Saphnelo™ (anifrolumab-fnia)

Covered for adults (≥18) with moderate-to-severe, autoantibody‑positive SLE receiving standard therapy (or with documented significant intolerance) when prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist; pediatric patients, autoantibody‑negative patients, and non‑SLE indications are excluded. Approval (up to 12 months) requires lab evidence of ANA/anti‑dsDNA/anti‑Sm positivity, documentation of concurrent standard therapy or intolerance, dosing per label (300 mg IV over 30 minutes every 4 weeks), and renewals require documented clinical response.

"Documentation of SLE diagnosis and characterization as moderate to severe."

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