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    v1.0.28
    OpenPayerPolicy UpdatesClinical/Medical PolicyAlaska Medicaid Krystexxa Prior Auth Coverage | Op…
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    CurrentAlaska MedicaidPolicy N/A

    Krystexxa (pegloticase) prior authorization

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    Prior authorization criteria for coverage of Krystexxa (pegloticase) for adults with chronic gout refractory to conventional therapy under Alaska Medicaid.

    Policy Summary
    PayerAlaska Medicaid
    PolicyKrystexxa (pegloticase) prior authorization
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Last ReviewMar 1, 2021
    Next Review DateN/A
    Key ActionObtain prior authorization with documentation demonstrating age ≥18, specialty consultation, baseline serum uric acid ≥6 mg/dL, G6PD screening, prior trial of allopurinol and febuxostat, and gout flare prophylaxis or contraindication.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    18+minimum patient age
    3 moinitial approval duration
    12 moreauthorization duration
    8 mg q2wdosing/quantity limit

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    J2507
    HCPCS code (max units)

    Coverage Criteria for Krystexxa (pegloticase)

    Initial Therapy Criteria

    Covered when ALL of the following are met:

    Initial Approval Criteria: 1) Patient is 18 years of age or older.
    Initial Approval Criteria: 2) Prescribed by or in consultation with a rheumatologist or nephrologist.

    Initial Approval Criteria

    • ONE of: a) Three or more flares in the past 18 months.
    • ONE of: b) At least 1 gout tophus.
    • ONE of: c) Chronic gouty arthritis.
    Initial Approval Criteria: 4) Baseline serum uric acid level >= 6 mg/dL.
    Initial Approval Criteria: 5) Patient has been screened for G6PD deficiency.
    Initial Approval Criteria: 6) Patient has a contraindication, intolerance, or treatment failure after 3 months of therapy with both allopurinol (Zyloprim) and febuxostat (Uloric).
    Initial Approval Criteria: 7) Patient is currently (within the last 30 days) receiving prophylaxis for gout flares with NSAID, colchicine, or both, or has a contraindication to prophylaxis.

    Continuation Therapy Criteria

    Reauthorization covered when the following is met:

    Reauthorization: Prescriber documents positive clinical response to therapy.

    Reauthorization may be approved for up to 12 months when response is documented.

    There are no separate exclusions beyond the clinical cautions and screening requirements described in this policy. Providers should follow the listed precautions—such as premedication and monitoring for infusion-related anaphylaxis, screening for G6PD deficiency, using gout flare prophylaxis, and monitoring for potential congestive heart failure exacerbation—when considering Krystexxa (pegloticase).

    Use of Krystexxa (pegloticase) is not authorized if the documented information does not meet the stated approval criteria. Failure to meet the approval criteria will result in denial of coverage.

    Coding and Clinical Thresholds

    Covered HCPCS Codes / Quantity LimitHCPCSCovered
    J2507Pegloticase, for intravenous infusion
    inv-06: Baseline serum uric acid — threshold value
    Baseline serum uric acid threshold>= 6 mg/dL
    Measurement timingBaseline (pre-treatment) serum uric acid must be documented
    Documentation requiredPrescriber must include baseline serum uric acid in prior authorization request

    Provider Actions, Prior Authorization and Documentation

    Prior Authorization

    Authorization and quantity limits

    Prior authorization is required. Initial approval is granted for up to 3 months; reauthorization may be approved for up to 12 months when the prescriber documents a positive clinical response. Quantity is limited to one 8 mg IV infusion every two weeks (HCPCS J2507, max 16 billable units).

    • Initial Approval: up to 3 months.
    • Reauthorization Approval: up to 12 months with documented positive clinical response.
    • Quantity limit: one 8 mg IV infusion every two weeks (HCPCS J2507, max 16 billable units).
    Step Therapy

    Required prior urate-lowering therapy

    Patient must have a contraindication, intolerance, or treatment failure after at least 3 months of therapy with both allopurinol (Zyloprim) and febuxostat (Uloric) prior to approval.

    • Requirement applies to both: Zyloprim (allopurinol) and Uloric (febuxostat).

    Background

    Pegloticase (Krystexxa) is a PEGylated uric acid–specific enzyme approved for adult patients with chronic gout refractory to conventional therapy. It is reserved for individuals who have failed or cannot tolerate standard urate-lowering treatments and requires pre-treatment screening for G6PD deficiency and monitoring for infusion reactions, including potential anaphylaxis and exacerbation of congestive heart failure.

    Definitions

    inv-12: Chronic gout refractory to conventional therapy — operational definition and criteria
    Operational definitionChronic gout refractory to conventional therapy: adults with persistent gout meeting at least one of the following—three or more flares in the past 18 months, at least one gout tophus, or chronic gouty arthritis
    Prior therapy requirementContraindication, intolerance, or treatment failure after at least 3 months of therapy with both allopurinol (Zyloprim) and febuxostat (Uloric)
    Age and specialtyPatient must be ≥18 years and therapy prescribed by or in consultation with a rheumatologist or nephrologist
    Safety screening and prophylaxisPatient must be screened for G6PD deficiency and currently (within last 30 days) receiving gout flare prophylaxis (NSAID or colchicine) or have a contraindication to prophylaxis
    Policy Summary
    PayerAlaska Medicaid
    PolicyKrystexxa (pegloticase) prior authorization
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Last ReviewMar 1, 2021
    Next Review DateN/A
    Key ActionObtain prior authorization with documentation demonstrating age ≥18, specialty consultation, baseline serum uric acid ≥6 mg/dL, G6PD screening, prior trial of allopurinol and febuxostat, and gout flare prophylaxis or contraindication.
    SourceLink
    On This Page
    Coverage Criteria for Krystexxa (pegloticase)Coding and Clinical ThresholdsProvider Actions, Prior Authorization and DocumentationBackgroundDefinitions
  1. Failure, intolerance, or contraindication after 3 months of therapy is required.
    2. Documentation Required

    Required documentation

    Document the prescriber specialty and patient details: patient is age 18 or older; prescribed by or in consultation with a rheumatologist or nephrologist; diagnosis of chronic gout per criteria; baseline serum uric acid ≥ 6 mg/dL; screening for G6PD deficiency; prior therapy history; and current gout-flare prophylaxis or documented contraindication.

    • Patient age ≥ 18 years.
    • Prescribed by or in consultation with a rheumatologist or nephrologist.
    • Diagnosis meeting chronic gout criteria (three+ flares in 18 months OR ≥1 tophus OR chronic gouty arthritis).
    • Baseline serum uric acid ≥ 6 mg/dL.
    • Documented G6PD screening.
    • Documentation of prior allopurinol and febuxostat therapy outcomes.
    • Current prophylaxis for gout flares within last 30 days or a contraindication to prophylaxis.
    Denial Risk

    Denial for unmet criteria

    Use is not authorized if the approval criteria are not met; failure to meet the stated approval criteria will result in denial.

    • Denial occurs when any of the approval criteria (age, prescriber specialty, diagnosis, laboratory/screening, prior therapy, or prophylaxis requirements) are unmet.