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Prior Authorization Protocol
ALLEGRAR(fexofenadine), ALLEGRA-DR 12 and 24 HOUR (fexofenadine/pseudoephedrine),
CLARINEX
R(desloratadine), CLARINEX-DR12 and 24 HOUR (desloratadine/pseudoephedrine), XYZALR (levocetirizine)

HNMC
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:
    Allegra
    • Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older
    • Chronic Idiopathic Urticaria: treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months of age and older
    Allegra-D 12 and 24 Hour
    • Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older
    Clarinex
    • Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older
    • Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older
    • Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 6 months of age and older
    Clarinex-D 12 and 24 Hour
    • Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older
    Xyzal
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of allergic rhinitis or chronic idiopathic urticaria
    AND
    • Failure or clinically significant adverse effects to Over The Counter (OTC) cetirizine (ZyrtecR) and OTC loratadine (ClaritinR)
  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:

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  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Over the Counter Antihistamines
    (Coverage of OTC agents may vary with plan formulary and benefit design)

    ClaritinR (OTC Loratadine)

    2 to 5 yrs:
    5 mg PO QD
    ≥6 yrs:
    10 mg PO QD

    2 to 5 yrs: 5 mg/day
    ≥6 yrs: 10 mg/day

    Claritin-DR 12 Hour (5 mg loratadine/120 mg pseudoephedrine) and 24 Hour (10 mg loratadine/240 mg pseudoephedrine) (OTC loratadine/pseudoephedrine)

    ≥ 12 yrs:
    1 tab PO BID (12hr) or
    QD (24hr)

    Loratadine: 10 mg/day
    Pseudoephedrine: 240 mg/day

    ZyrtecR (OTC cetirizine)

    6 to 12 months: 2.5 mg PO QD

    12-23 months: up to 2.5 mg PO BID

    2 to 5 yrs: up to 2.5 mg BID or 5 mg PO QD

    ≥ 6 yrs: 10 mg PO QD

    6 to 12 months :2.5 mg/day
    12-23 months: 5 mg/day
    2 to 5 yrs: 5 mg/day
    6 yrs: 10 mg/day

    Zyrtec-D 12 Hour (cetirizine 5 mg /pseudoephedrine 120 mg)

    ≥ 12 yrs:
    1 tab PO BID
    Cetirizine: 10 mg/day
    Pseudoephedrine: 120 mg/day

    Intranasal Antihistamine

    azelastne (AstelinR)

    5 to 11 yrs:
    1 spray in each nostril BID
    ≥12 yrs:
    1-2 sprays in each nostril BID

    4 sprays in each nostril/day

    Intranasal Steroids

    fluticasone propionate (FlonaseR)

    4 yrs: 1-2 sprays in each nostril QD
    12 yrs: 1-2 sprays in each nostril QD

    2 sprays in each nostril/day

    triamcinolone acetonide (Nasacort AQR)
    2 to 12 yrs: 1 spray in each nostril QD
    12 yrs: 2 sprays in each nostril QD
    2 to 5 yrs: 1 spray in each nostril/day
    6 yrs: 2 sprays in each nostril/day
    NasonexR (mometasone furoate monohydrate)
    2 to 11 yrs: 1 spray in each nostril QD
    12 yrs: 2 sprays in each nostril QD
    2 to 11 yrs: 1-2 sprays in each nostril QD
    ≥ 12 yrs: 2 sprays in each nostril/day
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Allegra

    Chronic Idiopathic Urticaria
    6 months - 2 yrs: 15 mg PO BID
    2 to 11 yrs: 30 mg PO BID
    >12 yrs: 60 mg PO BID or 180 mg PO QD
    Seasonal Allergic Rhinitis
    2 to 11 yrs: 30 mg PO BID
    >12 yrs: 60 mg PO BID or 180 mg PO QD

    Length of benefit

    Allegra-D

    Seasonal Allergic Rhinitis
    > 12 yrs: 1 tab PO BID (12hr) or QD (24hr)

    Length of benefit

    Clarinex

    Perennial Allergic Rhinitis and Chronic Idiopathic Urticaria
    6 to 11 months: 1 mg PO QD
    12 months to 5 yrs: 1.25 mg PO QD
    6 to 11 yrs: 2.5 mg PO QD
    > 12 yrs: 5 mg PO QD

    Seasonal Allergic Rhinitis
    2-5 yrs: 1.25 mg PO QD
    6 to 11 yrs: 2.5 mg PO QD
    > 12 yrs: 5 mg PO QD

    Length of benefit

    Clarinex-D 12 hour and 24 Hour

    Seasonal Allergic Rhinitis
    > 12 yrs: 2.5 mg/120 mg PO BID or 5 mg/240 mg PO QD

    Length of Benefit

    Xyzal

    Perennial Allergic Rhinitis & Urticaria
    6 months to 5 yrs: 1.25 mg PO QD
    6 to 11 yrs: 2.5 mg PO QD
    > 12 yrs: 5 mg PO QD

    Seasonal Allergic Rhinitis
    2 to 5 yrs: 1.25 mg PO QD
    6 to 11 yrs: 2.5 mg PO QD
    > 12 yrs: 5 mg PO QD

    Length of Benefit

  7. Product Availability:
    Allegra (fexofenadine) Tablet: 30 mg, 60 mg, 180 mg
    Allegra Orally Disintegrating Tablet: 30 mg
    Allegra Suspension: 6 mg/ml (300 ml bottle)
    Allegra-D 12 Hour Tablet: 60 mg/120 mg
    Allegra-D 24 Hour Tablet: 180 mg/240 mg
    Clarinex Tablet: 5 mg
    Clarinex Reditabs: 2.5 mg, 5 mg
    Clarinex Syrup: 0.5 mg/ml (120 ml or 473 ml bottle)
    Clarinex-D 12 Hour Tablet: 2.5 mg/120 mg
    Clarinex-D 24 Hour Tablet: 5 mg/240 mg
    Xyzal Tablet: 5 mg
    Xyzal Oral Solution: 2.5 mg/5 ml (148 ml bottle)
  8. References:
    1. Allegra [Prescribing Information] Bridge Water, NJ: Sanofi-Aventis; June 2008.
    2. Allegra-D 12 Hour. [Prescribing information] Bridge Water, NJ: Sanofi-Aventis; June 2015.
    3. Allegra-D 24 Hour. [Prescribing information] Bridge Water, NJ: Sanofi-Aventis; June 2015.
    4. Clarinex Tablets, Oral Solution, Reditabs [Prescribing Information] Whitehouse Station, NJ: Schering Corp; April 2014.
    5. Clarinex-D 12 Hour [Prescribing Information] Kenilworth, NJ: Schering Corp; March 2014.
    6. Clarinex-D 24 Hour [Prescribing Information] Whitehouse Station, NJ: Schering Corp;. March 2014.
    7. Xyzal [Prescribing Information]. Smyrna, GA: UCB, Inc; November 2013..
    8. Dykewicz et al. Diagnosis and management of rhinitis: Complete guidelines of the Joint Task Force on Practice Parameters in allergy, asthma and immunology. Ann Allergy Asthma Immunol 1998;81:478-518.Allergic rhinitis and it's impact on asthma. J Allergy Clin Immunol 2001 Nov;108(5):S147-334.
    9. Institute for Clinical Systems Improvement (ICSI). Rhinitis. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2003.
    11. DRUGDEXRSystem [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed June 26 ,2015.
    12. American Hospital Formulary Service Drug Information. AHFS Web site. Available at:http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 26, 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.