Prior Auth Protocol

FDA Approved Indications:

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:

Seasonal Allergic Rhinitis-relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older
Perennial Allergic Rhinitis-relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older
Chronic Idiopathic Urticaria-treatment of uncomplicated skin manifestations of chronic idiopathic urticarial in adults and children 6 months of age and older

Health Net Approved Indications and Usage Guidelines:

Diagnosis of allergic rhinitis or chronic idiopathic urticaria

AND

Failure or clinically significant adverse effects to two of the following: OTC (Over The Counter) cetirizine (Zyrtec^R) OTC loratadine (Claritin^R) or OTC fexofenadine (Allegra^R Allergy)

Coverage is Not Authorized For:

Xyzal, Clarinex and Clarinex-D 12 and 24 Hour are not covered by Health Net Arizona
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.

General Information:

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Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Prescription and Over the Counter (OTC) Antihistamines (Coverage of OTC agents may vary with plan formulary and benefit design) OTC loratadine (Claritin^R)	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
OTC loratadine-pseudoephedrine (Claritin-D^R 12 Hour and 24 Hour)	≥12 yrs: 1 tablet PO BID (12hr) or QD (24hr)	Loratadine-10 mg/day Pseudoephedrine-240 mg/day
OTC cetirizine (Zyrtec^.)	6 to 23 months:2.5 mg PO QD 12-23 months:2.5 mg PO every 12 hours 2 to 5 yrs: 2.5-5 mg PO QD ≥6 yrs: 10 mg PO QD	6 to 23 months:2.5 mg/day 12-23 months:5 mg/day 2 to 5 yrs:5 mg/day ≥6 yrs:10 mg/day
OTC cetirizine pseudoephedrine (Zyrtec-D^R 12 Hour)	≥12 yrs: 1 tablet PO BID	Cetirizine-10 mg/day Pseudoephedrine-120 mg/day
OTC fexofenadine (Allegra Allergy^R)	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	6 months-2 yrs:30 mg/day 2 to 11 yrs: 60 mg/day ≥12 yrs:180 mg/day
fexofenadine-D (Allegra-D^R12 and 24 Hour)	≥12 yrs: 1 tablet PO BID (12hr) or QD (24hr)	Fexofenadine-180 mg/day Pseudoephedrine-240 mg/day
Intranasal Steroids fluticasone propionate (Flonase^R)	≥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 AQ^R)	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
Nasonex^R(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
Intraneasal Antihistamine azelastine (Astelin^R)	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

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Clarinex	Perennial Allergic Rhinitis and Chronic Idiopathic Urticaria 6-11 months: 1 mg PO QD 12 months-5 yrs: 1.25 mg PO QD 6-11 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

Product Availability:

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)

References:

1. Clarinex Tablets, Oral Solution, Reditabs [Prescribing Information] Whitehouse Station, NJ: Schering Corp; April 2014.

2. Clarinex-D 12 Hour [Prescribing Information] Kenilworth, NJ: Schering Corp; March 2014.

3. Clarinex-D 24 Hour [Prescribing Information] Kenilworth, NJ: Schering Corp;. March 2014.

4. Xyzal [Prescribing Information] Smyrna, GA: UCB, Inc; November 2013.

5. 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.

6. Institute for Clinical Systems Improvement (ICSI). Rhinitis. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2003.

7. Clinical Pharmacology Website. Available at: http://cpip.gsm.com/. Accessed June 17,2015.

8. DRUGDEX^RSystem [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed June 17,2015.

9. American Hospital Formulary Service Drug Information. AHFS Web site. Available at:http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 17, 2015.