Pharmacy Prior Authorization Criteria

Saphnelo (anifrolumab-fnia)

For diagnosis of Systemic Lupus Erythematosus (SLE)
Indicated for the treatment of adult patients with moderate to severe SLE, who are receiving standard therapy.
Limitations of Use: The efficacy of Saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of Saphnelo is not recommended in these situations.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A]

AND

Trial and failure, contraindication, or intolerance to two standard of care treatments for active SLE (e.g., antimalarials [e.g., Plaquenil (hydroxychloroquine)], corticosteroids [e.g., prednisone], or immunosuppressants [e.g., methotrexate, Imuran (azathioprine)]) [4]

AND

Currently receiving standard of care treatment for SLE (e.g., antimalarials [e.g., Plaquenil (hydroxychloroquine)], corticosteroids [e.g., prednisone], or immunosuppressants [e.g., methotrexate, Imuran (azathioprine)]) [1-3]

AND

Prior Authorization (Reauthorization)

Length of Approval: 6 Months [A]

Patient demonstrates positive clinical response to therapy (e.g., decrease or stabilization of symptoms, improvement in functional impairment, decrease of corticosteroid dose, decrease in pain medications)

2024-10-18, 2023-10-04, 2022-10-05, 2021-10-06

Saphnelo Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. August 2024.
Per clinical consult with rheumatologist, October 4, 2017.
American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Guidelines for referral and management of systemic lupus erythematosus. Arthritis Rheum. 1999 Sep;42(9):1785-96.
Fanouriakis A, Kostopoulou M, Alunno A, et al. Ann Rheum Dis 2019;78:736–745.
Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024 Jan 2;83(1):15-29.

SLE is a disease that fluctuates. The undulating course of typical lupus patients requires frequent reassessment. A 6-month authorization period is reasonable. [2]

2024-10-18: 2024 Annual Review. Updated reauthorization language from "Documentation of" to "Patient Demonstrates". Updated references.
2023-10-04: Annual review: No updates required.
2022-10-05: Annual review: Updated criteria and background.
2021-10-06: New program