RESTASIS, Cyclosporine (Ophth) Form

Cyclosporine ophthalmic (Cequa™, Restasis®, Verkazia®) is a topical calcineurin inhibitor immunosuppressant. ____ *For Commercial, if request is through pharmacy benefit, Cequa is non-formulary and should not be approved using these criteria; refer to the formulary exception policy, CP.CPA.190. Restasis does not require prior authorization. FDA Approved Indication(s) Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Verkazia is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and 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 Cequa, Restasis, and Verkazia are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Keratoconjunctivitis Sicca (must meet all):

1. Diagnosis of keratoconjunctivitis sicca with suppressed tear production due to ocular inflammation;
2. Request is for Cequa or Restasis;
   3. Member meets one of the following: a. For Restasis: Age ≥ 16 years;
      b. For Cequa: Age ≥ 18 years;

3. Failure of artificial tears at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; Page 1 of 8

   CLINICAL POLICY Cyclosporine Ophthalmic Emulsion

4. Failure of at least one ophthalmic anti-inflammatory agent (see Appendix B for examples) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
5. Member must use generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis), unless contraindicated or clinically significant adverse effects are experienced;
6. The requested agent is not prescribed in combination with other ophthalmic cyclosporine products (e.g., Verkazia);
7. Request does not exceed 60 vials per 30 days.
   Approval duration:
   Commercial – Restasis does not require prior authorization; refer to CP.CPA.190 for Cequa HIM – 6 months Medicaid – Length of Benefit B. Vernal Keratoconjunctivitis (must meet all):
8. Diagnosis of VKC;
   2. Request is for Verkazia;
   3. Age ≥ 4 years;
   4. Failure of artificial tears at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
9. Failure of a topical mast cell stabilizer and topical antihistamine (as a single dual- acting product or as two products used in combination; see Appendix B for examples) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
10. Verkazia is not prescribed in combination with other ophthalmic cyclosporine products (e.g., Cequa, Restasis);
11. Request does not exceed 120 vials per affected eye per 30 days.
    Approval duration: 6 months C. Other diagnoses/indications (must meet 1 or 2):
12. 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

13. 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 8

    CLINICAL POLICY Cyclosporine Ophthalmic Emulsion of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    II. Continued Therapy A. Keratoconjunctivitis Sicca (must meet all):

14. 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);
15. Request is for Cequa or Restasis;
    3. Member is responding positively to therapy;
    4. Member must use generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis), unless contraindicated or clinically significant adverse effects are experienced;
16. The requested agent is not prescribed in combination with other ophthalmic cyclosporine products (e.g., Verkazia);
17. If request is for a dose increase, request does not exceed 60 vials per 30 days.
    Approval duration: Commercial – Restasis does not require prior authorization; refer to CP.CPA.190 for Cequa HIM – 12 months Medicaid – Length of Benefit B. Vernal Keratoconjunctivitis (must meet all):
    
    1. 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);
18. Request is for Verkazia;
    3. Member is responding positively to therapy;
    4. Verkazia is not prescribed in combination with other ophthalmic cyclosporine products (e.g., Cequa, Restasis);
19. If request is for a dose increase, request does not exceed 120 vials per affected eye per 30 days.
    Approval duration: 12 months C. Other diagnoses/indications (must meet 1 or 2):

20. 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: Page 3 of 8

    CLINICAL POLICY Cyclosporine Ophthalmic Emulsion 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

21. 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, 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 VKC: vernal keratoconjunctivitis 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 Dose Limit/ Maximum Dose Various Various artificial tears (e.g., Visine dry eye relief) ophthalmic anti-inflammatory agents for keratoconjunctivitis sicca (e.g., loteprednol etabonate) 1 to 2 drops in affected eye(s) BID or QID 1 to 2 drops in each eye BID to QID for up to 2 weeks Note: Ophthalmic NSAIDs are not indicated.
    topical dual-acting mast cell stabilizer/antihistamine for VKC (e.g., azelastine, bepotastine, epinastine, ketotifen, olopatadine) topical mast cell stabilizer for VKC (e.g., cromolyn, lodoxamide, nedocromil) topical antihistamine for VKC (e.g., alcaftadine, emedastine) 1 to 2 drops in affected eye(s) per day Various 2 to 6 drops in affected eye(s) per day Various 1 to 4 drops in affected eye(s) per day Various Page 4 of 8

    CLINICAL POLICY Cyclosporine Ophthalmic Emulsion 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 • Contraindication(s):
    o Cequa, Verkazia: none reported o Restasis: hypersensitivity to cyclosporine or any of the ingredients in the formulation • Boxed warning(s): none reported Appendix D: General Information • Artificial tears are the standard therapy for all severity of dry eyes. • Restasis is likely to be given in conjunction with artificial tears. • Increased tear production was not seen in patients currently taking topical anti- inflammatory drugs or using punctal plugs. • Emulsion from one individual, single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration. V. Dosage and Administration
    Drug Name Cyclosporine ophthalmic solution (Cequa, Restasis) Cyclosporine ophthalmic solution (Verkazia) Indication Moderate to severe keratoconjunctivitis sicca VKC Dosing Regimen 1 drop BID in each eye approximately 12 hours apart 1 drop QID in each affected eye Maximum Dose 2 drops/day in each eye; 60 vials/30 days 4 drops/day in each eye VI. Product Availability
    Drug Name Cyclosporine ophthalmic solution (Cequa) Cyclosporine ophthalmic emulsion (Restasis) Cyclosporine ophthalmic emulsion (Verkazia) Availability Single use vial: 0.09%, 0.25 mL each of 60 vials/tray • Single use vial: 0.05%, 0.4 mL each of 30 vials/tray and 60 vials/tray • MultiDose bottle: 0.05%, 5.5 mL total Single use vial: 0.1% (1 mg/mL), 0.3 mL each of 30, 60, or 120 vials/box VII.