Service Line: Rheumatology

• Formulary location: Ambulatory, Outpatient Infusion
• Patient Population: Adults
• Service Location: Outpatient infusion center, Home Infusion
• Prior Authorization Required: yes
• Criteria of Use/Restriction, all apply unless specified:
  • Adults age ≥ 18 years diagnosed with active moderate to severe SLE
  • Patient is receiving standard-of-care therapy with at least one of the following: prednisone (or equivalent), hydroxychloroquine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate
  • Patient does not have severe active central nervous system (CNS) lupus, active lupus nephritis, or active severe SLE-driven renal disease
  • Patient has tried/failed therapy with Benlysta or has an intolerance or contraindications to therapy with Benlysta for active, autoantibody positive SLE
  • Patient is not using Saphnelo concurrently with Benlysta
  • No hepatitis B/hepatitis C infection or known history of any underlying condition that predisposes the patient to infection 
  • No prior severe herpes infection at any time prior to administration
    • Herpes zoster vaccination recommended
  • No history of cancer, apart from: Squamous or basal cell carcinoma of the skin that has been successfully treated and cervical cancer in situ that has been successfully treated
  • Negative TB result within 12 months (on either chest radiograph or by QuantiFERON gold test)
  • Women of child-bearing potential should have a negative urine pregnancy test prior to initiation of therapy and are advised to avoid / prevent pregnancy during therapy with anifrolumab   

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