Anifrolumab-fnia (Saphnelo™)

Anifrolumab‑fnia (Saphnelo) is covered for adults (≥18) with moderate-to-severe, autoantibody‑positive SLE (positive ANA, anti‑dsDNA, or anti‑Sm) who are on concurrent standard therapy (or have documented intolerance) when prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist; excluded are patients <18, autoantibody‑negative or mild SLE, monotherapy without documented intolerance, non‑FDA indications, or dosing outside the recommended 300 mg IV over 30 minutes every 4 weeks. Initial approval is up to 6 months (renewal 12 months) and renewals require documented clinical response (e.g., fewer flares, steroid dose reduction, improved anti‑dsDNA/complement or organ‑specific improvement).

"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."