When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
Belimumab (Benlysta). Elsevier’s Clinical Pharmacology Compendium. 05/03/2019. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed March 20, 2020.
Belimumab (Benlysta). Lexi-Drugs Compendium. 01/27/2020. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 20, 2020.
Belimumab (Benlysta). Micromedex® DrugDex® Compendium. [Micromedex® Solutions Web site]. 11/06/2019. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed March 20, 2020.
Bishton M, Spencer A, Dickinson M, et al. A single-arm, phase II study of the anti-Blys monoclonal antibody belimumab in symptomatic Waldenstrom macroglobulinemia. Clin Lymphoma Myeloma Leuk. 2013;13(5):575-8.
Dooley MA, Houssiau F, Aranow C, et al. Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE. Lupus. 2013;22(1):63-72.
Furie R, Stohl W, Ginzler EM, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res Ther.2008;10(5):R109.
Ginzler EM, Wallace DJ, Merrill JT, et al. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014;41(2):300-9.
Human Genome Sciences, Rockville MD. and GlaxoSmithKline, Research Triangle Park, NC. Benlysta® (belimumab) Prescribing Information. 01/2020. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG.PDF. Accessed March 20, 2020.
Lateef A, Petri M. Biologics in the treatment of systemic lupus erythematosus. Curr Opin Rheumatol. 2010;22(5):504-509.
Lutalo PM, D'Cruz DP. Update on belimumab for the management of systemic lupus erythematosus. Expert Opin Biol Ther. 2014;14(11):1701-8.
Mariette X, Seror R, Quartuccio L, et al. Efficacy and safety of belimumab in primary Sjögren's syndrome: results of the BELISS open-label phase II study. Ann Rheum Dis. 2015;74(3):526-31.
Navarra S, Buzman R, Gallacher A, et al. Belimumab, a BLyS-specific inhibitor, reduces disease activity and flares, and predinosone use in patients with active SLE: efficacy and safety results from the phase 3 BLISS-52 study. Late Breaking Abstract B L1. Presented at the ACR/ARHP meeting. 2009.
Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lypus erythematosus: a randomized, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721:-731.
Novitas Solutions, Inc. Article (A53127) For Self-Administered Drug Exclusion List. [Novitas Medicare Services Web site]. Original: 10/01/2015, Revised: 12/02/2019. Available at:
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53127&ver=88&name=331*1&UpdatePeriod=855&bc=AAAAEAAAAAAA&. Accessed March 20, 2020.
Novitas Solutions, Inc. FUTURE Article (A53127) For Self-Administered Drug Exclusion List. [Novitas Medicare Services Web site]. Original: 10/01/2015, Revised: 05/03/2020. Available at:
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53127&ver=96&name=331*1&UpdatePeriod=877&bc=AAAACAAAAAAA&. Accessed March 23, 2020.
Singh JA, Noorbaloochi S, Tucker MD. Belimumab for systemic lupus erythematosus (Protocol). Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD010668.
Stohl W, Merrill JT, McKay JD, et al. Efficacy and safety of belimumab in patients with rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled, dose-ranging Study. J Rheumatol. 2013;40(5):579-89.
Thanou-Stavrakil A, Sawalha H. An update on belimumab for the treatment of lupus. Biologics. 2011;5:33-43.
van Vollenhoven RF, Zamani O, Wallace DJ, et al. Belimumab, a BLyS-Specific inhibitor, reduces disease activity and severe flares in seropositive SLE patients: BLISS-76 study. Ann Rheum Dis. 2010;69(suppl 3):74.
Wallace DJ, Navarra S, Petri MA, et al. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013;22(2):144-54.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Belimumab (Benlysta). Approval letter and prescribing information. [FDA web site]. 01/17/2020. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed March 20, 2020.
M32.0 Drug-induced systemic lupus erythematosus
M32.10 Systemic lupus erythematosus, organ or system involvement unspecified
M32.11 Endocarditis in systemic lupus erythematosus
M32.12 Pericarditis in systemic lupus erythematosus
M32.13 Lung involvement in systemic lupus erythematosus
M32.14 Glomerular disease in systemic lupus erythematosus
M32.15 Tubulo-interstitial nephropathy in systemic lupus erythematosus
M32.19 Other organ or system involvement in systemic lupus erythematosus
M32.8 Other forms of systemic lupus erythematosus
M32.9 Systemic lupus erythematosus, unspecified
THE FOLLOWING MODIFIER IS USED WHEN REPORTING
Belimumab (Benlysta®) for Intravenous Use
JA Intravenous administration
Policy: 08.00.78ae:Self-Administered Drugs
Policy: 12.01.01aw:Experimental/Investigational Services