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Clinical and economic analysis of effectiveness of Nivolumab (Opdivo®) use as second-line monotherapy in adult patients with advanced renal cell carcinoma after previous systemic therapy

https://doi.org/10.17650/1726-9776-2017-13-1-53-66

Abstract

Objecktive. To conduct a comparative pharmacoeconomic analysis of using nivolumab (Opdivo®) as monotherapy in advanced renal cell carcinoma (RCC) in adult patients 2-line therapy.

Materials and methods. “Cost–effectiveness” was assessed using a Markov model for one patient with advanced RCC. “Cost–effectiveness” analysis, “cost–utility” analysis “budget impact” analysis were performed. Overall survival and QALYs were included into the model as the effectiveness criteria. All the direct costs were calculated from the Russian healthcare system perspective.

Results. Treatment with nivolumab was associated with lower total direct costs, less frequent adverse events compared with the combination lenvatinib + everolimus. Total costs per patient were 2 451 712 rubles and 5232592 rubles for nivolumab and the combination lenvatinib + everolimus, respectively. The incremental “cost–effectiveness” ratio was 5 561760 rubles per life-months gained and 2339823 rubles per quality-adjusted life month. A sensitivity analysis confirmed the base case results. “Budget impact” analysis showed that the using of nivolumab allows to save budget costs and to treat additional 198 patients without spending healthcare resources.

Conclusion. The results of the study showed that using nivolumab (Opdivo®) as monotherapy in advanced RCC in adult patients as 2-line therapy is clinically effective and “cost–effective” method of treatment of adult patients with RCC in theRussian Federation. 

About the Authors

M. Yu. Frolov
Volgograd State Medical University
Russian Federation


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


V. S. Krysanova
I.M. Sechenov First Moscow State Medical University
Russian Federation


References

1. Минимальные клинические рекомендации Европейского общества медицинской онкологии (ESMO). Клинические рекомендации ESMO по диагностике, лечению и наблюдению при почечно-клеточном раке. М.: Издательская группа РОНЦ им. Н.Н. Блохина РАМН, 2010. 436 с. [Minimal clinical recommendations of the European Society for Medical Oncology (ESMO). Renal cell carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Moscow: Izdatelskaya gruppa RONC im. N.N. Blokhina RAMN, 2010. 436 p. (In Russ.)].

2. Злокачественные новообразования в России в 2015 году (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой. М.: Московский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «Национальный медицинский исследовательский радиологический центр» Минздрава России, 2017. 250 с. [Malignant tumors in Russia in 2015 (morbidity and fatality). Eds. by: А.D. Kaprin, V.V. Starinskiy, G.V. Petrova. Мoscow: FGBU “Moskovskiy nauchno-issledovatel’skiy onkologicheskiy institut im. P.A. Gertsena” – filial FGBU “Natsional’nyy meditsinskiy issledovatel’skiy radiologicheskiy tsentr” Minzdrava Rossii, 2017. 250 p. (In Russ.)].

3. Renal cell carcinoma: ESMO Clinical Practice Guidelines. European Society for Medical Oncology, ESMO. Ann Oncol 2016;27(suppl 5):58–68. DOI: https://doi.org/10.1093/annonc/ mdw328.

4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: kidney cancer. Fort Washington, PA: National Comprehensive Cancer Network, 2016. Version 2. 2017. Available at: www.nccn.org/professionals/physician_gls/f_guidelines.asp.

5. Алексеев Б.Я., Волкова М.И., Калпинский А.С. и др. Общероссийский союз общественных объединений. Ассоциация онкологов России. Клинические рекомендации по диагностике и лечению рака почки. Утверждено на Заседании правления Ассоциации онкологов России. М., 2014. Доступно по: http://oncologyassociation.ru/docs/recomend/jun2015/38vzrek.pdf. [Alekseev B.Ya., Volkova M.I., Kalpinskiy A.S. et al. All-Russian Union of NonGovernmental Organizations. Association of Russian Oncologists. Clinical guidelines for kidney cancer diagnosis and treatment. Approved at the Association of Russian Oncologists board meeting. Moscow, 2014. Available at: http://oncology-association.ru/docs/recomend/jun2015/38vz-rek.pdf. (In Russ.)].

6. Носов Д.А., Воробьев Н.А., Гладков О.А. и др. Практические рекомендации по диагностике и лечению почечно-клеточного рака. Злокачественные опухоли 2016;4(2): 333–

7. [Nosov D.A., Vorob’ev N.A., Gladkov O.A. et al. Practical guidelines on renal cell carcinoma diagnosis and treatment. Zlokachestvennye opukholi = Malignant Tumors 2016;4(2):333–7. (In Russ.)]. DOI: 10.18027/2224-5057-2016-4s2-333-337. 7. Lee S., Margolin K. Cytokines in cancer immunotherapy. Cancers (Basel) 2011;3(4):3856–93. DOI: 10.3390/cancers3043856. PMID: 24213115.

8. Hudes G., Carducci M., Tomczak P. et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356(22):2271–81. DOI: 10.1056/NEJMoa066838. PMID: 17538086.

9. Motzer R.J., Escudier B., McDermott D.F. et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med 2015;373(19):1803–13. DOI: 10.1056/NEJMoa1510665. PMID: 26406148.

10. Motzer R.J., Hutson T.E., Glen H. et al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncology 2015;16(15):1473–82. DOI: 10.1016/S1470-2045(15)00290-9. PMID: 26482279.

11. Воробьев П.А., Авксентьева М.В., Борисенко О.В. и др. Клинико-экономический анализ. Издание 3-е, доп., с прил. М.: НЬЮДИАМЕД, 2008. [Vorob’ev P.A., Avksent’eva M.V., Borisenko O.V. et al. Clinical and economic analysis. 3rd edt., updated, with appendixes. Moscow: N’YUDIAMED, 2008. (In Russ.)].

12. Ягудина Р.И., Сороковиков И.В. Методология проведения анализа «затраты–полезность» при проведении фармакоэкономических исследований. Фармакоэкономика 2012;(2):9–12. [Yagudina R.I., Sorokovikov I.V. Methodology of cost–utility analysis in pharmacoeconomic studies. Farmakoekonomika = Pharmacoeconomics 2012;(2):9–12. (In Russ.)].

13. Ridge C.A., Pua B.B., Madoff D.C. Epidemiology and staging of renal cell carcinoma. Semin Intervent Radiol 2014;31(1):3–8. DOI: 10.1055/s-0033-1363837. PMID: 24596434.

14. Бюро по изучению рака почки. Рак почки 2017. Практическое руководство. Доступно по: http://www.rakpochki.net/ rakpochki2017. [Bureau of Kidney Cancer Research. Kidney cancer 2017. Practical Guidelines. Available at: http://www.rakpochki. net/rakpochki2017. (In Russ.)].

15. Motzer R.J., Mazumdar M., Bacik J. et al. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol 1999;17(8):2530–40. DOI: 10.1200/JCO.1999.17.8.2530. PMID: 10561319.

16. Remak E., Charbonneau C., Negrier S. et al. Economic evaluation of sunitinib malate for the first-line treatment of metastatic renal cell carcinoma. J Clin Oncol 2008;26(24):3996–4000. DOI: 10.1200/JCO.2007.13.2662. PMID: 18711190.

17. Benedict A., Figlin R.A., Sandström P. et al. Economic evaluation of new targeted therapies for the first-line treatment of patients with metastatic renal cell carcinoma. BJU Int 2011;108(5):665–72. DOI: 10.1111/j.1464-410X.2010.09957.x. PMID: 21265994.

18. Delea T.E., Amdahl J., Diaz J. et al. Cost– effectiveness of pazopanib versus sunitinib for renal cancer in the United States. J Manag Care Spec Pharm 2015;21(1):46–54, 54a–b. DOI: 10.18553/jmcp.2015.21.1.46. PMID: 25562772.

19. Kilonzo M., Hislop J., Elders A. et al. Pazopanib for the first-line treatment of patients with advanced and/or metastatic renal cell carcinoma: a NICE single technology appraisal. Pharmacoeconomics 2013;31(1): 15–24. DOI: 10.1007/s40273-012-0006-5. PMID: 23329590.

20. MacLean E.A., Sandin R., Mardekian J. Health care costs among renal cancer patients using pazopanib and sunitinib. J Manag Care Spec Pharm 2015;21(9):841–3. DOI: 10.18553/jmcp.2015.21.9.841. PMID: 26308231.

21. Villa G., Hernández-Pastor L.J. Budget impact analysis of first-line treatment with pazopanib for advanced renal cell carcinoma in Spain. BMC Cancer 2013;13:399. DOI: 10.1186/1471-2407-13-399. PMID: 24004638.

22. Зырянов С.К., Фролов М.Ю., Дьяков И.Н. Клинико-экономическая оценка применения пазопаниба в терапии распространенного рака почки. Онкоурология 2016;12(1):106–14. [Zyryanov S.K., Frolov M.Yu., Dyakov I.N. Clinical economic assessment of the use of pazopanib in the therapy of disseminated kidney cancer. Onkourologiya = Cancer Urology 2016;12(1):106–14. (In Russ.)]. DOI: 10.17650/1726-9776-2016-12-1-106-114.

23. Perrin A., Sherman S., Pal S. et al. Lifetime cost of everolimus vs axitinib in patients with advanced renal cell carcinoma who failed prior sunitinib therapy in the US. J Med Econ 2015;18(3):200–9. DOI: 10.3111/13696998.2014.985789. PMID: 25422989.

24. Casciano R., Chulikavit M., Di Lorenzo G. et al. Economic evaluation of everolimus versus sorafenib for the treatment of metastatic renal cell carcinoma after failure of first-line sunitinib. Value Health 2011;14(6):846–51. DOI: 10.1016/j.jval.2011.04.008. PMID: 21914504.

25. Petrou P. Cost–effectiveness analysis of axitinib through a probabilistic decision model. Expert Opin Pharmacother 2015;16(8):1233–43. DOI: 10.1517/14656566.2015.1039982. PMID: 25958963.

26. Колбин А.С., Фролов М.Ю., Курылев А.А. и др. Фармакоэкономический анализ применения эверолимуса по сравнению с акситинибом во второй линии при метастатическом раке почки. Клиническая фармакология и терапия 2015;24(1):88–92. [Kolbin A.S., Frolov M.Yu., Kurylyev A.A. et al. Pharmacoeconomic analysis of everolimus use in comparison with axitinib as second-line therapy for metastatic kidney cancer. Klinicheskaya farmakologiya i terapiya = Clinical Pharmacology and Therapy 2015;24(1):88–92. (In Russ.)].

27. Johal S., Johannesen K.M., Malcolm B. et al. Cost–effectivness of nivolumab in patients with advanced renal cell carcinoma in Sweden. Ann Oncol 2016;27(6):351–8. DOI: 10.1093/annonc/mdw377.12.

28. Verleger K., Almedia A.J., Verheggen B. et al. Cost–effectiveness of nivolumab in patients with advanced or metastatic renal cell carcinoma on Portugal. ISPOR 19th Annual European Congress, Vienna Austria, October 2016.


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For citations:


Frolov M.Yu., Krysanov I.S., Krysanova V.S. Clinical and economic analysis of effectiveness of Nivolumab (Opdivo®) use as second-line monotherapy in adult patients with advanced renal cell carcinoma after previous systemic therapy. Cancer Urology. 2017;13(1):53-66. (In Russ.) https://doi.org/10.17650/1726-9776-2017-13-1-53-66

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