Belatacept (Nulojix) (ARCHIVED)

Policy ID: I-24-013

Section: Injections

Effective Date: August 01, 2019

Revised Date: January 05, 2024

Revision Effective Date: March 04, 2023

Last Reviewed: January 16, 2024

Applies To: Commercial and Medicaid Expansion

This policy has been Archived effective March 04, 2024. Click the Archive tab above for more information.

Policy ID: I-24-012

Section: Injections

Effective Date: August 01, 2019

Revised Date: January 12, 2023

Revision Effective Date: March 01, 2023

Last Reviewed: January 26, 2023

Archived Date: March 04, 2024

Applies To: Commercial and Medicaid Expansion

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.

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 all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available 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.

Diagnosis Codes

Covered diagnosis codes for procedure code J0485

Z48.22

Z94.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-16-2019 Adopted policy

Internal Medical Policy Committee 7-22-2020 Annual review, no clinical content change

Internal Medical Policy Committee 7-22-2021 Annual review, no clinical content change

Internal Medical Policy Committee 9-21-2021 No clinical content change

Internal Medical Policy Committee 9-28-2022 Annual Review - No clinical content change

Internal Medical Policy Committee 1-26-2023 Effective March 01, 2023

Updated experimental/investigational statement

Internal Medical Policy Committee 1-16-2024 Effective March 04, 2024

Retire policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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