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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyCigna Adzynma Coverage Prior Auth Update | OpenPay…
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    CurrentCignaPolicy IP0606

    Hematology - Adzynma

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    Prior authorization and medical necessity criteria for Adzynma in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura.

    Policy Summary
    PayerCigna
    PolicyHematology - Adzynma
    Policy CodePolicy IP0606
    Change TypeRevised
    Effective DateOct 15, 2026
    Last ReviewSep 10, 2026
    Next Review DateN/A
    Key ActionSubmit patient-specific documentation showing baseline ADAMTS13 activity below 10%, no anti-ADAMTS13 autoantibodies, and a pathogenic ADAMTS13 gene variant.
    SourceLink
    POLICY UPDATE CHANGES

    The criterion requiring a pathogenic variant in the ADAMTS13 gene was revised to remove the alternative wording "or a mutation," and the related note was revised accordingly.

    1 yearApproval duration
    <10%Baseline ADAMTS13
    40 IU/kg weeklyRoutine prophylaxis
    135 IU/kg/weekOn-demand dose
    J7171Covered HCPCS code

    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.

    Medical Necessity and Coverage Criteria

    Adzynma for any use other than the covered indication of congenital thrombotic thrombocytopenic purpura is not covered under this policy.

    Adzynma used for any other indication is considered not medically necessary.

    Coding and Dosing Parameters

    Considered Medically Necessary HCPCS CodesHCPCSCovered
    J7171Injection, ADAMTS13, recombinant-krhn, 10 IU
    Baseline ADAMTS13 activity
    Threshold< 10% (< 10 IU/dL)
    Routine prophylaxis dose
    Maximum routine doseUp to 40 IU/kg by intravenous infusion once weekly
    On-demand therapy dose
    Maximum weekly doseUp to 135 IU/kg by intravenous infusion per week as needed for the treatment of acute event(s)

    Authorization, Documentation, and Denial Risks

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for benefit coverage of Adzynma. Approval requires that the patient meet the applicable coverage criteria and dosing requirements for the listed indication.

    Documentation Required

    Hematologist Involvement Required

    Adzynma must be prescribed by or in consultation with a physician who specializes in the condition being treated. For congenital thrombotic thrombocytopenic purpura, this requires hematologist involvement.

    • Document the prescribing hematologist or hematologist consultation in the patient record.
    Documentation Required

    Diagnostic Documentation Required

    Condition and Treatment Context

    Congenital thrombotic thrombocytopenic purpura (TTP) is a rare inherited disorder caused by severe deficiency of ADAMTS13, an enzyme that regulates blood clotting. This deficiency promotes formation of small-vessel thrombi and may cause bleeding episodes, stroke, organ injury, and death if untreated.

    Policy Definitions

    Congenital thrombotic thrombocytopenic purpura
    ADAMTS13 activityBelow 10 IU/dL
    Anti-ADAMTS13 antibodiesAbsent
    Genetic confirmationHomozygous or compound heterozygous variants in the ADAMTS13 gene
    Baseline
    TimingBefore any treatment is received
    Included treatmentsAdzynma or plasma-based therapies
    Policy Summary
    PayerCigna
    PolicyHematology - Adzynma
    Policy CodePolicy IP0606
    Change TypeRevised
    Effective DateOct 15, 2026
    Last ReviewSep 10, 2026
    Next Review DateN/A
    Key ActionSubmit patient-specific documentation showing baseline ADAMTS13 activity below 10%, no anti-ADAMTS13 autoantibodies, and a pathogenic ADAMTS13 gene variant.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaCoding and Dosing ParametersAuthorization, Documentation, and Denial RisksCondition and Treatment ContextPolicy Definitions

    Submit patient-specific documentation supporting all required diagnostic criteria. Documentation may include chart notes, laboratory results, medical test results, claims records, or other relevant information, and must include patient-specific identifying information.

    • Baseline, prior-to-therapy ADAMTS13 activity < 10% (< 10 IU/dL); baseline must be before Adzynma or any plasma-based therapy.
    • Diagnostic test showing the patient does not have anti-ADAMTS13 autoantibodies.
    • Documentation of a pathogenic variant in the ADAMTS13 gene; variants are usually homozygous or compound heterozygous.
    • Documentation that Adzynma is prescribed by or in consultation with a hematologist.
    Denial Risk

    Required Diagnostic and Specialist Criteria Not Met

    Coverage approval for congenital thrombotic thrombocytopenic purpura requires all diagnostic and specialist criteria. Requests that do not establish each required criterion may be denied.

    • ADAMTS13 activity at baseline is not < 10% (< 10 IU/dL), or baseline testing was not performed before treatment.
    • Anti-ADAMTS13 autoantibody status is positive or not documented by a diagnostic test.
    • A pathogenic ADAMTS13 gene variant is not documented.
    • Adzynma is not prescribed by or in consultation with a hematologist.
    Denial Risk

    Non-Covered Indication

    Adzynma used for indications other than congenital thrombotic thrombocytopenic purpura is considered not medically necessary under this policy.

    • The covered indication is congenital thrombotic thrombocytopenic purpura.
    • Criteria may be updated as new published data become available.
    Billing Rule

    Nonstandard Dosing or Coding Requires Review

    Requests outside the established dosing or coding parameters are not automatically approved and require case-by-case review by a Cigna clinician, such as a Medical Director or Pharmacist.

    • Routine prophylaxis: up to 40 IU/kg by intravenous infusion once weekly.
    • On-demand therapy: up to 135 IU/kg per week by intravenous infusion as needed for acute events.
    • On-demand therapy may be given daily until 2 days after the acute event resolves, but the total weekly dose must not exceed 135 IU/kg.
    • Doses outside the established dosing require case-by-case clinical review.