Nexlizet — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years; AND
• Patient meets one of the following: untreated LDL-C level ≥ 190 mg/dL (prior to treatment); OR phenotypic confirmation of heterozygous familial hypercholesterolemia; OR diagnosis confirmed by Dutch Lipid Network criteria score > 5 OR Simon Broome criteria meeting 'definite' or 'possible (or probable)' familial hypercholesterolemia; AND
• Patient meets one of the following: has tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily; rosuvastatin ≥ 20 mg daily) for ≥ 8 weeks AND LDL-C level remains ≥ 70 mg/dL; OR has been determined to be statin intolerant by either (1) statin-related rhabdomyolysis OR (2) skeletal-related muscle symptoms occurred on both atorvastatin and rosuvastatin and resolved after discontinuation

Reauthorization criteria

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

Approval duration

1 year