CurrentMolina HealthcarePolicy C9968-A

Nulojix (belatacept) Coverage for Kidney Transplant Rejection Prophylaxis

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Prior authorization and coverage criteria for intravenous Nulojix (belatacept) to prevent organ rejection in adult kidney transplant recipients, requiring transplant documentation, specified concomitant immunosuppression, EBV seropositivity, and transplant specialist or nephrologist involvement.

Policy Summary

PayerMolina Healthcare

PolicyNulojix (belatacept) Coverage for Kidney Transplant Rejection Prophylaxis

Policy CodePolicy C9968-A

Change TypeNo material clinical or coverage changes

Effective DateDec 17, 2025

Next Review DateOct 1, 2026

Key ActionObtain prior authorization from a transplant specialist or nephrologist before initiating Nulojix for kidney transplant rejection prophylaxis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+ yearsMinimum age

Kidney onlySupported organ

SeropositiveRequired EBV status

6 monthsInitial authorization

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CurrentMolina HealthcarePolicy C9968-A

Nulojix (belatacept) Coverage for Kidney Transplant Rejection Prophylaxis

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Policy Summary

PayerMolina Healthcare

PolicyNulojix (belatacept) Coverage for Kidney Transplant Rejection Prophylaxis

Policy CodePolicy C9968-A

Change TypeNo material clinical or coverage changes

Effective DateDec 17, 2025

Next Review DateOct 1, 2026

Key ActionObtain prior authorization from a transplant specialist or nephrologist before initiating Nulojix for kidney transplant rejection prophylaxis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+ yearsMinimum age

Kidney onlySupported organ

SeropositiveRequired EBV status

6 monthsInitial authorization

12 monthsContinuation authorization

Coverage Criteria

Initial Therapy — Prophylaxis of Organ Rejection

Covered when ALL of the following are met:

ALL of the following

ONE of
- Documentation of a history of renal transplant.
- Documentation of a renal transplant scheduled within the next 14 days.
Documentation that the member is Epstein-Barr virus (EBV) seropositive.
Documentation required.
Documentation that Nulojix (belatacept) will be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
Prescriber attests that the member does not have an active or latent untreated infection, including tuberculosis, according to the FDA label.
For patients continuing therapy after an inpatient stay for transplant, transplant team approval and referral data are required.

Continuation Therapy — Prophylaxis of Organ Rejection

Covered when ALL of the following are met:

ALL of the following

Documentation that the member is responsive to therapy, demonstrated by no signs or symptoms of acute or chronic kidney rejection.
Prescriber attests that continued mycophenolate and corticosteroid utilization is consistent with the Nulojix clinical trial experience, including tapering corticosteroids to 10 mg per day for the first 6 months post-transplant.

Labeled Kidney Transplant Indication

Nulojix (belatacept) is covered for the labeled indication when ALL of the following are met:

ALL of the following

The member is an adult receiving a kidney transplant.
Therapy is used for prophylaxis of organ rejection.
Therapy is used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Conversion From Calcineurin Inhibitor Therapy

Conversion from calcineurin inhibitor (CNI)-based maintenance therapy to a Nulojix-based maintenance regimen is covered only when the member is CNI intolerant, because conversion increases the risk of acute rejection and is otherwise not recommended.

ALL of the following

The member is being converted from a stable CNI-based maintenance regimen.
The member is CNI intolerant.

Nulojix must be used only in patients who are EBV seropositive. Coverage is not provided for use in patients who are not EBV seropositive.

Prophylaxis of organ rejection in transplanted organs other than the kidney is outside the stated FDA-approved use of Nulojix.

Nulojix is contraindicated and excluded for transplant recipients who are EBV seronegative or whose EBV serostatus is unknown, due to the risk of post-transplant lymphoproliferative disorder, predominantly involving the central nervous system.

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

Use of Nulojix in patients with a history of liver transplant is not recommended.

All other uses of Nulojix (belatacept) are considered experimental or investigational and will be reviewed under Molina's Off-Label policy.

Candidate Criteria

Kidney Transplant Eligibility

Kidney transplant rejection prophylaxis is covered when ALL of the following are met.

Kidney transplant candidate criteria

Member has a history of renal transplant or a scheduled transplant within the next 14 days.
Member is EBV seropositive.
Therapy is combined with basiliximab induction, mycophenolate mofetil, and corticosteroids.
The prescriber attests that there is no active or latent untreated tuberculosis infection according to the FDA label.

Adult Kidney Transplant Recipient

Nulojix is indicated for eligible adult kidney transplant recipients.

Contraindications and Exclusions

EBV-seronegative status is a limitation of use and does not meet the stated coverage criteria. Patients who are EBV seronegative or whose EBV serostatus is unknown are contraindicated because of PTLD risk.

The prescriber must attest that the member does not have an active or latent untreated tuberculosis infection.

Prophylaxis coverage for transplanted organs other than the kidney is not established.

Nulojix is contraindicated in transplant recipients with EBV-seronegative or unknown EBV serostatus because of the risk of PTLD, predominantly involving the central nervous system.

Use in patients with a history of liver transplant is not recommended.

During treatment, avoid prolonged exposure to ultraviolet light and sunlight and avoid live vaccines.

Evaluation Requirements

Documentation Required

Indication and Eligibility Documentation

Document the indication and all eligibility requirements before requesting Nulojix (belatacept), including renal transplant timing, EBV seropositivity, concomitant immunosuppression, infection status, and any continuation after an inpatient transplant stay.

Document a history of renal transplant or a renal transplant scheduled within the next 14 days.
Document that the member is EBV seropositive.
Document concomitant use with basiliximab induction, mycophenolate mofetil, and corticosteroids.
The prescriber must attest that the member does not have an active or latent untreated tuberculosis infection, consistent with the FDA label.
For therapy continuing after an inpatient transplant stay, obtain transplant team approval and provide referral data.
For conversion from a calcineurin inhibitor (CNI), document CNI intolerance; conversion without documented CNI intolerance does not meet eligibility requirements.

Authorization and Documentation

Prior Authorization

Secure transplant specialist authorization

Obtain prior authorization for adult members receiving Nulojix for kidney transplant rejection prophylaxis. The drug must be prescribed by or in consultation with a transplant specialist or nephrologist.

If prescribed in consultation, submit consultation notes with the initial request and reauthorization requests.

Prior Authorization

Track authorization periods

Initial authorization is available for 6 months; continuation authorization is available for 12 months.

Prior Authorization

Provide post-inpatient transplant approval

For patients continuing therapy after an inpatient transplant stay, obtain transplant team approval and provide the required referral data.

Prescriber and Center Requirements

Note

Use an experienced transplant prescriber

Nulojix should be prescribed only by physicians experienced in immunosuppressive therapy and management of kidney transplant patients.

Billing and Coding

HCPCS CodeHCPCS

J0485

Injection, belatacept 1mg

Background

Nulojix (belatacept) is a selective T-cell costimulation blocker administered intravenously for prophylaxis of organ rejection in adult kidney transplant recipients. The FDA-approved regimen is used with basiliximab induction, mycophenolate mofetil, and corticosteroids. Use is limited to EBV-seropositive patients, and safe use has not been established for transplanted organs other than the kidney. Nulojix should be administered intravenously over 30 minutes; doses higher than or more frequent than recommended should be avoided because of increased infection or malignancy risk.

Definitions

FDA-approved use

IndicationProphylaxis of organ rejection in adult patients receiving a kidney transplantation.

Combination regimenUsed in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Limitation of useUse only in patients who are EBV seropositive; use has not been established for transplanted organs other than the kidney.

Selective T-Cell Costimulation Blockers

Drug classSelective T-Cell Costimulation Blockers.

Mechanism classificationNulojix (belatacept) is a selective T-cell costimulation blocker.

Administration context

Post-Transplant Coverage Details

Nulojix (belatacept) for kidney transplant rejection prophylaxis

Response requirementContinuation requires responsiveness to therapy, demonstrated by no signs or symptoms of acute or chronic kidney rejection.

Ongoing regimenContinued mycophenolate and corticosteroid use must be consistent with the Nulojix clinical trial experience, including tapering corticosteroids to 10 mg per day for the first 6 months post-transplant.

Continuation authorizationContinuation authorization is available for 12 months.

Intravenous Nulojix (belatacept)

Covered indicationIntravenous Nulojix is covered for prophylaxis of organ rejection in adult kidney transplant recipients.

Required regimenUse in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Policy Summary

PayerMolina Healthcare

PolicyNulojix (belatacept) Coverage for Kidney Transplant Rejection Prophylaxis

Policy CodePolicy C9968-A

Change TypeNo material clinical or coverage changes

Effective DateDec 17, 2025

Next Review DateOct 1, 2026

Key ActionObtain prior authorization from a transplant specialist or nephrologist before initiating Nulojix for kidney transplant rejection prophylaxis.

SourceLink

On This Page

Kidney transplant recipient eligibility

The patient is an adult kidney transplant recipient.Adult
The patient is EBV seropositive.EBV seropositive
Unknown or negative EBV status is contraindicated.
Nulojix is used with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Prior Authorization

Transplant Specialist or Nephrologist Requirement

Nulojix must be prescribed by, or in consultation with, a transplant specialist or nephrologist. When prescribed in consultation, submit the consultation notes with the initial request and with reauthorization requests.

Consultation documentation is required for both initial requests and reauthorization requests.

Documentation Required

Confirm EBV Serostatus Before Treatment

Confirm and submit documentation of the member’s EBV serostatus before treatment is initiated. EBV seropositivity is required for eligibility.

EBV serostatus must be confirmed before treatment.
Documentation of EBV seropositivity is required.

Denial Risk

EBV Seronegativity or Unknown Status

Do not approve or initiate Nulojix when the member is EBV seronegative or when EBV serostatus is unknown or undocumented.

Exclude members with documented EBV seronegativity.
Exclude members whose EBV serostatus is unknown or cannot be documented.

Documentation Required

Submit medical necessity records

Submit complete medical rationale and supporting records requested for the coverage determination. Records may include patient records, test results, provider credentials, and member-specific dosing information such as weight or body surface area when applicable.

Documentation Required

Document transplant and EBV status

Document a history of renal transplant or a renal transplant scheduled within the next 14 days and document that the member is EBV seropositive.

Documentation Required

Document concomitant therapy and infection status

Document use with basiliximab induction, mycophenolate mofetil, and corticosteroids. The prescriber must attest that the member does not have an active or latent untreated tuberculosis infection according to the FDA label.

Documentation Required

Document response for continuation

For continuation, document responsiveness to therapy, demonstrated by no signs or symptoms of acute or chronic kidney rejection. The prescriber must also attest that continued mycophenolate and corticosteroid utilization is consistent with the Nulojix clinical trial experience.

This includes tapering corticosteroids to 10 mg per day for the first 6 months post-transplant.

Documentation Required

Submit consultation notes

If Nulojix is prescribed in consultation, submit consultation notes with the initial request and with each reauthorization request.

Documentation Required

Document indication and regimen

Document that the patient is an adult kidney transplant recipient, is EBV seropositive, and is receiving Nulojix with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Denial Risk

Avoid incomplete supporting documentation

Coverage or reimbursement may be denied when submitted documentation does not support medical necessity, non-investigational or non-experimental status, benefit eligibility, or appropriate billing and utilization.

Denial Risk

Verify all transplant eligibility criteria

Requests may not meet coverage criteria when the member is not an adult kidney transplant recipient, is not EBV seropositive, lacks the required concomitant immunosuppression, or has an active or latent untreated tuberculosis infection.

Denial Risk

Do not treat with negative or unknown EBV status

Use in EBV-seronegative transplant recipients or recipients with unknown EBV serostatus is contraindicated and subject to exclusion because of the risk of post-transplant lymphoproliferative disorder.

Denial Risk

Route other uses through the Off-Label policy

Uses other than the covered kidney-transplant indication are considered experimental or investigational and follow Molina’s Off-Label policy. Prophylaxis coverage is not established for transplanted organs other than the kidney.

Step Therapy

Require documented CNI intolerance for conversion

Do not convert a stable kidney transplant recipient from a calcineurin-inhibitor maintenance regimen to belatacept unless the patient is calcineurin-inhibitor intolerant, because conversion increases the risk of acute rejection.

Nulojix is administered by intravenous injection for prophylaxis of organ rejection after kidney transplantation.

PTLD

DefinitionPost-transplant lymphoproliferative disorder (PTLD) is a serious lymphoid malignancy occurring after transplantation and associated with immunosuppression.

Safety warningNulojix carries a boxed warning for PTLD, other malignancies, and serious infections.

Risk contextPTLD was more common with belatacept, particularly among EBV-seronegative patients.

CNI-based maintenance regimen

DefinitionA calcineurin inhibitor-based maintenance immunosuppression regimen.

ExamplesExamples include maintenance regimens based on tacrolimus or cyclosporine.

Conversion requirementConversion to a belatacept-based maintenance regimen is not recommended unless the patient is calcineurin-inhibitor intolerant because of increased acute rejection risk.

PML

DefinitionProgressive multifocal leukoencephalopathy (PML) is a serious neurologic infection.

Nulojix riskNulojix treatment increases the risk of PML.

Safety contextNulojix also carries a boxed warning for other malignancies and serious infections.

AdministrationAdminister intravenously over a 30-minute period.