Leqvio® (inclisiran subcutaneous injection)

Leqvio (inclisiran) is covered for adults ≥18 with hypercholesterolemia — including HeFH, primary hyperlipidemia (with diabetes or CAC ≥300), and established cardiovascular disease — when the policy’s specific diagnostic and LDL thresholds are met; patients who do not meet those criteria are excluded. Coverage requires documented age ≥18, the specified diagnostic/LDL thresholds (HeFH: untreated LDL‑C ≥190 mg/dL or genetic/clinical confirmation with on‑treatment LDL‑C ≥70 mg/dL; primary hyperlipidemia: diabetes or CAC ≥300 and on‑treatment LDL‑C ≥70 mg/dL; established CVD: on‑treatment LDL‑C ≥55 mg/dL), prior trial of high‑intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg for ≥8 weeks — plus ezetimibe for primary hyperlipidemia) unless meeting strict statin‑intolerance (rhabdomyolysis or qualifying muscle symptoms with both atorvastatin and rosuvastatin), documentation of labs/prior therapy, 12‑month approval with reauthorization requiring objective lipid response, and dosing at baseline, 3 months, then every 6 months.