Качественная клиническая практика (May 2018)
Economic expertise of alirocumab in standard lipid lowering therapy insusceptibility
Abstract
Usage of PCSK9 inhibitors is a new approach of lipid lowering therapy allowing overcomes as well insusceptibility of standard statins’ therapy as their intolerance. In last case PCSK9 inhibitors can substitute statins in the treatment program. Introduction to the Russian clinical practice the new PCSK9 inhibitor alirocumab (INN) requires it’s economic evaluation. Aim: To evaluate of alirocumab reasonability from pharmacoeconomic point of view to the Governmental program of free medical aid and others programs of reimbursement for the treatment of high cardiac risks patients also. Materials and methods. Retrospective comparative economic analysis of published data on efficacy and safety of new technology with alirocumab using and standard statin therapy. Budget impact analysis has been performed in according to Methodological guidelines for evaluation of influence on the Governmental program of free medical aid and coat of illness of the Russian Ministry of Health with Markov’s model usage with direct medical costs calculation. Costs were calculated on 1 000 pts and then recalculated on one patient. For stability results checking the sensitivity analysis has been performed. Cost of illness has been calculated as sum of direct costs (remedies, cost of one case of cardiac event etc.) and indirect cost (GDP loss due to temporary and permanent disability or premature death due to cardiac events). Results. Alirocumab during two years could save at least 6,635 bln RUR of budget’s funds and decrease on 45,52% of Governmental budget impact in a treatment of high cardiac risks patients in case of it’s inclusion into the Governmental program of free medical aid. This result was stable in sensitive analysis on 25%. Cost of illness analysis with evaluation of indirect costs has shown that alirocumab could lead to burden of illness decreasing on 9,04 bln RUR in the frames of targeted group of patients (or 58,92% vs current methodology of the treatment) during two years. Conclusion. Alirocumab has pharmacoeconomics evidences to be included into the Governmental program of free medical aid, Essential Drug List and different reimbursement programs.