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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCountyCare Alpha1 Inhibitors Prior Auth | OpenPaye…
    Ask Trek AI about this page
    ModifiedCountyCarePolicy 5003.CC

    Alpha1 Proteinase Inhibitors

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    This guideline governs prior authorization for alpha1 proteinase inhibitors provided under the health plan's medical benefit and applies to practitioners providing the requested drug for Medicaid members.

    Policy Summary
    PayerCountyCare
    PolicyAlpha1 Proteinase Inhibitors
    Policy CodePolicy 5003.CC
    Change TypeModified
    Effective DateMarch 2026
    Next Review DateNot specified
    Key ActionObtain prior authorization and document the member's diagnosis, qualifying phenotype, laboratory results, pulmonary function findings, nonsmoking status, and IgA status.
    SourceLink
    POLICY UPDATE CHANGES

    Initial criteria include forced expiratory volume in one second (FEV1) thresholds for authorization.

    Reauthorization criteria were updated to require documented positive clinical response and continued nonsmoking status.

    The guideline was converted to a new format without major changes.

    4Alpha1 proteinase inhibitor brands identified
    18+Minimum member age for initial therapy
    <11 μmol/LBaseline serum alpha1-antitrypsin concentration

    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.

    <65% or ≥100 mL/yearFEV1 threshold for initial authorization
    Up to 1 yearInitial authorization duration
    AnnualReauthorization review frequency

    Coverage Criteria

    Initial Therapy

    Covered when ALL of the following are met.

    Initial therapy

    • Provider and member eligibility

      • The drug is prescribed by, or in consultation with, a pulmonologist.
      • The member is age 18 years or older.≥18 years

    • Diagnosis and phenotype

      • The member has a confirmed diagnosis of congenital alpha1-antitrypsin deficiency with clinically evident emphysema or airflow obstruction.
      • The member has an alpha1-antitrypsin phenotype of PI*ZZ, PI*ZNull, or PI*NullNull.

    • Serum concentration

      • The baseline pretreatment serum alpha1-antitrypsin concentration is below the required threshold by either accepted testing method.<11 μmol/L; alternatively <57 mg/dL by nephelometry or <80 mg/dL by radial immunodiffusion

        Either laboratory measurement method may establish the threshold.

    • ONE of: Pulmonary function requirement

      • FEV1 is less than 65% of predicted value.FEV1 <65% of predicted value
      • FEV1 has declined by at least 100 mL per year.Decline ≥100 mL/year

    • Dose and safety requirements

      • The prescribed dose is within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, as listed in the FDA-approved labeling.
      • The member is currently a non-smoker.
      • The member does not have selective immunoglobulin A deficiency with known antibodies against IgA (anti-IgA antibodies).

    Reauthorization Criteria

    Covered for annual reauthorization when ALL of the following are met.

    Annual continuation therapy

    • The member demonstrates a positive clinical response.

      Examples include decreased frequency of exacerbations or a slowed rate of FEV1 decline.

    • The member remains a non-smoker.
    • The prescribed dose is within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, as listed in the FDA-approved labeling.

    Authorization is excluded for members with selective immunoglobulin A deficiency and known antibodies against IgA (anti-IgA antibodies).

    Applicable Codes and Clinical Thresholds

    Applicable CodesHCPCS
    J0256Injection, alpha 1-proteinase inhibitor (human), not otherwise specified, 10mg
    J0257Injection, alpha 1 proteinase inhibitor (human), (GLASSIA), 10 mg
    Baseline serum alpha1-antitrypsin concentration
    Required concentrationLess than 11 μmol/L
    Nephelometry alternativeLess than 57 mg/dL by nephelometry
    Radial immunodiffusion alternativeLess than 80 mg/dL by radial immunodiffusion
    FEV1
    Predicted-value thresholdFEV1 less than 65% of predicted value
    Annual decline thresholdFEV1 decline of at least 100 mL per year
    Coverage pathway

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for alpha1 proteinase inhibitors requested under the Health Plan’s medical benefit. The process applies to practitioners involved in providing the requested drug and uses FDA criteria to determine Medical Necessity.

    • Applies to the Health Plan’s medical benefit.
    • Requests are reviewed under the Health Plan’s prior authorization process.
    Documentation Required

    Diagnostic and Laboratory Documentation

    For an initial request, document the required diagnosis, clinical manifestations, phenotype, and laboratory findings confirming severe alpha1-antitrypsin deficiency.

    • Confirmed congenital alpha1-antitrypsin deficiency with clinically evident emphysema or airflow obstruction.
    • Alpha1-antitrypsin phenotype of PI*ZZ, PI*ZNull, or PI*NullNull.

    Clinical Background

    Alpha1-antitrypsin deficiency is a rare genetic condition characterized by low serum alpha1-antitrypsin, a serine protease inhibitor that limits neutrophil elastase activity. This imbalance increases the risk of emphysema and may also contribute to liver disease and other conditions.

    Key Definition

    Alpha1-antitrypsin deficiency
    DefinitionA rare genetic condition characterized by low levels of serum alpha1-antitrypsin (AAT).
    Protective functionAAT is a serine protease inhibitor that inhibits neutrophil elastase (NE).
    Tissue effectsNeutrophil elastase degrades elastin and other extracellular matrix components.
    Emphysema riskThe imbalance between AAT and NE increases the risk of emphysema.
    Other risksAAT deficiency also increases the risk of liver disease and several other conditions.

    Initial Therapy

    Initial Therapy

    Initial therapy requires all listed clinical, diagnostic, safety, and dosing criteria.

    Initial drug authorization

    • Prescriber and age

      • The drug is prescribed by, or in consultation with, a pulmonologist.
      • The member is age 18 years or older.≥18 years

    • Clinical diagnosis and phenotype

      • The member has a confirmed diagnosis of congenital alpha1-antitrypsin deficiency with clinically evident emphysema or airflow obstruction.

    Annual Reauthorization

    Annual Reauthorization

    Annual reauthorization requires ALL of the following criteria.

    Annual continuation therapy

    • The member demonstrates a positive clinical response.

      Examples include decreased frequency of exacerbations or a slowed rate of FEV1 decline.

    • The member remains a non-smoker.
    • The prescribed dose is within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, as listed in the FDA-approved labeling.
    Policy Summary
    PayerCountyCare
    PolicyAlpha1 Proteinase Inhibitors
    Policy CodePolicy 5003.CC
    Change TypeModified
    Effective DateMarch 2026
    Next Review DateNot specified
    Key ActionObtain prior authorization and document the member's diagnosis, qualifying phenotype, laboratory results, pulmonary function findings, nonsmoking status, and IgA status.
    SourceLink
    On This Page
    Coverage CriteriaApplicable Codes and Clinical ThresholdsAuthorization and Documentation RequirementsClinical BackgroundKey DefinitionInitial TherapyAnnual Reauthorization
    Either pulmonary function criterion may satisfy the requirement
    Member age
    Minimum age18 years or older
    ApplicabilityRequired for initial therapy
    Prescriber requirementPrescribed by, or in consultation with, a pulmonologist
  1. Baseline pretreatment serum alpha1-antitrypsin concentration <11 μmol/L, documented as either <57 mg/dL by nephelometry or <80 mg/dL by radial immunodiffusion.
    2. Documentation Required

    Pulmonary Function Documentation

    Include pulmonary function documentation demonstrating the required severity of airflow limitation or rate of decline.

    • Forced expiratory volume (FEV1) <65% of predicted, or
    • FEV1 decline of ≥100 mL per year.
    Documentation Required

    Smoking and IgA Status Attestation

    The provider must document or attest that the member meets the smoking-status requirement and does not have the specified IgA-related exclusion.

    • Member is currently a non-smoker.
    • Member does not have selective immunoglobulin (IgA) deficiency with known antibodies against IgA (anti-IgA antibodies).
    Documentation Required

    Renewal Documentation

    Renewals are reviewed annually for continued Medical Necessity. Document a positive clinical response, continued nonsmoking status, and dosing within the FDA-approved manufacturer guidelines.

    • Positive clinical response, such as decreased frequency of exacerbations or a slowed rate of FEV1 decline.
    • Member remains a non-smoker.
    • Dose remains within the manufacturer’s dosing guidelines based on diagnosis, weight, and other applicable factors listed in the FDA-approved labeling.
    Denial Risk

    Failure to Meet Authorization Criteria

    If the established authorization criteria are not met, the request may be referred to a Medical Director for review when required by the plan and level of request. Requests that do not satisfy the applicable criteria may not be approved.

    • Ensure all initial or renewal criteria are addressed before submission.
    • Medical Director review does not guarantee approval.
    Denial Risk

    Missing Clinical Eligibility

    Initial requests are at risk for denial when required clinical eligibility is not documented. Missing or insufficient evidence of the qualifying deficiency, eligible phenotype, or required clinical findings may prevent approval.

    • No confirmed congenital alpha1-antitrypsin deficiency with emphysema or airflow obstruction.
    • Phenotype is not PI*ZZ, PI*ZNull, or PI*NullNull.
    • Required serum alpha1-antitrypsin laboratory documentation is absent or does not meet the threshold.
    • Required FEV1, smoking-status, IgA-status, prescriber, age, or FDA-approved dosing documentation is absent.
    The member has an alpha1-antitrypsin phenotype of PI*ZZ, PI*ZNull, or PI*NullNull.

  2. Laboratory requirement

    • The baseline pretreatment serum alpha1-antitrypsin concentration is less than 11 μmol/L, documented by either accepted laboratory method.<11 μmol/L; <57 mg/dL by nephelometry; or <80 mg/dL by radial immunodiffusion

      Either laboratory measurement method may establish the threshold.

  3. ONE of: Pulmonary function requirement

    • FEV1 is less than 65% of predicted value.FEV1 <65% of predicted value
    • FEV1 has declined by at least 100 mL per year.Decline ≥100 mL/year

  4. Safety and dosing requirements

    • The prescribed dose is within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, as listed in the FDA-approved labeling.
    • The member is currently a non-smoker.
    • The member does not have selective immunoglobulin A deficiency with known antibodies against IgA (anti-IgA antibodies).