Prior Auth Protocol

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

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 Over The Counter (OTC) cetirizine (Zyrtec^R) and OTC loratadine (Claritin^R)

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

General Information:

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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) Claritin^R (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-D^R 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
Zyrtec^R(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 (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
*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

* Requires Prior Authorization

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

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)

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. DRUGDEX^RSystem [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.