Pharmacoeconomic evaluation of the tixagevimab and cilgavimab combination using for pre-exposure prophylaxis of COVID-19

Cover Page

Cite item

Full Text

Abstract

Aim. To evaluate pharmacoeconomic feasibility using of the tixagevimab and cilgavimab combination for pre-exposure prophylaxis of COVID-19 in immunocompromised patients.

Materials and methods. Cost-effectiveness of tixagevimab and cilgavimab in persons ≥12 years old who weigh ≥40 kg and have either a history of allergy that prevents their vaccination against COVID-19 or moderate or immunocompromised was assessed based on PROVENT phase III study results. The quantity of life years or quality-adjusted life years gained was calculated. Direct medical cost associated with prophylaxis of COVID-19, treatment of infected patients and those experiencing long COVID post infection were assessed. Results were compared with wiliness-to-pay threshold, measured as tripled gross domestic product per capita and equal to 2.69 mln RUB in 2022.

Results. Pre-exposure prophylaxis of COVID-19 results in additional 0.0287 life years or 0.0247 quality-adjusted life years. The cost of additional life year gained is equal to 1.12 mln RUB, the cost of additional quality-adjusted life years is 1.30 mln RUB. Both costs of additional life year and cost of quality-adjusted life years appeared to be significantly less compared to wiliness-to-pay threshold.

Conclusion. Pre-exposure prophylaxis of COVID-19 with combination of tixagevimab and cilgavimab is economically feasible and may be recommended for wide use in Russian healthcare system.

About the authors

Marina V. Zhuravleva

Sechenov First Moscow State Medical University (Sechenov University); Scientific Centre for Expert Evaluation of Medicinal Products

Email: doc@pharmset.ru
ORCID iD: 0000-0002-9198-8661

д-р мед. наук, проф. каф. клинической фармакологии и пропедевтики внутренних болезней; зам. дир. Центра клинической фармакологии

Russian Federation, Moscow; Moscow

Vladimir P. Chulanov

Sechenov First Moscow State Medical University (Sechenov University); National Medical Research Center for Phthisiopulmonology and Infectious Diseases

Email: vladimir.chulanov@rcvh.ru
ORCID iD: 0000-0001-6303-9293

д-р мед. наук, проф. каф. инфекционных болезней; зам. дир. по научной работе и инновационному развитию

Russian Federation, Moscow; Moscow

Julia V. Gagarina

Sechenov First Moscow State Medical University (Sechenov University)

Author for correspondence.
Email: doc@pharmset.ru
ORCID iD: 0000-0002-4459-3034

ассистент каф. клинической фармакологии и пропедевтики внутренних болезней

Russian Federation, Moscow

Elena A. Shabalina

Sechenov First Moscow State Medical University (Sechenov University)

Email: doc@pharmset.ru
ORCID iD: 0000-0002-6802-4602

ассистент каф. клинической фармакологии и пропедевтики внутренних болезней

Russian Federation, Moscow

References

  1. Гриневич В.Б., Губонина И.В., Дощицин В.Л., и др. Особенности ведения коморбидных пациентов в период пандемии новой коронавирусной инфекции (COVID-19). Национальный Консенсус 2020. Кардиоваскулярная терапия и профилактика. 2020;19(4):2630 [Grinevich VB, Gubonina IV, Doshchitsin VL, et al. Management of patients with comorbidity during novel coronavirus (COVID-19) pandemic. National Consensus Statement 2020. Cardiovascular Therapy and Prevention. 2020;19(4):2630 (in Russian)]. doi: 10.15829/1728-8800-2020-2630
  2. Жидкова Е.А., Шабуров Р.И., Черемушкин С.В., и др. Экономические аспекты лечения COVID-19 в условиях стационара. Инфекционные болезни: новости, мнения, обучение. 2021;10(3):41-8 [Zhidkova EA, Shaburov RI, Cheremushkin SV, et al. Economic aspects of COVID-19 treatment in a hospital setting. Infektsionnye bolezni: novosti, mneniya, obuchenie (Infectious Diseases: News, Opinions, Training). 2021;10(3):41-8 (in Russian)]. doi: 10.33029/2305-3496-2021-10-3-41-48
  3. Рекомендации по ведению больных с коронавирусной инфекцией COVID-19 в острой фазе и при постковидном синдроме в амбулаторных условиях. Под ред. проф. Воробьева П.А. Проблемы стандартизации в здравоохранении. 2021;7-8:3-96 [Recommendations for the management of patients with coronavirus infection COVID-19 in the acute phase and with post-covid syndrome on an outpatient basis. Ed. prof. Vorobieva PA. Problems of standardization in health care. 2021;7-8:3-96 (in Russian)]. doi: 10.26347/1607-2502202107-08003-096
  4. Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: an overview. Diabetes Metab Syndr. 2021;15(3):869-75. doi: 10.1016/j.dsx.2021.04.007
  5. Временные методические рекомендации. Профилактика, диагностика и лечение новой коронавирусной инфекции (COVID-19). Версия 16 (18.08.2022 г.) [Temporary guideline on Prevention, diagnosis and treatment of novel coronavirus infection (COVID-19). Version 16, 08/18/2022 (in Russian)].
  6. Приказ №8н от 13.01.2022 «Об утверждении перечня медицинских противопоказаний к проведению профилактических прививок против новой коронавирусной инфекции COVID-19», зарегистрирован Минюстом России 17 января 2022 г. [Order 8н of 13.01.2022 «On approval of the list of medical contraindications to conduct preventive vaccinations against new coronavirus infection COVID-19», registered by the Ministry of Justice of Russia on 17 January 2022 (in Russian)].
  7. Dooling K. Evidence to recommendation framework: an additional dose of mRNA COVID-19 vaccine following a primary series in immunocompromised people. 2021. Available at: https://bit.ly/2Uqqy3H. Accessed: 09.01.2023.
  8. Реестр решений об обращении ЛП во время пандемии. Режим доступа: https://grls.rosminzdrav.ru/PandemicPermissions.aspx?IdStatement=&DateBegin=&DateEnd=&Status=0&InNumber=&ClaimId=&StatDateBegin=&StatDateEnd=&Org=&TorgName=%d0%ad%d0%b2%d1%83%d1%88%d0%b5%d0%bb%d0%b4&MNN=&DrugForm=&Dosage=&DeliveryNumber=&All=0&PageSize=17&order=dt&orderType=desc&pagenum=1. Ссылка активна на 09.01.2023 [Register of decisions on drug circulation during pandemic. Available at https://grls.rosminzdrav.ru/PandemicPermissions.aspx?IdStatement=&DateBegin=&DateEnd=&Status=0&InNumber=&ClaimId=&StatDateBegin=&StatDateEnd=&Org=&TorgName=%d0%ad%d0%b2%d1%83%d1%88%d0%b5%d0%bb%d0%b4&MNN=&DrugForm=&Dosage=&DeliveryNumber=&All=0&PageSize=17&order=dt&orderType=desc&pagenum=1. Accessed: 09.01.2023 (in Russian)].
  9. Levin MJ, Ustianowski A, De Wit S, et al. Intramuscular AZD7442 (tixagevimab–cilgavimab) for prevention of COVID-19. N Engl J Med. 2022;386(23):2188-200. doi: 10.1056/NEJMoa2116620
  10. Обновленная расшифровка клинико-статистических групп заболеваний с учетом особенностей оказания медицинской помощи, определенных Приказом № 344н 20 мая 2022 г. Режим доступа: https://www.ffoms.gov.ru/documents/the-orders-oms/ Ссылка активна на 09.01.2023 [Decoding of clinical and statistical groups of diseases, taking into account the specifics of the provision of medical care, update determined by Order No. 344n May 20, 2022. Available at https://www.ffoms.gov.ru/documents/the-orders-oms/ Accessed: 09.01.2023 (in Russian)].
  11. Письмо Минздрава России от 04.02.2022 N 11-7/И/2-1631 «О методических рекомендациях по способам оплаты медицинской помощи за счет средств обязательного медицинского страхования» (вместе с «Методическими рекомендациями по способам оплаты медицинской помощи за счет средств обязательного медицинского страхования», утв. Минздравом России N 11-7/И/2-1619, ФФОМС N 00-10-26-2-06/750 02.02.2022 [Letter of the Ministry of Health of Russia dated 04.02.2022 N 11-7 / I / 2-1631 "On guidelines on methods of paying for medical care at the expense of compulsory medical insurance" (together with "Methodological recommendations on methods of paying for medical care at the expense of compulsory medical insurance", approved by the Ministry of Health of Russia N 11-7/И/2-1619, ФФОМС N 00-10-26-2-06/750 02.02.2022 (in Russian)].
  12. Официальная информация о коронавирусе в России. Режим доступа: https://xn--80aesfpebagmfblc0a.xn--p1ai/ Ссылка активна на 09.01.2023 [Official information about coronavirus in Russia. Available at https://xn--80aesfpebagmfblc0a.xn--p1ai/ Accessed: 09.01.2023 (in Russian)].
  13. Численность постоянного населения на 1 января 2021 года. Федеральная служба госстатистики. Режим доступа: https://showdata.gks.ru/report/278928/ Ссылка активна на 09.01.2023 [Resident population as of January 1, 2021. Federal State Statistics Service. Available at https://showdata.gks.ru/report/278928/ Accessed: 09.01.2023 (in Russian)].
  14. Информационная справка по противодействию эпидемии COVID-19 в Санкт-Петербурге на 01.05.2021, включая итоги за апрель. Режим доступа: https://www.gov.spb.ru/press/government/213164/ Ссылка активна на 09.01.2023 [Information note on countering the COVID-19 epidemic in St. Petersburg as of 05/01/2021, including the results for April. Available at https://www.gov.spb.ru/press/government/213164/ Accessed: 09.01.2023 (in Russian)].
  15. Матюшков Н.С., Тюрин И.Н., Авдейкин С.Н., и др. Респираторная поддержка у пациентов с COVID-19. Опыт инфекционного госпиталя в коммунарке: одноцентровое ретроспективное исследование. Вестник интенсивной терапии им. А.И. Салтанова. 2021;3:47-60 [Matiushkov NS, Tyurin IN, Avdeikin SN, et al. Respiratory support in COVID-19 patients in Kommunarka hospital: a single-centered, retrospective study. Annals of Critical Care. 2021;3:47-60 (in Russian)]. doi: 10.21320/1818-474X-2021-3-47-60
  16. Численность населения Российской Федерации по полу и возрасту. Режим доступа: https://rosstat.gov.ru/compendium/document/13284. Ссылка активна на 09.01.2023 [The population of Russian Federation by sex and age. Available at https://rosstat.gov.ru/compendium/document/13284. Accessed: 09.01.2023 (in Russian)].
  17. Ожидаемая продолжительность жизни при рождении по субъектам Российской Федерации за 2021 год (предварительные оценка). Режим доступа: https://rosstat.gov.ru/storage/mediabank/ozhid_life_pr_2021.xlsx. Ссылка активна на 09.01.2023 [Life expectancy at birth by constituent entities of the Russian Federation for 2021 (preliminary estimate). Available at https://rosstat.gov.ru/storage/mediabank/ozhid_life_pr_2021.xlsx. Accessed: 09.01.2023 (in Russian)].
  18. Taquet M, Dercon Q, Luciano S. et al. Incidence, co-occurrence, and evolution of long-COVID features: A 6-month retrospective cohort study of 273,618 survivors of COVID-19. PLoS Med. 2021;18(9):e1003773. doi: 10.1371/journal.pmed.1003773
  19. Huang L, Yao Q, Gu X, et al. 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study. Lancet. 2021;398(10302):747-58. doi: 10.1016/S0140-6736(21)01755-4
  20. Информация о принятых субъектами Российской Федерации решений по изменению предельных размеров оптовых и розничных надбавок к фактическим отпускным ценам, установленным производителями лекарственных препаратов на лекарственные препараты, включенные в перечень ЖНВЛП, а также о субъектах Российской Федерации, не принявших такие решения по состоянию на 12 июля 2022 года. Режим доступа: https://fas.gov.ru/documents/687916. Ссылка активна на 09.01.2023 [Information on the decisions taken by the constituent entities of the Russian Federation to change the maximum wholesale and retail mark-ups to the actual selling prices set by drug manufacturers for drugs included in the Vital and Essential Drugs List, as well as on the constituent entities of the Russian Federation that have not made such decisions as of July 12, 2022 of the year. Available at https://fas.gov.ru/documents/687916. Accessed: 09.01.2023 (in Russian)].
  21. Постановление Правительства РФ от 28 декабря 2021 г. №2505 «О Программе государственных гарантий бесплатного оказания гражданам медицинской помощи на 2021 год и на плановый период 2022 и 2023 годов» [Decree of the Government of the Russian Federation of December 28, 2021 №2505 “On the Program of State Guaranties of Free Provision of Medical Care to Citizens for 2021 and planning period of 2022 and 2023” (in Russian)].
  22. Государственный реестр лекарственных средств. Режим доступа: https://grls.rosminzdrav.ru/default.aspx. Ссылка активна на 09.01.2023 [The State Register of medicines. Available at https://grls.rosminzdrav.ru/default.aspx. Accessed: 09.01.2023 (in Russian)].
  23. Ohsfeldt RL, Choong CK, Mc Collam PL, et al. Inpatient Hospital Costs for COVID-19 Patients in the United States. Adv Ther. 2021;38(11):5557-95. doi: 10.1007/s12325-021-01887-4
  24. Tenforde MW, Kim SS, Lindsell CJ, et al. Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network – United States, March–June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(30):993-8. doi: 10.15585/mmwr.mm6930e1
  25. Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the Treatment of Covid-19 – Final Report. N Engl J Med. 2020;383(19):1813-26. doi: 10.1056/NEJMoa2007764
  26. Institute for Clinical and Economic Review. Special Assessment: COVID-19 – Modeling Analysis Plan 11/22/21. Available at: https://icer.org/wp-content/uploads/2021/08/ICER_COVID_19_Draft_Evidence_Report_020322.pdf. Accessed: 09.01.2023.
  27. Campbell JD, Whittington MD. Alternative Pricing Models for Remdesivir and Other Potential Treatments for COVID-19; Updated Report. Available at: https://collections.nlm.nih.gov/master/borndig/101769591/ICER-COVID_Revised_Report_20200624.pdf. Accessed: 09.01.2023.
  28. Таблицы смертности в РФ за 2014 год. Режим доступа: https://www.mortality.org/Country/Country?cntr=RUS. Ссылка активна на 09.01.2023 [Tables of Mortality in Russian Federation. Available at Accessed: 09.01.2023 (in Russian)].
  29. Lone NI, Gillies MA, Haddow C, et al. Five-Year Mortality and Hospital Costs Associated with Surviving Intensive Care. Am J Respir Crit Care Med. 2016;194(2):198-208. doi: 10.1164/rccm.201511-2234OC
  30. Sullivan PW, Ghushchyan V. Preference-Based EQ-5D index scores for chronic conditions in the United States. Med Decis Making. 2006;26(4):410-20. doi: 10.1177/0272989X06290495
  31. Sheinson D, Dang J, Shah A, et al. Cost-Effectiveness Framework for COVID-19 Treatments for Hospitalised Patients in the United States. Adv Ther. 2021;38(4):1811-31. doi: 10.1007/s12325-021-01654-5
  32. Ягудина Р.И., Куликов А.Ю., Нгуен Т. Определение «Порога готовности платить» в России, в Европейских странах и в странах СНГ. Фармакоэкономика. Современная фармакоэкономика и фармакоэпидемиология. 2011;4(1):129 [Yagudina R, Kulikov A, Nguyen T. Place of threshold willingness-to-pay of russia among those of other european countries and cis countries. Modern Pharmacoeconomics and Pharmacoepidemiology. 2011;4(1):129 (in Russian)].
  33. Валовой внутренний продукт на душу населения. Режим доступа: https://rosstat.gov.ru/storage/mediabank/VVP_na_dushu_s1995.xls. Ссылка активна на 09.01.2023 [Gross domestic product per capita. Available at https://rosstat.gov.ru/storage/mediabank/VVP_na_dushu_s1995.xls. Accessed: 09.01.2023 (in Russian)].
  34. Карпова Л.С., Столяров К.А., Поповцева Н.М., и др. Сравнение первых трех волн пандемии COVID-19 в России (2020–2021 гг.). Эпидемиология и Вакцинопрофилактика. 2022;21(2):4-16 [Karpova LS, Stolyarov KA, Popovtseva NM, et al. Comparison of the First Three Waves of the COVID-19 Pandemic in Russia in 2020–21. Epidemiology and Vaccinal Prevention. 2022;21(2):4-16 (in Russian)]. doi: 10.31631/2073-3046-2022-21-2-4-16
  35. Young-Xu Y, Epstein L, Marconi VC, et al. Tixagevimab/cilgavimab for prevention of COVID-19 during the Omicron surge: retrospective analysis of national VA electronic data. Preprint. medRxiv. 2022. doi: 10.1101/2022.05.28.22275716
  36. Kertes J, David SSB, Engel-Zohar N, et al. Association Between AZD7442 (Tixagevimab-Cilgavimab) Administration and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection, Hospitalization, and Mortality. Clin Infect Dis. 2022;ciac625. doi: 10.1093/cid/ciac625
  37. Nguyen Y, Flahault A, Chavarot N, et al. Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients. Clin Microbiol Infect. 2022;28(12):1654.e1-4. doi: 10.1016/j.cmi.2022.07.015

Supplementary files

Supplementary Files
Action
1. JATS XML
Download
2. Fig. 1. Routing of a patient with COVID-19 depending on the severity of the active phase of the disease.

Download (103KB)
Indexing metadata
3. Fig. 2. Decision Tree Model for Calculation of Costs and Outcomes in the Treatment of the active phase of COVID-19, percentage values.

Download (192KB)
Indexing metadata
4. Fig. 3. Markov model for calculation of costs and outcomes after the end of the active phase of COVID-19

Download (65KB)
Indexing metadata

Copyright (c) 2023 Consilium Medicum

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


This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies