Clinical and economic analysis of genetically engineered biologics consumption by patients with COVID-19

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Abstract

The aim of the article is a comparative clinical and economic assessment of genetically engineered monoclonal antibodies against interleukins in infectious diseases facilities in Volgograd region, reassigned to treat COVID-19 patients.

Materials and methods. ABC analysis of the drug consumption in infectious disease facilities in Volgograd region in 2020 and 2021, cost-minimization analysis, and volume of consumption (standard dose per 1000 patients) for geneti- cally engineered monoclonal antibodies against interleukins, were performed on the basis of pharmacies dispensing drug reports on infectious diseases facilities, Russian State Register of maximum selling prices, and Russian guidelines for COVID-19 treatment.

Results. Only a small proportion of COVID-19 patients (43.6 standard doses per 1000 patients in 2020 and 137.8 per 1000 patients in 2021) received genetically engineered biologics in infectious disease facilities in Volgograd Region. Ne- vertheless, in the studied facilities, medical drug expenses on them exceeded from 20% in 2020 to 40% of the total inventory value in 2021. In mild COVID-19 patients with a high comorbidity index, netaquimab was the least expensive drug therapy and levilimab was the most expensive one. For moderate COVID-19, a standart recommended dose of sarilumab was the least expensive among the drugs used in the studied facilities, and anakinra was the least expensive drug among all the recommended GEBs. In severe and extremely severe COVID-19 courses, tocilizumab and sarilumab were less the least expensive among the GEBs used in the infectious disease facilities, and anakinra was the least expensive among all the recommended GEBs.

Conclusion. Accepting a possible equal effectiveness based on the currently available data, sarilumab is the least expensive for moderate COVID-19 and tocilizumab is the least expensive for severe and extremely severe COVID-19.

About the authors

Vladimir I. Petrov

Volgograd State Medical University

Author for correspondence.
Email: brain@sprintnet.ru

Doctor of Sciences (Medicine), Professor, Academician of RAS, Head of the Department of Clinical Pharmacology and Intensive Care, chief freelance specialist, clinical pharmacologist of the Ministry of Healthcare of the Russian Federation, Honored Scientist of the Russian Federation, Honored Doctor of the Russian Federation

Russian Federation, 1, Pavshikh Bortsov Sq., Volgograd, 400131

Anastasiya Yu. Ryazanova

Volgograd State Medical University

Email: nastasyakus@mail.ru
ORCID iD: 0000-0002-4778-5015

Candidate of Sciences (Medicine), Associate Professor at the Department of Clinical Pharmacology and Intensive Care

Russian Federation, 1, Pavshikh Bortsov Sq., Volgograd, 400131

Angelika V. Ponomareva

Volgograd State Medical University

Email: angelvr@yandex.ru
ORCID iD: 0000-0002-8237-8335

Candidate of Sciences (Medicine), Professor at the Department of Clinical Pharmacology and Intensive Care

Russian Federation, 1, Pavshikh Bortsov Sq., Volgograd, 400131

Olga V. Shatalova

Volgograd State Medical University

Email: shov_med@mail.ru
ORCID iD: 0000-0002-7311-4549

Doctor of Sciences (Medicine), Professor at the Department of Clinical Pharmacology and Intensive Care

Russian Federation, 1, Pavshikh Bortsov Sq., Volgograd, 400131

Yana V. Levina

Volgograd State Medical University

Email: yanalevin@mail.ru
ORCID iD: 0000-0003-2019-2444

Candidate of Sciences (Medicine), Associate Professor at the Department of Clinical Pharmacology and Intensive Care

Russian Federation, 1, Pavshikh Bortsov Sq., Volgograd, 400131

References

  1. Melsheimer R, Geldhof A, Apaolaza I, Schaible T. Remicade® (infliximab): 20 years of contributions to science and medicine. Biologics. 2019 Jul 30;13:139–78. doi: 10.2147/BTT.S207246.
  2. Choy EH, Isenberg DA, Garrood T, Farrow S, Ioannou Y, Bird H, Cheung N, Williams B, Hazleman B, Price R, Yoshizaki K, Nishimoto N, Kishimoto T, Panayi GS. Therapeutic benefit of blocking interleukin-6 activity with an anti-interleukin-6 receptor monoclonal antibody in rheumatoid arthritis: a randomized, double-blind, placebo-controlled, doseescalation trial. Arthritis Rheum. 2002 Dec;46(12):3143–50. doi: 10.1002/art.10623.
  3. Nasonov EL, Eliseev MS The role of interleukin 1 in the development of human diseases. Scientific-Practical Rheumatology. 2016;54(1): 60–77. doi: 10.14412/1995-4484-2016-60-77. Russian
  4. Mihara M, Hashizume M, Yoshida H, Suzuki M, Shiina M. IL-6/IL-6 receptor system and its role in physiological and pathological conditions. Clin Sci (Lond). 2012 Feb;122(4):143–59. doi: 10.1042/CS20110340.
  5. Luo P, Liu Y, Qiu L, Liu X, Liu D, Li J. Tocilizumab treatment in COVID-19: a single center experience. J Med Virol. 2020;92(7):814–8. doi: 10.1002/jmv.25801.
  6. Xu X, Han M, Li T, Sun W, Wang D, Fu B, Zhou Y, Zheng X, Yang Y, Li X, Zhang X, Pan A, Wei H. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci U S A. 2020 May 19;117(20):10970–5. doi: 10.1073/pnas.2005615117.
  7. Fomina DS, Lysenko MA, Beloglazova IP, Mutovana ZYu, Poteshkina NG, Samsonova IV, Kruglova TS, Chernov AA, Karaulov AV, Lederman MM. Temporal clinical and laboratory response to interleukin-6 receptor blockade with tocilizumab in 89 hospitalized patients with COVID-19 pneumonia. Pathog Immun. 2020;5(1):327–41. doi: 10.20411/pai.v5i1.392
  8. RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021;397(10285):1637–45. doi: 10.1016/s0140-6736(21)00676-0.
  9. Moiseev SV, Avdeev EA Tao EA, Brovko MA, Yavorovsky AG, Umbetova KT, Bulanov NM, Zykova AS, Akulkina LA, Smirnova IG, Fomin VV, Efficiency of tocilizumab in patients with COVID-19 hospitalized in the ORIT: a retrospective cohort study. Clinical Pharmacology and Therapy. 2020.29(4):17–25. doi: 10.32756/0869-5490-2020-4-17-25. Russian
  10. Hasan MJ, Rabbani R, Anam AM, Huq SMR. Secukinumab in severe COVID-19 pneumonia: Does it have a clinical impact? J Infect. 2021 Jul;83(1):e11–e13. doi: 10.1016/j.jinf.2021.05.011.
  11. Rubbert-Roth A, Enejosa J, Pangan AL, Haraoui B, Rischmueller M, Khan N, Zhang Y, Martin N, Xavier RM. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020 Oct 15;383(16):1511-21. doi: 10.1056/NEJMoa2008250.
  12. Scott LJ. Tocilizumab: A Review in Rheumatoid Arthritis. Drugs. 2017 Nov;77(17):1865-1879. doi: 10.1007/s40265-017-0829-7.
  13. Van den Bosch F, Coates L. Clinical management of psoriatic arthritis. Lancet. 2018 Jun 2;391(10136):2285–94. doi: 10.1016/S0140-6736(18)30949-8.
  14. D’Amico F, Parigi TL, Bonovas S, Peyrin-Biroulet L, Danese S. Long-term safety of approved biologics for ulcerative colitis. Expert Opin Drug Saf. 2020 Jul;19(7):807–16. doi: 10.1080/14740338.2020.1773430.
  15. Honap S, Cunningham G, Tamilarasan AG, Irving PM. Positioning biologics and new therapies in the management of inflammatory bowel disease. Curr Opin Gastroenterol. 2019 Jul;35(4):296–301. doi: 10.1097/MOG.0000000000000546.
  16. McGregor MC, Krings JG, Nair P, Castro M. Role of Biologics in Asthma. Am J Respir Crit Care Med. 2019 Feb 15;199(4):433–45. doi: 10.1164/rccm.201810-1944CI.
  17. Sura MV, Ignatova TN, Rudneva NS, Sukhanova YN, Ulyanova NG, Khudyaev AS, Shelyakin VA, Shcherbakov DV. Regional adaptation of the federal model of payment for medical care by clinical and statistical groups on the example of hospitalization cases of patients requiring prescription of genetically engineered biological drugs. Pharmacoeconomics. Modern Pharmacoecon & Pharmacoepidem. 2018;11(2):44–52. doi: 10.17749/2070-4909.2018.11.2.044-052. Russian
  18. Del Valle DM, Kim-Schulze S, Huang HH, Beckmann ND, Nirenberg S, Wang B, Lavin Y, Swartz TH, Madduri D, Stock A, Marron TU, Xie H, Patel M, Tuballes K, Van Oekelen O, Rahman A, Kovatch P, Aberg JA, Schadt E, Jagannath S, Mazumdar M, Charney AW, Firpo-Betancourt A, Mendu DR, Jhang J, Reich D, Sigel K, Cordon-Cardo C, Feldmann M, Parekh S, Merad M, Gnjatic S. An inflammatory cytokine signature predicts COVID-19 severity and survival. Nat Med. 2020 Oct;26(10):1636–43. doi: 10.1038/s41591-020-1051-9.
  19. McElvaney OJ, McEvoy NL, McElvaney OF, Carroll TP, Murphy MP, Dunlea DM, Ní Choileáin O, Clarke J, O’Connor E, Hogan G, Ryan D, Sulaiman I, Gunaratnam C, Branagan P, O’Brien ME, Morgan RK, Costello RW, Hurley K, Walsh S, de Barra E, McNally C, McConkey S, Boland F, Galvin S, Kiernan F, O’Rourke J, Dwyer R, Power M, Geoghegan P, Larkin C, O’Leary RA, Freeman J, Gaffney A, Marsh B, Curley GF, McElvaney NG. Characterization of the Inflammatory Response to Severe COVID-19 Illness. Am J Respir Crit Care Med. 2020 Sep 15;202(6):812–21. doi: 10.1164/rccm.202005-1583OC.
  20. Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620–9. doi: 10.1172/JCI137244.
  21. Toniati P, Piva S, Cattalini M, Garrafa E, Regola F, Castelli F, Franceschini F, Airò P, Bazzani C, Beindorf EA, Berlendis M, Bezzi M, Bossini N, Castellano M, Cattaneo S, Cavazzana I, Contessi GB, Crippa M, Delbarba A, De Peri E, Faletti A, Filippini M, Filippini M, Frassi M, Gaggiotti M, Gorla R, Lanspa M, Lorenzotti S, Marino R, Maroldi R, Metra M, Matteelli A, Modina D, Moioli G, Montani G, Muiesan ML, Odolini S, Peli E, Pesenti S, Pezzoli MC, Pirola I, Pozzi A, Proto A, Rasulo FA, Renisi G, Ricci C, Rizzoni D, Romanelli G, Rossi M, Salvetti M, Scolari F, Signorini L, Taglietti M, Tomasoni G, Tomasoni LR, Turla F, Valsecchi A, Zani D, Zuccalà F, Zunica F, Focà E, Andreoli L, Latronico N. Tocilizumab for the treatment of severe COVID-19 pneumonia with hyperinflammatory syndrome and acute respiratory failure: A single center study of 100 patients in Brescia, Italy. Autoimmun Rev. 2020 Jul;19(7):102568. doi: 10.1016/j.autrev.2020.102568.
  22. Ramiro S, Mostard RLM, Magro-Checa C, van Dongen CMP, Dormans T, Buijs J, Gronenschild M, de Kruif MD, van Haren EHJ, van Kraaij T, Leers MPG, Peeters R, Wong DR, Landewé RBM. Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated cytokine storm syndrome: results of the CHIC study. Ann Rheum Dis. 2020 Sep;79(9):1143–51. doi: 10.1136/annrheumdis-2020-218479.
  23. Angus DC, Berry S, Lewis RJ, Al-Beidh F, Arabi Y, van Bentum-Puijk W, Bhimani Z, Bonten M, Broglio K, Brunkhorst F, Cheng AC, Chiche JD, De Jong M, Detry M, Goossens H, Gordon A, Green C, Higgins AM, Hullegie SJ, Kruger P, Lamontagne F, Litton E, Marshall J, McGlothlin A, McGuinness S, Mouncey P, Murthy S, Nichol A, O’Neill GK, Parke R, Parker J, Rohde G, Rowan K, Turner A, Young P, Derde L, McArthur C, Webb SA. The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design. Ann Am Thorac Soc. 2020 Jul;17(7):879–91. doi: 10.1513/AnnalsATS.202003-192SD.
  24. Bobkova SS, Zhukov AA, Protsenko DN, Samoilenko VV, Tyurin IN. Comparative efficacy and safety of monoclonal antibody preparations to IL-6 in patients with new severe COVID-19 coronavirus infection. A retrospective cohort study. Annals of Critical Care. 2021;1:69–76. doi: 10.21320/1818-474X-2021-1-69-76. Russian
  25. Pavlov R.E., Tsarenko S.V., Sekinaeva A.V., Rybin PN, Nagibina MV, Soshnikova EV, Klimova MS. Experience of using glucocorticoids and netakimab in the treatment of patients with COVID-19 in outpatient. Clinical Medicine. 2020. 98(6): 449–55. doi: 10.30629/0023-2149-2020-98-6-449-455. Russian

Supplementary files

Supplementary Files
Action
1. JATS XML
2. Figure 1 – GEBs consumption in infectious disease facilities in Volgograd region, reassigned to treat COVID-19 patients (2020–2021)

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Copyright (c) 2022 Petrov V.I., Ryazanova N.Y., Ponomareva A.V., Shatalova O.V., Levina Y.V.

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

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