Repatha — Medica

Initial criteria

• age ≥ 10 years
• ONE of the following: (a) diagnosis confirmed by genetic testing (LDLR, APOB, PCSK9, LDLRAP1) OR (b) untreated LDL-C > 400 mg/dL AND ONE of the following: clinical manifestations of HoFH before 10 years of age OR at least one parent had untreated LDL-C ≥ 190 mg/dL or total cholesterol > 250 mg/dL OR (c) treated LDL-C ≥ 300 mg/dL AND ONE of the following: clinical manifestations of HoFH before 10 years of age OR at least one parent had untreated LDL-C ≥ 190 mg/dL or total cholesterol > 250 mg/dL
• AND ONE of the following: (a) tried one high-intensity statin (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily as single-entity or combination) for ≥ 8 continuous weeks AND LDL-C after treatment remains ≥ 70 mg/dL OR (b) statin intolerant by either (1) rhabdomyolysis or (2) skeletal-related muscle symptoms occurring with both atorvastatin and rosuvastatin that resolved upon discontinuation

Reauthorization criteria

• Patient currently receiving Repatha and prescriber confirms response to therapy, such as decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels

Approval duration

1 year