Fluticasone Propionate (Xhance) Form

Fluticasone propionate (Xhance®) is a synthetic trifluorinated corticosteroid with anti- inflammatory activity with a unique nasal delivery device.
____ *For the Commercial line of business, this policy applies to Oregon formularies only. For California Commercial formularies, refer to the step therapy policy, CP.CPA.83. FDA Approved Indication(s) Xhance is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age or 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 Xhance is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Rhinosinusitis with Nasal Polyps (must meet all):

1. Diagnosis of CRSwNP;
   2. Age ≥ 18 years;
   3. Failure of one formulary intranasal steroid (e.g., fluticasone propionate, mometasone, budesonide), unless clinically significant adverse effects are experienced or all are contraindicated;
2. Dose does not exceed (a and b): a. 744 mcg per day; b. 2 devices per 30 days. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):

3. 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 Page 1 of 6

   CLINICAL POLICY
   Fluticasone Propionate 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

4. 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. Chronic Rhinosinusitis with Nasal Polyps (must meet all):
5. 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);
6. Member is responding positively to therapy (e.g., improvement in nasal congestion or obstruction, reduction of bilateral polyp grade);
7. If request is for a dose increase, new dose does not exceed (a and b): a. 744 mcg per day; b. 2 devices per 30 days. Approval duration: 12 months 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 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.
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   CLINICAL POLICY
   Fluticasone Propionate 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 CRSwNP: chronic rhinosinusitis with nasal polyps 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 Dosing Regimen mometasone furoate (Nasonex®) fluticasone propionate (Flonase®) budesonide (Rhinocort®) 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/nostril (50 mcg/spray) IN BID (400 mcg/day) 2-4 sprays/nostril (50 mcg/spray) IN QD or BID (200 - 800 mcg) 2 sprays/nostril (32 mcg/spray) IN QD (128 mcg) 800 mcg/day 128 mcg/day Dose Limit/
   Maximum Dose 400 mcg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to any ingredient in Xhance • Boxed warning(s): none reported V. Dosage and Administration Indication CRSwNP Dosing Regimen 1 to 2 sprays (93 mcg/spray) per nostril BID
   Maximum Dose 744 mcg/day VI. Product Availability Nasal spray: 93 mcg of fluticasone propionate in each 106-mg spray with 120 metered sprays per device VII.