Saphnelo™ (anifrolumab-fnia)

Covered: Saphnelo (anifrolumab‑fnia) is approved for adults (≥18) with moderate-to-severe, autoantibody‑positive SLE who are receiving standard therapy or have documented intolerance; it is not authorized for pediatric patients, seronegative SLE, or as monotherapy without documented intolerance. Key requirements: prescribing or consult by a rheumatologist/clinical immunologist/nephrologist/neurologist/dermatologist, documentation of diagnosis and positive ANA/anti‑dsDNA/anti‑Sm, evidence of concurrent standard therapy (or significant intolerance), recommended dosing 300 mg IV every 4 weeks, 12‑month approvals, and renewal only with documented clinical response.

"Saphnelo is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy."