Subject: Oralair Policy 1132-A 03-2019

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 10 through 65 years of age. Oralair is not indicated for the immediate relief of allergy symptoms.

1. Precertification Criteria

COVERAGE CRITERIA

The requested drug will be covered with prior authorization when the following criteria are met:

• The requested drug is being prescribed for the treatment of grass-pollen induced allergic rhinitis 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 Oralair

AND

• The patient does not have any of the following: 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, medical conditions that may reduce the ability of the patient to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration and is not on any medication(s) that can inhibit or potentiate the effect of epinephrine

AND

• The requested drug is being prescribed by or in consultation with an allergist/immunologist

Place of Service:

Outpatient

The above policy is based on the following references:

REFERENCES

1. Oralair [package insert]. Lenoir, NC: Greer Laboratories, Inc.; December 2016.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed March 2019.
3. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed March 2019.
4. Agency for Healthcare Research and Quality. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review. U.S. Department of Health and Human Services; 2013. https://www.effectivehealthcare.ahrq.gov/topics/asthma-immunotherapy-2010/research. Accessed March 2019.
5. Wallace DV, Dykewicz MS. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol. 2008; 122(2): S1-S84

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.

January 01, 2020