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RepathaMedical Mutual

Homozygous Familial Hypercholesterolemia (HoFH)

Initial criteria

  • Patient age ≥ 10 years AND
  • Patient meets one of the following: (a) diagnosis confirmed by genetic testing OR (b) untreated LDL-C > 400 mg/dL AND clinical manifestations before age 10 OR parent with FH-level cholesterol OR (c) treated LDL-C ≥ 300 mg/dL AND clinical manifestations before age 10 OR parent with FH-level cholesterol AND
  • Patient meets one of the following: (a) Tried high-intensity statin (atorvastatin ≥ 40 mg daily OR rosuvastatin ≥ 20 mg daily) for ≥ 8 continuous weeks AND LDL-C remains ≥ 70 mg/dL OR (b) Statin intolerant via rhabdomyolysis OR meeting criteria of skeletal-related muscle symptoms with both atorvastatin and rosuvastatin that resolved on discontinuation

Reauthorization criteria

  • Prescriber confirms patient has experienced a response to therapy (e.g., reductions in LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B)

Approval duration

1 year