Modeling of the impact of biological drugs in the economic burden of severe asthma
https://doi.org/10.24411/2588-0519-2019-10078
Abstract
Bronchial asthma (BA) is worldwide lungs’ illness, at least 1,5 mln people are on a dispensary in Russia. Non-control severe BA (SBA) can lead to increasing of direct Health Care System expenditures due to very oft en exacerbations (drugs costs, hospitalizations and out-patient cure etc.) as well as to increasing of non-direct costs because temporary and permanent disability can be a result of a disease progression. Treatment of SBA has difficulties, system steroids with their well-known side effects use often as remedy of choice. Biologicals with high efficacy potential and minimal side effects are used in a clinical practice during few last years.
Aim: evaluation of a comparative influence of two biologicals — dupilumab and omalizumab — on a calculated SBA burden in the Russian Federation.
Materials and methods: Modelling of SBA population size which has needed in biologicals has been prepared based on official statistics and Register of SBA. Direct costs (drugs costs, treatment costs in out-patient departments and in hospitals, visits to doctors etc.) and non-direct costs (payment for temporary and permanent disability, GDP losses) have been modelling and calculated.
Results: Estimated BA patient population size in Russia is 6.94 mln, and non-control SBA amount is 69,7 thousand (31.7 thousand patients in economic active age). The current treatment SBA option (w/o biologicals) has expenditures at least 1 447,2 RUR annually (direct and non-direct in total). Biologicals should decrease total expenditures due to high efficacy — for dupilumab total expenditures could be 495,42 mln RUR/year, for omalizumab — 559,81 mln RUR/year for all patients who are needed in these drugs. Omalizumab has higher weighted average estimated cost in compare with dupilumab (1.19 mln RUR/patient/year and 1.01 mln RUR/patient/year accordingly) and expenditures for omalizumab were higher due to less amount of prevention of exacerbations.
Conclusion: Expenditures for SBA w/o biologicals are higher in compare with biologicals treatment options. Treatment with dupilumab for all patients with non-control SBA could decrease a direct cost on 5,8 %. Dupilumab and omalizumab usage is economically proved in non-control SBA for total cost saving (direct and non-direct).
About the Authors
S. K. ZyryanovRussian Federation
Zyryanov Sergey - MD, professor, Head of Department of General and Clinical Pharmacology
SPIN-code: 2725-9981
Moscow
I. N. Dyakov
Russian Federation
Dyakov Ilya - Candidate of Biological Sciences, General Director
SPIN-code: 1854-0958
Moscow
O. I. Karpov
Russian Federation
Karpov Oleg - MD, DrSci, Professor, Head of Eurasia HEOR
Moscow
References
1. Enilari O, Sinha S. The Global Impact of Asthma in Adult Populations. Annals of Global Health. 2019;85(1):2,1-7. DOI: 10.5334/aogh.2412
2. Belevskiy AS, Zaitsev AA. Farmacoeconomicheskie aspekti bronchialnoy asthma: realnaya klinicheskaya praktika. Medicinskiy sovet. 2018;15:60-68. (In Russ). DOI: 10.21518/2079-701X-2018-15-60-68
3. Chuchalin AG. Advantages in the asthma treatment in Russia in the first millennium decade. Consilium Medicum (Suppl.). 2010:11-12 (In Russ).
4. Zaitsev AA. Asthma in adults: key questions of diagnostic and pharmacotherapy. RMJ. 2015;18:1096-1100 (In Russ).
5. Uryasyev OM. Bronchial asthma and cardio-vascular disorders Zemskiy doctor. 2015;28(4):5-13. (In Russ).
6. Expert Council of Federal Russian Duma “Social-economic burden of asthma and COPD in the Russian Federation”. Moscow. 2010. 15p. (In Russ).
7. Loftus PA, Wise SK. Epidemiology and economic burden of asthma. Int Forum Allergy Rhinol. 2015; Suppl 1:S7-10. DOI: 10.1002/alr.21547
8. Nagase H, Adachi M, Matsunaga K, et al. Prevalence, disease burden, and treatment reality of patients with severe, uncontrolled asthma in Japan. Allergol Int. 2019. pii: S1323-8930(19)30077-2. DOI: 10.1016/j.alit.2019.06.003
9. Al Efraij K, FitzGerald JM. Current and emerging treatments for severe asthma. J Th orac Dis. 2015;7:E522—E525. DOI: 10.3978/j.issn.2072-1439.2015.10.73
10. Farnaz T, Ledford DK. Omalizumab for severe asthma: toward personalized treatment based on biomarker profile and clinical history. J Asthma Allergy. 2018;3(11):53-61. DOI: 10.2147/JAA.S107982. eCollection 2018
11. Instrukciya po medicinskomu primeneniyu lekarstvennogo preparata Dupiksent® (dupilumab) ot 04.04.2019. Nomer LP-005440. (In Russ). Электронный ресурс: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=aefa9526-0e39-4644-8417-434fd40ebf95&t= дата доступа 13.08.2019.
12. Corren J, Castro M, Chanez P, et al. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019;122(1):41-49.e2. DOI: 10.1016/j.anai.2018.08.005
13. Busse WW, Maspero JF, Rabe KF, et al. A Randomized, Controlled Phase 3 Study, Liberty Asthma QUEST: Phase 3 randomized, double-blind, placebo-controlled, parallel-group study to evaluate Dupilumab Efficacy/ safety in patients with uncontrolled, moderate-to-severe Asthma. Adv Ther. 2018;35(5):737-748. DOI: 10.1007/s12325-018-0702-4
14. Rabe KF, Nair P, Brusselle G. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018;378(26):2475-2485. DOI: 10.1056/NEJMoa1804093
15. Salasyuk AS, Frolov MYu, Barykina IN. Dupilumab in the treatment of severe non-controlled bronchial asthma — economic aspects. Kachestvennaya klinicheskaya praktika. 2019;2:15-24. (In Russ). DOI: 10.24411/2588-0519-2019-10063
16. Humbert M, Bousquet J, Bachert C, et al. IgE-Mediated Multimorbidities in Allergic Asthma and the Potential for Omalizumab Therapy. J Allergy Clin Immunol Pract. 2019;7(5):1418-1429. DOI: 10.1016/j.jaip.2019.02.030
17. http://grls.rosminzdrav.ru обращение к ресурсу 11.08.2019
18. http://pharmindex.ru обращение к ресурсу 11.08.2019
19. Comparative Efficacy of Dupilumab vs. Approved Biologic Therapies for Persistent and Uncontrolled Asthma. Technical Report. EVA-22780 | October 8, 2018 | Version 5.0.
20. https://static-1.rosminzdrav.ru/system/attachments/attaches/000/046/251/original/%D0%9F%D0%A0%D0%9E%D0%A2%D0%9E%D0%9A%D0%9E%D0%9B_18.07.2019.PDF?1563902866, обращение к ресурсу 21.08.2019.
21. Kolbin AS, Klimko NN, Andreev BV. Kliniko-ekonomicheskoe obosnovanie primeneniya Xolair (omalizumab) pri bronchialnoy astme. Kachestvennaya klinicheskaya praktika. 2008;2:53-61. (In Russ).
22. Instrukciya po medicinskomu primeneniyu lekarstvennogo preparata Ksolar (omalizumab). (In Russ). http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=b90c60e3-61d3-4aa7-bf8c-c0663ed1394b&t= обращение к ресурсу 13.08.2019
23. Registr pacientov s tyazheloj bronhial’noj astmoj na territorii RF (In Russ). [Электронный ресурс] URL: https://rosmed.info/project?id=73 (дата обращения: 26.11.2018).
24. Kulikov AYu, Makarova EI, Avdeev SN, et al. Pharmacoeconomic analysis of therapy with reslizumab in severe eosinophilic asthma. Russian Pulmonology. 2018;28(1):50—60 (In Russ). DOI: 10.18093/0869-0189-2018-28-1-50-60
25. Tolkushin AG, Rogov VA, Ivanov DA, Pogudina NL. Cost-effectiveness analysis of the use of mepolizumab in omalizumab-resistant patients with severe asthma. Kachestvennaya klinicheskaya praktika. 2019;(1):19-26. (In Russ.)]. DOI: 10.24411/2588-0519-2019-10061
26. Governmental Program of Fee Medical Aid for 2019 and planned period of 2020-2021 yy. Decree 10/12/2018, #1506.
27. http://www.ffoms.ru/documents/the-orders-oms/, обращение к ресурсу 12.06.2019.
28. http://www.gks.ru/wps/wcm/connect/rosstat_main/rosstat/ru/statistics/wages/labour_costs/, обращение к ресурсу 08.01.2019
29. Luskin AT, Chipps BE, Rasouliyan L, et al. Impact of asthma exacerbations and asthma triggers on asthma-related quality of life in patients with severe or difficult-to-treat asthma. J Allergy Clin Immunol Pract. 2014;2:544-552.
30. Kolbin AS, Frolov MYu, Galankin TL. Pharmacoeconomic analysis of the severe non-control asthma treatment in Russia. Prakticheskaya pulmonologiya. 2015;4:10-17 (In Russ).
Review
For citations:
Zyryanov S.K., Dyakov I.N., Karpov O.I. Modeling of the impact of biological drugs in the economic burden of severe asthma. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2019;(3):4-12. (In Russ.) https://doi.org/10.24411/2588-0519-2019-10078