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Prior Authorization Protocol
BERINERTR [C1 Esterase Inhibitor (Human)], KALBITORR (ecallantide), FIRAZYRR (icatibant), RUCONESTR (C1 esterase inhibitor [recombinant])


NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    BERINERT
    • For the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients
    • The safety and efficacy of Berinert for prophylactic therapy have not been established.
    KALBITOR
    • For the treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
    FIRAZYR
    • For treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older
    RUCONEST
    • For the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE)
    • Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks
  2. Health Net Approved Indications and Usage Guidelines:

    AND

    • Diagnosis of HAE confirmed by a specialist (hematologist, allergist, immunologist)
    AND
    • Documentation of the following laboratory results:
      • C4 level less than 14 mg/L
    AND
      • C1 Inhibitor (antigenic) level less than 19.9 mg/dL
    OR
      • C1 Inhibitor (functional) level less than 72% of the reference range
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature

  4. General Information:
    • Kalbitor should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and HAE.
    • Patients may self-administer Berinert, Firazyr, and Ruconest upon recognition of an HAE attack after training under the guidance of a healthcare professional.
    • Plasma levels for the diagnosis of HAE include the following: C4 level less than 14 mg/L (diagnostic); C1 Inhibitor (antigenic) level less than 19.9 mg/dL (diagnostic); C1 Inhibitor (functional) level less than 72% of the reference range (diagnostic).
    • C4 is normal between swelling events in only 2% of cases.
    • Normal C4 levels: 9-36 mg/dL
    • Normal Complement C1 Esterase Inhibitor, Antigen Serum = 21-39 mg/dL
    • Normal Complement C1 Esterase Inhibitor, Functional = greater than 67%.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Berinert

    Appropriately trained patients may self-administer upon recognition of an HAE attack.

    20 units per kg body weight by IV injection

    Length of Benefit

    Firazyr

    Patients may self-administer upon recognition of an HAE attack.

    30 mg injected SC in the abdominal area.

    If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours.

    Do not administer more than 3 injections in 24 hours.

    Length of Benefit

    Kalbitor

    30 mg administered SC in three 10 mg injections.

    If an attack persists, an additional 30 mg dose may be administered within a 24 hour period.

    Length of Benefit

    Ruconest

    Appropriately trained patients may self-administer upon recognition of an HAE attack.

    Body weight < 84 kg:
    50 units per kg body weight by IV injection

    Body weight ≥ 84 kg:
    4200 units by IV injection

    If an attack persists, an additional (second) dose can be administered at the recommended dose level.
    Do not exceed 4200 units per dose
    No more than two doses should be administered within a 24 hour period

    Length of Benefit

  7. Product Availability:
    Berinert: Single-use Vial: 500 units
    Kalbitor: Single-use Vials: 10 mg/mL
    Firazyr: Single-use, prefilled syringe: 30 mg/3 ml
    Ruconest: Single-use Vial: 2100 units
  8. References:
    1. Berinert [Prescribing Information]. Kankakee, IL: CSL Behring LLC; February 2015.
    2. Kalbitor [Prescribing Information]. Burlington, MA: Dyax Corp; March 2014.
    3. Firazyr [Prescribing Information]. Lexington, MA: Shire Orphan Therapies, Inc., August 2013.
    4. Ruconest [Prescribing Information]. Netherlands: Pharming Group N.V. February 2015.
    5. Huang SW. Pediatric Angioedema: Differential Diagnoses & Workup. EMedicine website. Available at http://emedicine.medscape.com/article/885100-workup. Accessed July 1, 2015.
    6. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/. Accessed July 1, 2015.
    7. Berinert. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 1, 2015.
    8. Kalbitor. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 1, 2015.
    9. Firazyr. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 1, 2015.
    10. DRUGDEXR System [Internet database]. Greenwood Village, Colo: Truven Health Analytics. Updated periodically. Accessed July 1, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.