WHA

Allergen Immunotherapy Agents (Grastek®, Odactra™, Oralair®, Ragwitek®)

SELF-ADMINISTRATION - SUBLINGUAL

FDA Approved Indications:
  • Grastek
    • 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.
  • Odactra
    • Indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by 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. 
  • Oralair
    • Indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis 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. 
  • Ragwitek
    • 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.
Coverage Criteria:
 

1. Request for Grastek:

  • Dose does not exceed 2800 BAU* daily; AND
  • Prescribed by or in consultation with an allergist or immunologist; AND
  • Diagnosis of grass pollen-induced allergic rhinitis; AND
  • Patient is 5 to 65 years of age; 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
  • Inadequate response, intolerance, or contraindication to both of the following:
    • An intranasal corticosteroid (e.g., fluticasone nasal spray, mometasone nasal spray, flunisolide nasal spray); AND
    • An antihistamine (e.g., cetirizine, loratadine, azelastine nasal spray, olapatadine nasal spray)

*BAU - Bioequivalent Allergy Unit

2. Request for Odactra:

  • Dose does not exceed 12 SQ-HDM* daily; AND
  • Prescribed by or in consultation with an allergist or immunologist; AND
  • Diagnosis of house dust mite (HDM)-induced allergic rhinitis; AND
  • Patient is 18 to 65 years of age; AND
  • Positive for 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
  • Inadequate response, intolerance, or contraindication 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)

*SQ-HDM is the dose unit for Odactra.  SQ is a method of standardization of biological potency, major allergen content, and complexity of the allergen extract

3. Request for Oralair:

  • Dose does not exceed 300 IR* daily; AND
  • Prescribed by or in consultation with an allergist or immunologist; AND
  • Diagnosis of grass pollen-induced allergic rhinitis; AND
  • Patient is 5 to 65 years of age; 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 bluegrass mixed pollens; AND
  • Treatment will be initiated 4 months before the expected onset of the grass pollen season; AND
  • Inadequate response, intolerance, or contraindication 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)

*IR – index of reactivity 

4. Request for Ragwitek:

  • Dose does not exceed 12 Amb a 1-Unit daily; AND
  • Prescribed by or in consultation with an allergist or immunologist; AND
  • Diagnosis of short ragweed pollen-induced allergic rhinitis;  AND
  • Patient is 5 to 65 years of age; 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
  • Inadequate response, intolerance, or contraindication 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)
Reauthorization Criteria for Grastek, Odactra, Oralair, Ragwitek:
  • Dose does not exceed max FDA approved dose; AND
  • One of the following:
    • Patient has experienced an improvement in symptoms of their allergic rhinitis; OR
    • Patient has experienced a decrease in the number of medications needed to control allergy symptoms
Coverage Duration:
  • Initial: 12 months
  • Reauthorization: 12 months
     
Dosing:

1.  Grastek: One 2800 BAU tablet daily

2. Odactra: One 12 SQ-HDM tablet daily

3. Oralair:

  • For adults 18 through 65 years of age, One 300 IR tablet daily
  • For children and adolescents 5 through 17 years of age, the dose is increased over the first three days:
    • Age 5-17: 100 IR on day 1, 100 IR x 2 on day 2, and 300 IR on day 3 and thereafter
    • Age 18-65: 300 IR daily
  • Note: Oralair Child Starter Packs will only be approved for children less than 18 years of age

4. Ragwitek: One 12 Amb a 1-U tablet daily
 

Authorization is not covered for the following:
  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:

  • Administration

    • Administer first dose of Grastek, Odactra, Oralair, and Ragwitek under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. Observe patients in the office for at least 30 minutes following the initial dose

    • Safety and efficacy of initiating treatment in season has not been established

    • Data regarding the safety of restarting treatment after missing a dose are limited.  In the clinical trials, treatment interruptions for up to seven days were allowed.

    • Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use

  • Contraindications

    • Patient does not have severe, unstable, or uncontrolled asthma; history of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy; history of eosinophilic esophagitis; or hypersensitivity to any inactive ingredients contained in these products

Policy Updates:
  • 02/15/2022 – Updated policy approved by P&T to include Grastek, Oralair, Ragwitek
  • 02/18/2020 - Last reviewed Odactra policy
     
References:
  1. Grastek Prescribing Information. Catalent Pharma Solutions Limited. Swindon, UK. August 2020.
  2. Oralair Prescribing Information. GREER Laboratories, Inc. Lenoir, NC. December 2020.
  3. Ragwitek Prescribing Information. Catalent Pharma Solutions Limited. Swindon, UK. April 2021.
  4. Odactra Prescribing Information. Catalent Pharma Solutions Limited. Swindon, UK. August 2019.

Last review date: February 15, 2022