Subject: Oralair PA 1132-A P02-2026 v2

Drug

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

Policy:

Indications

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

Grass Pollen-Induced Allergic Rhinitis

Authorization may be granted when the requested drug is being prescribed as immunotherapy for the treatment of grass pollen-induced allergic rhinitis when ALL of the following criteria are met:

·        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 the requested drug.

·        The patient does not have ANY of the following: severe, unstable or uncontrolled asthma; history of any severe systemic allergic reaction; history of any severe local reaction to sublingual allergen immunotherapy; history of eosinophilic esophagitis.

·        The requested drug is being prescribed by, or in consultation with, a healthcare professional with adequate training and experience in the diagnosis and treatment of allergic diseases.

Continuation of Therapy

Grass Pollen-Induced Allergic Rhinitis

Authorization may be granted when the requested drug is being prescribed as immunotherapy for the treatment of grass pollen-induced allergic rhinitis when ONE of the following criteria is met:

·        The patient has achieved or maintained improvement in rhinoconjunctivitis symptoms (e.g., runny nose, stuffy nose, sneezing, itchy nose, gritty/itchy eyes, watery eyes).

·        The patient had a reduction in use of allergy symptom-relieving medications (e.g., antihistamines, corticosteroids).

Duration of Approval (DOA)

·        1132-A: DOA: 12 months

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, Lexi-Drugs. Waltham, MA: UpToDate, Inc.; 2026. https://online.lexi.com. Accessed January 03, 2026.

3.     Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 01/02/2026).

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.

June 13, 2026