COMPARATIVE ANALYSIS OF THERAPEUTIC EFFICACY AND COST-EFFECTIVENESS OF PCSK9 INHIBITORS FOR THE TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA

Abstract

The aim of this study was to model local data on the long-term costs and health benefits of alternative health technologies for the treatment of patients with primary hypercholesterolemia and mixed dyslipidemia (PH/MD) and implement an indirect comparison based on network meta-analysis. Model inputs were measured and assessed clinical endpoints in the randomized multicenter clinical trials ORION-10 and LAPLACE-2. Indirect comparison is possible due to the presence of a common therapeutic alternative in the control groups of the trials. Data modelling of future health benefits and costs after the end of the clinical trials was performed using a Markov model with three health and one absorption state. The model included all possible health states reflecting the course of the disease and predicted all transition probabilities from one health state to another. The time horizon of the model is lifetime. Costs and benefits are discounted at 3.5% per year. The perspective chosen is that of the third party payer. The selected method for comparative evaluation of alternative health technologies for the treatment of patients with PH/MD is cost-effectiveness analysis (CEA). The preferred method for assessing therapeutic efficacy and cost-effectiveness is consistent with published recommendations, EUnetHTA guidelines and is appropriate on how to measure health benefits within randomised clinical trials. In conclusion, inclisiran is a cost-effective therapy compared to evolocumab for the treatment of patients with PH/MD and high cardiovascular risk as a result of improved therapeutic efficacy and reasonable cost per year of therapy. The incremental cost-effectiveness ratio of inclisiran compared with evolocumab is below the cost-effectiveness threshold of three times the previous year's per capita gross domestic product in Bulgaria (ICER ≤ 50 000 BGN). A probabilistic sensitivity analysis revealed a 63% probability of inclisiran being a cost-effective therapy compared with evolocumab.