GRASTEK, Timothy Grass Pollen Allergen Extract Form

Timothy grass pollen allergen extract (Grastek®) is an allergen extract. FDA Approved Indication(s) Grastek 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 Timothy grass or cross-reactive grass pollens. Grastek is approved for use in persons 5 through 65 years of age. Grastek 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 Grastek 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 Timothy grass pollen or cross-reactive grass pollens (e.g., sweet vernal, orchard, perennial rye, Kentucky blue/June grass, meadow fescue, or redtop);
   5. Failure of one intranasal corticosteroid, unless clinically significant adverse effects are experienced or all are contraindicated;
2. Failure of one oral antihistamine at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;

3. 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 Timothy Grass Pollen Allergen Extract B. Other diagnoses/indications (must meet 1 or 2):

4. 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
5. 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):
6. 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.
      Medicaid/HIM – 12 months
      Commercial – 12 months or duration of request, whichever is less
      B. Other diagnoses/indications (must meet 1 or 2):
7. 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

8. 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 Page 2 of 6

   CLINICAL POLICY Timothy Grass Pollen Allergen Extract 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 BAU: bioequivalent allergy unit 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®) 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 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. 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 Page 3 of 6

   CLINICAL POLICY Timothy Grass 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 (gelatin, mannitol, and sodium hydroxide) contained in this product. • Boxed warning(s): severe allergic reactions V. Dosage and Administration
   Indication Grass 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 each grass pollen season and continue treatment throughout the season. For sustained effectiveness for one grass pollen season after cessation of treatment, Grastek may be taken daily for three consecutive years. VI. Product Availability
   Tablet: 2,800 bioequivalent allergy units (BAUs) VII.