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Praluent (alirocumab) — Blue Cross Blue Shield of Texas

homozygous familial hypercholesterolemia (HoFH)

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 (≥2 such variants at different loci) OR history of untreated LDL-C >400 mg/dL AND ONE of the following: cutaneous or tendon xanthomas before age <10 years OR untreated elevated LDL-C levels consistent with heterozygous FH in both parents (or in digenic form, one parent normal, one parent HoFH-levels)
  • AND ONE of the following: tried high-intensity statin (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 (statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab)
  • OR diagnosis of HeFH confirmed by ONE of the following: genetic confirmation of one mutant allele at LDLR, Apo-B, PCSK9, or LDLRAP1 gene OR pre-treatment LDL-C >190 mg/dL OR clinical manifestations of HeFH (cutaneous xanthomas, tendon xanthomas, corneal arcus) OR 'definite' or 'possible' FH by Simon Broome criteria OR Dutch Lipid Clinic Network score >5 OR treated LDL-C ≥100 mg/dL after statin ± ezetimibe
  • OR clinical ASCVD with ONE of the following: acute coronary syndrome, history of myocardial infarction, stable/unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, peripheral arterial disease (including aortic aneurysm) presumed atherosclerotic
  • OR primary hyperlipidemia with ONE of the following: coronary artery calcium score ≥300 Agatston units OR pre-treatment LDL-C ≥190 mg/dL
  • OR 20–29% 10-year ASCVD risk AND LDL-C ≥130 mg/dL on maximally tolerated statins
  • OR 30–39% 10-year ASCVD risk AND LDL-C ≥100 mg/dL on maximally tolerated statin therapy
  • OR ≥40% 10-year ASCVD risk AND LDL-C ≥70 mg/dL on maximally tolerated statin therapy
  • AND patient adherent to high-intensity statin therapy (atorvastatin 40–80 mg or rosuvastatin 20–40 mg daily) for ≥8 consecutive weeks unless contraindicated or intolerant