NASONEX, Mometasone Furoate (Nasal) Form

Mometasone (Nasonex®) is a corticosteroid. FDA Approved Indication(s) Nasonex is indicated for the: • Prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older • Treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older 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 Nasonex is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Allergic Rhinitis or Nasal Polyps (must meet all):

1. Diagnosis of allergic rhinitis or nasal polyps;

2. Member meets one of the following (a or b): a. Request for allergic rhinitis: Age ≥ 12 years;
   b. Request for nasal polyps: Age ≥ 18 years;

   3. Failure of intranasal fluticasone (generic Flonase®) or intranasal triamcinolone (generic Nasacort®), unless clinically significant adverse effects are experienced or both are contraindicated;
   4. Dose does not exceed 400 mcg per day (8 sprays per day, or 2 bottles per 30 days).
      Approval duration: 12 months
      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: HIM.PA.33 for health insurance marketplace; or Page 1 of 5

   CLINICAL POLICY Mometasone b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

   2. 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: HIM.PA.154 for health insurance marketplace. II. Continued Therapy A. Allergic Rhinitis or Nasal Polyps (must meet all):
3. 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);
4. Member is responding positively to therapy;

5. If request is for a dose increase, new dose does not exceed 400 mcg per day (8 sprays per day, or 2 bottles per 30 days).
   Approval duration: 12 months
   B. Other diagnoses/indications (must meet 1 or 2):

   1. 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: HIM.PA.33 for health insurance marketplace; 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: HIM.PA.103 for health insurance marketplace; or
   2. 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: HIM.PA.154 for health insurance marketplace. 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 – HIM.PA.154 for health insurance marketplace or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Page 2 of 5

   CLINICAL POLICY Mometasone 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 fluticasone propionate (Flonase®) triamcinolone (Nasacort®) 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. 2 sprays in each nostril BID
   1-2 sprays in each nostril QD Dose Limit/ Maximum Dose 4 sprays/nostril/day
   4 sprays/nostril/day
   Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to mometasone furoate or any of the ingredients of Nasonex • Boxed warning(s): none reported V. Dosage and Administration
   Indication Allergic rhinitis Age ≥ 12 years: 2 sprays in each nostril QD Age ≥ 18 years: 2 sprays in each nostril BID Nasal polyps Dosing Regimen Maximum Dose 2 sprays/nostril/day 4 sprays/nostril/day
   VI. Product Availability
   Nasal spray: 50 mcg/100 mcL spray VII.