Praluent — Medical Mutual

Initial criteria

• Patient age ≥ 18 years; AND
• Diagnosis of HoFH confirmed by ONE of: (a) Genetic testing confirming pathogenic variants (LDLR, APOB, PCSK9, LDLRAP1); OR (b) Untreated LDL-C > 400 mg/dL with onset of clinical manifestations before age 10 OR at least one parent with LDL-C or cholesterol consistent with FH; OR (c) Treated LDL-C ≥ 300 mg/dL plus clinical manifestations before age 10 OR parental untreated cholesterol consistent with FH; AND
• Patient meets one of: (a) Tried high-intensity statin (atorvastatin ≥ 40 mg daily OR rosuvastatin ≥ 20 mg daily) for ≥ 8 weeks AND LDL-C remains ≥ 70 mg/dL; OR (b) Statin intolerance (rhabdomyolysis OR muscle symptoms occurring with atorvastatin and rosuvastatin separately, resolving upon discontinuation)

Reauthorization criteria

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

Approval duration

1 year