Mometasone Furoate (Sinuva) Form

Mometasone furoate (Sinuva®) sinus implant is a self-expanding, bioabsorbable, corticosteroid- eluting implant provided with a crimper and a single-use delivery system.
FDA Approved Indication(s) Sinuva is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients ≥ 18 years of age who have had ethmoid sinus surgery. 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 Sinuva 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. Prescribed by or in consultation with an otolaryngologist;
   4. Member has had ethmoid sinus surgery;
   5. Failure of all of the following, unless clinically significant adverse effects are experienced or all are contraindicated (a, b, and c): a. Mometasone nasal spray; b. Xhance®; c. One additional formulary intranasal steroid (e.g., budesonide);
2. Medical justification why Sinuva will work despite inadequate response to generic mometasone nasal spray (e.g., contraindications to excipients);
3. Sinuva will be inserted by an otolaryngologist;
   8. Dose does not exceed 1,350 mcg (1 implant) per sinus per 90 days. Approval duration: 4 months (1 implant per sinus) 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): Page 1 of 6

   CLINICAL POLICY
   Mometasone Furoate 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. Chronic Rhinosinusitis with Nasal Polyps (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);
7. Member is responding positively to therapy (e.g., improvement in nasal congestion or obstruction, reduction of bilateral polyp grade);
8. Ethmoid sinus polyps grade ≥ 1 on the sinus(es) receiving the implant(s);
   4. If request is for a dose increase, new dose does not exceed 1,350 mcg (1 implant) per sinus per 90 days. Approval duration: 4 months (1 implant per sinus) B. Other diagnoses/indications (must meet 1 or 2):
9. 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

10. 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
    Mometasone Furoate 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 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®) Xhance™ (fluticasone propionate) 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) 1 to 2 sprays (93 mcg/spray) to nostril IN BID
    800 mcg/day 744 mcg/day 128 mcg/day Dose Limit/
    Maximum Dose 400 mcg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to mometasone furoate and any of the ingredients of the Sinuva sinus implant • Boxed warning(s): none reported V. Dosage and Administration Indication CRSwNP Dosing Regimen • 1 implant (1,350 mcg) inserted in the ethmoid sinus via endoscopic visualization. The implant may be left in the sinus to gradually release the corticosteroid over 90 days. The implant can be removed at Day 90 or earlier at the physician's discretion using standard surgical instruments. Maximum Dose 1,350 mcg/90 days Page 3 of 6

    CLINICAL POLICY
    Mometasone Furoate Indication Dosing Regimen • To be inserted by physicians trained in otolaryngology. Maximum Dose VI. Product Availability Sinus implant: 1,350 mcg
    VII.