Anifrolumab-fnia (Saphnelo) (CPB 0997, reviewed 2026-06-05)

IMMEDIATE ACTION REQUIRED: (1) Before June 5, 2026, implement precertification workflow in billing system requiring authorization before Saphnelo (J0491) claims are submitted. Route all Saphnelo requests to (866) 752-7-021 or fax (888) 267-3277 per policy. (2) Update encounter forms and EMR templates to require rheumatologist or SLE specialist sign-off (NOT primary care providers). (3) Create claims denial protocol for: severe active lupus nephritis, severe CNS lupus, or concurrent biologic use—these are non-covered exclusions. (4) Ensure all supporting autoantibody testing (CPT 86038, 86039, 86146, 86147, 86148, 86160, 86161, 86162, 86225, 86235) is documented and attached to precertification requests. (5) Verify member is on concurrent standard SLE therapy (glucocorticoids, antimalarials, or immunosuppressants) before approval—claims without evidence of baseline therapy will be denied. (6) Train billing, authorization, and clinical staff that Saphnelo reauthorization requires documented clinical response (low disease activity or symptom improvement). (7) Update billing software to link J0491 to ICD-10 M32.x codes and flag claims without qualifying autoantibody labs for rejection. Failure to implement precertification will result in claim denials and member out-of-pocket liability.