Subject: Benlysta 1764-A SGM P2022
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, autoantibody-
positive, systemic lupus erythematosus (SLE) who are
receiving standard therapy.
B. Adult patients 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. Benlysta has not
been studied in combination with other biologics. Use of
Benlysta is not recommended in these situations.
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, cerebrovascular accident, 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)
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 has clinically active lupus renal disease and is
receiving a stable standard induction and maintenance
treatment for lupus nephritis (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; March 2021.
- 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.
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 26, 2022
