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Nexlizet — United Healthcare

Primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)

Preferred products

  • atorvastatin
  • rosuvastatin
  • simvastatin
  • pravastatin
  • lovastatin
  • fluvastatin
  • Livalo
  • ezetimibe

Initial criteria

  • Diagnosis of ONE of the following: (a) Primary hyperlipidemia, including HeFH OR (b) Established CVD as documented by coronary artery disease OR symptomatic peripheral arterial disease OR cerebrovascular atherosclerotic disease OR (c) High risk for CVD as documented by diabetes and age ≥ 60 years OR Reynolds risk score > 30% OR coronary artery calcium score > 400 Agatston units OR ASCVD risk score ≥ 20% using ACC/AHA estimator
  • AND ONE of the following statin use conditions: (a) Receiving ≥ 12 consecutive weeks of high-intensity statin therapy [atorvastatin 40–80 mg, rosuvastatin 20–40 mg] and will continue at maximally tolerated dose OR (b) BOTH: (i) Unable to tolerate high-intensity statin due to persistent (> 2 weeks) myalgia or myositis (CK < 10 × ULN), AND (ii) Receiving ≥ 12 consecutive weeks of low- or moderate-intensity statin [atorvastatin 10–20 mg, rosuvastatin 5–10 mg, simvastatin ≥ 10 mg, pravastatin ≥ 10 mg, lovastatin 20–40 mg, fluvastatin ER 80 mg, fluvastatin 20–40 mg up to 40 mg BID, or pitavastatin ≥ 1 mg] and will continue at maximally tolerated dose OR (c) Unable to tolerate low, moderate, and high-intensity statins due to (i) persistent (> 2 weeks) myalgia or myositis (CK < 10 × ULN) OR (ii) labeled contraindication to all statins OR (iii) history of rhabdomyolysis or muscle symptoms with CK > 10 × ULN
  • AND ONE of the following LDL-C criteria: (a) LDL-C ≥ 100 mg/dL with ASCVD OR ≥ 130 mg/dL without ASCVD WHILE on maximally tolerated lipid lowering therapy ≥ 12 weeks within last 120 days OR (b) BOTH: (i) LDL-C 55–99 mg/dL with ASCVD OR 100–129 mg/dL without ASCVD while on maximally tolerated lipid lowering therapy ≥ 12 weeks within last 120 days, AND (ii) Evidence of ≥ 12 consecutive weeks of ezetimibe (Zetia) therapy adjunct to maximally tolerated statin OR contraindication/intolerance to ezetimibe

Reauthorization criteria

  • Documentation of a positive clinical response to therapy
  • Patient continues to receive statin at maximally tolerated dose unless documented inability to take statins

Approval duration

12 months