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BETA v.3.0

2025 HCPCS code J0491

Injection, anifrolumab-fnia, 1 mg

Medically necessary for treatment of moderate to severe SLE in adults receiving standard therapy. Not medically necessary for severe active lupus nephritis, severe active central nervous system lupus, or in combination with other biologics or Benlysta.

In simple words: This code represents 1 mg of Saphnelo (anifrolumab-fnia), a medicine given through a vein by IV drip to treat lupus in adults.

Anifrolumab-fnia is a monoclonal antibody administered via intravenous infusion, typically used to treat moderate to severe systemic lupus erythematosus (SLE) in adults. The standard dosage is 300 mg supplied in a single-dose vial (300 mg/2 mL). This code is reported for each 1 mg of anifrolumab-fnia.

Example 1: A 45-year-old female with moderate to severe SLE, receiving standard therapy, receives a 300 mg dose of anifrolumab-fnia via IV infusion. 300 units of J0491 are reported., A patient with SLE experiences a missed dose of Saphnelo. The provider reschedules the infusion ensuring a minimum of 14 days between infusions., A patient with SLE receives a partial dose of Saphnelo due to an adverse reaction. The provider documents the administered amount and may use modifier JW to indicate wasted medication.

Documentation should include diagnosis of moderate to severe SLE, use of standard therapy, dosage administered, and any adverse reactions or missed doses.

** Brand name: Saphnelo. Check with individual payers for coverage policies. Modifier JW may be applicable for discarded medication. This code represents the drug supply. Administration may be reported separately.

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