Overview

This document addresses the use of Nulojix (belatacept). Nulojix is a selective T-cell co-stimulation blocker indicated for the prophylaxis of organ rejection in Epstein-Barr virus (EBV) seropositive adults receiving a kidney transplant. Nulojix is used during the initial phase beginning on the day of kidney transplantation prior to implantation and for maintenance phase post kidney transplantation. It is indicated for use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. Use of this drug has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney.

Patients who are EBV seronegative are at higher risk for post-transplant lymphoproliferative disorder (PTLD) compared to patients who are EBV seropositive. EBV seropositive patients are defined as having IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA). Patients who are EBV seronegative or with unknown serostatus should not receive Nulojix.

Nulojix has the following black box warnings:

• Increased risk for developing PTLD, predominantly involving the central nervous system. Recipients without EBV immunity are at an increased risk; therefore, Nulojix is used only in EBV seropositive patients.
• Increased susceptibility to infection and the possible development of malignancies as a result of immunosuppression.
• Use in liver transplant patients is not recommended due to increased risk of graft loss and death.

In addition, Nulojix should only be prescribed by physicians experienced in immunosuppressive therapy and management of kidney transplant patients. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (includingprior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Nulojix (belatacept)

Requests for Nulojix (belatacept) may be approved if the following criteria are met:

1. Individual is an adult using for prevention of organ rejection in kidney transplant; AND
2. Individual is Epstein-Barr virus (EBV) seropositive; AND
3. If initiating therapy, Nulojix (belatacept) is used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Requests for Nulojix (belatacept) may not be approved when the above criteria are not met and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusionor exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

• HCPCS
• J0485 - Injection, belatacept, 1 mg [Nulojix]

• ICD-10 Diagnosis
• D82.3 - Immunodeficiency following hereditary defective response to Epstein-Barr virus
• Z48.22 - Encounter for aftercare following kidney transplant
• Z94.0 - Kidney transplant status

Document History

Reviewed: 06/12/2023