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Praluent (alirocumab) — Blue Cross Blue Shield of New Mexico

Primary hyperlipidemia

Preferred products

  • Repatha (evolocumab)

Initial criteria

  • ONE of the following:
  • A. The patient has a diagnosis of homozygous familial hypercholesterolemia (HoFH) AND ALL of the following:
  • 1. 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: cutaneous/tendon xanthomas before age 10 years OR untreated elevated LDL-C levels consistent with heterozygous FH in both parents.
  • 2. ONE of the following: tried a high-intensity statin (atorvastatin 40–80 mg, rosuvastatin 20–40 mg daily) for ≥ 8 weeks and had inadequate response OR intolerance/hypersensitivity OR contraindication to all high-intensity statins.
  • 3. The patient will use other lipid-lowering therapy (e.g., statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab).
  • OR
  • B. BOTH of the following:
  • 1. ONE of the following indications:
  • A. Heterozygous familial hypercholesterolemia (HeFH) AND one of the following: genetic confirmation of one mutant allele at LDLR, Apo-B, PCSK9, or LDLRAP1 OR pre-treatment LDL-C > 190 mg/dL OR clinical manifestations (xanthomas, corneal arcus) OR definite/possible FH by Simon Broome criteria OR 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/unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, peripheral arterial disease (including aortic aneurysm) presumed of atherosclerotic origin.
  • C. Primary hyperlipidemia AND one of: coronary artery calcium score ≥ 300 Agatston units OR pre-treatment LDL-C ≥ 190 mg/dL.
  • D. 10-year ASCVD risk 20–29% AND LDL-C ≥ 130 mg/dL on maximally tolerated statins.
  • E. 10-year ASCVD risk 30–39% AND LDL-C ≥ 100 mg/dL on maximally tolerated statins.
  • F. 10-year ASCVD risk ≥ 40% AND LDL-C ≥ 70 mg/dL on maximally tolerated statins.
  • 2. ONE of the following: adherence to high-intensity statin therapy (atorvastatin 40–80 mg, rosuvastatin 20–40 mg daily) for ≥ 8 consecutive weeks AND LDL-C remains elevated (details continue on later section).