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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
    • The relief of symptoms associated with seasonal and perennial allergic rhinitis
    • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of allergic rhinitis or chronic idiopathic urticaria
    AND
    • Failure or clinically significant adverse effects to 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




    10 mg/day

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

    >/= 12 yrs:
    1 tab PO BID (12hr) or
    QD (24hr)

    10 mg loratadine/240 mg pseudoephedrine

    Zyrtec (OTC cetirizine)

    2 to 5 yrs:
    2.5-5 mg PO QD
    >/= 6 yrs:
    10 mg PO QD

    10 mg/day

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

    >/= 12 yrs:
    1 tab PO BID

    10 mg cetirizine/240 mg pseudoephedrine

    Intranasal Antihistamine

    azelastne (AstelinR)



    5 to 11 yrs:
    1 spray each nostril BID
    >/=12 yrs:
    2 sprays each nostril BID



    4 sprays 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 (150 ml bottle)
  8. References:
    1. Allegra [Prescribing Information]. Bridge Water, NJ: Sanofi-Aventis; July 2007.
    2. Allegra-D 12 Hour. Prescribing information, Aventis. December 2009.
    3. Allegra-D 24 Hour. Prescribing information, Aventis. December 2009.
    4. Clarinex Tablets, Oral Solution, Reditabs [Prescribing Information]. Whitehouse Station, NJ: Schering Corp; December 2010.
    5. Clarinex-D 12 Hour [Prescribing Information]. Kenilworth, NJ: Schering Corp; December 2009.
    6. Clarinex-D 24 Hour [Prescribing Information]. Whitehouse Station, NJ: Schering Corp;. December 2009.
    7. Xyzal [Prescribing Information]. Smyrna, GA: UCB, Inc; September 2012.
    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.
    10. Clinical Pharmacology Website. Available at: http://cpip.gsm.com/. Accessed July 19, 2013.
    11. DRUGDEXR System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 19, 2013.
    12. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 19, 2013.
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.