Nexlizet — Medica
Primary Hyperlipidemia
Initial criteria
- Patient meets ALL of the following:
- i. age ≥ 18 years; AND
- ii. ONE of the following:
- a) Coronary artery calcium or calcification score ≥ 300 Agatston units; OR
- b) Patient has diabetes; AND
- iii. ONE of the following:
- a) BOTH of the following:
- (1) Tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily as single-entity or combination); AND
- (2) LDL-C level after this regimen remains ≥ 70 mg/dL; OR
- b) Determined to be statin intolerant by meeting ONE of the following:
- (1) Experienced statin-related rhabdomyolysis (CK ≥ 10× ULN with end organ damage or myoglobinuria); OR
- (2) 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; AND
- (c) Symptoms resolved upon discontinuation of each statin.
Reauthorization criteria
- 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.
Approval duration
1 year