Simulation study on LDL cholesterol target attainment, ASCVD events, and treatment cost of bempedoic acid in a representative German cohort of high- and very-high-CV risk patients

Abstract

Abstract Background The LDL cholesterol (LDL-C) treatment goals recommended by the 2019 ESC/EAS guidelines are only achieved in a minority of patients. For patients above goal despite statins and ezetimibe, additional LDL-C lowering can be achieved by treatment with bempedoic acid (BA) or PCSK9 inhibitors (PCSK9i). Purpose Simulation of LDL-C target attainment with BA as additional lipid-lowering medication in a representative cohort of German outpatients at high or very-high cardiovascular (CV) risk, calculation of the number of prevented atherosclerotic cardiovascular disease (ASCVD) events and budget impact. Methods Data were obtained from IQVIA™ Disease Analyzer database containing a representative sample of German outpatients. We selected patients with high or very-high CV risk (based on ESC/EAS guidelines), diagnosed hypercholesterolaemia and treatment with lipid-lowering medication. In patients with uncontrolled LDL-C, sequentially adding ezetimibe and BA was simulated using a Monte Carlo approach. Drug costs to control LDL-C by adding BA vs. PCSK9i were calculated based on current pricing in Germany. Considered were a scenario without BA and one with BA, in which BA was replaced by PCSK9i if LDL-C was still not controlled. The number of prevented events was calculated based on simulated LDL-C reduction. Results 105,577 patients met the inclusion criteria and entered the simulation model. 76,900 patients had very-high and 28,677 high CV risk. The baseline characteristics are depicted in Table 1. Only a minority of total patients (11.2%) achieved their risk-based LDL-C goal. Simulation of the sequential addition of ezetimibe to statins resulted in controlled LDL-C in 33.1% of total patients. Simulated addition of BA in patients with uncontrolled LDL-C despite statin and ezetimibe increased the percentage of controlled patients to 61.9% of total. The proportion of patients achieving LDL-C goals was higher in high- compared to very-high risk patients (Figure 1). Treatment with BA reduced the need for PCSK9i in patients on statin and ezetimibe from 66.6% to 37.8%. The considered scenario resulted in an anticipated reduction of drug costs by 35.9% per year on stable lipid-lowering medication. This effect was more pronounced in high-risk compared to very-high-risk patients (cost reductions of 40.6% and 34.4%, respectively). In this simulation model, the BA/PCSK9i strategy is projected to prevent 6,148 ASCVD events annually per 1 million patients on top of statin+ezetimibe, whereas LDL-C target achievement with PCSK9i alone would prevent 7,939 events. Conclusions A considerable larger proportion of high- and very-high-risk patients can achieve guideline-recommended LDL-C targets with escalated lipid-lowering medication. BA is projected to substantially decrease the need for PCSK9i treatment to achieve LDL-C targets which reduces drug costs compared to PCSK9i. LDL-C target attainment is projected to markedly reduce ASCVD events. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Deutschland GmbH