PHARMACOECONOMICAL RESEARCH OF THE USE OF SORAFENIB IN MALIGNANT TUMORS
https://doi.org/10.17709/2409-2231-2016-3-3-1
Abstract
Purpose. Pharmacoeconomic rationale for the use of sorafenib in malignant tumors in comparison with drugs that are included in the list of pharmaceuticals to provide to certain categories of citizens.
Method of the study. Pharmacoeconomic rationale for the use of sorafenib in this study is made by analyzing the impact on the budget. The calculated costs of treatment with sorafenib at a hypothetical group of 100 patients with metastatic renal cell carcinoma (MRCC), hepatocellular carcinoma (HCC) and differentiated thyroid cancer resistant to radioactive iodine (DCT). These costs were compared with costs of treatment of a similar group of 100 patients, with treatment of MRCC applied bevacizumab (original or generic) in combination with interferon α, and patients with HCC and DCT were excluded from receiving drugs from a program of providing with necessary medicines (PNM). As a result the potential economic effect of the inclusion of sorafenib in the list of PNM was calculated.
Results. Treatment of MRCC is cheaper with the use of sorafenib compared to bevacizumab in combination with interferon α: savings is 592 878 rubles in the original use of bevacizumab and 274 976 rubles in the use of generic bevacizumab for one patient-year. If we use sorafenib in a group of 100 people with MRCC, HCC and DCT suitable for treatment with sorafenib, the overall expenses are more than 175 million rubles, while using the original combination of bevacizumab with interferon α – more than 204 million rubles, and in the application of the generic combination of bevacizumab with interferon α – more than 176 million rubles, while in the two last cases the treatment of patients with HCC and DCT is not carried out. The total amount of annual budget savings in the treatment of 100 patients is more than 28.5 million rubles at the account of original of bevacizumab or more than 1 million rubles in accounting of generic bevacizumab.
Conclusion. The inclusion of the targeted drug sorafenib in the list of pharmaceuticals to provide certain categories of citizens is economically justified. The use of sorafenib, instead of the combination of bevacizumab + interferon-α in patients with MRCC gives us the opportunity to release the funds and provide a systemic treatment of patients with other malignancies (HCC, DCT) while reducing the burden on the budget.
About the Authors
M. Y. FrolovRussian Federation
PhD, docent of the course FID, department of clinical pharmacology and intensive care, Volgograd State Medical University; the Executive Director of the Association of clinical pharmacologists
N. A. Avksentjev
Russian Federation
advisor, Scientific and research financial institute; researcher of The Russian Presidential Academy оf National Economy аnd Public Administration
I. G. Rusakov
Russian Federation
MD, professor, vice-president of Russian society of Oncourologists; Deputy chief physician at cancer care of «City clinical hospital №57 of Department of health of Moscow»
E. V. Derkach
Russian Federation
PhD, leading researcher of laboratory of evaluation of health care technologies, The Russian Presidential Academy оf National Economy аnd Public Administration; Executive
Director of Center for technology assessment in health care
References
1. Wilking N., Jönsson B. A pan-European comparison regarding patient access to cancer drugs. Karolinska Institutet in collaboration with Stockholm School of Economics Stockholm, Sweden. 2007. 77 p.
2. Wilking N., Jönsson B., Högberg D., Justo N. Comparator Report on Patient Access to Cancer Drugs in Europe. Karolinska Institutet, Stockholm School of Economics, i3 Innovus, Stockholm, Sweden. 2009. 117 p.
3. Soerensen A. V., Donskov F., Hermann G. G., Jensen N. V., Petersen A., Spliid H., et al. Improved overall survival after implementation of targeted therapy for patients with metastatic renal cell carcinoma: results from the Danish Renal Cancer Group (DARENCA) study‑2. Eur J Cancer. 2014 Feb;50 (3):553–62. doi: 10.1016/j.ejca.2013.10.010.
4. Shinohara N., Obara W., Tatsugami K., Naito S., Kamba T., Takahashi M., et al. Prognosis of Japanese patients with previously untreated metastatic renal cell carcinoma in the era of molecular-targeted therapy. Cancer Sci. 2015 May;106 (5):618–26. doi:10.1111/cas.12646.
5. Wahlgren T., Harmenberg U., Sandström P., Lundstam S., Kowalski J., Jakobsson M., et al. Treatment and overall survival in renal cell carcinoma: a Swedish population-based study (2000–2008). Br J Cancer. 2013 Apr 16;108 (7):1541–9. doi: 10.1038/bjc.2013.119.
6. The decree of the RF Government No. 2724‑R dated December 26, 2015 “On approval of the list of vital and essential medical products by 2016, as well as lists of medical preparations for medical application and the minimum assortment of medical preparations necessary for rendering of medical care” [Electronic resource]. Available at: https://www.consultant.ru/document/cons_doc_LAW_192036/ Accessed:27.03.2016. (In Russian).
7. Escudier B., Eisen T., Stadler W. M., Szczylik C., Oudard S., Siebels M., for the TARGET study group. Sorafenib in Advanced Clear- ell Renal-Cell Carcinoma. N Engl J Med 2007;356:125–34. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa060655
8. Escudier B., Szczylik C., Hutson T. E., Demkow T., Staehler M., Rolland F., et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa‑2a in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Mar 10;27 (8):1280–9. doi: 10.1200/JCO.2008.19.3342.
9. Escudier B., Eisen T., Stadler W. M., Szczylik C., Oudard S., Staehler M., et al. Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009;27 (20): 3312–8. doi: 10.1200/JCO.2008.19.5511.
10. Negrier S., Jäger E., Porta C., McDermott D., Moore M., Bellmunt J., et al. Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. Med Oncol. 2010;27 (3):899–906. doi: 10.1007/s12032–009–9303‑z.
11. Thomas L., Lai S. Y., Dong W., Feng L., Dadu R., Regone R. M. Sorafenib in metastatic thyroid cancer: a systematic review. Oncologist. 2014 Mar;19 (3):251–8. doi: 10.1634/theoncologist.2013–0362.
12. Llovet J. M., Ricci S., Mazzaferro V., Hilgard P., Gane E., Blanc J. F., et al; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359 (4):378–90. doi: 10.1056/NEJMoa0708857.
13. Brose M. S., Nutting C. M., Jarzab B., Elisei R., Siena S., Bastholt L., et al. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319–8. doi: 10.1016/S0140–6736 (14)60421–9.
14. Shen C. T., Qiu Z. L., Luo Q. Y. Sorafenib in the treatment of radioiodine-refractory differentiated thyroid cancer: a meta-analysis. Endocr Relat Cancer. 2014 Feb 27;21 (2):253–61. doi: 10.1530/ERC‑13–0438.
15. NCCN Clinical Practice Guidelines in Oncology. Kidney Cancer. Version 2.2016. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf
16. Practical recommendations for drug treatment of patients with rena cell cancer. p. 273–277. The Internet portal of the Russian society of clinical Oncology in the project oncology.ru. Available at: http://www.rosoncoweb.ru/standarts/RUSSCO/. Accessed 20.09.2015. (In Russian).
17. EASL–EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56 (4):908–43. doi: 10.1016/j.jhep.2011.12.001.
18. Practical recommendations for drug treatment of patients with primary liver cancer. Hepatocellular carcinoma (HCC). p. 243–252. The Internet portal of the Russian society of clinical Oncology in the project oncology.ru. Accessed 20.09.2015. Available at: http://www.rosoncoweb.ru/standarts/RUSSCO/ (In Russian).
19. Shen C. T., Qiu Z. L., Luo Q. Y. Sorafenib in the treatment of radioiodine-refractory differentiated thyroid cancer: a meta-analysis. Endocr Relat Cancer. 2014 Feb 27;21(2):253–61. doi: 10.1530/ERC‑13–0438.
20. Practical recommendations for drug treatment of tumors of the head and neck. p.42–47. The Internet portal of the Russian society of clinical Oncology in the project oncology.ru. Accessed 20.09.2015. Available at: http://www.rosoncoweb.ru/standarts/RUSSCO/ (In Russian).
21. NCCN Clinical Practice Guidelines in Oncology. Thyroid Carcinoma. Version 2.2015. URL: http://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf
22. Rasporyazhenie Pravitel’stva RF № 2724‑r ot 26 dekabrya 2015 g. «Ob utverzhdenii perechnya zhiznenno neobkhodimykh i vazhneishikh lekarstvennykh preparatov na 2016 god, a takzhe perechnei lekarstvennykh preparatov dlya meditsinskogo primeneniya i minimal’nogo assortimenta lekarstvennykh preparatov, neobkhodimykh dlya okazaniya meditsinskoi pomoshchi». Available at: https://www.consultant.ru/document/cons_doc_LAW_192036/ Accessed 27.03.2016. (In Russian).
23. Malignant neoplasms in Russia in 2014. Ed by Kaprin A. D., Starinskii V. V., Petrova G. V. Moscow, 2016. Available at: http://www.oncology.ru/service/statistics/malignant_tumors/2014.pdf. Accessed 27.03.2016. (In Russian).
24. Ljungberg B., Campbell S. C., Cho H. Y., Jacqmin D, Lee JE, Weikert S, et al. The Epidemiology of Renal Cell Carcinoma. Eur Urol. 2011;6:615–21. doi: 10.1016/j.eururo.2011.06.049.
25. State of cancer care in Russia in 2014. Ed by Kaprin A. D., Starinskii V. V., Petrova G. V. Moscow, 2015. Available at: http://www.oncology.ru/service/statistics/condition/ 2014.pdf Accessed 27.03.2016. (In Russian).
26. Athar U., Gentile T. C. Treatment options for metastatic renal cell carcinoma: a review. Can J Urol. Available at: 2008;15:3954–66. http://www.canjurol.com/abstract.php?ArticleID=&version=1.0&PMID=18405442
27. Mills E. J., Rachlis B., O’Regan C., Thabane L., Perri D. Metastatic renal cell cancer treatments: An indirect comparison meta- nalysis. BMC Cancer 2009;9:34. doi: 10.1186/1471–2407–9-34.
28. Goryajnov S. V., Rebrova O.Yu. Indirect comparisons in health technology assessment. Medical technologies. assessment and choice. 2011;3:9–12.
29. Eisen T., Sternberg C. N., Robert C., Mulders P., Pyle L., Zbinden S., et al. Targeted therapies for renal cell carcinoma: review of adverse event management strategies. J Natl Cancer Inst. 2012 Jan 18;104 (2):93–113. doi: 10.1093/jnci/djr511.
30. Thompson Coon J., Hoyle M., Green C., Liu Z., Welch K., Moxham T., et al. Bevacizumab, sorafenib tosylate, sunitinib and temsirolimus for renal cell carcinoma: a systematic review and economic evaluation. Health Technol Assess. 2010 Jan;14 (2):1–184, iii-iv. doi: 10.3310/hta14020.
31.
Review
For citations:
Frolov M.Y., Avksentjev N.A., Rusakov I.G., Derkach E.V. PHARMACOECONOMICAL RESEARCH OF THE USE OF SORAFENIB IN MALIGNANT TUMORS. Research and Practical Medicine Journal. 2016;3(3):8-16. (In Russ.) https://doi.org/10.17709/2409-2231-2016-3-3-1