Nexlizet — Medica

Established cardiovascular disease (ASCVD)

Initial criteria

Patient meets ONE of the following (A or B):
A) Initial Therapy. Approve if ALL of the following are met:
(1) Patient has tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily as a single-entity or combination product) for ≥ 8 continuous weeks; AND
(2) Low-density lipoprotein cholesterol (LDL-C) level after this therapy remains ≥ 55 mg/dL; OR
B) Patient has been determined to be statin intolerant by meeting ONE of the following:
(1) Patient experienced statin-related rhabdomyolysis (statin-induced muscle breakdown with creatine kinase levels ≥ 10× ULN and evidence of end organ damage such as acute renal injury or myoglobinuria); OR
(2) Patient meets ALL of the following:
(a) Experienced skeletal-related muscle symptoms (e.g., myopathy, myalgia); AND
(b) Symptoms occurred while receiving separate trials of both atorvastatin and rosuvastatin (single-entity or combination); AND
(c) Symptoms resolved upon discontinuation of each statin therapy.

Patient currently receiving Nexlizet. 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).
If the patient is restarting therapy or has not previously received approval, Initial Therapy criteria must be met.

1 year