Praluent (alirocumab) — United Healthcare

Preferred products

• Repatha (evolocumab)

Initial criteria

• For Primary Hyperlipidemia (including HeFH) or ASCVD:
• 1. One of the following diagnoses:
• a. Heterozygous familial hypercholesterolemia (HeFH)
• OR
• b. Atherosclerotic cardiovascular disease (ASCVD) (e.g., acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin)
• OR
• c. Primary hyperlipidemia
• AND
• 2. One of the following:
• a. Patient has been receiving at least 12 consecutive weeks of high-intensity statin therapy [atorvastatin 40–80 mg, rosuvastatin 20–40 mg] and will continue to receive a high-intensity statin at maximally tolerated dose
• OR
• b. Both of the following:
• i. Patient is unable to tolerate high-intensity statin as evidenced by one of the following intolerable and persistent (>2 weeks) symptoms:
• • Myalgia (muscle symptoms without creatine kinase elevations)
• • Myositis (muscle symptoms with creatine kinase elevations < 10 × ULN)
• AND
• ii. Patient has been receiving at least 12 consecutive weeks of low- or moderate-intensity statin therapy [atorvastatin 10–20 mg, rosuvastatin 5–10 mg, simvastatin ≥ 10 mg, pravastatin ≥ 10 mg, lovastatin 20–40 mg, fluvastatin XL 80 mg, fluvastatin 20–40 mg up to 40 mg twice daily, or Livalo (pitavastatin) ≥ 1 mg] and will continue to receive at maximally tolerated dose
• OR
• c. Patient is unable to tolerate low-, moderate-, and high-intensity statins as evidenced by:
• i. One of the following intolerable and persistent (>2 weeks) symptoms:
• • Myalgia (muscle symptoms without CK elevations)
• • Myositis (muscle symptoms with CK elevations < 10 × ULN)
• OR
• ii. Patient has a contraindication to all statins
• OR
• iii. Patient has experienced rhabdomyolysis or muscle symptoms with statin treatment with CK elevations > 10 × ULN
• AND
• 3. Both of the following:
• a. LDL-C ≥ 55 mg/dL
• AND
• b. One of the following:
• i. Patient has been receiving at least 12 consecutive weeks of ezetimibe therapy as adjunct to maximally tolerated statin therapy
• OR
• ii. Patient has a history of contraindication or intolerance to ezetimibe
• AND
• 4. One of the following:
• a. Patient is less than 10 years of age
• OR
• b. History of failure, contraindication, or intolerance to Repatha (evolocumab) (document date of trial and reason)
• AND
• 5. Not used in combination with another PCSK9 inhibitor [e.g., Repatha (evolocumab)]
• AND
• 6. Not used in combination with Leqvio (inclisiran)
• Authorization will be issued for 12 months.
• For Homozygous Familial Hypercholesterolemia (HoFH):
• 1. Diagnosis confirmed by one of the following:
• a. Genetic confirmation of bi-allelic pathogenic/likely pathogenic variants on different chromosomes in LDLR, APOB, PCSK9, or LDLRAP1 genes or ≥ 2 such variants at different loci
• OR
• b. Both:
• i. Untreated LDL-C > 400 mg/dL
• AND
• ii. One of the following:
• • Xanthoma before 10 years of age
• • Familial hypercholesterolemia in at least one parent
• AND
• 2. Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe, LDL apheresis)
• AND
• 3. Not used in combination with another PCSK9 inhibitor [e.g., Repatha (evolocumab)]
• AND
• 4. Not used in combination with Juxtapid (lomitapide)
• AND
• 5. History of failure, contraindication, or intolerance to Repatha (evolocumab) (document date of trial and reason)
• Authorization will be issued for 12 months.

Approval duration

12 months