Varenicline (Tyrvaya) Form

Varenicline (Tyrvaya®) nasal spray is a cholinergic agonist. FDA Approved Indication(s) Tyrvaya 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 Tyrvaya 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 ≥ 18 years;
   3. Failure of artificial tears agent (see Appendix B for examples) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
2. 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;
3. Dose does not exceed 2 nasal spray bottles per 30 days. Approval duration: 6 months 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): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or Page 1 of 6

   CLINICAL POLICY Varenicline

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: 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 2 nasal spray bottles 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: 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: 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: 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 – 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 AAO: American Academy of Ophthalmology
      DED: Dry Eye Disease
      FDA: Food and Drug Administration Page 2 of 6

   CLINICAL POLICY Varenicline 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 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 Varies Varies OTC artificial tear product examples: • glycerin, hypromellose, polyethylene glycol ophthalmic solution (Visine®)
   • artificial tear ophthalmic ointment (Refresh P.M.®) • white petrolatum-mineral oil ophthalmic ointment (Systane® Nighttime) • carboxymethylcellulose ophthalmic solution (Refresh® Tears) • polyvinyl alcohol ophthalmic solution 1.4% ophthalmic anti-inflammatory agent: • loteprednol suspension (Lotemax®)
   • Maxidex® (dexamethasone solution/suspension • fluorometholone ointment/suspension (FML®, FML® Forte®, Flarex®) • prednisolone (Pred Mild®) Note: Ophthalmic NSAIDs are not indicated. 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): None reported • Boxed warning(s): None reported Appendix D: General Information • Per American Academy of Ophthalmology (AAO) guidelines, artificial tears are the • standard therapy for all severity of dry eyes.
   If artificial tears are inadequate, then the next trial in therapy per AAO guidelines would be ophthalmic anti-inflammatory therapies such as topical non-glucocorticoid immunomodulatory drugs (e.g. cyclosporine), topical LFA-1 antagonist drugs (e.g. lifitegrast), and topical corticosteroid drugs (e.g. loteprednol, prednisolone).
   V. Dosage and Administration
   Indication Dosing Regimen DED 1 spray (0.03 mg/ actuation) in each nostril twice daily 2 sprays/nostril/day Maximum Dose Page 3 of 6

   CLINICAL POLICY Varenicline VI. Product Availability
   Nasal spray: 0.03 mg of varenicline in each spray (0.05 mL)
   VII.