Cost-effectiveness and budget impact analyses of using implantable cardioverter-defibrillators in the Russian Federation

Objective: to evaluate cost-effectiveness and budget impact of using single and dual chamber implantable cardioverter-defibrillators (ICD) adjunctive to the standard drug therapy (DT) compared to the standard DT alone for the primary and secondary prevention of sudden cardiac death (SCD).

Material and methods. Original partitioned survival analysis model was developed to assess the cost-effectiveness of using ICD within the modelling horizon of 8 years. The following model outcomes were used: life years and quality-adjusted life years (QALY). Primary prevention model was focused on patients after myocardial infarction with left ventricular ejection fraction (LVEF) ≤30%, whilst secondary prevention model considered cardiac arrest survivors and/or patients diagnosed with ventricular tachycardia or ventricular fibrillation with LVEF ≤35%. The model summarizes treatment effect and costs for ICD and DT specific to the healthcare system of the Russian Federation (RF). The main scenario accounted for ICD implantation cost in accordance with general reimbursement price asserted in the high technology medical care list part 2 (HТMC 2). Additionally, alternative scenario of ICD reimbursement level was developed to account for general tariff split onto singleand dual-chamber ICD implantation reimbursement tariffs which can be financed through high technology medical care list part 1 (HТMC 1). Budget impact analysis compared the costs of using ICD within the current volume of the annual increase in ICD implantations and a threefold increased volume of ICD implantations.

Results. By the end of the modelling period, additional 34% of patients survived in the ICD group compared to the DT group. Incremental cost-effectiveness ratio (ICER) per 1 QALY constituted 2.8 and 2.2 million rubles for primary and secondary prevention, respectively. ICER values are slightly above or lower than the willingness-to-pay threshold of 2.5 million rubles per 1 QALY in the RF in the segment of primary and secondary SCD prevention, respectively. Additional HТMC 1 scenario incorporating lower ICD implantation prices resulted in an average ICER drop by 13% compared to HTMC 2. Overall patient population requiring SCD prevention comprised of 7,161 and 3,341 patients in primary and secondary prevention, respectively. Budget impact analysis showed that threefold rise in the ICD implantations rate will require additional 648 million rubles for primary prevention cohort to provide additional 573 patients with ICD, and 230 million rubles for secondary prevention cohort with additional 267 patients covered with ICD. ICD reimbursement price drop within the HТMC 1 scenario will save 133 million rubles and allow to provide additional 143 patients with ICDs for a given budget.

Conclusion. ICD is a cost-effective option of secondary prevention of SCD. Additional analysis of ICD reimbursement price drop drives ICER downwards to a considerable extent which in turn increases the accessibility of ICDs to patients. In scenario of ICD implantation financing within HТMC 1, ICD is established to be a cost-effective option for primary and secondary prevention of SCD in the RF.

1. Rosstat. Number of deaths by causes of death in 2020. Available at: https://rosstat.gov.ru (in Russ.) (accessed 03.02.2022).

2. Clinical guidelines. Ventricular arrhythmias. Ventricular tachycardia and sudden cardiac death. Available at: https://scardio.ru/content/Guidelines/2020/Clinic_rekom_ZHNR.pdf (in Russ.) (accessed 03.02.2022).

3. Fatenkov O.V., Rubanenko O.A., Yashin S.S., Avezova D.B. Current aspects of the concept, etiology, pathogenesis and prevention of sudden cardiac death. Science & Innovations in Medicine. 2017; 2: 20–5 (in Russ.).

4. Filippov E.V., Yakushin S.S. Sudden cardiac death: problems of risk stratification and choice of therapy. Rational Pharmacotherapy in Cardiology. 2011; 7 (2): 212–8 (in Russ.).

5. Ladzeyeu A.Y., Marochkov A.V., Dzmitryieva V.N. The history of creation and development of implantable cardioverter defibrillators. Surgery News. 2016; 24 (4): 317–27 (in Russ.).

6. Ardashev A.V., Zhelyakov E.G. Implantable cardioverter-defibrillator use for sudden cardiac death prevention. Experience of Burdenko Main Military Clinical Hospital. Russian Journal of Cardiology. 2004; 9 (3): 35–41 (in Russ.).

7. Bockeria L.A., Milievskaya E.B., Kudzoeva Z.F., et al. Cardiovascular surgery – 2018. Diseases and congenital anomalies of the circulatory system. Moscow; 2019: 270 pp. (in Russ.).

8. Bockeria L.A., Milievskaya E.B., Pryanishnikov V.V., Yurlov I.A. Cardiovascular surgery – 2020. Diseases and congenital anomalies of the circulatory system. Moscow; 2021: 294 pp. (in Russ.).

9. Omelyanovskiy V.V., Avxentyeva M.V., Khachatryan G.R., et al. Methodological recommendations on the use of mathematical modeling in clinical and economic research and research using budget impact analysis. Мoscow; 2019: 59 pp. (in Russ.).

10. Teptsova T.S., Musina N.Z., Omelyanovsky V.V. Evaluation of the reference value of the incremental parameter "cost-effectiveness" for Russian healthcare system. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2020; 13 (4): 367–76 (in Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika.2020.071.

11. International Monetary Fund. Inflation rate, average consumer prices. 2022. Available at: https://www.imf.org/external/datamapper/PCPIPCH@WEO/OEMDC/RUS (accessed 06.02.2022).

12. Goldenberg I., Gillespie J., Moss A.J., et al. Long-term benefit of primary prevention with an implantable cardioverter-defibrillator: an extended 8-year follow-up study of the Multicenter Automatic Defibrillator Implantation Trial II. Circulation. 2010; 122 (13): 1265–71. https://doi.org/10.1161/CIRCULATIONAHA.110.940148.

13. Connolly S.J., Hallstrom A.P., Cappato R., et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillator Study. Eur Heart J. 2000; 21 (24): 2071–8. https://doi.org/10.1053/euhj.2000.2476.

14. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997; 337 (22): 1576–84. https://doi.org/10.1056/NEJM199711273372202.

15. Kuck K.H., Cappato R., Siebels J., Rüppel R. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest: the Cardiac Arrest Study Hamburg (CASH). Circulation. 2000; 102 (7): 748–54. https://doi.org/10.1161/01.cir.102.7.748.

16. Connolly S.J., Gent M., Roberts R.S., et al. Canadian implantable defibrillator study (CIDS): a randomized trial of the implantable cardioverter defibrillator against amiodarone. Circulation. 2000; 101 (11): 1297–302. https://doi.org/10.1161/01.cir.101.11.1297.

17. WebPlotDigitizer 4.5. Available at: https://apps.automeris.io/wpd/ (accessed 05.12.2021).

18. Guyot P., Ades A.E., Ouwens M.J., Welton N.J. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC Med Res Methodol. 2012; 12: 9. https://doi.org/10.1186/1471-2288-12-9.

19. RStudio Team. Available at: https://www.rstudio.com/ (accessed 02.02.2022).

20. Jackson C.H. flexsurv: a platform for parametric survival modeling in R. J Stat Softw. 2016; 70: i08. https://doi.org/10.18637/jss.v070.i08.

21. Ranasinghe I., Parzynski C.S., Freeman J.V., et al. Long-term risk for device-related complications and reoperations after implantable cardioverter-defibrillator implantation: an observational cohort study. Ann Intern Med. 2016; 165 (1): 20–9. https://doi.org/10.7326/M15-2732.

22. Gidwani R., Russell L.B. Estimating transition probabilities from published evidence: a tutorial for decision modelers. Pharmacoeconomics. 2020; 38 (11): 1153–64. https://doi.org/10.1007/s40273-020-00937-z.

23. da Silva K.R., Costa R., Garcia Rodrigues C., et al. Quality of life in patients with implantable cardioverter-defibrillator: systematic review of randomized controlled trials. Eur J Cardiovasc Nurs. 2018; 17 (3): 196–206. https://doi.org/10.1177/1474515117739619.

24. Tomzik J., Koltermann K.C., Zabel M., et al. Quality of life in patients with an implantable cardioverter defibrillator: a systematic review. Front Cardiovasc Med. 2015; 2: 34. https://doi.org/10.3389/fcvm.2015.00034.

25. Cowie M.R., Marshall D., Drummond M., et al. Lifetime costeffectiveness of prophylactic implantation of a cardioverter defibrillator in patients with reduced left ventricular systolic function: results of Markov modelling in a European population. Europace. 2009; 11 (6): 716–26. https://doi.org/10.1093/europace/eup068.

26. Smith T., Jordaens L., Theuns D.A., et al. The cost-effectiveness of primary prophylactic implantable defibrillator therapy in patients with ischaemic or non-ischaemic heart disease: a European analysis. Eur Heart J. 2013; 34 (3): 211–9. https://doi.org/10.1093/eurheartj/ehs090.

27. Sanders G.D., Kong M.H., Al-Khatib S.M., Peterson E.D. Costeffectiveness of implantable cardioverter defibrillators in patients ≥65 years of age. Am Heart J. 2010; 160 (1): 122–31. https://doi.org/10.1016/j.ahj.2010.04.021.

28. Owens D.K., Sanders G.D., Heidenreich P.A., et al. Effect of risk stratification on cost-effectiveness of the implantable cardioverter defibrillator. Am Heart J. 2002; 144 (3): 440–8. https://doi.org/10.1067/mhj.2002.125501.

29. Decree of the Government of the Russian Federation of 28.12.2021 No. 2505 “On the Program of state guarantees of free medical care to citizens for 2022 and for the planning period of 2023 and 2024”. Available at: https://base.garant.ru/403335795/ (in Russ.) (accessed 18.02.2022).

30. Draft Order of the Ministry of Health of the Russian Federation “On approval of the standard of medical care for adults with ventricular arrhythmias” (as of 21.12.2020). Available at: http://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=PNPA&n=66310#uvKXB1Tucu4VwBtu (in Russ.) (accessed 18.02.2022).

31. KRASOFT. Information and analytical system “Procurement”. Available at: http://krasoft.ru/ (in Russ.) (accessed 15.05.2021).

32. Letter of the Ministry of Health of the Russian Federation of 31.12.2020 No. 11-7/I/2-20700 “On sending explanations on the formation and economic justification of territorial programs of state guarantees of free medical care to citizens for 2021 and for the planning period of 2022 and 2023”. Available at: https://docs.cntd.ru/document/573366545 (in Russ.) (accessed 18.02.2022).

33. Shavarov A.A., Dzhandzhgava A.O., Ardashev A.V. Disorders of pacemakers and cardioverters defibrillators functioning. In: Ardashev A.V. (Ed.) Clinical arrhythmology. Мoscow: Medpraktika; 2009: 689– 705 (in Russ.).

34. Decree of the Government of the Russian Federation of 28.12.2020 No. 2299 “On the Program of state guarantees of free medical care to citizens for 2021 and for the planning period of 2022 and 2023”. Available at: https://base.garant.ru/400165890/ (in Russ.) (accessed 18.02.2022).

35. Seryapina Yu.V., Pustovalov D.N., Musina N.Z. Need for implantable cardioverter-defibrillators in the Russian Federation. Medical Technologies. Assessment and Choice. 2021; 1: 46–53 (in Russ.). https://doi.org/10.17116/medtech20214301146.

36. Völler H., Kamke W., Klein H.U., et al. Clinical practice of defibrillator implantation after myocardial infarction: impact of implant time: results from the PreSCD II Registry. Europace. 2011; 13 (4): 499–508. https://doi.org/10.1093/europace/euq426.