House Dust Mite Allergen Extract (Odactra) Form

House dust mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) allergen extract (Odactra™) is an allergen extract. FDA Approved Indication(s) Odactra is indicated as immunotherapy for 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 allergy symptoms. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Odactra is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Allergic Rhinitis (must meet all):

1. Diagnosis of HDM-induced allergic rhinitis;
   2. Prescribed by or in consultation with an allergist or immunologist;
   3. Age ≥ 12 years and ≤ 65 years;
   4. Member meets one of the following (a or b): a. Confirmation of the presence of IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus HDM;
      b. Positive skin testing to licensed HDM allergen extracts;
2. Failure of one intranasal corticosteroid, unless clinically significant adverse effects are experienced or all are contraindicated;
3. Failure of one oral antihistamine at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;

4. Dose does not exceed one tablet per day. Approval duration:
   Medicaid/HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less Page 1 of 6

   CLINICAL POLICY House Dust Mite Allergen Extract B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Allergic Rhinitis (must meet all):
7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed one tablet per day.
      Approval duration:
      Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 2 of 6

   CLINICAL POLICY House Dust Mite Allergen Extract criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration HDM: house dust mite Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Dosing Regimen Drug Name OTC loratadine (Claritin®)
   OTC loratadine-D (Claritin-D® 12 and 24 hour) OTC cetirizine (Zyrtec®) OTC fexofenadine (Allegra Allergy®) fluticasone propionate (Flonase®) triamcinolone acetonide (Nasacort AQ®) 2 to 5 years: 5 mg PO QD ≥ 6 years: 10 mg PO QD ≥ 12 years: 1 tablet PO BID (12 hr) QD (24 hr) 2 to 5 years: 2.5-5 mg PO QD ≥ 6 years: 10 mg PO QD 6-months to 2 years: 15 mg PO BID 2 to 11 years: 30 mg PO BID ≥ 12 years: 60 mg PO BID or 180 mg PO QD ≥ 4 years: 1-2 sprays each nostril QD ≥ 12 years: 1-2 sprays each nostril QD 2-11 years: 1 spray each nostril QD ≥ 12 years: 1-2 sprays each nostril QD Dose Limit/ Maximum Dose 10 mg/day 10 mg/day 10 mg/day 180 mg/day 2 sprays each nostril/day 2-11 years: 1 spray each nostril/day

   12 years: 2 sprays each nostril/day 2-11 years: 1 spray each
   nostril/day 12 years: 2 sprays each nostril/day 2-11 years: 1 spray each nostril QD ≥ 12 years: 2 sprays each nostril QD mometasone furoate monohydrate (Nasonex®) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Page 3 of 6

   CLINICAL POLICY House Dust Mite Allergen Extract Appendix C: Contraindications/Boxed Warnings • Contraindication(s): severe, unstable or uncontrolled asthma; history of eosinophilic esophagitis; history of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy; hypersensitivity to any of the inactive ingredients contained in this product. • Boxed warning(s): severe allergic reactions V. Dosage and Administration
   Indication HDM-induced allergic rhinitis Dosing Regimen One tablet SL QD Maximum Dose 1 tablet/day VI. Product Availability
   Tablet: 12 SQ-HDM VII.