CurrentCignaPolicy IP0516

Odactra (house dust mite sublingual immunotherapy) — Coverage Criteria

Defines medical necessity, reauthorization, duration, and exclusions for coverage of Odactra (house dust mite allergen extract sublingual tablets) for treatment of house dust mite‑induced allergic rhinitis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOdactra (house dust mite sublingual immunotherapy) — Coverage Criteria

Policy CodePolicy IP0516

Change TypeRevised age criterion

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization and document age ≥ 5 years, diagnostic confirmation of house dust mite sensitivity, and failure/contraindication/intolerance to required prior therapies.

SourceLink

POLICY UPDATE CHANGES

Criteria were updated to require the patient to be ≥ 5 years of age; previously criteria required the patient be ≥ 12 years of age.

Removed documentation from failure, contraindication or intolerance to covered alternatives criterion.

Age 5–65FDA indicated age range

1 tablet/dayMax covered dose

Up to 12 moAuthorization duration

ExcludedConcurrent immunotherapy

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inv-01: COVERAGE CRITERIA — Covered when ALL of the following are met

Covered when ALL of the following are met

House Dust Mite-Induced Allergic Rhinitis

Age 5 years or older>= 5 years
Diagnostic confirmation: Diagnosis confirmed by ONE of: positive skin test to house dust mite extracts OR positive in vitro test for house dust mite-specific IgE
Prior therapy: Failure, contraindication, or intolerance to BOTH: (a) intranasal corticosteroid therapy AND (b) either oral or intranasal antihistamine
When criteria are met, a maximum of 1 tablet per day will be covered. Receipt of sample product does not satisfy any criteria requirements for coverage.

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inv-02: Reauthorization — Continuation covered when ALL of the following are met

Continuation covered when ALL of the following are met

Reauthorization: Initial medical necessity criteria continue to be met AND there is documentation of beneficial response to therapy

inv-03: Conditions Not Covered — 1 top-level node

Concurrent immunotherapy: Any concurrent use of Odactra with subcutaneous allergen immunotherapy or other sublingual allergen immunotherapy (e.g., Grastek, Oralair, Ragwitek) is considered experimental, investigational or unproven

Approved product labeling states concomitant dosing may increase risk of local or systemic adverse events.

The policy excludes the concurrent use of Odactra with subcutaneous allergen immunotherapy or other sublingual allergen immunotherapy (for example, allergy shots or products such as Grastek, Oralair, or Ragwitek). The document states that efficacy and safety of Odactra have not been evaluated when used concomitantly with other allergen immunotherapy and that product labeling warns concomitant dosing may increase the risk of local or systemic adverse events.

Use of Odactra at the same time as any other form of allergen immunotherapy is considered not medically necessary/experimental. The policy lists concurrent administration with subcutaneous or other sublingual immunotherapies as an unproven indication and therefore not covered.

Provider Actions & Authorization

Prior Authorization

Prior authorization and duration

Prior authorization is required. When criteria are met, initial and reauthorization approvals are granted for up to 12 months.

Step Therapy

Step therapy requirement

Patient must have failed, have a contraindication to, or be intolerant of BOTH intranasal corticosteroid therapy AND either an oral or intranasal antihistamine prior to initiation of Odactra.

Documentation Required

Required clinical documentation

For initial authorization, documentation must show age ≥ 5 years, diagnosis confirmation by positive skin test or specific IgE for house dust mite, and failure/contraindication/intolerance to required prior therapies. For reauthorization, documentation must show the above criteria are met and there is documentation of beneficial response. Receipt of sample product does not satisfy documentation requirements.

Note

Sample product note

Receipt of sample product does not satisfy any criteria requirements for coverage.

Billing Rule

Claims coding and coverage determination

Claims submitted without covered diagnosis or procedure codes referenced in the Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service; reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this policy.

Definitions

House dust mite–induced allergic rhinitis — definition and diagnostic confirmation

DefinitionAllergic rhinitis due to Dermatophagoides farinae and/or Dermatophagoides pteronyssinus confirmed by positive skin test or in vitro specific IgE testing.

Confirmation methodsPositive skin test to licensed house dust mite extracts OR positive in vitro testing for IgE antibodies to house dust mites.

Age range in indicationApproved for patients aged 5 to 65 years in the product indication; pivotal trials included patients as young as 5 years.

Clinical noteOdactra is indicated for house dust mite–induced allergic rhinitis with or without conjunctivitis and is not for immediate symptom relief.

Background

Odactra is a sublingual tablet formulation of house dust mite allergen extract indicated for immunotherapy in patients with house dust mite–induced allergic rhinitis, with or without conjunctivitis. Clinical trials supporting approval included patients as young as 5 years, and product labeling notes that Odactra is not intended for immediate symptom relief. The policy references confirmatory testing by skin or in vitro specific IgE is used to establish the diagnosis for treatment consideration.

OpenPayer

Odactra (house dust mite sublingual immunotherapy) — Coverage Criteria

Coverage Criteria

Coding

Provider Actions & Authorization

Definitions

Background