Pharmacy Prior Authorization Criteria

Benlysta (belimumab)

Indications for Prior Authorization

Benlysta (belimumab IV), Benlysta (belimumab SC)

• For diagnosis of Systemic Lupus Erythematosus (SLE)
  Indicated for the treatment of patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy.

  Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Use of Benlysta is not recommended in these situations.

• For diagnosis of Lupus Nephritis
  Indicated for the treatment of patients aged 5 years and older with active lupus nephritis who are receiving standard therapy.

  Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Use of Benlysta is not recommended in these situations.

Criteria

Benlysta SC prefilled syringe

Prior Authorization (Initial Authorization)

Length of Approval: 6 months [A]
For diagnosis of Systemic lupus erythematosus

• Diagnosis of active systemic lupus erythematosus (SLE)
AND
• Autoantibody positive (i.e., anti-nuclear antibody [ANA] titer greater than or equal to 1:80 or anti-dsDNA level greater than or equal to 30 IU/mL) [2, 3]
AND
• Patient is 18 years of age or older
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)]) [5]
AND
• Currently receiving at least one standard of care treatment for active SLE (e.g., antimalarials [e.g., Plaquenil (hydroxychloroquine)], corticosteroids [e.g., prednisone], or immunosuppressants [e.g., methotrexate, Imuran (azathioprine)]) [2, 3]
AND
• Prescribed by or in consultation with a rheumatologist

Benlysta IV or Benlysta SC autoinjector

Prior Authorization (Initial Authorization)

Length of Approval: 6 months [A]
For diagnosis of Systemic lupus erythematosus

• Diagnosis of active systemic lupus erythematosus (SLE)
AND
• Autoantibody positive (i.e., anti-nuclear antibody [ANA] titer greater than or equal to 1:80 or anti-dsDNA level greater than or equal to 30 IU/mL) [2, 3]
AND
• Patient is 5 years of age or older
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)]) [5]
AND
• Currently receiving at least one standard of care treatment for active SLE (e.g., antimalarials [e.g., Plaquenil (hydroxychloroquine)], corticosteroids [e.g., prednisone], or immunosuppressants [e.g., methotrexate, Imuran (azathioprine)]) [2, 3]
AND
• Prescribed by or in consultation with a rheumatologist

Benlysta IV or Benlysta SC

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Lupus nephritis

• Diagnosis of active lupus nephritis
AND
• One of the following:
• For Benlysta IV, patient is 5 years of age or older
• For Benlysta SC, patient is 18 years of age or older
AND
• Currently receiving standard of care treatment for active lupus nephritis (e.g., corticosteroids [e.g., prednisone] with mycophenolate or cyclophosphamide) [1, 4]
AND
• Prescribed by or in consultation with one of the following:
• Nephrologist
• Rheumatologist

Benlysta IV or Benlysta SC

Prior Authorization (Reauthorization)

Length of Approval: 6 months [2, A]
For diagnosis of All indications listed above

• 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)

P & T Revisions

2024-08-12, 2023-09-29, 2023-08-02, 2023-03-31, 2022-08-31, 2022-08-30, 2022-08-04, 2021-12-01, 2021-07-26, 2021-02-03, 2020-07-14, 2019-09-16

References

1. Benlysta Prescribing Information. GlaxoSmithKline LLC. Philadelphia, PA. June 2024.
2. Per clinical consult with rheumatologist, October 4, 2017.
3. 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.
4. American College of Rheumatology Guidelines for Screening, Case Definition, Treatment and Management of Lupus Nephritis. Arthritis Care Res (Hoboken). 2012 Jun; 64(6): 797-808.
5. Fanouriakis A, Kostopoulou M, Alunno A, et al. Ann Rheum Dis 2019;78:736–745.

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Revision History

• 2024-08-12: Annual review: Updated systemic lupus erythematosus criteria for subcutaneous formulation based on age requirement. Removed non-formulary criteria.
• 2023-09-29: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-08-02: Annual review: Background updates.
• 2023-03-31: Update to age criteria
• 2022-08-31: Updated criteria
• 2022-08-30: Updated criteria (reauthorization).
• 2022-08-04: Annual review: Updated criteria.
• 2021-12-01: Added EHB formulary and NF criteria for the IV formulation.
• 2021-07-26: 2021 Annual Review: updated reference; no criteria changes.
• 2021-02-03: Added criteria for new indication of lupus nephritis.
• 2020-07-14: 2020 Annual Review: removed reference to drug name in reauth criteria; updated references. No changes to clinical criteria.
• 2019-09-16: Annual Review Oct P&T

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