Acquisition costs and cost-effectiveness have limited access and recommendations to use proprotein convertase subtilisin/kexin type 9 (PCSK9)–inhibiting monoclonal antibodies (mAbs). Recently, prices were reduced by 60% for alirocumab and evolocumab. This statement systematically reviewed subgroup analyses from statin and PCSK9 mAb trials to identify higher risk groups for which PCSK9 mAbs at the new price could be considered a reasonable (<US$100,000 per quality adjusted life year [QALY]) or high (<US$50,000 per QALY) value. In patients at extremely high risk, with a high burden of athersclerotic cardiovascular disease (ASCVD) or ASCVD with multiple poorly controlled or adverse risk factors, PCSK9 mAbs can provide reasonable value when low-density lipoprotein cholesterol (LDL-C) is ≥70 mg/dL. In patients at very high risk (ASCVD without peripheral arterial disease and lower levels of poorly controlled risk factors), PCSK9 mAbs provide a reasonable value when LDL-C levels are ≥100 mg/dL. High-risk patients (less-extensive ASCVD with well-controlled risk factors) may experience reasonable value when LDL-C levels are ≥130 mg/dL. Patients with heterozygous familial hypercholesterolemia or severe hypercholesterolemia with untreated LDL-C levels ≥220 mg/dL also should experience reasonable or high value from PCSK9 mAbs when LDL-C is ≥100 mg/dL for primary prevention and ≥70 mg/dL for secondary prevention.

购置成本和成本效益有限，获取和建议使用抑制蛋白原酶的枯草杆菌蛋白酶/ kexin 9型（PCSK9）-单克隆抗体（mAbs）。最近，alirocumab和evolocumab的价格降低了60％。该声明系统地审查了他汀类药物和PCSK9 mAb试验的亚组分析，以确定较高的风险组，对于这些较高的风险组，可以将新价格的PCSK9 mAb认为是合理的（每质量调整生命年[QALY]低于100,000美元）或较高（每50,000美元<50,000美元QALY）值。在动脉粥样硬化性心血管疾病（ASCVD）或具有多种不良控制或不良危险因素的ASCVD高负担的极高风险患者中，当低密度脂蛋白胆固醇（LDL-C）≥70 mg时，PCSK9 mAb可以提供合理的价值/ dL。在高风险患者（无周围动脉疾病的ASCVD和较低水平的不良控制危险因素）中，当LDL-C水平≥100mg / dL时，PCSK9 mAbs可提供合理的价值。当LDL-C水平≥130mg / dL时，高危患者（ASCVD程度较轻，危险因素得到很好控制）可能会具有合理的价值。未经治疗的LDL-C水平≥220mg / dL的杂合性家族性高胆固醇血症或重度高胆固醇血症的患者，如果一级预防的LDL-C≥100mg / dL，二级预防的≥70mg / dL，则PCSK9 mAbs也应具有合理或较高的价值预防。当LDL-C水平≥130mg / dL时，高危患者（ASCVD程度较轻，危险因素得到很好控制）可能会具有合理的价值。未经治疗的LDL-C水平≥220mg / dL的杂合性家族性高胆固醇血症或重度高胆固醇血症的患者，如果一级预防的LDL-C≥100mg / dL，二级预防的≥70mg / dL，则PCSK9 mAbs也应具有合理或较高的价值预防。当LDL-C水平≥130mg / dL时，高危患者（ASCVD程度较轻，危险因素得到很好控制）可能会具有合理的价值。未经治疗的LDL-C水平≥220mg / dL的杂合性家族性高胆固醇血症或重度高胆固醇血症的患者，如果一级预防的LDL-C≥100mg / dL，二级预防的≥70mg / dL，则PCSK9 mAbs也应具有合理或较高的价值预防。