Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract (Oralair) Form

Sweet vernal, orchard, perennial rye, timothy, and Kentucky blue grass mixed pollens allergen extract (Oralair®) is a mixed allergen extract. FDA Approved Indication(s) Oralair is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen- specific IgE antibodies for any of the five grass species contained in this product. Oralair is approved for use in persons 5 through 65 years of age. Oralair 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 Oralair is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Allergic Rhinitis (must meet all):

1. Diagnosis of grass pollen-induced allergic rhinitis;
   
   2. Prescribed by or in consultation with an allergist or immunologist;
   3. Age ≥ 5 years and ≤ 65 years;
   4. Confirmation of a positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the following grass species: a. Sweet vernal; b. Orchard; c. Perennial rye; d. Timothy; e. Kentucky blue grass;
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; Page 1 of 7

   CLINICAL POLICY Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract

4. Dose does not exceed: a. Age 5 to 17 years: 100 IR (1 tablet) on Day 1, 200 IR (2 tablets) on Day 2, then 300 IR (1 tablet) per day thereafter; b. Age ≥ 18 years: 300 IR (1 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):
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 300 IR (1 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): Page 2 of 7

   CLINICAL POLICY Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract 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 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 IR: index of reactivity 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.
   Drug Name Dosing Regimen OTC loratadine (Claritin®)
   OTC loratadine-D (Claritin-D® 12 and 24 hour) OTC cetirizine (Zyrtec®) OTC fexofenadine (Allegra Allergy®) fluticasone propionate (Flonase®) Age 2 to 5 years: 5 mg PO QD Age ≥ 6 years: 10 mg PO QD Age ≥ 12 years: 1 tablet PO BID (12 hr) QD (24 hr) Age 2 to 5 years: 2.5-5 mg PO QD Age ≥ 6 years: 10 mg PO QD Age 6-months to 2 years: 15 mg PO QD Age 2 to 11 years: 30 mg PO QD Age ≥ 12 years: 60 mg PO BID or 180 mg PO QD Age ≥ 4 years: 1-2 sprays each nostril QD Age ≥ 12 years: 1-2 sprays each nostril QD Page 3 of 7 Dose Limit/ Maximum Dose 10 mg/day 10 mg/day 10 mg/day 180 mg/day 2 sprays each nostril/day

   CLINICAL POLICY Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Drug Name Dosing Regimen triamcinolone acetonide (Nasacort AQ®) Age 2 to 11 years: 1 spray each nostril QD Age ≥ 12 years: 1-2 sprays each nostril QD mometasone furoate monohydrate (Nasonex®) Age 2 to 11 years: 1 spray each nostril QD Age ≥ 12 years: 2 sprays each nostril QD Dose Limit/ Maximum Dose Age 2 to 11 years: 1 spray each nostril/day Age ≥ 12 years: 2 sprays each nostril/day Age 2 to 11 years: 1 spray each
   nostril/day Age ≥ 12 years: 2 sprays each nostril/day 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. 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 Grass pollen- induced allergic rhinitis Dosing Regimen Age 5 to 17 years: 100 IR (index of reactivity) sublingually (SL) on day 1 followed by 200 IR SL on day 2 and 300 IR SL QD on day 3 and thereafter.
   Maximum Dose 300 IR/day Age 18 to 65 years: 300 IR SL QD Treatment should be initiated 4 months before the expected onset of each grass pollen season and continue treatment throughout the season VI. Product Availability
   Tablets: 100 IR, 300 IR VII.