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PraluentCigna

Homozygous Familial Hypercholesterolemia (HoFH)

Initial criteria

  • Patient age ≥ 18 years; AND
  • Diagnosis confirmed by genetic testing (LDLR, APOB, PCSK9, or LDLRAP1 variants); OR untreated LDL-C > 400 mg/dL AND either (1) clinical manifestations before age 10 years OR (2) at least one parent with untreated LDL-C ≥ 190 mg/dL or total cholesterol > 250 mg/dL; OR treated LDL-C ≥ 300 mg/dL AND either (1) clinical manifestations before age 10 years OR (2) at least one parent with untreated LDL-C ≥ 190 mg/dL or total cholesterol > 250 mg/dL; AND
  • Patient meets ONE of the following (a or b): a) BOTH of the following [(1) and (2)]: (1) tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily) for ≥ 8 continuous weeks; AND (2) LDL-C after treatment remains ≥ 70 mg/dL; OR b) patient determined statin intolerant by having statin-related rhabdomyolysis OR skeletal muscle symptoms with both atorvastatin and rosuvastatin trials resolving upon discontinuation.

Reauthorization criteria

  • Patient currently receiving Praluent and, according to the prescriber, has experienced a response to therapy (e.g., decrease in LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels).

Approval duration

1 year