Prior Auth Protocol

FDA Approved Indications:

Ragwitek: For the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Ragwitek is approved for use in adults 18 through 65 years of age.
Grastek: Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Grastek is approved for use in person 5 through 65 years of age.
Oralair: Oralair is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. Oralair is approved for use in person 10 through 65 years of age.

Health Net Approved Indications and Usage Guidelines:

AND

Failure or clinically significant adverse effects to 2 of the following: oral antihistamines, leukotriene modifiers or nasal steroids

OR

AND

Positive skin test or in vitro testing for pollen-specific IgE antibodies for allergens based on the requested drug (Ragwitek: short rageweed pollen, Grastek: Timothy grass or cross reactive species [Sweet vernal, Meadow fescue, Rye, June, Kentucky blue, Orchard, Red top, Velvet, Canary, Cereal grains (eg wheat, rye, barley)], Oralair: Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass

AND

Failure or clinically significant adverse effects to 2 of the following: oral antihistamines, leukotriene modifiers or nasal steroids

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.
Severe, unstable or uncontrolled asthma
History of any severe allergic reaction to allergen immunotherapy

General Information:

Patients should have confirmed IgE-mediated allergic reaction.
All agents can cause life-threatening allergic reactions such as anaphylaxis and severe layngopharyngeal restriction.
Agents should not be given to patients with severe, unstable, or uncontrolled asthma.
Patients should be observed for at least 30 minutes following the initial dose.
Patients should have an auto-injectable epinephrine and be instructed on its appropriate use.
Agents may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators such as those taking beta-blockers.
Safety and efficacy of Oralair in the pediatric population >= 5 years of age was demonstrated in a randomized clinical trial
Grastek was studied in patients for 3 years; patients maintained the effect for 1 year after discontinuing the drug, but not for the 2nd year.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Subcutaneous Immunotherapy (SCIT)	Various	Various
OTC loratadine (Claritin)	2 to 5 years: 5 mg PO QD ≥6 years: 10 mg PO QD	10 mg/day
OTC loratadine-D (Claritin-D 12 and 24 hour)	≥ 12 years: 1 tablet PO BID (12 hr) QD (24 hr)	10 mg/day
OTC cetirizine (Zyrtec)	2 to 5 years: 2.5-5 mg PO QD ≥6 years: 10 mg PO QD	10 mg/day
OTC fexofenadine (Allegra Allergy)	6-months to 2 years: 15 mg PO QD 2 to 11 years: 30 mg PO QD ≥ 12 years: 60 mg PO BID or 180 mg PO QD	180 mg/day
fluticasone priopionate (Flonase)	≥ 4 years: 1-2 sprays each nostril QD ≥ 12 years: 1-2 sprays each nostril QD	2 sprays each nostril/day
triamcinolone acetonide (Nasacort AQ)	2-11 years: 1-2 sprays each nostril QD ≥ 12 years: 2 sprays each nostril QD	2 sprays each nostril/day
Nasonex (mometasone furoate monohydrate)	2-11 years: 1-2 sprays each nostril QD ≥ 12 years: 2 sprays each nostril QD	2 sprays each nostril/day
azelastine (Astelin)	5-11 years: 1 spray each nostril BID ≥ 12 years: 2 sprays each nostril BID	4 sprays each nostril/day
Montelukast (Singulair)	2 to 5 years: 4 mg PO QD 6 to 14 years: 5 mg PO QD ≥15 years: 10 mg PO QD	10 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Oralair	Ages 18-65 years: 300 IR SL QD Ages 10-17 years: Day 1: 100 IR, Day 2: 2x100 IR: Day 3 and continuing: 300 IR SL QD Initiate treatment 4 months prior to and continuing throughout the grass pollen season	Length of Benefit
Ragwitek	1 tablet SL QD	Length of Benefit
Grastek	Ages ≥ 5 years: 1 tablet SL QD, starting 12 weeks before grass pollen season.	Length of Benefit

Product Availability:

Oralair Sublingual Tablets: 100 IR and 300 IR
Ragwitek: Tablet 12 Amb a 1-Unit (Amb a 1-U)
Grastek: Sublingual Tablet 2800 BAU

References:

Ragwitek [Package Insert]. Whitehouse Station, NJ. Merck Sharpe & Dohme Corp; 2014.
Grastek [Prescribing Information] Whitehouse Station, NJ: Merck & Co., Inc.; April 2014
Oralair [Prescribing Information]. Antony, France Stallergenes S.A: April 2014
Oralair: FDA Allergenic Products Advisory Committee Briefing Document: November 2013. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm367268.htm. Last accessed June 17, 2015
Wahn U et al. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjuncitivitis. J Allergy Clin Immunol 2009;123:160-166.e3
Didier A, et al. Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol 2011;128:559-66.
Cox L, et al. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: The importance of allergen-specific serum IgE. J Allergy Clin Immunol 2012;130:1327-34.e.1