49401-0101-XX Benlysta 120 MG SOLR (GLAXO SMITH KLINE)
49401-0102-XX Benlysta 400 MG SOLR (GLAXO SMITH KLINE)
Belimumab is a human IgG1 monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS), a B cell survival factor. It is produced by recombinant DNA technology in a mammalian cell expression system. Belimumab does not bind to B cells directly but blocks access of soluble BLyS to its receptors on B cells. This inhibits the survival of B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Treatment with belimumab leads to reductions in circulating CD19+, CD20+, naïve and activated B cells along with plasmacytoid cells and the systemic lupus erythematosus (SLE) B-cell subset.
Belimumab for the treatment of systemic lupus erythematosus (SLE)is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Belimumab or the treatment of other conditions/diseases, including, but not limited to, the following is considered investigational:
Active lupus nephritis
Active central nervous system lupus
Belimumab is considered medically appropriate if ALL of the following criteria are met:
Individual is 5 years of age or older
Diagnosis of active systemic lupus erythematosus (SLE)
Disease is autoantibody-positive (e.g., anti-nuclear antibody [ANA] greater than or equal to laboratory reference range and/or anti-double-stranded DNA [anti-dsDNA] greater than 2 fold the laboratory reference range if tested by ELISA
Individual has failed to respond to a minimum of two (2) standard therapies (e.g., corticosteroids, antimalarials, nonsteroidal anti-inflammatories [NSAIDS], immunosuppressive agents [excluding intravenous cyclophosphamide]) Individual has one of the following:
Safety of Estrogen in Lupus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of 6-12
British Isles Lupus Assessment Group (BILAG) A organ domain score ≥1
BILAG B organ domain score ≥2
Individual must NOT have an active infection
Individual has NOT received a live vaccine within 30 days before starting or concurrently with belimumab
Individual must NOT have any of the following exclusionary criteria:
Concomitant treatment with intravenous cyclophosphamide or other biological agents
Severe active central nervous system lupus
Severe active lupus nephritis
Belimumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Adequate documentation of disease stability and/or improvement as indicated by ANY ONE of the following when compared to baseline:
≥4 point improvement in the SELENA-SLEDAI score
No new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores
No worsening (<0.30-point increase) in Physician’s Global Assessment (PGA) score
Seroconverted (negative) or had a 20% reduction in autoantibody level
Absence of unacceptable toxicity from the drug, e.g., depression, suicidal thoughts, serious infections, malignancy, signs or symptoms of progressive multifocal leukoencephalopathy (PML), severe hypersensitivity reaction, etc.
DOSAGE & ADMINISTRATION
Systemic lupus erythematosus (SLE)
Intravenous Infusion: 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Reconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour.
• Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions.
Subcutaneous Injection: 200 mg subcutaneously (may be self-administered) once weekly.
If transitioning from intravenous therapy, administer the first subcutaneous
dose 1 to 4 weeks after the last IV dose
LENGTH OF AUTHORIZATION
Coverage will be provided for 12 months and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Lexi-Comp Online. (2018). AHFS DI. Belimumab. Retrieved August 29, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, July). Belimumab. Retrieved August 29, 2018 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, June). Center for Drug Evaluation and Research. Benlysta® (belimumab) for injection, for intravenous use only. Retrieved August 29, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf.
ORIGINAL EFFECTIVE DATE: 8/13/2011
MOST RECENT REVIEW DATE: 10/31/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10 mg