Subject: Oralair PA Policy 1132-A 04-2022

Drug

ORALAIR  (sweet vernal, orchard, perennial rye, timothy and kentucky blue grass mixed pollens allergen extract)

Policy:

FDA-APPROVED INDICATIONS
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 persons 5 through 65 years of age.

Oralair is not indicated for the immediate relief of allergy symptoms.

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
    •   The requested drug is being prescribed as immunotherapy for the treatment of grass pollen-induced
         allergic rhinitis
    AND
    •   The diagnosis has been confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies
         for any of the 5 grass species (sweet vernal, orchard, perennial rye, timothy, kentucky blue grass)
         contained in this product
    AND
    •   The patient does not have any of the following: A) Severe, unstable or uncontrolled asthma, B) History
         of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy,
         C) History of eosinophilic esophagitis
    AND
    •   The requested drug is being prescribed by, or in consultation with, an allergist or immunologist

Place of Service:

Outpatient

The above policy is based on the following references:

1. Oralair [package insert]. Lenoir, North Carolina: GREER Laboratories, Inc.; November 2018.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2021; Accessed March 14, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed March 14, 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 14, 2022