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Praluent (alirocumab) — Blue Cross Blue Shield of Alabama

Primary hyperlipidemia

Preferred products

  • Repatha (evolocumab)

Initial criteria

  • - Homozygous familial hypercholesterolemia (HoFH): • Diagnosis confirmed by EITHER genetic confirmation of bi-allelic pathogenic/likely pathogenic variants on different chromosomes at the LDLR, Apo-B, PCSK9, or LDLRAP1 genes (≥2 variants at different loci) OR history of untreated LDL-C >400 mg/dL and EITHER cutaneous/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 consistent with HoFH) • AND the patient has tried a high-intensity statin (atorvastatin 40–80 mg or rosuvastatin 20–40 mg daily) for ≥8 weeks with inadequate response OR has intolerance/hypersensitivity 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)
  • - Heterozygous familial hypercholesterolemia (HeFH): • Diagnosis confirmed by EITHER genetic confirmation of one mutant allele at LDLR, Apo-B, PCSK9, or LDLRAP1 OR pre-treatment LDL-C >190 mg/dL OR clinical manifestations (cutaneous/tendon xanthomas, corneal arcus) OR 'definite/possible' FH per Simon Broome criteria OR Dutch Lipid Clinic Network Criteria score >5 OR treated LDL-C ≥100 mg/dL after statin ± ezetimibe
  • - Clinical atherosclerotic cardiovascular disease (ASCVD): • Diagnosis of clinical ASCVD with ≥1 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) of presumed atherosclerotic origin
  • - Primary hyperlipidemia: • Diagnosis of primary hyperlipidemia AND ≥1 of: ◦ Coronary artery calcium or calcification (CAC) score ≥300 Agatston units ◦ Pre-treatment LDL-C ≥190 mg/dL ◦ 20–29% 10-year ASCVD risk and LDL-C ≥130 mg/dL while on maximally tolerated statins ◦ 30–39% 10-year ASCVD risk and LDL-C ≥100 mg/dL while on maximally tolerated statin therapy ◦ ≥40% 10-year ASCVD risk and LDL-C ≥70 mg/dL while on maximally tolerated statin therapy