Clinical Policy: Belatacept (Nulojix) Form

CENTENE
Corporation

Clinical Policy: Belatacept (Nulojix)
Reference Number: CP.PHAR.201
Effective Date: 03.01.16
Last Review Date: 11.25
Line of Business: Commercial, HIM, Medicaid

Coding Implications
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal
information.

Description
Belatacept (Nulojix®) is a selective T-cell costimulation blocker.

FDA Approved Indication(s)
Nulojix is indicated for prophylaxis of organ rejection in adult patients receiving a kidney
transplant. Nulojix is to be used in combination with basiliximab induction, mycophenolate
mofetil, and corticosteroids.

Limitation(s) of use:

• Use Nulojix only in patients who are Epstein-Barr virus (EBV) seropositive.

• Use of Nulojix for the prophylaxis of organ rejection in transplanted organs other than kidney
  has not been established.

  a. Initial: 10 mg/kg on Day 1 (day of transplantation) and Day 5, end of Week 2,

  Week 4, Week 8, and Week 12 post-transplantation;

  b. Maintenance: 5 mg/kg at the end of Week 16 post-transplantation and every 4

  weeks (± 3 days) thereafter.

Approval duration:
Medicaid/HIM – 12 months
Commercial – 6 months or to the member’s renewal date, whichever is longer

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B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g.,
   newly approved indication, age expansion, new dosing regimen) that is not yet
   reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL
   (Medicaid), the no coverage criteria policy for the relevant line of business:
   CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and
   CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or
   PDL (Medicaid), the non-formulary policy for the relevant line of business:
   CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and
   CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed
   under section III (Diagnoses/Indications for which coverage is NOT authorized) AND
   criterion 1 above does not apply, refer to the off-label use policy for the relevant
   line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance
   marketplace, and CP.PMN.53 for Medicaid.

II. Continued Therapy
A. Kidney Transplant (must meet all):

Approval duration:
Medicaid/HIM – 12 months
Commercial – 6 months or to the member’s renewal date, whichever is longer

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g.,
   newly approved indication, age expansion, new dosing regimen) that is not yet
   reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL
   (Medicaid), the no coverage criteria policy for the relevant line of business:
   CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and
   CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or
   PDL (Medicaid), the non-formulary policy for the relevant line of business:
   CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and
   CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed
   under section III (Diagnoses/Indications for which coverage is NOT authorized) AND
   criterion 1 above does not apply, refer to the off-label use policy for the relevant line
   of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and
   CP.PMN.53 for Medicaid.

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of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance
marketplace, and CP.PMN.53 for Medicaid.

III.Diagnoses/Indications for which coverage is NOT authorized:
A. Non-FDA approved indications, which are not addressed in this policy, unless there is
sufficient documentation of efficacy and safety according to the off label use policies –
CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and
CP.PMN.53 for Medicaid, or evidence of coverage documents.

IV.Appendices/General Information
Appendix A: Abbreviation/Acronym Key
EBV: Epstein-Barr virus
FDA: Food and Drug Administration

Appendix B: Therapeutic Alternatives
This table provides a listing of preferred alternative therapy recommended in the approval
criteria. The drugs listed here may not be a formulary agent for all relevant lines of business
and may require prior authorization.

| Drug Name | Dosing Regimen | Dose Limit/

Maximum Dose |

|-----------|----------------|----------------|

| Simulect® (basiliximab) | 20 mg IV within 2 hours prior to

transplantation surgery, followed by 20
mg IV 4 days after transplantation | 20 mg/dose |

| mycophenolate mofetil

(Cellcept®) | 1 g PO BID after transplantation
1 g IV over at least 2 hours BID initiated
within 24 hours after transplantation for
up to 14 days (recommended for patients
unable to take an oral formulation) | 2 g/day |

| corticosteroids (e.g.,

prednisone,
methylprednisolone) | Varies | Varies |

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only
and generic (Brand name®) when the drug is available by both brand and generic.

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s): transplant recipients who are EBV seronegative or with unknown
  EBV serostatus due to the risk of post-transplant lymphoproliferative disorder,
  predominantly involving the central nervous system
• Boxed warning(s): post-transplant lymphoproliferative disorder, other malignancies, and
  serious infections

V. Dosage and Administration

organ rejection
in kidney | Dosing for Initial Phase: | 10 mg/kg/dose for
first 6 doses then 5
mg/kg/dose |

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implantation) and Day 5 (approximately 96
hours after Day 1 dose): 10 mg per kg IV

• End of Week 2 and Week 4 after
  transplantation: 10 mg per kg IV
• End of Week 8 and Week 12 after
  transplantation: 10 mg per kg IV

Dosing for Maintenance Phase:
End of Week 16 after transplantation and every 4
weeks (plus or minus 3 days) thereafter: 5 mg per
kg IV

The prescribed dose must be evenly divisible by
12.5 mg in order for the dose to be prepared
accurately using the reconstituted solution and
provided syringe. | |

VI.Product Availability
Vial: 250 mg

VII.References

1. Nulojix Prescribing Information. Princeton, New Jersey: Bristol-Myers Squibb Company;
   July 2021. Available at: https://packageinserts.bms.com/pi/pi_nulojix.pdf. Accessed July 15,
   2025.
2. Van Gelder T, Hesselink DA. Mycophenolate revisited. Transpl Int. 2015 May;28(5):508-15.
   doi: 10.1111/tri.12554.
3. Malhotra D, Jethwani P. Preventing Rejection of the Kidney Transplant. J Clin Med.
   2023;12(18):5938.
4. Clinical Pharmacology [database online]. Philadelphia, PA: Elsevier. Updated periodically.
   Available at: http://www.clinicalkey.com/pharmacology. Accessed August 11, 2025.

Coding Implications
Codes referenced in this clinical policy are for informational purposes only. Inclusion or
exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-
date sources of professional coding guidance prior to the submission of claims for
reimbursement of covered services.

| HCPCS

Codes | Description |

|--------|-------------|

| J0485 | Injection, belatacept, 1 mg |

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| Reviews, Revisions, and Approvals | Date | P&T

Approval Date |

|---------------------------------|------|----------------|

| 4Q 2021 annual review: no significant changes; added Commercial

line of business; references to HIM.PHAR.21 revised to HIM.PA.154;
references reviewed and updated. | 06.28.21 | 11.21 |

| 4Q 2022 annual review: no significant changes; references reviewed

and updated. Template section applied to other diagnoses/indications
and continued therapy section. | 07.05.22 | 11.22 |

| 4Q 2023 annual review: no significant changes; COC applied as a

transplant-related indication in continued therapy section; references
reviewed and updated. | 08.05.23 | 11.23 |

| 4Q 2024 annual review: no significant changes; references reviewed

and updated. | 07.19.24 | 11.24 |

| 4Q 2025 annual review: revised Medicaid and HIM initial approval

durations to 12 months; revised Commercial approval durations for
initial and continued therapy to “6 months or to the member’s renewal
date, whichever is longer”; references reviewed and updated. | 07.15.25 | 11.25 |

Important Reminder
This clinical policy has been developed by appropriately experienced and licensed health care
professionals based on a review and consideration of currently available generally accepted
standards of medical practice; peer-reviewed medical literature; government agency/program
approval status; evidence-based guidelines and positions of leading national health professional
organizations; views of physicians practicing in relevant clinical areas affected by this clinical
policy; and other available clinical information. The Health Plan makes no representations and
accepts no liability with respect to the content of any external information used or relied upon in
developing this clinical policy. This clinical policy is consistent with standards of medical
practice current at the time that this clinical policy was approved. “Health Plan” means a health
plan that has adopted this clinical policy and that is operated or administered, in whole or in part,
by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a
component of the guidelines used to assist in making coverage decisions and administering
benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage
decisions and the administration of benefits are subject to all terms, conditions, exclusions, and
limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy,
contract of insurance, etc.), as well as to state and federal requirements and applicable Health
Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting
may not be the effective date of this clinical policy. This clinical policy may be subject to
applicable legal and regulatory requirements relating to provider notification. If there is a
discrepancy between the effective date of this clinical policy and any applicable legal or
regulatory requirement, the requirements of law and regulation shall govern. The Health Plan

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retains the right to change, amend or withdraw this clinical policy, and additional clinical
policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment, or medical care. It is
not intended to dictate to providers how to practice medicine. Providers are expected to exercise
professional medical judgment in providing the most appropriate care, and are solely responsible
for the medical advice and treatment of members. This clinical policy is not intended to
recommend treatment for members. Members should consult with their treating physician in
connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent
judgment and over whom the Health Plan has no control or right of control. Providers are not
agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and
distribution of this clinical policy or any information contained herein are strictly prohibited.
Providers, members, and their representatives are bound to the terms and conditions expressed
herein through the terms of their contracts. Where no such contract exists, providers, members
and their representatives agree to be bound by such terms and conditions by providing services to
members and/or submitting claims for payment for such services.

Note: For Medicaid members, when state Medicaid coverage provisions conflict with the
coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence.
Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical
policy.

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