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NexlizetCigna

Heterozygous Familial Hypercholesterolemia (HeFH)

Initial criteria

  • Patient is ≥ 18 years of age; AND
  • Diagnosis confirmed by ONE of: a) untreated LDL-C ≥ 190 mg/dL prior to therapy; OR b) confirmed by genetic testing (pathogenic variant in LDLR, APOB, PCSK9, or LDLRAP1); OR c) meets diagnostic criteria thresholds: (1) Dutch Lipid Network score > 5; OR (2) Simon Broome criteria 'definite' or 'possible/probable' familial hypercholesterolemia; AND
  • Patient meets ONE of the following (a or b): a) BOTH (1) tried one high-intensity statin (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily as single-entity or combination) for ≥ 8 continuous weeks AND (2) LDL-C remains ≥ 70 mg/dL; OR b) statin intolerant defined as ONE of: (1) statin-related rhabdomyolysis; OR (2) ALL of: (a) skeletal-related muscle symptoms (myopathy or myalgia); AND (b) symptoms occurred with separate trials of both atorvastatin and rosuvastatin (single-entity or combo); AND (c) symptoms resolved upon discontinuation of each statin)

Reauthorization criteria

  • Patient currently receiving Nexlizet AND prescriber confirms a response to therapy (e.g., decreased LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels)

Approval duration

1 year