Subject: Odactra PA 1610-A P02-2026 v2

Drug

ODACTRA  (house dust mite allergen extract)

Policy:

Indications

FDA-approved Indications

Odactra is an allergen extract indicated as immunotherapy for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. Odactra is approved for use in persons 12 through 65 years of age.

Odactra is not indicated for the immediate relief of allergic symptoms.

Coverage Criteria

House Dust Mite (HDM)-Induced Allergic Rhinitis

Authorization may be granted when the requested drug is being prescribed as immunotherapy for house dust mite (HDM)-induced allergic rhinitis when ALL of the following criteria are met:
·        The diagnosis has been confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, OR positive skin testing to licensed house dust mite allergen extracts.

·        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 after taking any 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

House Dust Mite (HDM)-Induced Allergic Rhinitis

Authorization may be granted when the requested drug is being prescribed as immunotherapy for house dust mite (HDM)-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)

·        1610-A: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Odactra [package insert]. Hørsholm, Denmark: ALK-Abelló A/S; February 2025.

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 15, 2026