Belatacept (Nulojix)

Section: Injections
Effective Date: August 01, 2019
Revised Date: July 31, 2019

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.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Food and Drug Administration (FDA) Indication
Belatacept (Nulojix) is considered medically necessary for prophylaxis of organ rejection in adult individuals receiving de novo kidney transplants when BOTH of the following criteria are met:

  • Used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids; and
  • Transplant recipients are Epstein-Barr virus (EBV) seropositive (i.e., having evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen[VCA] and EBV nuclear antigen [EBNA]).

The use of belatacept (Nulojix) for any other indication, including prophylaxis of organ rejection in transplanted organs other than kidney, is considered experimental/investigational and therefore, non-covered, due to lack of supporting published peer reviewed literature.

Procedure Codes

J0485

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Z48.22
Z94.0