Nexletol — Cigna

Heterozygous Familial Hypercholesterolemia (HeFH)

Initial criteria

Patient meets ALL of the following (i, ii, and iii):
i. Patient is ≥ 18 years of age; AND
ii. Patient meets ONE of the following (a, b, or c): (a) Untreated LDL-C level ≥ 190 mg/dL (prior to treatment with antihyperlipidemic agents); OR (b) Diagnosis confirmed by genetic testing (e.g., pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes); OR (c) Diagnosed with HeFH by ONE of the following: (1) Dutch Lipid Network criteria score > 5; OR (2) Simon Broome criteria meeting 'definite' or 'possible/probable' familial hypercholesterolemia; AND
iii. Patient meets ONE of the following (a or b):
a) Patient meets ALL of the following [(1), (2), and (3)]: (1) Patient has tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily; rosuvastatin ≥ 20 mg daily as single-entity or combination product); AND (2) Patient has tried the high-intensity statin above plus ezetimibe (as single-entity or combination) for ≥ 8 continuous weeks; AND (3) LDL-C after regimen remains ≥ 70 mg/dL; OR
b) Patient determined to be statin intolerant by ONE of the following [(1) or (2)]: (1) Statin-related rhabdomyolysis; OR (2) Patient meets ALL of the following [(a), (b), and (c)]: (a) Skeletal-related muscle symptoms; AND (b) Occurred while receiving separate trials of atorvastatin and rosuvastatin (single-entity or combination); AND (c) Symptoms resolved upon discontinuation of each statin therapy.

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

1 year