Inclisiran

This policy covers inclisiran (Leqvio®) for LDL‑lowering in adults with heterozygous or homozygous familial hypercholesterolemia (FH) or primary hyperlipidemia at high cardiovascular risk. Coverage requires LDL‑C ≥70 mg/dL despite maximally tolerated statin therapy (statins to be continued if not contraindicated), prohibits concurrent use with other PCSK9 therapies, and is limited to FDA‑approved or HHS‑compendium/peer‑review‑supported off‑label uses and is subject to the member’s benefit plan and state regulations.

"Coverage of FDA-approved prescription drugs when prescribed for an off-label use recognized as safe and effective in one or more standard medical reference compendia adopted by the U."

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