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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsFlorida AHCA Carbaglu Prior Auth | OpenPayer
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    CurrentAgency for Health Care AdministrationPolicy N/A

    Carbaglu (carglumic acid) Coverage Criteria

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    This policy governs prior authorization for Carbaglu (carglumic acid) for patients with specified causes of acute or chronic hyperammonemia. It applies to providers submitting medical records and laboratory documentation for initial or continued therapy.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCarbaglu (carglumic acid) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit medical records confirming a covered diagnosis and official laboratory results for the applicable therapy review.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsMaximum authorization duration
    3Covered clinical indication pathways
    3 monthsInitial ammonia result recency
    6 monthsContinuation ammonia result recency
    200 mg

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    Available tablet strength

    Coverage Criteria

    Initial Therapy

    Covered for initial therapy when all of the following are met.

    Initial therapy requirements

    • Covered indication

      • Acute hyperammonemia due to NAGS deficiency: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
      • Chronic hyperammonemia due to NAGS deficiency: Maintenance therapy for the treatment of chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
      • Acute hyperammonemia due to PA or MMA: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA).
    • Elevated ammonia laboratory result: Official laboratory results indicate an elevated ammonia level.Results dated within the past 3 months

    Continuation Therapy

    Covered for continuation therapy when all of the following are met.

    Continuation therapy requirements

    • Prior approval criteria met: The patient met initial approval criteria.
    • Normal or improved ammonia laboratory result: Official laboratory results indicate a normal or improved ammonia level.Results dated within the past 6 months

    Submission Requirements and Denial Risks

    Prior Authorization

    Obtain prior authorization before treatment

    Carbaglu requires prior authorization. Initial approval is available for up to 6 months when the patient has a confirmed covered indication and current laboratory evidence of elevated ammonia.

    Documentation Required

    Document the diagnosis and treatment indication

    Submit medical records confirming one of the covered diagnoses and the applicable treatment indication.

    • Adjunctive therapy to standard of care for acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
    • Maintenance therapy for chronic hyperammonemia due to NAGS deficiency.
    • Adjunctive therapy to standard of care for acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA).

    Policy Background

    Carbaglu (carglumic acid) is reviewed for the treatment of hyperammonemia associated with covered metabolic disorders. Coverage includes adjunctive treatment for acute hyperammonemia due to N-acetylglutamate synthase deficiency, propionic acidemia, or methylmalonic acidemia, and maintenance treatment for chronic hyperammonemia due to N-acetylglutamate synthase deficiency. Initial and continued therapy require supporting ammonia laboratory results; initial results must show an elevated ammonia level and be dated within the past 3 months, while continuation results must show a normal or improved ammonia level and be dated within the past 6 months.

    Clinical Abbreviations

    NAGS
    TermN-acetylglutamate synthase (NAGS)
    Acute-use contextNAGS deficiency associated with acute hyperammonemia requiring adjunctive therapy to standard of care.
    Chronic-use contextNAGS deficiency associated with chronic hyperammonemia requiring maintenance therapy.
    PA
    TermPropionic acidemia (PA)
    Covered treatment contextPA associated with acute hyperammonemia requiring adjunctive therapy to standard of care.
    Review requirement

    Initial Therapy

    Initial Therapy

    Initial therapy is covered when all of the following are met.

    Initial therapy requirements

    • ONE of the covered indication pathways

      • NAGS acute hyperammonemia: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
      • NAGS chronic hyperammonemia: Maintenance therapy for the treatment of chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
      • PA or MMA acute hyperammonemia: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA).

    Continuation Therapy

    Continuation Therapy

    Continuation therapy is covered when all of the following are met.

    Continuation requirements

    • Prior approval criteria met: The patient met initial approval criteria.
    • Normal or improved ammonia laboratory result: Official laboratory results indicate a normal or improved ammonia level.Results dated within the past 6 months
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCarbaglu (carglumic acid) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit medical records confirming a covered diagnosis and official laboratory results for the applicable therapy review.
    SourceLink
    On This Page
    Coverage CriteriaSubmission Requirements and Denial RisksPolicy BackgroundClinical AbbreviationsInitial TherapyContinuation Therapy
    Documentation Required

    Submit a recent elevated ammonia result

    For initial review, submit official laboratory results dated within the past 3 months showing an elevated ammonia level.

    Documentation Required

    Submit a recent normal or improved ammonia result

    For continuation, submit official laboratory results dated within the past 6 months showing a normal or improved ammonia level.

    Denial Risk

    Avoid submitting an unconfirmed or noncovered diagnosis

    Authorization may be denied when the patient does not have a confirmed covered diagnosis of N-acetylglutamate synthase deficiency, propionic acidemia, or methylmalonic acidemia, as applicable.

    Denial Risk

    Do not omit the recent elevated ammonia result

    Initial authorization may be denied when submitted records do not include official laboratory results dated within the past 3 months showing an elevated ammonia level.

    Denial Risk

    Meet all continuation criteria

    Continuation may be denied when the patient did not meet initial approval criteria or when official laboratory results dated within the past 6 months do not show a normal or improved ammonia level.

    • Document that the patient met initial approval criteria.
    • Provide official laboratory results dated within the past 6 months.
    • Results must show a normal or improved ammonia level.
    Official laboratory results dated within the past 3 months must indicate an elevated ammonia level.
    MMA
    TermMethylmalonic acidemia (MMA)
    Covered treatment contextMMA associated with acute hyperammonemia requiring adjunctive therapy to standard of care.
    Review requirementOfficial laboratory results dated within the past 3 months must indicate an elevated ammonia level.
  1. Elevated ammonia laboratory result: Official laboratory results indicate an elevated ammonia level.Results dated within the past 3 months