Short Ragweed Pollen Allergen Extract (Ragwitek) Form

Short ragweed pollen allergen extract (Ragwitek®) is an allergen extract. FDA Approved Indication(s) Ragwitek is indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Ragwitek is approved for use in persons 5 through 65 years of age. Ragwitek is not indicated for the immediate relief of allergic 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 Ragwitek is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Allergic Rhinitis (must meet all):

1. Diagnosis of short ragweed 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 short ragweed pollen;
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 1 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 Short Ragweed Pollen 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 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): 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 Short Ragweed Pollen 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 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®) triamcinolone acetonide (Nasacort AQ®) mometasone furoate monohydrate (Nasonex®) 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 QD 2 to 11 years: 30 mg PO QD ≥ 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 2-11 years: 1 spray each nostril QD ≥ 12 years: 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 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 Short Ragweed Pollen 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 Short ragweed pollen-induced allergic rhinitis Dosing Regimen One tablet SL QD Maximum Dose 1 tablet/day Treatment should be initiated at least 12 weeks before the expected onset of ragweed pollen season and continue treatment throughout the season. VI. Product Availability
   Tablet: 12 Amb a 1-Unit (Amb a 1-U)
   VII.