Subject: Benlysta 1764-A SGM P2023
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 within 60 days 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. 2019 Update of the EULAR Recommendations for the Management of Systemic Lupus Erythematosus. Ann Rheum Dis. 2019;78:736-745.
- 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) Golmerular Disease Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct; 100(4S):S1-S276.
- 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.
- 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 March 22, 2023.
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.
June 18, 2023
