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.

Objective: to evaluate the clinical and economic feasibility of expanding the preferential drug provision (PDP) program for adult patients at very high cardiovascular (CV) risk, including those who have not reached lipid targets on statin therapy, by increasing the frequency of use of ezetimibe, alirocumab, evolocumab and inclisiran used in combination with statins, compared with current PDP practice (use of atorvastatin, simvastatin and minimal use of other drugs).Material and methods. A Markov model was constructed to characterize the development of atherosclerotic heart disease in patients with very high CV risk and to suggest a consistent change in hypolipidemic therapy if it is ineffective. The model considered patients' compliance to drug therapy over time and the factor of non-prescription of any treatment. The modeling horizon was 30 years, and the model cycle was 1 year. The outcomes used were quality-adjusted life years (QALY), life years gained (LYG), and probabilities of various individual and combined CV events. The baseline modeling scenario was to increase the frequency of рroprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors’ prescriptions. In addition, alternative scenarios were modeled that included prescription of highly effective lipid-lowering therapy for all patients who had not reached target low-density lipoprotein cholesterol (LDL-C) on statin therapy, and the scenario with 100% compliance to statin therapy.Results. In comparison with current practice of treatment of patients with very high CV risk, clinical and economic modeling showed a decrease in the incidence of combined outcomes (combined CV events – by 8%, extended combined CV events – by 9%) and individual CV events (heart attack – by 4%, stroke – by 3%, unstable angina – by 2%, revascularization – by 3%) in the baseline scenario. In scenarios of prescribing PCSK9 inhibitors and inclisiran to all patients who have not reached target values of LDL-C on statin therapy, the frequency of individual events ranged from 4% to 8%. In the scenario, which also implies 100% drug compliance, the reduction was from 8% to 17% compared with current patient management practices, characterized by lower frequency of hypolipidemic drugs, including PCSK9 inhibitors and inclisiran. The incremental cost-effectiveness ratio (ICER) for QALY in the baseline scenario was 3,598,156 rubles, the ICER for LYG was 1,949,393 rubles. When comparing the ICER with willingness-to-pay (WTP) threshold in the Russian Federation (calculated as three times the gross domestic product per capita and in 2022 amounting to 2.8 million rubles per effect unit) the ICER for LYG did not exceed the WTP in all scenarios, while the ICER for QALY exceeded the WTP by 29–44%, depending on the realized scenario.Conclusion. Expanding the PDP program for high CV risk patients will have a positive impact on their quality of life and life expectancy, as well as significantly reduce the likelihood of acute CV events. Comparison of ICER with estimated WTP suggests that expansion of the PBP program is a cost-effective organizational technology according to LYG criterion, but not according to the QALY criterion.

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