Coverage Policies

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INDEX:



Effective Date: 01/01/2012	Title: Benlysta (Belimumab)
Revision Date: 02/01/2021	Document: BI336:00
CPT Code(s): J0490
Public Statement
*Effective Date:* a) This policy will apply to all services performed on or after the above revision date which will become the new effective date. b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply. 1. Benlysta (Belimumab) requires prior authorization. 2. Benlysta is used to treat a type of active systemic lupus erythematosus (SLE). 3. Benlysta is not covered for more serious types of lupus affecting the central nervous system.
Medical Statement
Benlysta (Belimumab) is considered medically necessary (for those plans in which it is covered) for members meeting the following conditions: 1) Member is age 5 years or older AND 2) Member has a diagnosis of active systemic lupus erythematosus (SLE) based on ACR criteria or active lupus nephritis AND 3) Member has a positive autoantibody test (e.g. anti-nuclear antibody [ANA] greater than or equal to 1:80 and/or anti-double-stranded DNA [anti-dsDNA] greater than or equal to 30 IU/ml) AND 4) Member has at least one of the following 3 baseline measurement scores: SELENA-SLEDAI, British Isles Lupus Assessment Group (BILAG) scores, or Physician’s Global Assessment (PGA) score AND 5) Member has had an insufficient response to at least two (2) standard of care drug classes: a. Anti-malarials b. Corticosteroids c. Immunosuppressives (excluding intravenous cyclophosphamide) Benlysta is not covered for individuals with active severe central nervous system (CNS) lupus, individuals who require high-dose prednisone (greater than 100mg/day) or use in combination with other biologics or intravenous cyclophosphamide. Codes Used In This BI: J0490 Belimumab Injection, 10mg
Background
Benlysta (Belimumab) is approved by the FDA for treatment of adults with active, autoantibody-positive systemic lupus erythematosus (SLE) and active lupus nephritis. It is the first biologic agent approved for SLE and the first drug of any kind to be approved for this disease in over 50 years. In two clinical trials, BLISS-52 and BLISS-76, a total of 1,684 patients with active SLE were randomized to receive, in addition to their current therapy, Belimumab 1mg/kg, 10mg/kg, or placebo IV at 0, 2, and 4 weeks, and then every 4 weeks. The primary endpoint in both trials was improvement in the SLE Responder Index (SRI) at week 52. In BLISS-52, significantly more patients receiving Belimumab achieved an SRI response at week 52 (51% and 58%) compared to those receiving placebo (44%). In BLISS-76 significantly more patients receiving Belimumab 10mg//kg achieved an SRI response at 52 weeks (43% vs 34%), but not at 76 weeks (39% vs 32%), compared to placebo. Belimumab-treated patients had significantly fewer disease flares (including severe flares) and significantly more of them were able to decrease their prednisone dosage. African-American patients enrolled in these studies did not appear to benefit from treatment with Belimumab.
Reference
1. Benlysta Product Information. GlaxoSmithKline. July 2022. 2. Clinical Pharmacology Online. “Belimumab”, retrieved 11-01-2022. 3. Navarro SV, Guzman RM, Gallacher AE, et al. Efficacy and safety of Belimumab in patients with active systemic lupus erythematosus: a randomized, placebo-controlled, phase 3 trial. Lancet 2011;377:721-31 4. Belimumab (Benlysta) for Systemic Lupus Erythematosus. The Medical Letter. Volume 53 (1366). June 13, 2011. Addendum: Effective 01/01/2017: Added coverage criteria for plans that cover this product. Effective 04/01/2018: Added coverage of Benlysta SQ injection. Effective 04/01/2020: Updated coverage for IV infusion to age 5 or older. Effective 02/01/2021: Updated to include coverage for active lupus nephritis. Effective 01/01/2023: Update age for either diagnosis to 5 years and older.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.

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