Nexletol — Medical Mutual

Initial criteria

• Patient age ≥ 18 years
• Patient meets ONE of the following: untreated LDL-C level ≥ 190 mg/dL prior to therapy OR phenotypic confirmation of HeFH (e.g., pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1) OR diagnosis by Dutch score > 5 OR Simon Broome 'definite' or 'possible/probable' criteria
• Patient meets ONE of: (a) tried one high-intensity statin (atorvastatin ≥ 40 mg or rosuvastatin ≥ 20 mg daily single or combo) AND statin + ezetimibe for ≥ 8 weeks AND LDL-C remains ≥ 70 mg/dL OR (b) statin intolerant (statin-related rhabdomyolysis OR skeletal muscle symptoms occurred during trials of atorvastatin and rosuvastatin and resolved upon discontinuation)

Reauthorization criteria

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

Approval duration

1 year