Nexletol — Medica

primary hyperlipidemia

Initial criteria

Patient is ≥ 18 years of age
Patient meets ONE of the following (a or b):
a) Coronary artery calcium or calcification score ≥ 300 Agatston units; OR
b) Patient has diabetes
AND
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 [single-entity or combination])
(2) Patient has tried one high-intensity statin above along with ezetimibe (as single-entity or combination product) for ≥ 8 continuous weeks
(3) LDL-C level after this treatment regimen remains ≥ 70 mg/dL
OR
b) Patient has been determined to be statin intolerant by meeting ONE of the following [(1) or (2)]:
(1) Patient experienced statin-related rhabdomyolysis; OR
(2) Patient meets ALL of the following [(a), (b), and (c)]:
(a) Patient experienced skeletal-related muscle symptoms (e.g., myopathy or myalgia)
(b) The skeletal-related muscle symptoms occurred while receiving separate trials of both atorvastatin and rosuvastatin (as single-entity or combination products)
(c) The skeletal-related muscle symptoms resolved upon discontinuation of each respective statin therapy (atorvastatin and rosuvastatin)

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

1 year