Pharmacy Prior Authorization Criteria

Sublingual Allergen Immunotherapy Products (Grastek, Odactra, Oralair, Ragwitek)

Indications for Prior Authorization

Grastek (Timothy Grass Pollen Allergen Extract)

• For diagnosis of Allergic Rhinitis
  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 persons 5 through 65 years of age. Grastek is not indicated for the immediate relief of allergic symptoms.

Odactra (House Dust Mite [Dermatophagoides farinae and Dermatophagoides pteronyssinus] Allergen Extract)

• For diagnosis of Allergic Rhinitis
  Indicated as immunotherapy for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. Odactra is approved for use in persons 12 through 65 years of age. Odactra is not indicated for the immediate relief of allergic symptoms.

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)

• For diagnosis of Allergic Rhinitis
  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 persons 5 through 65 years of age. Oralair is not indicated for the immediate relief of allergy symptoms.

Ragwitek (Short Ragweed Pollen Allergen Extract)

• For diagnosis of Allergic Rhinitis
  Indicated as immunotherapy 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 persons 5 through 65 years of age. Ragwitek is not indicated for the immediate relief of allergic symptoms.

Criteria

Grastek

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of grass pollen-induced allergic rhinitis
AND
• Patient has a positive skin test or in vitro test for pollen-specific IgE antibodies to Timothy Grass or cross-reactive grass pollens
AND
• Treatment will be initiated 3 months before the expected onset of the grass pollen season
AND
• Patient is 5 to 65 years of age
AND
• Trial and failure, contraindication, or intolerance to both of the following:
• An intranasal corticosteroid (e.g., fluticasone nasal spray, mometasone nasal spray, flunisolide nasal spray)
• An antihistamine (e.g., cetirizine, loratadine, azelastine nasal spray, olapatadine nasal spray)
AND
• Prescribed by or in consultation with an allergist or immunologist

Odactra

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of house dust mite (HDM)-induced allergic rhinitis
AND
• Positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts
AND
• Patient is 12 to 65 years of age
AND
• Trial and failure, contraindication, or intolerance to both of the following:
• An intranasal corticosteroid (e.g., fluticasone nasal spray, mometasone nasal spray, flunisolide nasal spray)
• An antihistamine (e.g., cetirizine, loratadine, azelastine nasal spray, olapatadine nasal spray)
AND
• Prescribed by or in consultation with an allergist or immunologist

Oralair

ORALAIR Child Starter Packs/Sample Kits will only be approved for children less than 18 years of age

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of grass pollen-induced allergic rhinitis
AND
• Patient has a positive skin test or in vitro test for pollen-specific IgE antibodies to any of the five grass species including sweet vernal, orchard, perennial rye, timothy or kentucky blue grass mixed pollens
AND
• Treatment will be initiated 4 months before the expected onset of the grass pollen season
AND
• Patient is 5 to 65 years of age
AND
• Trial and failure, contraindication, or intolerance to both of the following:
• An intranasal corticosteroid (e.g., fluticasone nasal spray, mometasone nasal spray, flunisolide nasal spray)
• An antihistamine (e.g., cetirizine, loratadine, azelastine nasal spray, olapatadine nasal spray)
AND
• Prescribed by or in consultation with an allergist or immunologist

Ragwitek

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of short ragweed pollen-induced allergic rhinitis
AND
• Patient has a positive skin test or in vitro test for pollen-specific IgE antibodies to short ragweed pollen
AND
• Treatment will be initiated 3 months before the expected onset of the ragweed pollen season
AND
• Patient is 5 to 65 years of age
AND
• Trial and failure, contraindication, or intolerance both of the following:
• An intranasal corticosteroid (e.g., fluticasone nasal spray, mometasone nasal spray, flunisolide nasal spray)
• An antihistamine (e.g., cetirizine, loratadine, azelastine nasal spray, olapatadine nasal spray)
AND
• Prescribed by or in consultation with an allergist or immunologist

Grastek, Odactra, Oralair, Ragwitek

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• One of the following:
• Patient has experienced improvement in the symptoms of their allergic rhinitis
OR
• Patient has experienced a decrease in the number of medications needed to control allergy symptoms

P & T Revisions

2024-12-20, 2023-12-11, 2023-02-13, 2023-01-04, 2021-12-11, 2021-08-02, 2021-06-01, 2020-12-29, 2020-01-24, 2020-01-21

References

1. Grastek Prescribing Information. Catalent Pharma Solutions Limited. Swindon, UK. August 2022.
2. Oralair Prescribing Information. GREER Laboratories, Inc. Lenoir, NC. October 2024.
3. Ragwitek Prescribing Information. Catalent Pharma Solutions Limited. Swindon, UK. September 2022.
4. Odactra Prescribing Information. Catalent Pharma Solutions Limited. Swindon, UK. October 2023.
5. Dykewicz MS, Wallace DV, Amrol DJ, et al. Rhinitis 2020: a practice parameter update. J Allergy Clin Immunol. 2020;146(4):721-767. doi:10.1016/j.jaci.2020.07.007.

---

Revision History

• 2024-12-20: 2025 UM Annual Review. No changes. Background updates
• 2023-12-11: 2024 UM Annual Review. No criteria changes. Updated references
• 2023-02-13: Updated Odactra for expanded indication for use in persons 12 through 65 years of age.
• 2023-01-04: 2023 UM Annual Review. No changes to criteria. Updated References
• 2021-12-11: Annual review - updated references.
• 2021-08-02: Updated criteria to include expanded indication for Ragwitek (age criterion). Updated background and references.
• 2021-06-01: Updated criteria to include expanded indication for Ragwitek (age criterion). Updated background and references.
• 2020-12-29: Annual review - updated references.
• 2020-01-24: Added examples of antihistamines and intranasal corticosteroids per PA request.
• 2020-01-21: Annual review - updated background and references. Combined reauth criteria in one section as they align for all products.

---