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    v1.0.28
    OpenPayerPolicy UpdatesAllergy/Clinical ImmunologyAetna Cinryze Precertification Prior Auth | OpenPa…
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    CurrentAetnaPolicy N/A

    Cinryze (C1 esterase inhibitor, human) Medication Precertification Request Form and Requirements

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    Aetna precertification form and requirements for requesting initial or continuation authorization for Cinryze infusion therapy, intended for providers and facilities submitting precertification for members in North Carolina.

    Policy Summary
    PayerAetna
    PolicyCinryze precertification request form and requirements
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective Date
    Next Review Date
    Key ActionSubmit the completed 2-page Cinryze precertification form with all required clinical documentation and contact Aetna Precertification Notification (Phone: 1-866-752-7021; Fax: 1-888-267-3277).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2 pagesform length
    Required

    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.

    clinical info
    1-866-752-7021precert phone
    1-888-267-3277precert fax

    Coverage Criteria

    Initial and Continuation Therapy Documentation Requirements

    Coverage consideration requires completion of the precertification form and documentation of diagnosis and clinical response.

    Form completion: Completed precertification form with patient demographics, insurance, prescriber and dispensing provider details, product dose/frequency, place of administration, and administration site information

    All required clinical information must be completed in its entirety and legible; failure to complete may prevent evaluation of the request

    Diagnosis confirmation: Documentation that the patient has hereditary angioedema (HAE) and specification of HAE type: either (a) HAE with C1-INH deficiency/dysfunction confirmed by laboratory testing (low C1-INH antigenic level or low functional C1-INH, e.g., <50% or below the laboratory lower limit of normal) OR (b) HAE with normal C1-INH confirmed by genetic testing for known mutations or by clinical criteria (angioedema refractory to a trial of high-dose antihistamine for ≥1 month plus family history)

    Select and document which diagnostic criteria apply on the form

    Prescriber involvement: Requested medication prescribed by or in consultation with a prescriber who specializes in management of HAE

    Form includes checkbox asking whether specialist is involved

    Continuation therapy response

    • Attack frequency reduction: Patient experienced a significant reduction in frequency of acute HAE attacks (example threshold: >= 50% reduction)>= 50% reduction in frequency of acute attacks

      Document number of HAE attacks per month before and after treatment on the form

    • Reduced acute-attack medication use: Patient has reduced the use of medications to treat acute HAE attacks since starting the requested medication

      Document types and frequency of acute-attack medications used before and after treatment

    Outpatient infusion considerations and safety: If infusion is to occur in an outpatient hospital setting, document reason (e.g., prior severe infusion-related adverse event not responsive to conventional interventions, severe venous access issues, significant behavioral or cognitive impairment without caregiver access, or medical instability requiring monitored setting)

    Form includes specific checkboxes and request for descriptive details for these scenarios

    The precertification form includes a specific question asking whether the requested medication will be used in combination with any other medication used for the prophylaxis of hereditary angioedema (HAE) attacks. Providers must indicate combination use on the form when applicable so that concurrent prophylactic therapy is clear for the reviewer.

    Failure to provide required clinical information in full may prevent the reviewer from evaluating the request and can result in denial or requests for additional information. The form explicitly states that required clinical information must be completed in its entirety for all precertification requests, including diagnosis confirmation, attack frequency, prior therapy response, and relevant infusion safety details.

    Coding

    Administration CPT codes (provider-supplied)CPT
    Administration code(s) (CPT):Placeholder on form for provider to supply applicable CPT administration codes
    Diagnosis codes (provider-supplied)ICD-10
    Primary ICD Code, Secondary ICD Code, Other ICD CodePlaceholders for ICD-10 diagnosis codes relevant to HAE and other diagnoses
    inv-06: Response threshold for continuation
    Continuation response threshold>= 50% reduction in frequency of acute attacks since starting treatment (documented on continuation request)
    Alternative continuation evidenceReduced use of medications to treat acute attacks since starting treatment (documented yes/no on form)
    Documentation requirementFor continuation requests, clinical documentation of response must be provided for all requests

    Provider Actions / Submission Requirements

    Prior Authorization

    Precertification required — contact Aetna Precertification Notification

    Precertification (prior authorization) is required for Cinryze. Contact Aetna Precertification Notification by phone or fax and submit the completed form to initiate review.

    • Phone: 1-866-752-7021
    • Fax: 1-888-267-3277
    • Submit the completed Cinryze medication precertification request form with all fields legible
    Step Therapy

    Requirements for HAE with normal C1‑INH

    When requesting Cinryze for HAE with normal C1‑INH, include objective genetic testing results or documentation that angioedema was refractory to a trial of high‑dose antihistamine and a family history, as specified on the form.

    • Genetic testing showing mutation in F12, angiopoietin‑1, plasminogen, KNG1, HS3ST6, or MYOF
    • OR documentation of angioedema refractory to high‑dose antihistamine (e.g., cetirizine 40 mg/day or equivalent for ≥1 month) plus family history of angioedema

    Background

    Cinryze is a human C1 esterase inhibitor indicated for prevention of hereditary angioedema (HAE) attacks. The precertification form requests documentation confirming the HAE diagnosis (laboratory or genetic testing as applicable) and clinical response information for continuation requests, such as reduction in attack frequency and decreased use of acute-attack medications.

    Definitions

    inv-12: HAE with C1 inhibitor deficiency/dysfunction — lab criteria
    DefinitionHAE with C1 inhibitor deficiency/dysfunction confirmed by laboratory testing
    Antigenic level criterionC1-INH antigenic level below the lower limit of normal as defined by the laboratory performing the test
    Functional level criterionNormal C1-INH antigenic level with low functional C1-INH (functional C1-INH < 50% or below the laboratory lower limit of normal)
    Form selectionProvider must indicate which diagnostic condition applied at time of diagnosis on the precertification form
    inv-13: HAE with normal C1 inhibitor
    DefinitionHAE with normal C1 inhibitor confirmed by laboratory testing or clinical criteria
    Policy Summary
    PayerAetna
    PolicyCinryze precertification request form and requirements
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective Date
    Next Review Date
    Key ActionSubmit the completed 2-page Cinryze precertification form with all required clinical documentation and contact Aetna Precertification Notification (Phone: 1-866-752-7021; Fax: 1-888-267-3277).
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider Actions / Submission RequirementsBackgroundDefinitions
    Documentation Required

    Complete and legible two‑page form submission required

    Submit the completed two‑page Cinryze medication precertification request form with all fields legible, including patient demographics, insurance, prescriber and dispensing provider details, product dose/frequency, ICD codes, and required clinical information.

    • Required clinical information: diagnosis confirmation, lab or genetic test results, number of HAE attacks, prior therapy response, and continuation outcomes
    • Indicate whether prescribed by or in consultation with an HAE specialist
    Denial Risk

    Incomplete clinical information may lead to denial or inability to evaluate request

    Failure to complete the required clinical information in its entirety for all precertification requests may prevent evaluation of the request and can result in denial or requests for additional information.

    • Ensure sections G (Clinical Information) and the continuation therapy questions are fully completed
    • Provide lab values, genetic test results, trial details (e.g., antihistamine dose/duration), and response data
    Genetic testing confirmationPresence of F12, angiopoietin-1, plasminogen, KNG1, HS3ST6 or MYOF gene mutation as confirmed by genetic testing
    Clinical confirmation alternativeBoth: angioedema refractory to a trial of high‑dose antihistamine therapy (e.g., cetirizine 40 mg/day or equivalent for ≥1 month) AND family history of angioedema
    Form selectionProvider must indicate which diagnostic condition applied at time of diagnosis on the precertification form