Nexletol — Cigna

Initial criteria

• Patient meets ALL of the following (i, ii, and iii):
• i. Patient is ≥ 18 years of age; AND
• ii. Patient has a history of atherosclerotic cardiovascular disease (ASCVD) defined by at least one of the following: myocardial infarction, stroke, symptomatic peripheral arterial disease, or history of coronary revascularization (coronary artery bypass graft surgery, percutaneous coronary intervention, angioplasty, or coronary stent procedure); 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 a single entity or as combination product); AND (2) Patient has tried one high-intensity statin above along with ezetimibe (as single-entity or combination product) for ≥ 8 continuous weeks; AND (3) Low-density lipoprotein cholesterol level after this regimen remains ≥ 55 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; AND (b) The skeletal-muscle related symptoms occurred while receiving separate trials of both atorvastatin and rosuvastatin (as single-entity or combination products); AND (c) When receiving separate trials of both atorvastatin and rosuvastatin, the skeletal-related muscle symptoms resolved upon discontinuation of each respective statin therapy.

Reauthorization criteria

• 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).

Approval duration

1 year