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Praluent (alirocumab)Blue Cross Blue Shield of Illinois

primary hyperlipidemia

Preferred products

  • Repatha (evolocumab)

Initial criteria

  • Diagnosis of HoFH confirmed by ONE of the following: genetic confirmation of bi-allelic pathogenic/likely pathogenic variants on different chromosomes at the LDLR, Apo-B, PCSK9, or LDLRAP1 genes OR history of untreated LDL-C > 400 mg/dL AND either cutaneous or tendon xanthomas before age 10 years OR untreated elevated LDL-C levels consistent with heterozygous FH in both parents
  • AND ONE of the following: patient has tried a high-intensity statin (e.g., atorvastatin 40–80 mg or rosuvastatin 20–40 mg daily) for ≥ 8 weeks with inadequate response OR intolerance or hypersensitivity to ALL high-intensity statins OR FDA-labeled contraindication to ALL high-intensity statins
  • AND patient will use other lipid-lowering therapy (e.g., statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab)
  • OR for heterozygous familial hypercholesterolemia (HeFH): genetic confirmation of one mutant allele at LDLR, Apo-B, PCSK9, or LDLRAP1 OR pre-treatment LDL-C > 190 mg/dL OR clinical manifestations of HeFH (e.g., cutaneous xanthomas, tendon xanthomas, corneal arcus) OR definite/possible FH by Simon Broome criteria OR Dutch Lipid Clinic Network Criteria score > 5 OR treated LDL-C ≥ 100 mg/dL after statin ± ezetimibe
  • OR diagnosis of clinical ASCVD with at least one of: acute coronary syndrome, history of myocardial infarction, stable/unstable angina, coronary/arterial revascularization, stroke, transient ischemic attack, peripheral arterial disease or aortic aneurysm of atherosclerotic origin
  • OR diagnosis of primary hyperlipidemia with CAC score ≥ 300 Agatston units OR pre-treatment LDL-C ≥ 190 mg/dL
  • OR 10-year ASCVD risk 20–29% with LDL-C ≥ 130 mg/dL on maximally tolerated statins
  • OR 10-year ASCVD risk 30–39% with LDL-C ≥ 100 mg/dL on maximally tolerated statin therapy
  • OR 10-year ASCVD risk ≥ 40% with LDL-C ≥ 70 mg/dL on maximally tolerated statin therapy
  • AND patient has been adherent to high-intensity statin therapy (atorvastatin 40–80 mg or rosuvastatin 20–40 mg daily) for ≥ 8 consecutive weeks