Pharmacoeconomic Aspects of Using New-Generation Drugs of the PCSK-9 Inhibitor Class and Those Utilizing the Effect of Ribonucleic Acid Interference in the Treatment of Patients With Hypercholesterolemia.

Abstract

Aim     Clinical and economic analysis of the feasibility of using new-generation drugs of the PCSK-9 inhibitor class (alirocumab and evolocumab) and the drugs that utilize in their action the effect of ribonucleic acid interference (inclisiran) in the treatment of patients with a high risk of cardiovascular events in medical organizations of the Moscow Region (MR).Material and methods            Based on statistical and literature data on morbidity, as well as data from real-life practice about using alirocumab, evolocumab, and inclisiran in medical organizations of the MR, populations of patients with hypercholesterolemia and cardiovascular pathology were identified in that region. Two analytical models were developed that include the structure and number of patients receiving a combination therapy (high-dose statins + ezetimibe + alirocumab/evolocumab/inclisiran). To estimate the economic feasibility of the treatment with innovative drugs, direct medical costs were calculated for various therapeutic regimens. The cost of pharmacotherapy was calculated per patient per one-year course. A budget impact analysis (BIA) and a sensitivity analysis of the results were performed. The modeling period of the study was 3 years.Results            The number of patients in different populations receiving the combination therapy will be 12,228 and 895 people in the first year, and 12,973 and 950 people in the third year, taking into account the determined increase in the patient number. The total costs of treating one patient with hypercholesterolemia and cardiovascular diseases during the first year of therapy with inclisiran are 23.31 and 27.66% lower than with evolocumab and alirocumab, respectively. The BIA revealed a slight increase in the total cost of treating patients in each population (by 1.39 and 1.69% compared to 2024). The increase in the regional budget will be related only with the annual increase in the number of patients with hypercholesterolemia. The sensitivity analysis showed the robustness of the results to changes in the initial parameter values.Conclusion      The treatment of patients with dyslipidemia and high risk of cardiovascular events with alirocumab/evolocumab/inclisiran as part of the combination therapy is an economically justified strategy in the settings of the regional healthcare system.