Inclisiran Injection, for Subcutaneous Use (Leqvio®) HCPCS Code J3490: Billing Guidelines

Effective with date of service Dec. 22, 2021, Medicaid and NC Health Choice cover inclisiran injection, for subcutaneous use (Leqvio®).

Effective with date of service Dec. 22, 2021, the Medicaid and NC Health Choice programs cover inclisiran injection, for subcutaneous use (Leqvio®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified Drugs.

Strength/Package Size: Injection: 284 mg/1.5 mL (189 mg/mL) in a single-dose prefilled syringe.

Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Limitations of Use: the effect of Leqvio® on cardiovascular morbidity and mortality has not been determined.

Recommended Dose: The recommended dosage, in combination with maximally tolerated statin therapy, is 284 mg administered as a single subcutaneous injection initially, again at three months, and then every six months. See full prescribing information for further detail.

The ICD-10-CM diagnosis codes required for billing are available in a PDF version of this bulletin.

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