Inclisiran Subcutaneous Injection (Leqvio®)

Inclisiran (Leqvio) is covered as an adjunct to diet and maximally tolerated statin therapy for adults (≥18) with clinical ASCVD or heterozygous familial hypercholesterolemia who need additional LDL‑C lowering; patients <18, those who do not meet the ASCVD/HeFH diagnostic thresholds, who have not completed required statin/ezetimibe therapy (unless meeting strict statin‑intolerance criteria), or whose LDL‑C is <70 mg/dL after the required regimen are not eligible. Approval requires documentation of diagnosis and age, prior high‑intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) and ≥8 weeks of high‑intensity statin+ezetimibe with post‑therapy LDL‑C ≥70 mg/dL (or detailed statin‑intolerance evidence such as rhabdomyolysis or resolved muscle symptoms on separate atorvastatin and rosuvastatin trials), prescription/consultation by a cardiologist/endocrinologist or lipid specialist, adherence to the 284 mg SC dosing schedule (0, 3 months, then every 6 months), and approvals are granted for 12 months.