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NexlizetMedica

Primary Hyperlipidemia

Initial criteria

  • Patient meets ALL of the following:
  • i. age ≥ 18 years; AND
  • ii. ONE of the following:
  • a) Coronary artery calcium or calcification score ≥ 300 Agatston units; OR
  • b) Patient has diabetes; AND
  • iii. ONE of the following:
  • a) BOTH of the following:
  • (1) Tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily as single-entity or combination); AND
  • (2) LDL-C level after this regimen remains ≥ 70 mg/dL; OR
  • b) Determined to be statin intolerant by meeting ONE of the following:
  • (1) Experienced statin-related rhabdomyolysis (CK ≥ 10× ULN with end organ damage or myoglobinuria); OR
  • (2) ALL of the following:
  • (a) Experienced skeletal-related muscle symptoms (e.g., myopathy, myalgia); AND
  • (b) Symptoms occurred while receiving separate trials of both atorvastatin and rosuvastatin; AND
  • (c) Symptoms resolved upon discontinuation of each statin.

Reauthorization criteria

  • Patient currently receiving Nexlizet. Approve if according to the prescriber the patient has experienced a response to therapy (e.g., decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels).
  • If the patient is restarting therapy or has not previously received approval, Initial Therapy criteria must be met.

Approval duration

1 year