Belatacept (Nulojix®) is considered medically necessary and, therefore, covered for prophylaxis of organ rejection in adult individuals receiving de novo kidney transplants when all of the following criteria are met:

• Belatacept (Nulojix® ) must be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
• Transplant recipients are Epstein-Barr virus (EBV) seropositive (ie, having evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen [VCA] and EBV nuclear antigen [EBNA]).
• Belatacept (Nulojix®) must be administered intravenously over 30 minutes, at the following predetermined intervals:
  • Initial phase
    • Day 1 of transplantation, prior to implantation
    • Day 5 (approximately 96 hours after day 1 does)
    • End of weeks 2, 4, 8, and 12 after transplantation
  • Maintenance phase
    • End of week 16 after transplantation and every 4 weeks (plus or minus 3 days) thereafter

The use of belatacept for any other indication, including prophylaxis of organ rejection in transplanted organs other than kidney, is considered experimental/investigational and therefore, non-covered. A participating, preferred, or network provided can bill the member for the non-covered service.

Description

Belatacept (Nulojix®) is an intravenous drug that is a selective T-cell co-stimulation blocker that binds to CD80 and CD86 on antigen-presenting cells, thereby blocking CD28 mediated costimulation of T lymphocytes. In vitro, belatacept inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-y, interleukin-4, and TNF-cx. Activated T lymphocytes are the predominant mediators of immunologic rejection. 

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

Vicenti F, Larsen C, Durrbach A, Wekerle T, et al. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005; 353(8):770-781.

Durrbach A, Pestana JM, Pearson T, Vicenti F, et al. A Phase III study of belatacept versus cyclosporine kidney transplants from extended criteria donors (BENEFIT-EXT Study). American Journal of Transplantation. 2010; 10:547-557.

Gupta G, Womer K L. Profile of belatacept and its potential role in prevention of graft rejection following renal transplantation. Drug Design, Development and Therapy. 2010(4);375-382.

Nulojix® (belatacept) [package insert]. Bristol-Myers Squibb. Princeton, NJ, 06/2011