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Praluent (alirocumab) — Blue Cross Blue Shield of Montana

Clinical atherosclerotic cardiovascular disease (ASCVD)

Preferred products

  • Repatha (evolocumab)

Initial criteria

  • The patient has a diagnosis of homozygous familial hypercholesterolemia (HoFH) AND ALL of the following:
  • • 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 ≥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 10 years of age OR untreated elevated LDL-C consistent with heterozygous FH in both parents (or in digenic form, one parent normal, one consistent with HoFH)
  • AND ONE of the following:
  • – Tried a 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 the patient will use other lipid-lowering therapy (e.g., statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab).
  • OR BOTH of the following:
  • 1. ONE of the following conditions:
  • A. Heterozygous familial hypercholesterolemia (HeFH) confirmed by ONE of: genetic confirmation of one mutant allele at LDLR, Apo-B, PCSK9, or 1/LDLRAP1 gene; pre-treatment LDL-C > 190 mg/dL; clinical manifestations of HeFH (cutaneous xanthomas, tendon xanthomas, corneal arcus); 'definite' or 'possible' familial hypercholesterolemia per Simon Broome criteria; Dutch Lipid Clinic Network score > 5; or treated LDL-C ≥ 100 mg/dL after statin ± ezetimibe.
  • B. Clinical atherosclerotic cardiovascular disease (ASCVD) AND ONE of: acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, peripheral arterial disease (including aortic aneurysm) presumed atherosclerotic.
  • C. Primary hyperlipidemia AND ONE of: coronary artery calcium (CAC) score ≥ 300 Agatston units OR pre-treatment LDL-C ≥ 190 mg/dL.
  • D. 20–29% 10-year ASCVD risk AND LDL-C ≥ 130 mg/dL on maximally tolerated statins.
  • E. 30–39% 10-year ASCVD risk AND LDL-C ≥ 100 mg/dL on maximally tolerated statins.
  • F. ≥40% 10-year ASCVD risk AND LDL-C ≥ 70 mg/dL on maximally tolerated statins.
  • 2. ONE of the following:
  • A. Patient has been adherent to high-intensity statin therapy (atorvastatin 40–80 mg or rosuvastatin 20–40 mg daily) for at least 8 consecutive weeks.