ALLERGEN EXTRACT-MIXED GRASS POLLEN

Guidelines for Use

INITIAL CRITERIA (NOTE:  FOR RENEWAL CRITERIA SEE BELOW)

Our guideline named ALLERGEN EXTRACT-MIXED GRASS POLLEN (Oralair) requires the following rule(s) be met for approval:

1. You have a diagnosis of allergic rhinitis (itchy, watery eyes, sneezing) caused by grass pollen
2. Your diagnosis is confirmed by a positive skin prick test and/or a positive titer (the amount of antibodies in the blood) to specific IgE (Immunoglobulin E) antibodies for any of the five grass types included in Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens)
3. You have tried or have a contraindication or intolerance to TWO of the following:
   1. Oral antihistamine
   2. Intranasal antihistamine
   3. Intranasal corticosteroid
   4. Leukotriene inhibitor
4. You have tried and failed subcutaneous allergen immunotherapy (SCIT) containing any of the five grass species included in Oralair (i.e., Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue grass mixed pollens)
5. You are between 5 and 65 years of age

RENEWAL CRITERIA

Our guideline named ALLERGEN EXTRACT-MIXED GRASS POLLEN (Oralair) requires the following rules be met for renewal:

1. You have history of paid claim(s) for the requested medication in the past 90 day
2. You have a previous authorization on file for the requested medication

Rationale

Promote appropriate utilization of Oralair based on FDA approved indication, dosage, and guidelines adopted from ARIA (Allergic Rhinitis and its Impact on Asthma) as well as the AAAAI (American Academy of Allergy, Asthma & Immunology) Practice Parameter on Allergen Immunotherapy.

Indications for Use

Oralair (5-Grass Pollen Allergy Extract Sublingual tablet containing Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass) is indicated 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 Oralair, in people ages 10 through 65 years.

Dosage and Administration

For adults 18 through 65 years of age, the dose is 300 IR daily.

For children and adolescents 10 through 17 years of age, the dose is increased over the first three days (day 1 = 1 x 100 IR, day 2 = 2 x 100 IR, day 3 = 1 x 300 IR).

References

GREER Laboratories, Inc. Oralair Package Insert. Lenoir, NC. December 2018.