Economic analysis of implementing Systemic Coronary Risk Estimation (SCORE2) scale and long-term consequences

Objective: to assess the demand for pharmacotherapy in risk groups on adverse cardiovascular (CV) events identified during prophylactic medical examination of the adult population according to the SCORE2 (Systemic Coronary Risk Estimation) scale, which is being introduced into clinical practice.

Material and methods. To analyze the economic consequences of including diagnostic examinations to assess the risk by SCORE and SCORE2 scales, a Markov model was developed, which described the course of lipid metabolism disorders in adult patients aged 40 to 69 years without concomitant diseases identified during prophylactic medical examination. The model cycle was 2 months (the average waiting time for response to therapy); the modeling horizon was 3 years; the calculated values were estimated for the period 2024–2026. The economic analysis of long-term consequences involved calculating the cost of pharmacotherapy and the costs associated with CV events at outpatient and inpatient stages of medical care. The costs of drug therapy were determined based on dosage regimens presented in instructions for medical use in Russia, and clinical guidelines.

Results. According to the modeling results, in the period 2024–2026, the administration of pharmacotherapy to reduce the risks of CV events will enable to achieve 23,224 potentially saved lives through exclusively government funding or 23,605 through mixed sources of funding (government and citizens’ own funds). The cost of the analyzed pharmacotherapy upon the introduction of the SCORE2 scale will be from 50.18 billion rubles (with government funding) to 318.14 billion rubles. Concurrently, pharmacocorrection will provide a reduction in the costs of inpatient treatment and outpatient medical services to 4.1 billion rubles due to the achieving of intended low-density lipoprotein level, and 1.6 billion rubles due to the achieving of intended triglyceride levels.

Conclusion. Using new SCORE2 scale may lead to changes in the practice of prescribing lipid-lowering prophylaxis of CV diseases, as well as to a sharp increase in the number of patients who may require earlier prescription of pharmacotherapy to prevent CV events.

1. World Health Organization. Cardiovascular diseases (CVDs). Available at: https://www.who.int/news-room/fact-sheets/detail/cardiovasculardiseases-(cvds) (accessed 15.06.2024).

2. Federal State Statistics Service. Demographics. The natural movement of the population. The number of deaths according to the main classes of causes of death. Available at: https://rosstat.gov.ru/folder/12781 (in Russ.) (accessed 15.06.2024).

3. Federal State Statistics Service. The situation of the disabled. Medical and social expertise and social services for the disabled. Available at: https://rosstat.gov.ru/folder/13964 (in Russ.) (accessed 15.06.2024).

4. Resolution of the Government of the RF dated 26.12.2017 No. 164 "On approval of the state program of the Russian Federation ‘Development of healthcare’ ”. Available at: https://base.garant.ru/71848440/ (in Russ.) (accessed 15.06.2024).

5. Resolution of the Government of the RF dated 30.11.2019 No. 1569 “On amendments to the state program of the Russian Federation ‘Development of healthcare’ ”. Available at: https://base.garant.ru/73169732/ (in Russ.) (accessed 15.06.2024).

6. Order of the Ministry of Health of the RF dated 29.09.2022 No. 639n “On approval of the list of medicines for medical use in order to provide outpatient care to persons under dispensary supervision who have suffered acute cerebral circulatory disorder, myocardial Infarction, and who have undergone coronary artery bypass grafting, coronary artery angioplasty with Stenting and catheter ablation for cardiovascular diseases, within 2 years from the date of diagnosis and (or) surgical intervention”. Available at: https://base.garant.ru/405567511/ (in Russ.) (accessed 15.06.2024).

7. Kukharchuk V.V., Ezhov M.V., Sergienko I.V., et al. Eurasian Association of Cardiology (EAC) / Russian National Atherosclerosis Society (RNAS, Russia) guidelines for the diagnosis and correction of dyslipidemia for the prevention and treatment of atherosclerosis (2020). Eurasian Heart Journal. 2020; 2: 6–29 (in Russ.). https://doi.org/10.38109/2225-1685-2020-2-6-29.

8. Order of the Ministry of Health of the RF dated 27.04.2021 No. 404n “On approval of the Procedure for preventive medical examination and medical examination of certain groups of the adult population”. Available at: https://www.garant.ru/products/ipo/prime/doc/401314440/ (in Russ.) (accessed 15.06.2024).

9. Visseren F.L.J., Mach F., Smulders Y.M., et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies with the special contribution of the European Association of Preventive Cardiology (EAPC). Eur J Prevent Cardiol. 2022; 29 (1): 5–115. https://doi.org/10.1093/eurjpc/zwab154.

10. Disorders of lipid metabolism. Rubricator of clinical recommendations. 2023. Available at: https://cr.minzdrav.gov.ru/recomend/752_1 (in Russ.) (accessed 15.06.2024).

11. SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021; 42 (25): 2439–54. https://doi.org/10.1093/eurheartj/ehab309.

12. Conroy R.M., Pyörälä K., Fitzgerald A.P., et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J. 2003; 24 (11): 987–1003. https://doi.org/10.1016/s0195668x(03)00114-3.

13. Tregubov A.V., Tregubova A.A., Alekseeva I.V., et al. Comparison of the results of cardiovascular risk assessment using the SCORE and SCORE2 scales. The Journal of Atherosclerosis and Dyslipidemias. 2022; 3: 41–7 (in Russ.). https://doi.org/10.34687/2219-8202.JAD.2022.03.0005.

14. Erina A.M., Usoltsev D.A., Boyarinova M.A., et al. Appointment of lipid-lowering therapy in the Russian population: comparison of SCORE and SCORE2 (according to the ESSE-RF study). Russian Journal of Cardiology. 2022; 27 (5): 5006 (in Russ.). https://doi.org/10.15829/1560-4071-2022-5006.

15. Bytyçi I., Penson P.E., Mikhailidis D.P., et al. Prevalence of statin intolerance: a meta-analysis. Eur Heart J. 2022; 43 (34): 3213–23. https://doi.org/10.1093/eurheartj/ehac015.

16. Mills E.J., O’Regan C., Eyawo O., et al. Intensive statin therapy compared with moderate dosing for prevention of cardiovascular events: a meta-analysis of >40 000 patients. Eur Heart J. 2011; 32 (11) 1409–15. https://doi.org/10.1093/eurheartj/ehr035.

17. Cannon C.P., Blazing M.A., Giugliano R.P., et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372 (25): 2387–97. https://doi.org/10.1056/NEJMoa1410489.

18. Zhan S., Tang M., Liu F., et al. Ezetimibe for the prevention of cardiovascular disease and all cause mortality events. Cochrane Database Syst Rev. 2018; 11 (11): CD012502. https://doi.org/10.1002/14651858.CD012502.pub2.

19. Schmidt A.F., Swerdlow D.I., Holmes M.V., et al. PCSK9 genetic variants and risk of type 2 diabetes: a mendelian randomisation study. Lancet Diabetes Endocrinol. 2017; 5 (2): 97–105. https://doi.org/10.1016/S2213-8587(16)30396-5.314

20. Ray K.K., Wright R.S., Kallend D., et al. Two Phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020; 382 (16): 1507–19. https://doi.org/10.1056/NEJMoa1912387.

21. Birjmohun R.S., Hutten B.A., Kastelein J.J.P., Stroes E.S.G. Efficacy and safety of high-density lipoprotein cholesterol-increasing compounds: a meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2005; 45 (2): 185–97. https://doi.org/10.1016/j.jacc.2004.10.031.

22. Roth E.M., Bays H.E., Forker A.D., et al. Prescription omega-3 fatty acid as an adjunct to fenofibrate therapy in hypertriglyceridemic subjects. J Cardiovasc Pharmacol. 2009; 54 (3): 196–203. https://doi.org/10.1097/FJC.0b013e3181b0cf71.

23. Choi H.D., Shin W.G. Safety and efficacy of statin treatment alone and in combination with fibrates in patients with dyslipidemia: a metaanalysis. Curr Med Res Opin. 2014; 30 (1): 1–10. https://doi.org/10.1185/03007995.2013.842165.

24. Wilson P.W.F., D’Agostino R. Sr., Bhatt D.L., et al. An international model to predict recurrent cardiovascular disease. Am J Med. 2012; 125 (7): 695–703. https://doi.org/10.1016/j.amjmed.2012.01.014.

25. Balanova Iu.A., Kontsevaia A.V., Shalnova S.A., et al. Prevalence of behavioral risk factors for cardiovascular diseases in the Russian population according to the results of the ESSE-RF study. Russian Journal of Preventive Medicine. 2014; 17 (5): 42–52 (in Russ.).

26. The Russian School of Economics. The Center for Demographic Research. Data. Available at: https://www.nes.ru/demogr-fermortdata?lang=ru (in Russ.) (accessed 15.06.2024).

27. Lindh M., Banefelt J., Fox K.M., et al. Cardiovascular event rates in a high atherosclerotic cardiovascular disease risk population: estimates from Swedish population-based register data. Eur Heart J Qual Care Clin Outcomes. 2019; 5 (3): 225–32. https://doi.org/10.1093/ehjqcco/qcy058.

28. Federal State Statistics Service. The population of the Russian Federation by gender and age as of January 1, 2022. Available at: https://rosstat.gov.ru/compendium/document/13284 (in Russ.) (accessed 15.06.2024).

29. Meshkov A.N., Ershova A.I., Deev A.D., et al. Distribution of lipid profile values in economically active men and women in Russian Federation: results of the ESSE-RF study for the years 2012–2014. Cardiovascular Therapy and Prevention. 2017; 16 (4): 62–7 (in Russ.). https://doi.org/10.15829/1728-8800-2017-4-62-67.

30. Taylor F., Huffman M.D., Macedo A.F., et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013; 2013 (1): CD004816. https://doi.org/10.1002/14651858.CD004816.pub5.

31. Baigent C., Blackwell L., Emberson J., et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010; 376 (9753): 1670–81. https://doi.org/10.1016/S0140-6736(10)61350-5.

32. Toth P.P., Bray S., Villa G., et al. Network meta-analysis of rando- mized trials evaluating the comparative efficacy of lipid-lowering therapies added to maximally tolerated statins for the reduction of lowdensity lipoprotein cholesterol. J Am Heart Assoc. 2022; 11 (18): e025551. https://doi.org/10.1161/JAHA.122.025551.

33. Burnett H., Fahrbach K., Cichewicz A., et al. Comparative efficacy of non-statin lipid-lowering therapies in patients with hypercholesterolemia at increased cardiovascular risk: a network meta-analysis. Curr Med Res Opin. 2022; 38 (5): 777–84. https://doi.org/10.1080/03007995.2022.2049164.

34. Briel M., Schwartz G.G., Thompson P.L., et al. Effects of early treatment with statins on short-term clinical outcomes in acute coronary syndromes: a meta-analysis of randomized controlled trials. JAMA. 2006; 295 (17): 2046–56. https://doi.org/10.1001/jama.295.17.2046.

35. Qi L., Zhang Q., Zheng Z., et al. Treatment of Chinese patients with hypertriglyceridemia with a pharmaceutical-grade preparation of highly purified omega-3 polyunsaturated fatty acid ethyl esters: main results of a randomized, double-blind, controlled trial. Vasc Health Risk Manag. 2021; 17: 571–80. https://doi.org/10.2147/VHRM.S325217.

36. Jakob T., Nordmann A.J., Schandelmaier S., et al. Fibrates for primary prevention of cardiovascular disease events. Cochrane Database Syst Rev. 2016; 11 (11): CD009753. https://doi.org/10.1002/14651858.CD009753.pub2.

37. Decree of the Government of the RF dated 29.12.2022 No. 2497 “On the Program of state guarantees of free medical care to citizens for 2023 and for the planning period of 2024 and 2025”. Available at: https://www.garant.ru/products/ipo/prime/doc/405965459/ (in Russ.) (accessed 15.06.2024).