Multicriteria analysis of the assortment of innovative drugs in oncohematology as a tool for supporting decision-making in the field of drug provision
https://doi.org/10.24411/2588-0519-2018-10040
Abstract
About the Authors
S. V. NedogodaRussian Federation
D.M., professor, Head of the Department of Therapy and Endocrinology of the Faculty of Advanced Training of Physicians
A. S. Salasyuk
Russian Federation
Ph.D., assistant of the Department of Therapy and Endocrinology of the Faculty of Advanced Training of Physicians
I. N. Barykina
Russian Federation
Ph.D., associate professor of the Department of Therapy and Endocrinology of the Faculty of Advanced Training of Physicians
V. O. Smirnova
Russian Federation
post-graduate student of the Department of Therapy and Endocrinology of the Faculty of Advanced Training of Physicians
E. A. Popova
Russian Federation
post-graduate student of the Department of Therapy and Endocrinology of the Faculty of Advanced Training of Physicians
References
1. Методические рекомендации по проведению сравнительной клинико-экономической оценки лекарственного препарата. ФГБУ «Центр экспертизы и контроля качества медицинской помощи Минздрава России». Москва, 2016. [Metodicheskie rekomendatsii po provedeniyu sravnitel'noi kliniko-ekonomicheskoi otsenki lekarstvennogo preparata. FGBU «Tsentr ekspertizy i kontrolya kachestva meditsinskoi pomoshchi Minzdrava Rossii». Moscow. 2016. (In Russ).]
2. Методические рекомендации по многокритериальному анализу принятия решений в здравоохранении. ФГБУ «Центр экспертизы и контроля качества медицинской помощи Минздрава России». Москва, 2016. [Metodicheskie rekomendatsii po mnogokriterial'nomu analizu prinyatiya reshenii v zdravookhranenii. FGBU «Tsentr ekspertizy i kontrolya kachestva meditsinskoi pomoshchi Minzdrava Rossii». Moscow. 2016. (In Russ).]
3. Омельяновский В.В., Федяева В.К., Реброва О.Ю. Возможности применения многокритериального анализа для оптимизации финансирования редких заболеваний. // Фармакоэкономика. 2014;7(4):29–35. [Omelyanovskiy VV, Fedyaeva VK, Rebrova OYu. Application of Multiple-Criteria Analysis for Optimization of Financing оf Rare Diseases. Pharmacoeconomics. 2014;7(4):29–35. (In Russ).]
4. Сайт Министерства здравоохранения РФ. URL: https://www.rosminzdrav.ru [Sait Ministerstva zdravookhraneniya RF. Available at: https://www.rosminzdrav.ru (In Russ).]
5. Туркина А.Г., Новицкая Н.В., Голенков А.К. и др. Регистр больных хроническим миелолейкозом в Российской Федерации: от наблюдательного исследования к оценке эффективности терапии в клинической практике. // Клиническая онкогематология. 2017;10(3):390–401. [Turkina AG, Novitskaya NV, Golenkov AK, et al. Chronic Myeloid Leukemia Patient Registry in the Russian Federation: From Observational Studies to the Efficacy Evaluation in Clinical Practice. Clinical oncohematology. 2017;10(3):390–401. (In Russ).] DOI: 10.21320/2500-2139-2017-10-3-390-401.
6. Бакиров Б.А. Клинико-патогенетическая характеристика и факторы прогноза в развитии и течении хронического лимфолейкоза, автореф. дис. на соискание ученой степени доктора медицинских наук, Санкт-Петербург, 2012. [Bakirov BA. Kliniko-patogeneticheskaya kharakteristika i faktory prognoza v razvitii i techenii khronicheskogo limfoleikoza. [dissertation] St. Petersburg; 2012 (In Russ).]
7. Абдулкадыров К.М., Шуваев В.А., Мартынкевич И.С. Что нам известно об истинной полицитемии (обзор литературы и собственные данные). // Онкогематология. 2015;3:45. [Abdulkadyrov KM, Shuvaev VA, Martynkevich IS. All we know about polycythemia vera: literature review and own experience. Oncogematology. 2015;3(10):28-42. (In Russ).] DOI: 10.17650/1818-8346-2015-10-3-28-42.
8. Ferlay J, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in Globocan 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. DOI: 10.1002/ijc.29210.
9. Prevalence and incidence of rare diseases: Bibliographic data Prevalence, incidence or number of published cases listed by diseases (in alphabetical order). Orphanet Report Series, Rare Diseases collection. 2017;1–74.
10. Никитин Е.А., Макарова М.В., Борисов Д.А, Поддубная И.В. Характеристика эпидемиологии, клинической картины и лечения хронического лимфолейкоза. Данные регистра лимфопролиферативных заболеваний. Тезисы Конгресс «Злокачественные лимфомы» 2015. [Kharakteristika epidemiologii, klinicheskoi kartiny i lecheniya khronicheskogo limfoleikoza. Dannye registra limfoproliferativnykh zabolevanii. EA Nikitin, MV Makarova, DA Borisov, IV Poddubnaya, Tezisy Kongress «Zlokachestvennye limfomy» 2015. (In Russ).]
11. Stilgenbauer S, Zenz T. Understanding and managing ultra high-risk chronic lymphocytic leukemia. ASH Education Program Book. 2010;(2010)1:481-488.
12. URL: https://www.nice.org.uk/guidance/ta401/documents/final-appraisaldetermination-document
13. Перечень жизненно необходимых и важнейших лекарственных препаратов для медицинского применения на 2017 год (утв. распоряжением Правительства РФ от 28 декабря 2016 г. № 2885-р). [Perechen' zhiznenno neobkhodimykh i vazhneishikh lekarstvennykh preparatov dlya meditsinskogo primeneniya na 2017 god (utv. rasporyazheniem Pravitel'stva RF ot 28 dekabrya 2016 g. № 2885-r). (In Russ).]
14. Rule S, et al. Outcomes in 370 patients with mantle cell lymphoma treated with ibrutinib: a pooled analysis from three open‐label studies. Br J Haematol. 2017 Nov;179(3):430–438. DOI: 10.1111/bjh.14870.
15. Kastritis E, et al. Dexamethasone, rituximab, and cyclophosphamide as primary treatment of Waldenström macroglobulinemia: final analysis of a phase 2 study. Blood. 2015;126:1392–1394. DOI: https://doi.org/10.1182/blood-2015-05-647420.
16. URL: http://www.lymphoma.org/atf/cf/%7B0363cdd6-51b5-427b-be48-e6af871acec9%7D/HL09RELREF.PDF
17. Hutchings M, et al. Advances in the diagnosis and treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Cancer Treatment Communications. 2015;4:1–11. DOI: 10.1016/j.ctrc.2015.06.002.
18. URL: https://www.cancer.org/cancer/acute-lymphocytic-leukemia/treating/typical-treatment.html
19. Российские клинические рекомендации по диагностике и лечению лимфопролиферативных заболеваний. Под руководством профессора И.В. Поддубной, профессора В.Г. Савченко. М., 2016. – 412 с. [Rossijskie klinicheskie rekomendacii po diagnostike i lecheniyu limfoproliferativnyh zabolevanij. Pod rukovodstvom professora IV Poddubnoy, professora VG Savchenko M. 2016. – 412 s. (In Russ).]
20. Usmani S, et al. Analysis of Real-World Data on Overall Survival in Multiple Myeloma Patients With ≥3 Prior Lines of Therapy Including a Proteasome Inhibitor (PI) and an Immunomodulatory Drug (IMiD), or Double Refractory to a PI and an IMiD. The Oncologist. November. 2016;21(11):1355–1361. DOI: 10.1634/theoncologist.2016-0104.
21. Cervantes F, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113(13):2895–2901.DOI: https://doi.org/10.1182/blood-2008-07-170449.
22. Manuel L, et al. Assessing The Level Of Resistance/Intolerance To Hydroxyurea Therapy Amongst Patients With Polycythemia Vera In Europe. Value in Health. 2015;(18)7:A436.
23. Badoux XC, et al. Fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy is highly effective treatment for relapsed patients with CLL. Blood. 2011;(117)11:3016-3024. DOI: https://doi.org/10.1182/blood-2010-08-304683.
24. URL: https://seer.cancer.gov/statfacts/more.html
25. Smith A, et al. Lymphoma incidence, survival and prevalence 2004–2014: sub-type analyses from the UK’s Haematological Malignancy Research Network. British journal of cancer. 2015;(112)9:1575–1584.
26. Buske C, et al. Waldenström's macroglobulinaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of oncology. 201;(24)6:vi155–vi159.
27. Cervantes F, et al. Improving survival trends in primary myelofibrosis: an international study. Journal of Clinical Oncology. 2012;(30)24:2981-2987.
28. Tefferi A, et al. Survival and prognosis among 1545 patients with contemporary polycythemia vera: an international study. Leukemia. 2013 Sep;27(9):1874–1881. DOI: 10.1038/leu.2013.163.
29. Sprangers MAG, Bonnetain F. EORTC QLQ-C30. Encyclopedia of Quality of Life and Well-Being Research. 2014: 1933–1935.
30. Hinz A, Singer S, Brähler E. European reference values for the quality of life questionnaire EORTC QLQ-C30: results of a German investigation and a summarizing analysis of six European general population normative studies. Acta Oncol. 2014 Jul;53(7):958–965. DOI: 10.3109/0284186X.2013.879998.
31. O'Brien S, et al. Five-Year Experience with Single-Agent Ibrutinib in Patients with Previously Untreated and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia, ASH 2016, Session: 642.
32. Rule S, et al. Ibrutinib versus Temsirolimus: Results From a Phase 3, International, Randomized, Open-Label, Multicenter Study in Patients With Previously Treated Mantle-Cell Lymphoma. Oral presentation presented at: the 14th International Conference on Malignant Lymphoma (ICML 2017).
33. Souchet L, et al. Efficacy and long‐term toxicity of the rituximab fludarabine‐cyclophosphamide combination therapy in Waldenstrom's macroglobulinemia. American journal of hematology. 2016; 91(8):782–786. DOI:10.1002/ajh.24405.
34. Hambley B, Caimi PF, William BM. Bortezomib for the treatment of mantle cell lymphoma: an update. Ther Adv Hematol. 2016 Aug;7(4):196–208. DOI: 10.1177/2040620716648566.
35. Al-Sawaf O, et al. Obinutuzumab in chronic lymphocytic leukemia: Design, development and place in therapy. Drug design, development and therapy. 2017;11:295–304. DOI: 10.2147/DDDT.S104869.
36. URL: http://www.onclive.com/conference-coverage/ash-2016/frontlineobinutuzumab-significantly-improves-pfs-in-follicular-lymphoma
37. Stewart AK, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142–152. DOI: 10.1056/NEJMoa1411321.
38. Hájek R, et al. A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS). Leukemia. 2017 Jan; 31(1):107–114. DOI: 10.1038/leu.2016.
39. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan;26(1):149–57. DOI: 10.1038/leu.2011.196.
40. Chen R, et al. Effect of pomalidomide on relapsed/refractory multiple myeloma: a systematic review and meta-analysis. J Cancer. 2017;8(10):1801–1808. DOI:10.7150/jca.17999.
41. Verstovsek S, et al. A Pooled Overall Survival (OS) Analysis of 5-Year Data from the COMFORT-I and COMFORT-II Trials of Ruxolitinib for the Treatment of Myelofibrosis (MF). 2016.
42. URL: https://www.nice.org.uk/guidance/ta425
43. Bonthapally V, et al. Brentuximab vedotin compared with other therapies in relapsed/refractory Hodgkin lymphoma post autologous stem cell transplant: median overall survival meta-analysis. Curr Med Res Opin. 2015;31(7):1377-89. DOI: 10.1185/03007995.2015.1048208.
44. Pro B, et al. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017: blood-2017-05-780049; DOI: https://doi.org/10.1182/blood-2017-05-780049.
45. Kantarjian H, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017 Mar 2;376(9):836–847. DOI: 10.1056/NEJMoa1609783.
46. Fischer K, et al. Bendamustine combined with rituximab in patients with relapsed and/or refractory chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2011 Sep 10;29(26):3559–3566. DOI: 10.1200/JCO.2010.33.8061.
47. Brown J, et al. Updated Efficacy Including Genetic and Clinical Subgroup Analysis and Overall Safety in the Phase 3 RESONATETM Trial of Ibrutinib Versus Ofatumumab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; ASH 2014, poster 3331.
48. Castillo JJ, et al. Ibrutinib in Waldenström macroglobulinemia: latest evidence and clinical experience. Therapeutic advances in hematology. 2016;(7)4:179–186.
49. Goede V, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101–1110. DOI: 10.1056/NEJMoa1313984.
50. Wendtner CM, Gregor M. Current perspectives on the role of chemotherapy in chronic lymphocytic leukemia. Leuk Lymphoma. 2018 Feb;59(2):300–310. DOI: 10.1080/10428194.2017.1330474.
51. Miguel JS, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1055–1066. DOI: 10.1016/S1470-2045(13)70380-2.
52. Harrison CN, et al. Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs best available therapy for myelofibrosis. Leukemia. 2016 Aug; 30(8):1701–1707. DOI: 10.1038/leu.2016.148.
53. Vannucchi AM, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015 Jan 29;372(5):426–435. DOI: 10.1056/NEJMoa1409002.
54. Cortes JE, et al. Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome–positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood. 2011; (118)17:4567–4576.
55. Dada R, Zekri J, Al Saadi R. Brentuximab vedotin in pretreated Hodgkin lymphoma patients: a systematic review and meta-analysis. Expert Opin Biol Ther. 2016 Jun;16(6):739–745. DOI: 10.1080/14712598.2016.1180362.
56. Pro B, et al. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190–2196. DOI: 10.1200/JCO.2011.38.0402.
57. Morel A, et al. Long-term outcomes of adults with first-relapsed/refractory systemic anaplastic large-cell lymphoma in the pre-brentuximab vedotin era: A LYSA/SFGM-TC study. Eur J Cancer. 2017 Sep;83:146–153. DOI: 10.1016/j.ejca.2017.06.026.
58. Montillo M, et al. Ibrutinib in previously treated chronic lymphocytic leukemia patients with autoimmune cytopenias in the RESONATE study. Blood cancer journal. 2017;(7)2:e524.
59. Dimopoulos MA, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016 Jan;17(1):27–38. DOI: 10.1016/S1470-2045(15)00464-7.
60. Hochhaus A, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016 May; 30(5):1044-54. DOI: 10.1038/leu.2016.5.
61. Cortes JE, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naïve chronic myeloid leukemia patients trial. J Clin Oncol. 2016 Jul 10;34(20):2333–2340. DOI: 10.1200/JCO.2015.64.8899.
62. Gopal AK, et al. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560–568. DOI: 10.1182/blood-2011-12-397893.
63. Burger JA, et al. Safety and activity of ibrutinib plus rituximab for patients with high-risk chronic lymphocytic leukaemia: a single-arm, phase 2 study. Lancet Oncol. 2014 Sep;15(10):1090–1099. DOI: 10.1016/S1470-2045(14)70335-3.
64. URL: https://clinicaltrials.gov/ct2/show/results/NCT01236391?sect=Xa0156#outcome4
65. Stewart AK, et al. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma. J Clin Oncol. 2016 Nov 10;34(32):3921–3930. DOI: 10.1200/JCO.2016.66.9648.
66. Song KW, et al. Health-related quality of life from the MM-003 trial of pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed and/or refractory multiple myeloma. Haematologica. 2015;(100)2:e63–e67. DOI:10.3324/haematol.2014.112557.
67. Mesa RA, et al. Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial. J Clin Oncol. 2013 Apr 1;31(10):1285–1292. DOI: 10.1200/JCO.2012.44.4489.
68. Mesa R, et al. Changes in quality of life and disease‐related symptoms in patients with polycythemia vera receiving ruxolitinib or standard therapy. European journal of haematology. 2016;(97)2:192–200.
69. Sacha T, et al. Adherence to second line therapy with nilotinib and quality of life of patients with chronic myeloid leukemia: a multicenter prospective observational study. Haematologica. – via giuseppe belli 4, 27100 pavia, italy: ferrata storti foundation, 2017;(102):437–437.
70. URL: https://clinicaltrials.gov/ct2/show/record/NCT01660906?sect=X90156
71. Trask PC, et al. Health-related quality of life of bosutinib (SKI-606) in imatinib-resistant or imatinib-intolerant chronic phase chronic myeloid leukemia. Leukemia research. 2012;(36)4:438–442.
72. Ramsey SD, et al. Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma. Br J Haematol. 2016 Dec;175(5):860–867. DOI: 10.1111/bjh.14316.
73. Topp MS, et al. Health-Related Quality of Life (HRQoL) of Blinatumomab Versus Standard of Care (SOC) Chemotherapy in Patients with Relaspsed or Refractory Philadelphia Negative B-Cell Precursor Acute Lymphoblastic Leukemia in a Randomized, Open-Label Phase 3 Study (TOWER). 2016.
Review
For citations:
Nedogoda S.V., Salasyuk A.S., Barykina I.N., Smirnova V.O., Popova E.A. Multicriteria analysis of the assortment of innovative drugs in oncohematology as a tool for supporting decision-making in the field of drug provision. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2018;(2):4-11. (In Russ.) https://doi.org/10.24411/2588-0519-2018-10040