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    v1.0.28
    OpenPayerPolicy UpdatesTransplantCountyCare Nulojix Prior Auth Coverage | OpenPayer
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    CurrentCountycarePolicy 5023.CC

    Nulojix (belatacept) prior authorization for kidney transplant

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    This guideline governs prior authorization and reauthorization for Nulojix (belatacept) under the Health Plan's medical benefit for adult members undergoing or having undergone renal transplantation.

    Policy Summary
    PayerCountycare
    PolicyNulojix (belatacept) prior authorization for kidney transplant
    Policy CodePolicy 5023.CC
    Change TypeRevised and added
    Effective DateAugust 1, 2025
    Next Review DateN/A
    Key ActionSubmit documentation of a negative TB skin test collected within the last 6 months.
    SourceLink
    POLICY UPDATE CHANGES

    The policy requires a negative tuberculosis skin test collected within the prior 6 months.

    The policy requires dosing within the manufacturer's FDA-approved labeling and dosing guidelines.

    Adults onlyMinimum age for initial authorization
    6 monthsMaximum age of acceptable negative TB testing
    Up to 1 yearInitial authorization duration
    AnnualReauthorization review frequency

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    J0485Applicable code for belatacept injection
    MedicaidApplicable line of business

    Coverage Criteria

    Initial Therapy

    Covered when all of the following are met, including at least one qualifying clinical pathway:

    Core eligibility and safety

    • Member, prescriber, dosing, and transplant requirements

      • The member has a negative tuberculosis skin test collected within the last 6 months.Negative test within 6 months

        Acceptable testing includes Tuberculin PPD or an IGRA whole-blood test, such as QuantiFERON-TB Gold In-Tube or T-SPOT.TB.

      • The member is age 18 years or older.Age ≥ 18 years
      • Nulojix is prescribed by a physician who specializes in immunosuppression or renal transplantation.
      • Nulojix is prescribed at a dose within the manufacturer's dosing guidelines listed in the FDA-approved labeling.
      • The member is undergoing or has undergone a renal transplant.

    • At least ONE qualifying clinical pathway

      • The member is at increased risk of renal failure before transplant.
      • The member has tried and failed, has an intolerance to, or has a contraindication to tacrolimus or cyclosporine.

    • Concomitant therapy and safety requirements

      • Nulojix is used in conjunction with basiliximab induction when given at the time of transplant, mycophenolate mofetil, and corticosteroids.
      • The member is EBV seropositive, as demonstrated by EBV serology.
      • The member has no evidence of infection, including progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV), or polyoma virus-associated nephropathy (PVAN).
      • The member has no history of or currently active malignancy.

    Reauthorization Therapy

    Covered for annual reauthorization when all of the following are met:

    Continuation therapy

    • The prescriber provides chart documentation that the member's condition has improved based on the prescriber's assessment while on therapy.Annual review
    • Nulojix is prescribed at a dose within the manufacturer's dosing guidelines based on diagnosis, weight, and other applicable factors, as listed in the FDA-approved labeling.

    Coverage is excluded when the member has evidence of infection, including progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV), or polyoma virus-associated nephropathy (PVAN).

    Coverage is excluded when the member has a history of malignancy or currently active malignancy.

    Applicable Codes

    Applicable HCPCS CodesHCPCS
    J0485Injection belatacept 1mg

    Provider Requirements and Decision Risks

    Prior Authorization

    Medical-Benefit Prior Authorization Required

    Prior authorization is required for Nulojix (belatacept) under the Health Plan's medical benefit. Requests are reviewed for Medical Necessity using FDA criteria and may require Medical Policy Committee approval; requests that do not meet established criteria may be referred to a Medical Director when required by the plan and request level.

    • Applies to all practitioners involved in providing the requested drug.
    • Review is specific to the Health Plan's medical benefit.
    Documentation Required

    Calcineurin Inhibitor or Renal-Failure-Risk Pathway

    Document that the member meets the calcineurin-inhibitor or renal-failure-risk pathway. At least one of the following must be established: increased risk of renal failure before transplant, or prior trial and failure, intolerance, or contraindication to tacrolimus or cyclosporine.

    Clinical Background

    Nulojix (belatacept) is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult kidney transplant recipients. The policy describes its use with basiliximab induction when administered at the time of transplant, mycophenolate mofetil, and corticosteroids. Use is limited to members who are EBV seropositive, because EBV-naive transplant recipients receiving chronic immunosuppression have an increased risk of post-transplant lymphoproliferative disorder.

    Key Definitions

    EBV Serology
    DefinitionLaboratory testing for Epstein-Barr virus antibodies.
    What it detectsThe presence of antibodies to Epstein-Barr virus.
    Policy useUsed to establish whether the member is EBV seropositive.
    Epstein-Barr Virus (EBV)
    ClassificationEpstein-Barr virus is a member of the herpesvirus family and one of the most common human viruses.
    Effect during immunosuppressionEBV can infect B cells and cause them to proliferate during chronic immunosuppression.
    Transplant relevance

    Renal Transplant Eligibility

    Renal Transplant Eligibility

    The member must be an adult undergoing or having undergone a renal transplant and meet all applicable clinical eligibility requirements.

    Kidney transplant candidate or recipient

    • The member is age 18 years or older.Age ≥ 18 years
    • The member is undergoing or has undergone a renal transplant.
    • Nulojix is prescribed by a physician who specializes in immunosuppression or renal transplantation.
    • The member has a negative tuberculosis skin test collected within the last 6 months.Negative test within 6 months

    Contraindications

    Do not approve Nulojix when the member has evidence of infection, including progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV), or polyoma virus-associated nephropathy (PVAN). Do not approve when the member has a history of malignancy or currently active malignancy.

    Do not approve Nulojix when the member is not EBV seropositive. EBV seropositivity must be demonstrated through EBV serology.

    Preauthorization Evaluation

    Documentation Required

    Complete required TB evaluation

    Obtain a negative tuberculosis skin test within the last 6 months before submitting the request.

    • Acceptable testing includes Tuberculin PPD.
    • An IGRA whole-blood test is acceptable, including QuantiFERON-TB Gold In-Tube or T-SPOT.TB.
    Documentation Required

    Complete EBV and safety evaluation

    Confirm EBV seropositivity through EBV serology and assess for infection and malignancy before approval.

    • The member must have no evidence of infection, including PML, CMV, or PVAN.
    • The member must have no history of or currently active malignancy.

    Continuation and Reauthorization

    Nulojix (Belatacept)
    Continuation reviewPrior authorization renewals are reviewed annually to determine the medical necessity of continuing therapy.
    Clinical responseThe prescriber must document that the member's condition has improved based on the prescriber's assessment while on therapy.
    Dosing requirementThe dose must remain within the manufacturer's dosing guidelines in the FDA-approved labeling, based on factors such as diagnosis and weight.
    Policy Summary
    PayerCountycare
    PolicyNulojix (belatacept) prior authorization for kidney transplant
    Policy CodePolicy 5023.CC
    Change TypeRevised and added
    Effective DateAugust 1, 2025
    Next Review DateN/A
    Key ActionSubmit documentation of a negative TB skin test collected within the last 6 months.
    SourceLink
    On This Page
    Coverage CriteriaApplicable CodesProvider Requirements and Decision RisksClinical BackgroundKey DefinitionsRenal Transplant EligibilityContraindicationsPreauthorization EvaluationContinuation and Reauthorization
  1. Qualifying history may include tried and failed tacrolimus or cyclosporine.
  2. Document intolerance or contraindication when applicable.
    3. Documentation Required

    Recent Negative Tuberculosis Test Required

    Submit documentation of a negative tuberculosis test collected within the previous 6 months.

    • Accepted examples include a Tuberculin PPD (purified protein derivative) skin test.
    • An Interferon-Gamma Release Assay (IGRA) whole-blood test is acceptable, including QuantiFERON-TB Gold In-Tube (QFT-GIT) or T-SPOT.TB.
    Documentation Required

    Member and Prescriber Eligibility

    Confirm that the member is an adult who is undergoing or has undergone a renal transplant, and that the prescriber meets the required specialty qualification.

    • Member must be age 18 years or older.
    • Prescriber must be a physician specializing in immunosuppression or renal transplantation.
    • Renal transplant may be planned/undergoing at the time of treatment or previously completed.
    Documentation Required

    EBV and Safety Documentation

    Document that the member is EBV seropositive and has no disqualifying infection or malignancy history or current malignancy.

    • EBV seropositivity must be demonstrated by EBV serology.
    • There must be no evidence of infection, including progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV), or polyoma virus-associated nephropathy (PVAN).
    • The member must not have a history of or currently active malignancy.
    Documentation Required

    Dose and Concomitant Immunosuppression

    Request the dose within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable FDA-approved labeling requirements, and document the required concomitant transplant immunosuppression regimen.

    • Use basiliximab induction if Nulojix is given at the time of transplant.
    • Use in conjunction with mycophenolate mofetil and corticosteroids.
    Documentation Required

    Annual Reauthorization Requires Clinical Response

    Annual reauthorization requires chart documentation from the prescriber that the member's condition has improved based on the prescriber's assessment while on therapy. The renewal request must also remain within the manufacturer's FDA-approved dosing guidelines.

    • All prior authorization renewals are reviewed annually for Medical Necessity and continuation of therapy.
    Denial Risk

    Eligibility or Prescriber Requirements Not Met

    The request may be denied when the member is younger than 18, is not undergoing or has not undergone a renal transplant, or the prescriber does not meet the required specialty qualifications.

    • Prescriber must be a physician specializing in immunosuppression or renal transplantation.
    Denial Risk

    Testing, EBV, or Dosing Requirements Not Met

    The request may be denied when the required negative tuberculosis test is absent or outside the 6-month window, EBV seropositivity is not demonstrated, or the requested dose is outside the manufacturer's FDA-approved dosing guidelines.

    • Acceptable tuberculosis testing includes PPD or an IGRA whole-blood test such as QFT-GIT or T-SPOT.TB.
    • EBV seropositivity must be supported by EBV serology.
    Denial Risk

    Infection or Malignancy Exclusion

    The request may be denied when there is evidence of infection or a history of or currently active malignancy.

    • Disqualifying infections include PML, CMV, and PVAN, among others.
    Denial Risk

    Required Concomitant Immunosuppression Absent

    The request may be denied when the required transplant immunosuppression regimen is absent or incomplete.

    • Required concomitant therapy includes mycophenolate mofetil and corticosteroids.
    • Basiliximab induction is required if Nulojix is administered at the time of transplant.
    Organ transplant recipients without prior EBV exposure have an increased risk of post-transplant lymphoproliferative disorder.
    T Lymphocyte (T-Cell)
    DefinitionAn activated T lymphocyte is an immune cell involved in the body's immune response.
    Role in rejectionActivated T cells are the predominant mediators of immunologic rejection.
    Clinical relevanceT-cell activity is directly relevant to the immune rejection of a transplanted organ.

    Acceptable testing includes Tuberculin PPD or an IGRA whole-blood test.

  3. The member is EBV seropositive, as demonstrated by EBV serology.
  4. The member has no evidence of infection, including progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV), or polyoma virus-associated nephropathy (PVAN).
  5. The member has no history of or currently active malignancy.