Subject: Odactra PA Policy 1610-A 04-2022

Drug

ODACTRA  (house dust mite allergen extract)

Policy:

FDA-APPROVED INDICATIONS
Odactra is an allergen extract 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. Odactra is approved for use in adults 18 through 65 years of age. 

Odactra is not indicated for the immediate relief of allergic 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 house dust mite (HDM)-induced allergic rhinitis
    AND
    •   The diagnosis has been 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
    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. Odactra [package insert]. Hørsholm, Denmark: ALK-Abelló A/S; March 2020.
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