Economic evaluation of PCSK9 inhibitors inclusion in the list of medicines for outpatient preferential drug provision ("23 INNs" list) for secondary prevention of cardiovascular events
Objective. To assess the feasibility of expanding the «23 INNs» list by including lipid-lowering drugs (inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9 - alirocumab, evolocumab)) considering clinical and cost-effectiveness analysis of patients with cardiovascular events (non-fatal stroke and myocardial infarction) or previous myocardial revascularization. Material and methods. A Markov model was developed to evaluate the cost-effectiveness of therapy with PCSK9 inhibitors (alirocumab and evolocumab) and statins (atorvastatin and simvastatin). We compared the current management (monotherapy with statins) and possible approach (combination of statins with PCSK9 inhibitors in patients with previous cardiovascular event and unfavorable lipid levels under monotherapy with statins) within the «23 INN» list. Modeling was carried out considering the lifetime horizon and the cycle equal to 1 year. The primary outcome was quality adjusted life years (QALY). Results. Combination of high doses of statins with PCSK9 inhibitors (alirocumab, evolocumab) will increase survival by 0.4 years and QALY by 0.35 in patients with unfavorable lipid levels under monotherapy with statins. The cost per a patient increased by 2.134.273 rubles. Additional costs for additional QALY will be 7.198.824 rubles, for additional year of life - 5.465.013 rubles, for prevention of a combined cardiovascular outcome (myocardial infarction, stroke, cardiovascular death, unstable angina, coronary revascularization) - 8.504.123 rubles. Conclusion. The incremental cost-effectiveness indicator of possible therapy (additional funding for prescription of evolocumab or alirocumab in equal shares) will be 7.198.824 rubles per added QALY that exceeds the reference value of the indicator (willingness to pay threshold). Indeed, the last value is 2.7 million rubles for QALY in the Russian Federation.