Enhancing the value of PCSK9 monoclonal antibodies by identifying patients most likely to benefit. A consensus statement from the National Lipid Association

      Highlights

      • Initial pricing limited uptake of highly effective proprotein convertase subtilisin/kexin type 9 monoclonal antibodies.
      • Recent price reductions call for new guidance in this National Lipid Association statement.
      • Value assessment may improve access to proprotein convertase subtilisin/kexin type 9 monoclonal antibodies for appropriate patient groups.

      Abstract

      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.

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