Subject: Benlysta 1764-A SGM P2024
Policy:
I. 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 Indications
Benlysta is indicated for the treatment of:
A. Patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are
receiving standard therapy.
B. 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 (CNS) lupus. Use of Benlysta is not recommended in this situation.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. 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)
B. Continuation requests: Medical records (e.g., chart notes, lab reports) documenting disease
stability or improvement.
III. EXCLUSIONS
Coverage will not be provided for members with any of the following exclusions:
A. 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.
B. Member is using Benlysta in combination with other biologics.
IV. CRITERIA FOR INITIAL APPROVAL
A. Systemic lupus erythematosus (SLE)
Authorization of 12 months may be granted for treatment of active SLE when all of the
following criteria are met:
1. 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)
2. The member is receiving a stable standard treatment for SLE with any of the following
(alone or in combination):
i. Glucocorticoids (e.g., prednisone, methylprednisolone, dexamethasone)
ii. Antimalarials (e.g., hydroxychloroquine)
iii. Immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate,
cyclosporine, cyclophosphamide)
iv. Nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen, naproxen)
B. Active lupus nephritis
Authorization of 12 months may be granted for the treatment of active lupus nephritis when
all of the following criteria are met:
1. 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.
2. Member is receiving a stable standard therapy regimen (e.g., cyclophosphamide,
mycophenolate mofetil, azathioprine, glucocorticoids).
V. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section IV 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:
- Benlysta [package insert]. Philadelphia, PA: GlaxoSmithKline LLC; February 2023.
- 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.
- 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.
- 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.
- 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.
- 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.
- Rovin BH, Adler SG, Barratt J, et al. Kidney Disease: Improving Global Outcomes (KDIGO) Lupus nephritis Work Group. KDIGO 2024 Clinical Practice Guideline for the Management of Lupus Nephritis. Kidney Int. 2024; 105(15):S1-S69.
- 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.
- Clinical Consult. CVS Caremark Clinical Programs Review: Focus on Rheumatology Clinical Programs. February 2022.
- 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 4, 2024.
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 27, 2024
