Preview

Oncohematology

Advanced search

RATIONAL SUPPORTIVE THERAPY FOR CHEMOTHERAPY INDUCED ANEMIA: A PHARMACO-ECONOMIC ANALYSIS OF ERYTHROPOIETIN THERAPY IN CANCER PATIENTS IN RUSSIAN FEDERATION

https://doi.org/10.17650/1818-8346-2018-13-2-48-61

Abstract

Modern anticancer therapy due to its intensity and molecular biology orientation allows achieving higher efficiency and theoretically reducing the incidence of complications. However, the increase in efficacy in the modern oncology really exists, but reducing complication frequency, unfortunately, is far from being solved. In many respects the problems of diagnosis, treatment and complications monitoring are associated with the impact on the complex physiological processes occurring in oncological patient. Timely implementation of modern and adequate programs for the prevention and treatment of these complications defines the concept of “supportive therapy”, which provides at least half the effectiveness of antitumor treatment.

To date, according to most studies, the most frequent complications of antitumor therapy are hematologic, in particular – anemia. In clinical practice, blood transfusions, recombinant human erythropoietins, hemopoiesis stimulating cofactors are used to correct this type of complications. The need for anemia treatment is determined by its negative impact on quality of life, as well as a negative prognostic impact on the life expectancy of cancer patients, because hypoxia of tumor tissue can be associated with resistance to chemoand radiation therapy, the stimulation of genetic mutations and neoangiogenesis, which make it difficult to control of tumor growth. In numerous studies using multivariate analysis confirmed the association of low hemoglobin levels and/or tumor tissue hypoxia with worsening prognosis and overall survival in many types of tumors. The modern anemia treatment should not be determined only by increased in hemoglobin level, but should be considered as an active prophylaxis for its reducing. Recombinant forms of human erythropoietin and intravenous forms of iron preparations should be the most popular correction methods in everyday practice.

The high cost of complex anemia therapy and the social significance of oncological diseases necessitate a pharmaco-economic analysis of registered in Russia erythropoietin preparations and the optimization of existing anemia treatment regimens in cancer patients in order to reduce the expenditures of the health budget. At present, an active import substitution program is underway in the Russian Federation to support the development of the Russian pharmaceutical industry and provide the population with more affordable medicines while maintaining its quality and efficiency. The need to address these issues, and the effective use of the domestic biological analogue epoetin alfa, served as an excuse for performing a comparative clinical and economic analysis. They were selected drugs that differ in pharmacokinetic properties: Eralfon® – analogue of epoetin alfa and Aranesp® – darbepoetin alfa.

The treatment model of adults oncological patients with anemia receiving chemotherapy was created, which takes into account various therapies using erythropoietin preparations. The total therapy cost for an oncological patient with anemia is less when using short-acting erythropoietin – epoetin alfa – 131 609 rubles in comparison with the long-acting erythropoietin – darbepoetin alfa – 245 159.2 rubles, the difference was 113 550.2 rubles (–46 %) in favor of the epoetin alfa.

According to pharmaco-economic analysis, the treatment of anemia with a Russian-produced drug epoetin alfa (Eralfon®) is preferred in comparison to darbepoetin alfa (Aranesp) in adult cancer patients with nonmyeloid malignancies in the Russian Federation, as it allows increasing the number of treated patients at a cost reduction.

About the Authors

V. B. Larionova
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
23 Kashirskoe Shosse, 115446 Moscow


I. S. Krysanov
Institute of Medical and Social Technologies of Moscow State University of Food Production; Research Institute of Clinical and Economic Expertise and Pharmacoeconomics
Russian Federation


A. V. Snegovoy
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
23 Kashirskoe Shosse, 115446 Moscow


P. A. Zeinalova
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
23 Kashirskoe Shosse, 115446 Moscow


V. S. Krysanova
Scientific and Practical Center for Clinical Research and Health Technology Assessment of Moscow Health Care Department
Russian Federation
12, bldg. 2, Minskaya St., 121096 Moscow


V. Yu. Ermakova
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
8, bldg. 2 Trubetskaya St., 119991 Moscow


References

1. Roé E., García Muret M.P., Marcuello E. et al. Description and management of cutaneous side effects during cetuximab or erlotinib treatments: a prospective study of 30 patients. J Am Acad Dermatol 2006;55(3):429–37. DOI: 10.1016/j.jaad.2006.04.062. PMID: 16908348.

2. Herrstedt J. Supportive Care and Palliative Care-Cooperation or Competition? International Symposium on Supportive Care in Cancer, Miami, USA, June 26– 28, 2014.

3. Snegovoy A.V., Davydov M.I. Modern possibilities of maintenance therapy in antitumor treatment. Vestnik RONTS im. N.N.Blokhina = Bulletin of the N.N. Blokhin RORC 2016;27(2):5–17 (In Russ.).

4. Metcalf D. Concise review: hematopoietic stem cells and tissue stem cells: current concepts and unanswered questions. Stem Cells 2007;25(10):2390–5. DOI: 10.1634/stemcells.2007-0544. PMID: 17690176.

5. Snegovoy A.V., Aapro M., Davidenko I.S. et al. Practical recommendations for anemia treatment in cancer patients. Zlokachestvennye opukholi = Malignant tumors 2015;4s:316–26 (In Russ.). DOI: 10.18027/2224-50572015-4s-316-326.

6. Kreys E.D., Koeller J.M. Documenting the Benefits and Cost Savings of a Large Multistate Cancer Pathway Program From a Payer’s Perspective. J Oncol Pract 2013;9(5):e241–7. DOI: 10.1200/JOP.2012.000871. PMID: 23943896.

7. Coleman R.E., Abrahamsson P.-A., Hadji P. Handbook of cancer-related bone disease. Bristol, UK: BioScientifica Ltd., 2010; 231 p.

8. Maddens S., Charruyer A., Plo I. et al. Kit signaling inhibits the sphingomyelinceramide pathway through PLC gamma 1: implication in stem cell factor radioprotective effect. Blood 2002;100(4):1294–301. PMID: 12149210.

9. Schwab M., Zanger U.M., Marx C. et al. German 5-FU Toxicity Study Group. Role of genetic and nongenetic factors for fluorouracil treatment-related severe toxicity: a prospective clinical trial by the German 5-FU Toxicity Study Group. J Clin Oncol 2008;26(13):2131–8. DOI: 10.1200/JCO.2006.10.4182. PMID: 18299612.

10. Food and Drug Administration. Jevtana (cabazitaxel) Injection Label Information. URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf. Accessed November 12, 2015.

11. Food and Drug Administration. Taxotere (docetaxel) Injection Label Information. URL: http://www.accessdata.fda.gov/drugsatfda_docslabel/2010/020449s059lbl.pdf. Accessed November 12, 2015.

12. Food and Drug Administration. Xtandi (enzalutamide) Capsules Label Information. URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf. Accessed November 12, 2015.

13. Groopman J., Itri L. Chemotherapy-induced anemia in adults: incidence and treatment. J Nat Cancer Inst 1999;91(19):1616–34. DOI: 10.1093/jnci/91.19.1616. PMID: 10511589.

14. Zhang G., Yang P., Guo P. et al. Unraveling the mystery of cancer metabolism in the genesis of tumor-initiating cells and development of cancer. Biochim Biophys Acta 2013;1836(1): 49–59. DOI: 10.1016/j.bbcan.2013.03.001. PMID: 23523716.

15. Caro J.J., Salas M., Ward A., Goss G. Anemia as an independent prognostic factor for survival in patients with cancer: a systemic, quantitative review. Cancer 2001;91(12):2214–21. DOI: 10.1002/1097-0142(20010615)91:12<2214::AID-CNCR1251>3.0.CO;2-P. PMID: 11413508.

16. URL: http://www.ncagip.ru/medical-services/price/trasfusion.php. Дата обращения 30.07.2016.

17. Hoff C.M., Lassen P., Eriksen J.G. et al. Does transfusion improve the outcome for HNSCC patients treated with radiotherapy? Results from the randomized DAHANCA 5 and 7 trials. Acta Oncologica 2011;50(7):1006–14. DOI: 10.3109/0284186X.2011.592650. PMID: 21790306.

18. Blajchman M.A. Transfusion immunomodulation or TRIM: what does it mean clinically? Hematology 2005;10(Suppl 1):208–14. DOI: 10.1080/10245330512331390447. PMID: 16188675.

19. Bohlius J., Wilson J., Seidenfeld J. et al. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 2006;98(10):708–714. DOI: 10.1093/jnci/djj189. PMID: 16705125.

20. Bennett C.L., Silver S., Djulbegovic B. et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia. JAMA 2008;299(8):914–24. DOI: 10.1001/jama.299.8.914. PMID: 18314434.

21. Glaspy J., Crawford J., Vansteenkiste J. et al. Erythropoiesis-stimulating agents in oncology: a study-level meta-analysis of survival and other safety outcomes. Br J Cancer 2010;102(2):301–15. DOI: 10.1038/sj.bjc.6605498. PMID: 20051958.

22. Glaspy J., Osterborg A., Ludwig H. et al. Evaluation of the association between (Hb) events and safety outcomes in cancer patients with chemotherapy induced anemia: an integrated analysis of patient-level data from 6 randomized, placebo-controlled trials of darbepoetin. Eur J Cancer Supplements 2007;5(4):147–8. DOI: 10.1016/s13596349(07)70639-0.

23. Ludwig H., Crawford J., Osterborg A. et al. Pooled analysis of individual patientlevel data from all randomized, double blind, placebo-controlled trials of darbepoetin alfa in the treatment of patients with chemotherapy-induced anemia. J Clin Oncol 2009;27(17):2838–47. DOI: 10.1200/jco.2008.19.1130. PMID: 19380447.

24. Oncologic Drug Advisory Committee (ODAC) Meeting Information Package. Darbepoetin alfa (BLA#103951) and Epoetin alfa (BLA#103234). URL: http://www.scribd.com/doc/1117102/US-Foodand-Drug-Administration-20074301b20101-Amgen.

25. Tonelli M., Hemmelgarn B., Reiman T. et al. Benefits and harms of erythropoiesisstimulating agents for anemia related to cancer: a meta-analysis. CMAJ 2009;180(11):E62–E71. DOI: 10.1503/cmaj.090470. PMID: 19407261.

26. Glaspy J., Osterborg A., Ludwig H. et al. Evaluation of the association between (Hb) events and safety outcomes in cancer patients with chemotherapy induced anemia: an integrated analysis of patientlevel data from 6 randomized, placebocontrolled trials of darbepoetin. Eur J Cancer Supplement 2007;5(4):147–8. DOI: 10.1016/s1359-6349(07)70639-0.

27. Delarue R., Haioun C., Coiffier B. et al. Survival effect of darbepoetin alfa in patients with diffuse large B-cell lymphoma (DLBCL) treated with immunochemotherapy: The LNH03-6B study. J Clin Oncol 2011;29(Suppl 15):9048. DOI: 10.1200/jco.2011.29.15_suppl.9048.

28. Technology appraisals: Guidance development Equality impact assessment for the multiple technology appraisal of erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating cancer-treatment induced anaemia (including review of TA142). URL: www.nice.org.uk. Issue date: November 2014.

29. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Cancerand ChemotherapyInduced Anemia. National Comprehensive Cancer Network, 2017. Version 1.2018; Fort Washington, PA.

30. Snegovoy A.V., Kononenko I.B., Larionova V.B. et al. Clinical recommendations protocols of maintenance therapy in oncology. Moscow: ABV-press, 2017. P. 11 (In Russ.).

31. Federal law No. 44-FZ dated April 5, 2013 “On the contract system in government procurement of goods and services for state and municipal needs” (In Russ.).

32. Order of the Ministry of Economic Development of the Russian Federation No. 155 dated March 25, 2014 “On the terms of admission of the goods produced in foreign countries to government procurement of goods and services for state and municipal needs”. (In Russ.).

33. Decree of the Russian Federation Government No. 102 dated February 5, 2015 “On the limitations and terms of admission of particular medical products produced in foreign countries to government procurement of goods and services for state and municipal needs” (In Russ.).

34. Forbes C.A., Worthy G., Harker J. et al. Dose efficiency of erythropoiesis-stimulating agents for the treatment of patients with chemotherapy-induced anemia: a systematic review. Clin Ther 2014;36(4):594–610. DOI: 10.1016/j.clinthera.2014.02.007. PMID: 24656152.

35. Crathorne L., Huxley N., Haasova M. et al. The effectiveness and cost-effectiveness of erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating cancer treatment-induced anaemia (including review of technology appraisal no. 142): a systematic review and economic model. Health Technol Assess 2016;20(13):1–588. DOI: 10.3310/hta20130. PMID: 26907163

36. Gabrilove J.L., Cleeland C.S., Livingston R.B. et al. Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: improvements in hemoglobin and quality of life are similar to threetimes-weekly dosing. J Clin Oncol 2001;19(11):2875–82. DOI: 10.1200/JCO.2001.19.11.2875. PMID: 11387360.

37. Pashos C.L., Larholt K., Fraser K.A. et al. Outcomes of erythropoiesis-stimulating agents in cancer patients with chemotherapy-induced anemia. Support Care Cancer 2012;20(1):159–65. DOI: 10.1007/s00520-010-1083-7. PMID: 21359879.

38. Steensma D.P., Dakhil S.R., Novotny P.J. et al. A randomized comparison of once weekly epoetin alfa to extended schedule epoetin or darbepoetin in chemotherapyassociated anemia. Am J Hematol 2015;90(10):877–81. DOI: 10.1002/ajh.24110. PMID: 26149465.

39. Vorobyev P.A., Avksentieva M.V., Borisenko O.V. et al. Clinical and economic analysis. 3rd ed., supplemented, with applications. Moscow: NEWDIAMED, 2008:226–9 (In Russ.).

40. Decree of the Moscow Government No. 163-PP dated February 24, 2012 “On the establishment of resale markups for drugs included into the list of vital and essential medicines” (In Russ.).

41. Medication package insert for Aranesp®. State Register of Medicines. Official website [Electronic source]. Accessed 24.10.2017. (In Russ.).

42. Medication package insert for Eralfon®. State Register of Medicines. Official website, [Electronic source]. Accessed 24.10.2017. (In Russ.).

43. Tariff agreement regulating the remuneration for medical care provided under the territorial program of compulsory medical insurance in Moscow city for 2017 dated December 29, 2016; Moscow City Fund of compulsory medical insurance. (In Russ.).

44. Appendix No. 6 to the tariff agreement regulating the remuneration for medical care provided under the territorial program of compulsory medical insurance in Moscow city for 2017 dated December 29, 2016; Moscow City Fund of compulsory medical insurance. (In Russ.].

45. Appendix No. 8.1 to the tariff agreement regulating the remuneration for medical care provided under the territorial program of compulsory medical insurance in Moscow city for 2017 dated December 29, 2016; Moscow City Fund of compulsory medical insurance. (In Russ.).

46. Rashid N., Koh H.A., Baca H.C. et al. Clinical Impact of Chemotherapy-Related Adverse Events in Patients with Metastatic Breast Cancer in an Integrated Health Care System. J Manag Care Spec Pharm 2015;21(10):863–71. DOI: 10.18553/jmcp.2015.21.10.863. PMID: 26402387.

47. Ludwig H., Aapro M., Bokemeyer C. et al. A European patient record study on diagnosis and treatment of chemotherapyinduced anaemia. Support Care Cancer 2014;22(8):2197–206. DOI: 10.1007/s00520-014-2189-0. PMID: 24659244.

48. Snegovoy A.V. Rational tactics of maintenance therapy in antitumor treatment. Diss. …D. of Medicine. Moscow, 2017 (In Russ.)

49. Repetto L., CIPOMO investigators. Incidence and clinical impact of chemotherapy induced myelotoxicity in cancer patients: an observational retrospective survey. Crit Rev Oncol Hematol 2009;72(2):170–9. DOI: 10.1016/j.critrevonc.2009.03.004. PMID: 19406660.

50. Avila M.A., Berasain C., Torres L. et al. Reduced mRNA abundance of the main enzymes involved in methionine metabolism in human liver cirrhosis and hepatocellular carcinoma. J Hepatol 2000;33(6):907–14. DOI: 10.1016/S01688278(00)80122-1. PMID: 11131452.

51.


Review

For citations:


Larionova V.B., Krysanov I.S., Snegovoy A.V., Zeinalova P.A., Krysanova V.S., Ermakova V.Yu. RATIONAL SUPPORTIVE THERAPY FOR CHEMOTHERAPY INDUCED ANEMIA: A PHARMACO-ECONOMIC ANALYSIS OF ERYTHROPOIETIN THERAPY IN CANCER PATIENTS IN RUSSIAN FEDERATION. Oncohematology. 2018;13(2):48-61. (In Russ.) https://doi.org/10.17650/1818-8346-2018-13-2-48-61

Views: 10378


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 1818-8346 (Print)
ISSN 2413-4023 (Online)