Cost-effectiveness of non-statin lipid-lowering therapies as an add-on to statins for achieving low-density lipoprotein cholesterol therapeutic targets in very high-risk patients in the Spanish setting

Aims: Our study aimed to estimate the cost-effectiveness of non-statin lipid-lowering therapies (LLTs) in patients with very-high cardiovascular risk, based on their relative efficacy and current yearly treatment costs in the Spanish setting.Materials and methods: We generated a cohort of patients in secondary prevention with low-density lipoprotein cholesterol (LDL-C) levels >100 mg/dL using a Monte Carlo simulation. Based on the relative LDL-C reductions described in the literature for each studied non-statin LLTs, we estimated the percentages of cohort patients that would achieve the 2019/2025 European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) dyslipidemia guidelines treatment targets (LDL-C levels <55 mg/dL and ≥50% reduction from baseline; defined as effectively treated patients). Derived, the annual costs per effectively treated patient were calculated.Results: Evolocumab 140 mg every 2 weeks (Q2W), followed by alirocumab 150 mg Q2W were modeled to be the most efficacious non-statin regimens, with 80% and 70% of effectively treated patients, respectively. The results for inclisiran and the other studied doses of alirocumab were modeled to be more modest (20% to 33%). The mean annual cost per patient effectively treated with evolocumab 140 mg Q2W was 6,200.1€, compared with 7,126.5€for alirocumab 150 mg Q2W, 15,159.1€with alirocumab 75 mg Q2W and 19,254.9€with alirocumab 300 mg every month. Inclisiran resulted in higher costs both during the first year (31,329.1€) and the subsequent time scenarios (26,107.6€and 22,974.7€during average first 2 and 5 years, respectively).Limitations: No head-to-head clinical trials comparing non-statin LLTs are available. We only considered the published direct pharmacological costs in the Spanish setting.Conclusions: In our simulation study, evolocumab 140 mg Q2W resulted in similar (versus alirocumab 150 mg Q2W) or better cost-effectiveness in achieving 2019/2025 ESC/EAS LDL-C targets for secondary prevention patients compared to other LLTs.