Subject: Benlysta SGM 1764-A P2025

Drug

BENLYSTA  (belimumab)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications¹

Benlysta is indicated for the treatment of:

• Patients 5 years of age and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy
• Patients 5 years of age 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 (CNS) lupus. Use of Benlysta is not recommended in this situation.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Initial requests

• Medical records (e.g., chart notes, lab reports) documenting the presence of autoantibodies relevant to SLE (e.g., ANA, anti-ds DNA, anti-Sm, antiphospholipid antibodies, complement proteins), or kidney biopsy supporting the diagnosis (where applicable)

Continuation requests

• Medical records (e.g., chart notes, lab reports) documenting disease stability or improvement.

Exclusions

Coverage will not be provided for members with any of the following exclusions:

• Severe active central nervous system (CNS) lupus (including seizures that are attributed to CNS lupus, psychosis, organic brain syndrome, cerebritis, or CNS vasculitis requiring therapeutic intervention before initiation of belimumab) in a member initiating therapy with Benlysta.
• Member is using Benlysta in combination with other biologics.

Coverage Criteria

Systemic Lupus Erythematosus (SLE)^1-4,6,8

Authorization of 12 months may be granted for treatment of active SLE when both of the following criteria are met:

• Prior to initiating therapy, the member is positive for autoantibodies relevant to SLE (e.g., ANA, anti-ds DNA, anti-Sm, antiphospholipid antibodies, complement proteins)
• The member is receiving a standard treatment for SLE with any of the following (alone or in combination):
  • Glucocorticoids (e.g., prednisone, methylprednisolone, dexamethasone)
  • Antimalarials (e.g., hydroxychloroquine)
  • Immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide)

Active Lupus Nephritis^1,4-5,7-8

Authorization of 12 months may be granted for treatment of active lupus nephritis when both of the following criteria are met:

• Prior to initiating therapy, the member is positive for autoantibodies relevant to SLE (e.g., ANA, anti-ds DNA, anti-Sm, antiphospholipid antibodies, complement proteins) or lupus nephritis was confirmed on kidney biopsy.
• Member is receiving a standard therapy regimen (e.g., cyclophosphamide, mycophenolate mofetil, azathioprine, glucocorticoids).

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Benlysta [package insert]. Philadelphia, PA: GlaxoSmithKline LLC; June 2024.
2. Fanouriakis A, Kostopoulou M, Alunno A, et al. 2023 Update of the EULAR Recommendations for the Management of Systemic Lupus Erythematosus. Ann Rheum Dis. 2024;83:15-29.
3. Rovin BH, Parikh SV, Hebert LA, et al. Lupus nephritis: induction therapy in severe lupus nephritis – should MMF be considered the drug of choice? Clin J Am Soc Nephrol. 2013;8(1):147-153.
4. Hahn BH, McMahon MA, Wilkinson A, et al. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care & Research. 2012;64(6):797-808.
5. Furie R, Rovin BH, Houssiau F, et al. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020;383(12):1117-1128.
6. Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis. 2019;78:1151-1159.
7. Rovin BH, Adler SG, Barratt J, et al. Kidney Disease: Improving Global Outcomes (KDIGO) Golmerular Disease Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct; 100(4S):S1-S276.
8. Gordon C, Amissah-Arthru MB, Gayed M, et al. The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults. Rheumatology (Oxford). 2018; 57(1):e1-e45.
9. Petri M, Orbai A-M, Alarcon GS, et al. Derivation and Validation of Systemic Lupus International Collaborating Clinics (SLICC) Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheum. 2012; 64:2677-2686. URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3409311/. Accessed January 21, 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 22, 2025