Anifrolumab-fnia (Saphnelo™)

Saphnelo (anifrolumab‑fnia) is covered only for adults (≥18) with moderate-to-severe, autoantibody‑positive SLE as an addition to standard therapy (or for patients intolerant to standard therapy); patients <18, autoantibody‑negative individuals, monotherapy without documented intolerance, and uses outside the FDA‑approved indication are excluded. Initial approval is 300 mg IV every 4 weeks for 6 months (renewal 12 months) when prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist, with documentation of positive ANA/anti‑dsDNA/anti‑Sm, concurrent standard therapy (or intolerance), infusion records, and—for reauthorization—objective clinical response (e.g., fewer flares, reduced steroid dose, decreased anti‑dsDNA or improved C3/C4 or organ function).

"Treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy."