Leqvio® (inclisiran subcutaneous injection)

Leqvio (inclisiran) is covered for adults (≥18) with primary hyperlipidemia (including HeFH) or established cardiovascular disease and is not covered for pediatric patients or adults who do not meet the specified diagnostic/LDL thresholds. Approval requires documented diagnosis and labs, prior trial of a high‑intensity statin and a high‑intensity statin plus ezetimibe for ≥8 continuous weeks (or documented statin intolerance defined as rhabdomyolysis or muscle symptoms on separate trials of both atorvastatin and rosuvastatin), post‑therapy LDL‑C ≥70 mg/dL for HeFH/primary (≥55 mg/dL for established CVD), medication doses/durations, adherence to the 284 mg SC dosing schedule, 12‑month approval periods, and evidence of lipid response for reauthorization.

"Primary hyperlipidemia additional eligibility: must have diabetes OR CAC score ≥300 Agatston units (if using CAC as risk marker)."