Inclisiran Subcutaneous Injection (Leqvio®)

Leqvio (inclisiran) is covered for adults (≥18) as an adjunct to diet and maximally tolerated statin therapy to lower LDL‑C in clinical ASCVD or heterozygous familial hypercholesterolemia (use in <18 is excluded). Approval requires documentation of ASCVD or HeFH (genetic or validated clinical criteria), either a trial of high‑intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) plus ≥8 weeks of high‑intensity statin + ezetimibe with post‑treatment LDL‑C ≥70 mg/dL — or documented statin intolerance limited to rhabdomyolysis or muscle symptoms on separate atorvastatin and rosuvastatin trials that resolved on discontinuation — plus prescription by/consult with a cardiologist/endocrinologist/lipid specialist; dosing is 284 mg SC at 0, 3 months, then every 6 months, and approvals are limited to 12 months.

"HeFH qualifying diagnostic criteria (one of): Dutch Lipid Network criteria score > 5"