Nexlizet — Highmark

Initial criteria

• age ≥ 18 years
• established ASCVD diagnosis (ICD-10: I25.1) including one of acute coronary syndrome, coronary or other arterial revascularization, history of myocardial infarction, history of stroke, history of transient ischemic attack, peripheral arterial disease presumed atherosclerotic, or stable/unstable angina OR prescriber attests member has high risk for cardiovascular disease
• current LDL-C ≥ 70 mg/dL OR current non-HDL-C ≥ 100 mg/dL OR meets very high-risk criteria (history of multiple major ASCVD events or one major ASCVD event and multiple high-risk conditions) with LDL-C ≥ 55 mg/dL or non-HDL-C ≥ 85 mg/dL OR <50% reduction in baseline LDL-C despite use with maximally tolerated statin therapy
• therapeutic failure to a maximally tolerated statin OR statin intolerance defined by one of the following: while receiving at least two separate trials of different statins, experienced statin-related rhabdomyolysis or skeletal-related muscle symptoms that resolved on discontinuation OR during any course of statin therapy had CK increase to 10× ULN, LFTs increase to 3× ULN, or hospitalization due to severe statin-related adverse event
• therapeutic failure, contraindication, or intolerance to ezetimibe

Reauthorization criteria

• member has experienced at least a 10% reduction in LDL-C from baseline

Approval duration

initial 6 months, reauthorization 12 months