Leqvio® (inclisiran subcutaneous injection)

Leqvio (inclisiran) is covered for adults (≥18) as adjunct to diet and statin therapy for primary hyperlipidemia (including HeFH) and for compendial use in established cardiovascular disease, but not for patients who do not meet the policy criteria or are under 18; it may be used without concomitant statin only if validated statin intolerance is documented. Key requirements include documentation of diagnosis (HeFH genetic/diagnostic criteria or untreated LDL‑C ≥190 mg/dL; for primary hyperlipidemia, diabetes or CAC ≥300 Agatston units; for CVD, prior MI/ACS, angina, stroke/TIA, PAD or revascularization), prior trial of a high‑intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) plus high‑intensity statin + ezetimibe for ≥8 continuous weeks or validated statin intolerance (rhabdomyolysis with CK ≥10× ULN and end‑organ damage or muscle symptoms with separate trials of both atorvastatin and rosuvastatin that resolved on discontinuation), LDL‑C thresholds after prior therapy (≥70 mg/dL for HeFH/primary, ≥55 mg/dL for CVD), dosing per label (284 mg SC: baseline, 3 months, then q6 months), 12‑month approvals, and reauthorization requiring evidence of lipid response.