Lifitegrast (Xiidra) Form

Lifitegrast (Xiidra®) is a lymphocyte function-associated antigen-1 antagonist. FDA Approved Indication(s) Xiidra is indicated for the treatment of the signs and symptoms of dry eye disease (DED). 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 Xiidra is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Dry Eye Disease (must meet all):

1. Diagnosis of DED;
   2. Age ≥ 17 years;
   3. Failure of any non-prescription wetting agent in the form of drops, ointments, or gels, unless clinically significant adverse effects are experienced or all are contraindicated;
2. Failure of at least one ophthalmic anti-inflammatory agent (see Appendix B for examples) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
3. Failure of generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis®), unless contraindicated or clinically significant adverse effects are experienced;
4. Dose does not exceed both of the following (a and b): a. 2 drops per day in each eye; b. 1 box 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: 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 Lifitegrast 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 and CP.PMN.16 for Medicaid; 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: CP.CPA.190 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Dry Eye Disease (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);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 2 drops per day in each eye; b. 1 box per 30 days.
      Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
7. 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

8. 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 – Page 2 of 6

   CLINICAL POLICY Lifitegrast 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 DED: dry eye disease
   FDA: Food and Drug Administration 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 Varies OTC wetting agents* • Refresh P.M.® (artificial tear ophthalmic ointment) • Systane® Nighttime (white petrolatum- mineral oil ophthalmic ointment) • Nature’s Tears® (hypromellose ophthalmic solution 0.4%) • Artificial Tears (polyvinyl alcohol ophthalmic solution 1.4%) • Lacri-Lube® (artificial tears ointment) Lotemax®, Alrex® (loteprednol suspension/ gel) dexamethasone solution/suspension (Maxidex®) fluorometholone ointment/suspension (FML®, FML® Forte®, FML® LiquifilmTM, Flarex®) Solution/gel: 1-2 drops into the affected eye(s) 2-4 times/day as needed Ointment: Apply small amount (~1/4 inch) to the inside of the lower eyelid 1-4 times/day as needed 1-2 drops into the conjunctival sac of the affected eye(s) QID 1-2 drops into conjunctival sac every hour during the day and every other hour during the night; gradually reduce dose to 1 drop every 4 hours, then to TID-QID Ointment (FML): Apply small amount (~1/2 inch ribbon) to conjunctival sac 1-3 times daily Suspension (Flarex): 1- 2 drops into conjunctival sac QID
   Page 3 of 6 Varies Varies Varies

   CLINICAL POLICY Lifitegrast Drug Name Dosing Regimen Dose Limit/ Maximum Dose Varies FML, FML Forte: 1 drop into conjunctival sac BID-QID 1-2 drops in the affected eye(s) BID- QID 1 drop OU BID prednisolone (Omnipred®, Pred Forte®, Pred Mild®) cyclosporine (Restasis®) 2 drops/eye/day 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. *Available over-the-counter in a number of preparations. This list is not all-inclusive Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity • Boxed warning(s): none reported V. Dosage and Administration
   Indication Dosing Regimen DED Instill 1 drop BID in each eye (~12 hours apart) Maximum Dose 2 drops/eye/day VI. Product Availability
   Ophthalmic solution containing lifitegrast 5% (50 mg/mL): 0.2 mL containers (60 single-use containers/box) VII.