Repatha — Cigna

Initial criteria

• For HeFH: Patient age ≥ 10 years AND (untreated LDL-C ≥ 190 mg/dL OR genetic confirmation of pathogenic variant in LDLR, APOB, PCSK9, or LDLRAP1 gene OR diagnosis confirmed by Dutch Lipid Network criteria score > 5 OR Simon Broome criteria threshold for definite/possible FH) AND (tried one high-intensity statin therapy [atorvastatin ≥ 40 mg daily OR rosuvastatin ≥ 20 mg daily] for ≥ 8 weeks with LDL-C remaining ≥ 70 mg/dL OR statin intolerance demonstrated by rhabdomyolysis OR muscle symptoms during and resolved after both atorvastatin and rosuvastatin).
• For HoFH: Patient age ≥ 10 years AND (genetic confirmation of pathogenic variant in LDLR, APOB, PCSK9, or LDLRAP1 gene OR untreated LDL-C > 400 mg/dL with either clinical manifestations of HoFH before age 10 OR one parent with untreated LDL-C or total cholesterol consistent with FH OR treated LDL-C ≥ 300 mg/dL with either clinical manifestations of HoFH before age 10 OR one parent with untreated LDL-C or total cholesterol consistent with FH) AND (tried one high-intensity statin therapy [atorvastatin ≥ 40 mg daily OR rosuvastatin ≥ 20 mg daily] for ≥ 8 weeks with LDL-C remaining ≥ 70 mg/dL OR statin intolerance demonstrated by rhabdomyolysis OR muscle symptoms during and resolved after both atorvastatin and rosuvastatin).
• For Primary Hyperlipidemia: Patient age ≥ 18 years AND (coronary artery calcium score ≥ 300 Agatston units OR patient has diabetes) AND (tried one high-intensity statin [atorvastatin ≥ 40 mg daily OR rosuvastatin ≥ 20 mg daily] plus ezetimibe for ≥ 8 weeks with LDL-C remaining ≥ 70 mg/dL OR statin intolerance demonstrated by rhabdomyolysis OR muscle symptoms during and resolved after both atorvastatin and rosuvastatin).
• For Established Cardiovascular Disease: Patient has ASCVD AND (tried one high-intensity statin for ≥ 8 weeks with LDL-C remaining ≥ 55 mg/dL OR statin intolerance demonstrated by rhabdomyolysis OR muscle symptoms during and resolved after both atorvastatin and rosuvastatin).

Reauthorization criteria

• Patient currently receiving Repatha AND per prescriber has experienced response to therapy (decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels). If restarting or not previously approved for specific indication, must meet initial criteria.

Approval duration

1 year