Nexlizet (bempedoic acid/ezetimibe) — Point32Health
management of clinical atherosclerotic cardiovascular disease (ASCVD) or high risk for cardiovascular disease event
Initial criteria
- For ASCVD or high risk for CVD event: one of the following: (a) patient has a history of clinical ASCVD or cardiovascular event, OR (b) patient is at high risk for CVD event defined by Reynolds Risk score > 30%, coronary artery calcium score > 400 AU, or Type 1 or Type 2 diabetes
- AND one of the following: (a) for ASCVD patients, current LDL-C ≥ 55 mg/dL while on maximally tolerated statin therapy in combination with ezetimibe (unless contraindicated or intolerant), OR (b) for high-risk patients, current LDL-C ≥ 70 mg/dL while on maximally tolerated statin therapy in combination with ezetimibe (unless contraindicated or intolerant)
- AND one of the following: (a) contraindication to statin therapy (e.g., rhabdomyolysis or allergic reaction), OR (b) statin intolerant to at least two statins, OR (c) currently on maximally tolerated statin
- AND one of the following: (a) currently on ezetimibe, OR (b) history of contraindication or intolerance to ezetimibe
- For primary or familial hyperlipidemia: documented diagnosis of primary or familial hyperlipidemia
- AND current LDL-C ≥ 70 mg/dL while on maximally tolerated statin therapy in combination with ezetimibe (unless contraindicated or intolerant to each)
- AND one of the following: (a) contraindication to statin therapy, OR (b) statin intolerance to at least two statins, OR (c) on maximally tolerated statin
- AND one of the following: (a) currently on ezetimibe, OR (b) contraindication or intolerance to ezetimibe
Reauthorization criteria
- Positive response to therapy confirmed by a reduction in LDL-C from baseline
Approval duration
12 months initial, 12 months renewal