Praluent — Medical Mutual

Initial criteria

• Patient age ≥ 8 years; AND
• Diagnosis of HeFH confirmed by one of: untreated LDL-C ≥ 190 mg/dL prior to therapy OR genetic testing with pathogenic variants (LDLR, APOB, PCSK9, LDLRAP1) OR diagnostic criteria: Dutch Lipid Network criteria score > 5 OR Simon Broome criteria 'definite' or 'possible'; AND
• Patient meets one of the following: (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) Documented statin intolerance (rhabdomyolysis OR muscle symptoms on separate trials of atorvastatin and rosuvastatin 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