CurrentCentenePolicy CP.PMN.111

House Dust Mite Allergen Extract (Odactra)

Policy governing medical necessity and prior authorization criteria for Odactra (house dust mite sublingual immunotherapy tablet) for members of Centene-affiliated health plans across specified lines of business.

Policy Summary

PayerCentene

PolicyHouse Dust Mite Allergen Extract (Odactra)

Policy CodePolicy CP.PMN.111

Change TypePediatric expansionannual review

Effective Date09.01.17

Next Review Date

Key ActionProvider must submit supporting clinical documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

RT4: updated indication and criteria with pediatric expansion to age 5 years.

3Q 2025 annual review: no significant changes; references reviewed and updated.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

5-65FDA-approved age range

1/dayMaximum daily dose

12 moApproval duration (Medicaid/HIM)

12 moApproval duration (Commercial)

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Coverage Criteria

Initial Therapy: Allergic Rhinitis

Covered when ALL of the following are met:

Initial approval - allergic rhinitis: 1. Diagnosis of HDM-induced allergic rhinitis; 2. Prescribed by or in consultation with an allergist or immunologist; 3. Age ≥ 5 years and ≤ 65 years; 4. Member meets one of: (a) confirmation of IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus; OR (b) positive skin testing to licensed HDM allergen extracts; 5. Failure of one intranasal corticosteroid unless clinically significant adverse effects or all are contraindicated; 6. Failure of one oral antihistamine at up to maximally indicated doses unless clinically significant adverse effects or all are contraindicated; 7. Dose does not exceed one tablet per day.age 5-65; ≤1 tablet/day

Provider must submit supporting documentation.

Continuation Therapy: Allergic Rhinitis

Covered when ALL of the following are met:

Continuation approval - allergic rhinitis: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed one tablet per day.≤1 tablet/day

Approval durations: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Other Diagnoses/Indications

If the requested use is not addressed in the policy or if the drug label recently changed:

Other uses: 1. If the drug label changed within the last 6 months and the change is not yet reflected in this policy, refer to the appropriate formulary/no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/no-coverage; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non-formulary). 2. If the requested use (diagnosis, age, dosing regimen) is not specifically listed under section III (Diagnoses/Indications NOT authorized) AND criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

See related policy references for specific procedures.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off-label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless the use is supported by the member's evidence of coverage.

Coverage determinations and benefit administration are subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, or contract of insurance). State Medicaid provisions supersede this clinical policy when there is a conflict. This policy is a guide to medical necessity and does not guarantee payment; providers must follow applicable state and federal requirements and Health Plan-level administrative policies and procedures.

Uses for diagnoses or indications that are non-FDA approved and not addressed in this policy will be considered not authorized unless the request includes adequate off-label justification and documentation of efficacy and safety consistent with the Health Plan’s off-label use policies referenced above.

Coding and Product Availability

Product Availabilitymixed

12 SQ-HDM

Tablet: 12 SQ-HDM

Product availabilitymixed

12 SQ-HDM

Tablet strength/product availability (Odactra)

inv-09: Maximum daily dose — 1 tablet/day

Maximum daily dose1 tablet per day

Dosing regimen (HDM-induced allergic rhinitis)One tablet sublingual once daily (SL QD)

Policy threshold referenceContinuation and initial approval criteria require dose ≤ 1 tablet/day

Provider Actions and Authorization

Prior Authorization

Prior Authorization/Approval Duration Note

Prior authorization is required. Approval durations: Medicaid/HIM — 12 months; Commercial — 12 months or duration of request, whichever is less. Providers should request renewal prior to expiration to avoid gaps in therapy.

Medicaid/HIM: 12 months
Commercial: 12 months or duration of request, whichever is less

Documentation Required

Submission of Supporting Clinical Documentation

Requests must include supporting clinical documentation such as office chart notes, laboratory results, or other relevant clinical information demonstrating the member meets all approval criteria (diagnosis, confirmatory testing, prescriber specialty, age limits, step therapy where applicable, and dose limits). Requests that lack required documentation may be denied or delayed.

Include documentation of diagnosis and confirmatory testing (IgE or skin test)

Background

Odactra (house dust mite sublingual immunotherapy tablet) is indicated for the treatment of house dust mite–induced allergic rhinitis with or without conjunctivitis in appropriately selected patients. This clinical policy was developed by licensed clinicians after review of current standards, peer-reviewed literature, regulatory approvals, and expert clinical input; it is intended to guide medical necessity determinations and is not a substitute for clinical judgment or a guarantee of payment.

Definitions

inv-19: HDM-induced allergic rhinitis — definition and confirmatory testing requirements.

DefinitionAllergic rhinitis caused by sensitization to Dermatophagoides farinae or D. pteronyssinus; may occur with or without conjunctivitis

Confirmatory testing requiredPositive in vitro IgE testing to D. farinae or D. pteronyssinus OR positive skin testing to licensed HDM allergen extracts

FDA‑approved age rangeApproved for persons 5 through 65 years of age

inv-20: Odactra / SQ-HDM — product and clinical evidence reference note.

ProductOdactra (house dust mite allergen extract) — sublingual immunotherapy tablet

Dosing statement in prescribing informationOne tablet sublingual once daily (SL QD); maximum 1 tablet/day