Pharmacoeconomic analysis of the use of ibrutinib in therapy of the first line of a chronic lymphocytic leukaemia for patients with 17p deletion
Abstract
We have performed the first-ever comparative pharmacoeconomic analysis in a Russian context of ibrutinib in the first line of therapy of chronic lymphocytic leukemia at patients with a 17p deletion. Research was conducted from a position of the state health system by means of mathematical modeling. It was considered direct and indirect costs. Markov modeling and the sensitivity analysis were used. It was as a result shown that application of Imbruvica® in therapy of chronic lymphocytic leukemia at patients with a 17p deletion is an economically advantageous medical technology from the point of view of a ratio of cost and efficiency in comparing with strategy of an ofatumumab. It was as a result shown that application of Imbruvica® in therapy of chronic lymphocytic leukemia at patients with a 17p deletion is economically expedient medical technology from the point of view of a ratio of cost and efficiency when comparing with strategy of an ofatumumab. Also, this strategy was characterized by high clinical effectiveness and a comparable profile of safety among other medical technologies. As for the budget impact analysis, comparing with strategy of an ofatumumab widespread use of ibrutinib would allow saving up to an additional 80.5 millions rub per 1 000 patients with chronic lymphocytic leukemia, thus the saved means allow to treat with this strategy in addition 16 patients.
About the Authors
A. S. Kolbin
First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia; Saint Petersburg State University, Saint Petersburg, Russia
Russian Federation
Russian Federation
I. A. Vilum
First Pavlov State Medical University of St. Peterburg; National Medical and Surgical Center of the N.I. Pirogov
Russian Federation
Russian Federation
Yu. E. Balykina
Saint-Petersburg State University
Russian Federation
Russian Federation
M. A. Proskurin
Saint-Petersburg State University
Russian Federation
Russian Federation
References
1. Hallek M., Cheson B.D., Catovsky D., et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines Blood. 2008;111(12):5446-5456.
2. Bloomfield C.D., Foon K.A., Lemine E.G. Basic Principles and Clinical Management of Cancer, N.Y., 1993, p. 459-468.
3. Caligaris-Cappio F., Hamblin T.J. B-cell chronic lymphocytic leukemia: a bird of different feather. J Clin Oncol 1999;17:399-412.
4. Pathology and Genetics of Tumors of Hematopoietic and Lymphoid Tissues. IARC Press, Lyon, 2008:180-2.
5. Döhner H., Stilgenbauer S., Benner A., et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med 2000; 343:1910-6.
6. Российские клинические рекомендации по диагностике и лечению лимфопролиферативных заболеваний. Под руководством проф. И.В. Поддубной, проф. В.Г. Савченко М.: ММА МедиаМедика, 2014. - с.128.
7. Stilgenbauer S., Dohner H. Molecular genetics and its clinical relevance. Hematol Oncol Clin North Am 2004; 18:827-48.
8. Byrd J., et al. Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia. N Engl J Med. 2014;17;371(3):213-23.
9. Byrd J., et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med 2013; 369: 32 - 42.
10. Honigberg L.A., et al. The Bruton tirosine kinase inhibitor PCI-32765 blocks B-cell activation and is efficacious in models of autoimmune disease and B-cell malignancy. Proc Natl Acad Sci USA 2010; 107: 13075 - 80.
11. Ponader S., Chen S.S., Buggy J.J., et al. The Bruton tyrosine kinase inhibitor PCI-32765 thwarts chronic lymphocytic leukemia cell survival and tissue homing in vitro and in vivo. Blood 2012;119:1182-9.
12. Byrd J.C., O’Brien S., James D.F. Ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med 2013;369:1278-9.
13. Neffendorf J.E., Gout I., Hildebrand G.D. Ibrutinib in relapsed chronic lymphocyticleukemia. N Engl J Med 2013; 369:1277.
14. Rushworth S.A., MacEwan D.J., Bowles K.M. Ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med 2013; 369:1277-8.
15. Advani R.H., Buggy J. J., Sharman J.P., et al. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol 2013;31:88-94.
16. Farooqui M., Lozier J., Valdez J., et al. Ibrutinib (PCI 32765) rapidly improves platelet counts in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients and has minimal effects on platelet aggregation. Blood 2014; https://ash.confex.com/ash/2012/webprogram/Paper50250.html. abstract.
17. Об утверждении отраслевого стандарта «Клинико-экономические исследования. Общие положения»: приказ №163 Министерства Здравоохранения Российской Федерации от 27.05.2011.
18. Josephine A. Mauskopf et al. Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices - Budget Impact Analysis, Value in Health. 2007;10(5):336-347.
19. Brosa M., et al. Principios, m?todos y aplicaciones del an?lisis del impacto presupuestario en el sector sanitario. Pharmacoeconomics - Spanish Research Articles 2005;2(2): 65-78.
20. URL: www.medlux.ru.
21. Сайт Государственного реестра лекарственных средств. http://grls.rosminzdrav.ru.
22. Постановление Правительства РФ от 18 октября 2013 г. № 932 «О программе государственных гарантий бесплатного оказания гражданам медицинской помощи на 2014 год и на плановый период 2015 и 2016 годов»
23. Информационный портал ОМС Санкт-Петербурга.
24. Территориальный орган Федеральной службы государственной статистики по г. Санкт-Петербургу и Ленинградской области, официальный сайт, http://petrostat.gks.ru/
25. Burger J.A., et al. Ibrutinib plus rituximab for patients with high-risk chronic lymphocytic leukaemia: a single-arm, phase 2 study. Lancet Oncol. 2014;15(10): 1090-1099.
26. Castro J.E., et al. Ofatumumab and high-dose methylprednisolone for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia. Blood Cancer Journal. 2014; 4, e258; doi:10.1038/bcj.2014.76.
27. Распоряжение Комитета по экономической политике и стратегическому планированию Санкт-Петербурга от 17.07.2013 N 103-р «Об утверждении нормативов финансовых затрат на оказание государственных услуг (выполнение работ) по специализированной медицинской помощи, оказываемой в гериатрических учреждениях (отделениях, кабинетах), медицинской помощи, оказываемой в хосписах (отделениях-хосписах), и медицинской помощи, оказываемой в отделениях сестринского ухода, государственными автономными и бюджетными учреждениями».
28. Федеральный закон от 29.12.2006 N 255-ФЗ (ред. от 03.12.2011) «Об обязательном социальном страховании на случай временной нетрудоспособности и в связи с материнством»
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For citations:
Kolbin A.S., Vilum I.A., Balykina Yu.E., Proskurin M.A. Pharmacoeconomic analysis of the use of ibrutinib in therapy of the first line of a chronic lymphocytic leukaemia for patients with 17p deletion. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2015;(1):32-43. (In Russ.)
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