Repatha® (evolocumab)

Repatha (evolocumab) is covered only for FDA‑approved indications—reducing major adverse CV events in adults with established CVD, treating primary hyperlipidemia in adults, and treating HeFH/HoFH in patients ≥10 years (adult indications ≥18 years)—and is not covered for patients who do not meet the policy’s age, diagnostic, LDL‑C, prior‑therapy, or statin‑intolerance criteria. Key requirements include documented age/diagnosis and LDL‑C thresholds (established CVD ≥55 mg/dL post high‑intensity statin; HeFH untreated ≥190 mg/dL or ≥70 mg/dL post‑statin; HoFH untreated >400 mg/dL or treated ≥300 mg/dL with genetic/clinical confirmation; primary hyperlipidemia ≥70 mg/dL after ≥8 weeks high‑intensity statin plus ezetimibe), an ≥8‑week trial of high‑intensity statin (or defined statin‑intolerance), 12‑month approvals with reauthorization contingent on documented lipid response, and adherence to specified dosing/apheresis timing.

"To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with est..."