliklinika s KDTs i NII DOGiT im. R.M. Gorbachevoi) (in Russian).
32. Poddubnaya IV, Bialik T., Glonina NN, et al. The role of second generation Bruton tyrosine kinase inhibitors in the treatment of chronic lymphocytic leukemia. Resolution. Journal of Modern Oncology. 2019;21(4):45-7 (in Russian).
DOI:10.26442/18151434.2019.4.190725
33. Zenz T, Häbe S, Denzel T, et al. Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contribution of 17p deletion, TP53 mutation, p53-p21 dysfunction, and miR34a in a prospective clinical trial. Blood. 2009;114(13):2589-97. DOI:10.1182/blood-2009-05-224071
34. Jansen JP. Network meta-analysis of survival data with fractional polynomials. BMC Medl Res Methodol. 2011;11:61. DOI:10.1186/1471-2288-11-61
35. Phillippo DM, Ades AE, Dias S, et al. Methods for population-adjusted indirect comparisons in health technology appraisal. Med Decis Making. 2018;38(2):200‑11. DOI:10.1177/0272989X17725740
36. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Eng J Med. 2019;380(23):2225-36. DOI:10.1056/NEJMoa1815281
37. Al-Sawaf O, Zhang C, Lu T, et al. Venetoclax‐Obinutuzumab for previously untreated chronic lymphocytic leukemia: 4‐year follow‐up analysis of the randomized CLL14 study. J Clin Oncol. 2021;39(36):4049-60. DOI:10.1200/JCO.21.01181
38. Kater AP, Seymour JF, Hillmen P, et al. Fixed duration of venetoclax-rituximab in relapsed/refractory chronic lymphocytic leukemia eradicates minimal residual disease and prolongs survival: post-treatment follow-up of the MURANO phase III study. J Clin Oncol. 2019;37(4):269-77. DOI:10.1200/JCO.18.01580
Авторы
С.В. Недогода, А.С. Саласюк*, И.Н. Барыкина, В.О. Лутова, Е.А. Попова
ФГБОУ ВО «Волгоградский государственный медицинский университет» Минздрава России, Волгоград, Россия
*salasyukas@outlook.com
ФГБОУ ВО «Волгоградский государственный медицинский университет» Минздрава России, Волгоград, Россия
*salasyukas@outlook.com
________________________________________________
Sergey V. Nedogoda, Alla S. Salasyuk*, Irina N. Barykina, Viktoria O. Lutova, Ekaterina A. Popova
Volgograd State Medical University, Volgograd, Russia
*salasyukas@outlook.com
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.