Saphnelo (anifrolumab-fnia)

Covered: Saphnelo (anifrolumab‑fnia) is authorized for adults (≥18) with moderate-to-severe, autoantibody‑positive SLE who are receiving standard therapy (or have documented intolerance); it is not authorized for patients <18, those without the specified autoantibody positivity, or as monotherapy unless intolerance is documented. Key requirements: initial approval 6 months (renewal 12 months), prescribing by or consultation with a rheumatologist/clinical immunologist/nephrologist/neurologist/dermatologist, documentation of positive ANA/anti‑dsDNA/anti‑Sm, concurrent standard therapy (or significant toxicity intolerance), recommended dosing 300 mg IV every 4 weeks, and evidence of clinical response for reauthorization.

"FDA-approved: Saphnelo is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy."