Oxymetazoline (Rhofade, Upneeq) Form

Oxymetazoline cream (Rhofade™) is an alpha-1a adrenoreceptor agonist. Oxymetazoline ophthalmic solution (Upneeq™) is an alpha-2 adrenergic receptor agonist. FDA Approved Indication(s) Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Upneeq is indicated for the treatment of acquired blepharoptosis in adults. 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 Rhofade and Upneeq are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Facial Erythema Associated with Rosacea (must meet all):

1. Diagnosis of persistent facial erythema associated with rosacea;
   2. Request is for Rhofade;
   3. Age ≥ 18 years;
   4. If papules or pustules are present, failure of, or concomitant treatment with, any of the following agents, unless clinically significant adverse effects are experienced or all are contraindicated: topical metronidazole, oral doxycycline, ivermectin cream, Finacea®;
2. Dose does not exceed both of the following (a and b): a. 30 mg per month; b. 1 tube per month. Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Acquired Blepharoptosis (must meet all):

3. Diagnosis of acquired blepharoptosis/ptosis (e.g., aponeurotic, neurologic ptosis);

   2. Request is for Upneeq;
   3. Prescribed by or in consultation with an optometrist or ophthalmologist;
   4. Age ≥ 13 years; Page 1 of 7

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   Oxymetazoline

4. Member does not have congenital or mechanical ptosis;
   6. Documentation of baseline visual peripheral field test (e.g., Leicester peripheral field test [LPFT]) demonstrating visual field loss;
5. Documentation of baseline marginal reflex distance 1 (MRD-1) ≤ 2 mm;
   8. Dose does not exceed both of the following (a and b): a. 1 carton per affected eye per month; b. 30 single use containers per affected eye per month. Approval duration: 12 months C. Other diagnoses/indications (must meet 1 or 2):
6. 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
7. 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. Facial Erythema Associated with Rosacea (must meet all):
8. 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);

9. Request is for Rhofade;

   3. Member is responding positively to therapy;
   4. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 30 mg per month; b. 1 tube per month. Approval duration:
      Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less Page 2 of 7

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   Oxymetazoline B. Acquired Blepharoptosis (must meet all):

10. 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);
11. Reqeust is for Upneeq;
    3. Member is responding positively to therapy as evidenced by, including but not limited to, improvement in visual peripheral field test (e.g., LPFT) or MRD-1;
12. Dose does not exceed both of the following (a and b): a. 1 carton per affected eye per month; b. 30 single use containers per affected eye per month. Approval duration: 12 months C. Other diagnoses/indications (must meet 1 or 2):
13. 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

14. 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. 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 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 LPFT: Leicester peripheral field test MRD: marginal reflex distance Page 3 of 7

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    Oxymetazoline 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 Rosacea Apply thin film topically to affected area QD for 1% and BID for 0.75% Dose Limit/ Maximum Dose No maximum dosage information is available metronidazole
    (Metrocream® 0.75%, Metrogel® 1%, Metrolotion® 0.75% ) azelaic acid 15% gel (Finacea®) Rosacea Apply in a thin film topically to the affected area BID Reassess if no improvement in 12 weeks. No maximum dosage information is available doxycycline (Oracea®) Rosacea ivermectin cream 1% (Soolantra®) Lesions (papules and pustules): 40 mg PO once daily in the morning (1 hour before or 2 hours after a meal)
    Rosacea Apply a pea-size amount to the affected areas of the face (forehead, chin, nose, each cheek) once daily. Spread as a thin layer, avoiding the eyes and lips. 300 mg/day;
    40 mg/day for Oracea
    4 oz/topical application 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. Appendix C: Contraindications/Boxed Warnings None reported
    Appendix D: General Information • Tetracycline agents, including doxycycline and minocycline exhibit anti-inflammatory activities at doses < 50 mg. Anti-inflammatory dose doxycycline does not exert antibiotic selection pressure and thus does not induce antibiotic resistance; its mechanism of action in rosacea appears to relate to the anti-inflammatory and biological activities of doxycycline. • The Phase 3 clinical trials of Upneeq excluded patients with congential ptosis and mechanical ptosis (e.g., ptosis due to excess weight on the upper lid possibly from infections, inflammation, and eyelid tumors). V. Dosage and Administration Drug Name Oxymetazoline cream (Rhofade) Indication Facial erythema associated with rosacea Dosing Regimen Apply a pea-size amount topically QD to each of the five areas of the face (forehead, chin, nose, Maximum Dose One application/day Page 4 of 7

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    Oxymetazoline Drug Name Indication Oxymetazoline ophthalmic solution (Upneeq) Blepharoptosis VI. Product Availability Dosing Regimen each cheek) avoiding the eyes and lips. Instill one drop into one or both ptotic eye(s) once daily. Maximum Dose One drop/eye/day Drug Name Oxymetazoline cream (Rhofade) Cream, 1%: 30 g tube or pump, 60 g tube or pump
    Oxymetazoline ophthalmic solution (Upneeq) Ophthalmic solution, 0.1%: 0.3 mL (carton of 30 single patient use containers) Availability VII.