PHARMACOECONOMIC EVALUATION OF POMALIDOMIDE (IMNOVID) FOR THE TREATMENT OF RECURRENT AND REFRACTORY MULTIPLE MYELOMA
https://doi.org/10.17749/2070-4909.2017.10.2.053-061
Abstract
The aim of the study is to assess the economic feasibility of using pomalidomide in patients with recurrent and refractory multiple myeloma (MM), who had received previous 1st and 2nd (bortezomib and lenalidomide) line therapy.
Materials and Methods. In this study, the methods of cost analysis, cost – effectiveness analysis, budget impact analysis (in relation to the State Guarantees Program) as well as sensitivity-toprice-change analysis were used.
Results. The results indicate that the pomalidomide therapy in patients with recurrent and refractory MM who had previously received 1st and 2nd (bortezomib and lenalidomide) line therapy is clinically beneficial and also economically feasible in terms of public procurement. If introduced this program can save the Federal budget up to 232 785 963 rubles.
Conclusion. According to the budget impact analysis, if pomalidomide (Innovid) is included in the list of public procurement, then the Federal spending on the treatment of MM with pomalidomide, lenalidomide and bortezomib will be less by 12% compared to the MM treatment with bortezomib and lenalidomide only.
About the Authors
M. Yu. FrolovRussian Federation
PhD, associate professor (Postgraduate Education), Department of Clinical Pharmacology and Intensive Care,
pl. Pavshikh bortsov, 1, Volgograd, 400131
O. V. Shatalova
Russian Federation
PhD, research assistant (Postgraduate Education), Department of Clinical Pharmacology and Intensive Care,
pl. Pavshikh bortsov, 1, Volgograd, 400131
References
1. Rajkumar S. V., Dimopoulos M. A., Palumbo A. et al. International Mye-loma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014; 15 (12): e538-e548.
2. Rajkumar S. V. Multiple myeloma: 2014 update on diagnosis, risk-stratification, and management. Am J Hematol. 2014; 89 (10): 999-1009; 23: 3-9.
3. Russian clinical guidelines for the diagnosis and treatment of lymphoproliferative diseases. Under the guidance of prof. I. V. Poddubnoy, prof. V. G. Savchenko [Rosciĭskie klinicheskie rekomendatsii po diagnostike i lecheniyu limfoproliferativnykh zabolevaniĭ. Pod rukovodstvom prof. I. V. Pod-dubnoĭ, prof. V. G. Savchenko (in Russian)] Moscow. 2014. 68 s.
4. Malignant neoplasms in Russia in 2014 (morbidity and mortality). Edited by A. D. Caprin, V. V. Starinskii, G. V. Petrova [Zlokachestvennye novoobrazovaniya v Rossii v 2014 godu (zabolevaemost’ i smertnost’). Pod red. A. D. Kaprina, V. V. Starinskogo, G. V. Petrovoi (in Russian)]. Moscow. 2014. 250 s.
5. Harousseau J.-L., Dreyling M. Multiple Myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 2010; 21 (5): 155-157.
6. Rajkumar S. V. Myeloma today: Disease definitions and treatment ad-vances. Am J Hematol. 2016; 91 (1): 90-100.
7. Richardson P. G., Barlogie B., Berenson J. et al. A phase 2 study of borte-zomib in relapsed, refractory myeloma. N Engl J Med. 2003; 348 (26): 2609-2617.
8. Kumar S. K., Rajkumar S. V., Dispenzieri A. et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008; 111 (5): 2516-2520.
9. Kumar S. K., Dispenzieri A., Lacy M. Q. et al. Continued improve- ment in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014; 28 (5): 1122-1128.
10. Quach H., Ritchie D., Stewart A. K., Neeson P., Harrison S., Smyth M. J. et al. Mechanism of action of immunomodulatory drugs (IMiDS) in multiple mye-loma. Leukemia. 2010; 24: 22-32.
11. San Miguel J., Weisel K., Moreau P. 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; 14 (11): 1055-1066.
12. Dimopoulos M., Palumbo A., Weisel K. et al. Safety and Efficacy in the Stratus (MM-010) Trial, a Single-Arm Phase 3b Study Evaluating Pomalidomide+ Low-Dose Dexamethasone in Patients with Refractory or Relapsed and Refrac-tory Multiple Myeloma. Blood (ASH Ann. Meet. Abstr.). 2014; 124 (21).
13. Rychak E., Mendy D., Miller K., Schafer P., Chopra R., Daniel T. O. et al. Overcoming resistance; the use of pomalidomide (POM) and dexame-thasone (DEX) in resensitizing lenalidomide (LEN)-resistant multiple myeloma (MM) cells. Haematologica (EHA Annu Meet Abstr). 2011; 96.
14. Ocio E. M., Fernández-Lázaro D., San-Segundo L., GonazálezMéndez L., Martı́nSánchez M., Garayoa M. et al. Reversibility of the resistance to lenalidomide and pomalidomide and absence of crossresistance in a murine model of MM. Blood (ASH Annu Meet Abstr). 2011; 118.
15. Rychak E., Mendy D., Shi T., Ning Y., Leisten J., Raymon H. et al. Pomalidomide and dexamethasone are synergistic in pre-clinical models of lenalidomide-refractory multiple myeloma (MM). Clin Lymphoma Myeloma Leuk (IMW Annu Meet Abstr). 2013; 13 (1): abstract P-294.
16. Richardson P. G., Siegel D. S., Vij R., Hofmeister C. C., Baz R., Jagannath S., Chen C., Lonial S., Jakubowiak A., Bahlis N., Song K., Belch A., Raje N., Shustik C., Lentzsch S., Lacy M., Mikhael J., Matous J., Vesole D., Chen M., Zaki M. H., Jacques C., Yu Z., Anderson K. C. Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. Blood. 2014 Mar 20; 123 (12): 1826-32.
17. Semochkin S. V. Onkogematologiya. 2015; 10 (3): 44-52.
18. Kumar A., Porwal M., Verma A., Mishra A. K. Impact of pomalidomide therapy in multiple myeloma: a recent survey. J. Chemother. 2014; 26 (6): 321-7.
19. Dimopoulos M. A., Leleu X., Palumbo A., Moreau P., Delforge M., Cavo M., Ludwig H., Morgan G. J., Davies F. E., Schey A., Zweegman S., Hansson M., Weisel K., Mateos M. V., Facon T., Miguel J. F.S. Leukemia. 2014; 1-13.
20. NCCN Clinical Practice Guidelines in Oncology, Multiple Myeloma, 2015; I. URL: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed: 01.03.17.
21. Yagudina, R. I., Khabriev R. U., Pravdyuk N. G. Health Technology Assessment [Otsenka tekhnologii zdra-vookhraneniya (in Russian)]. Moscow. 2013; 416 s.
22. Federal Law No. 415-FZ of December 19, 2016 “On the Federal Budget for 2017 and for the Planning Period of 2018 and 2019” [Federal’nyi zakon ot 19.12.2016 № 415-FZ «O federal’nom byudzhe-te na 2017 i na planovyi period 2018 i 2019 godov» (in Russian)].
23. Methodical recommendations for assessing the impact on the budget as part of the program of state guarantees for free provision of medical care to citizens. Approved by Order No. 145-FGBU “CECMPS” of the Ministry of Health of the Russian Federation of December 23, 2016 [Metodicheskie rekomendatsii po otsenke vliyaniya na byudzhet v ramkakh realizatsii programmy gosudarstvennykh garantii besplatnogo okazaniya grazhdanam meditsinskoi pomoshchi. Utverzhdeny prikazom № 145-od FGBU «TsEKKMP» Ministerstva zdravookhraneniya Rossiiskoi Federatsii ot 23.12.2016 (in Russian)].
24. Decree of the Government of the Russian Federation of December 19, 2016 No. 1403 “On the Program of State Guarantees of Free Medical Assistance to Citizens for 2017 and for the Planning Period of 2018 and 2019” [Postanovlenie Pravitel’stva RF ot 19 dekabrya 2016 goda № 1403 «O Programme gosudarstvennykh garantii besplatnogo okazaniya grazhdanam meditsinskoi pomoshchi na 2017 god i na planovyi period 2018 i 2019 godov» (in Russian)].
Review
For citations:
Frolov M.Yu., Shatalova O.V. PHARMACOECONOMIC EVALUATION OF POMALIDOMIDE (IMNOVID) FOR THE TREATMENT OF RECURRENT AND REFRACTORY MULTIPLE MYELOMA. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2017;10(2):53-61. (In Russ.) https://doi.org/10.17749/2070-4909.2017.10.2.053-061

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