ModifiedmhnPolicy CP.PMN.48

Clinical Policy: Cyclosporine (Cequa, Restasis, Verkazia, Vevye, Klarity-C)

Medical necessity and prior authorization criteria for ophthalmic cyclosporine products across specified Centene lines of business (Commercial, HIM/ICHRA, Medicaid).

Policy Summary

Payermhn

PolicyClinical Policy: Cyclosporine (Cequa, Restasis, Verkazia, Vevye, Klarity-C)

Policy CodePolicy CP.PMN.48

Change TypeApproval duration extended to 12 monthsadded Klarity-Cgeneric Restasis preference and step therapy updates (IL HIM bypass)

Effective Date05.01.12

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, prior therapy failures, age criteria, and adherence to product-specific supply limits.

SourceLink

POLICY UPDATE CHANGES

For all indications, extended initial and continued therapy approval duration from 6 months to 12 months for this maintenance medication for a chronic condition.

Added Klarity-C (a compounded product) to the policy.

Revised policy/criteria to include generic cyclosporine and removed Commercial formulary status notes for Cequa, Verkazia, Vevye, and Restasis where applicable.

Removed language referencing 'at up to maximally indicated doses' for failure of artificial tears and clarified examples in Appendix B per Clinical Pharmacology.

12 monthsupdated duration

60 vials/30dCequa/Restasis supply

1 bottle/50dVevye supply

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Coverage Criteria

Initial Approval — Keratoconjunctivitis Sicca

Covered when ALL of the following are met

Keratoconjunctivitis Sicca initial: 1. Diagnosis of keratoconjunctivitis sicca (dry eye) with suppressed tear production due to ocular inflammation; 2. Request is for Cequa, Restasis, or Vevye; 3. Member meets one of the following: (a) Restasis: age ≥ 16 years; (b) Cequa or Vevye: age ≥ 18 years; 4. Failure of artificial tears unless contraindicated or clinically significant adverse effects are experienced; 5. 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; 6. Member must use generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis), unless contraindicated or clinically significant adverse effects are experienced; 7. The requested agent is not prescribed in combination with other ophthalmic cyclosporine products (e.g., Klarity-C, Verkazia); 8. Request does not exceed either of the following supply limits: (a) For Cequa or Restasis: 60 vials per 30 days; (b) For Vevye: 1 bottle per 50 days.see node text

Approval duration: 12 months

Initial Approval — Vernal Keratoconjunctivitis (VKC)

Covered when ALL of the following are met

VKC initial: 1. Diagnosis of vernal keratoconjunctivitis (VKC); 2. Request is for Verkazia or Klarity-C; 3. Age ≥ 4 years; 4. Failure of artificial tears unless contraindicated or clinically significant adverse effects are experienced; 5. Failure of a topical mast cell stabilizer and topical antihistamine (as a single dual-acting product or as two products used in combination) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 6. Verkazia and Klarity-C are not prescribed in combination with other ophthalmic cyclosporine products (e.g., Cequa, Restasis, Vevye); 7. Request does not exceed 120 vials per affected eye per 30 days.see node text

Approval duration: 12 months

Continued Therapy — Keratoconjunctivitis Sicca

Covered when ALL of the following are met

Keratoconjunctivitis Sicca continued: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Request is for Cequa, Restasis, or Vevye; 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; 5. The requested agent is not prescribed in combination with other ophthalmic cyclosporine products (e.g., Klarity-C, Verkazia); 6. If request is for a dose increase, the request does not exceed either of the following supply limits: (a) For Cequa or Restasis: 60 vials per 30 days; (b) For Vevye: 1 bottle per 50 days.see node text

Approval duration: 12 months

Continued Therapy — Vernal Keratoconjunctivitis (VKC)

Covered when ALL of the following are met

VKC continued: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Request is for Verkazia or Klarity-C; 3. Member is responding positively to therapy; 4. Verkazia is not prescribed in combination with other ophthalmic cyclosporine products (e.g., Cequa, Restasis, Vevye); 5. If request is for a dose increase, the request does not exceed 120 vials per affected eye per 30 days.see node text

Approval duration: 12 months

Label-concordant use and supply limits

Covered when dosing and indication match product labeling and utilization management rules

Product-specific indication and dosing: Use consistent with labeled indications: Cequa/Restasis for moderate to severe keratoconjunctivitis sicca or dry eye disease at 1 drop BID each eye (maximum 2 drops/day per eye; supply limit 60 vials/30 days); Vevye 1 drop BID each eye (maximum 2 drops/day per eye; supply limit 1 bottle/50 days); Verkazia/Klarity-C for VKC at 1 drop QID each affected eye (maximum 4 drops/day per eye; supply limit 120 vials per affected eye per 30 days).supply limits per product

See dosing table in chunk 19 and policy updates in chunk 24

Authorization duration

Approval duration for initial and continued therapy

Duration: Initial and continued therapy authorization durations are 12 months for all indications for maintenance therapy.12 months

Updated during 2Q 2026 annual review

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of safety and efficacy consistent with the applicable off-label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (HIM/ICHRA), or CP.PMN.53 (Medicaid), or unless the member’s evidence of coverage document allows the use.

Klarity-C is a compounded cyclosporine ophthalmic emulsion and, unlike the FDA-approved branded products listed in this policy, its formulation has not been reviewed by the FDA for any indication. Compounded medications are not reviewed by the FDA for safety or efficacy; Klarity-C was added to this policy per the product listing updates.

Legacy state-specific exceptions and prior duration language previously included for WellCare have been removed; Medicaid approval durations take precedence where applicable. Providers should follow Medicaid duration rules in the member’s benefit when those rules differ from legacy language previously in the policy.

Product Coding, Strengths, and Supply Limits

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests for cyclosporine ophthalmic agents (Cequa, Klarity-C, Restasis, Verkazia, Vevye, and others) must have prior authorization; approvals are granted only when the diagnostic, age, step-therapy, product, supply, and other criteria in the policy are met.

Applies to initial and continued therapy requests
Approval durations: 12 months when criteria met

Documentation Required

Documentation Required — Include Clinical Supporting Information

Provider must submit supporting documentation (e.g., office chart notes, lab results, prior medication history, and other clinical information) demonstrating that the member meets all applicable approval criteria. Requests that do not include required documentation or adequate clinical justification will be denied or returned to the provider for additional information.

Background

Topical cyclosporine ophthalmic formulations act as a calcineurin inhibitor immunosuppressant applied directly to the eye to reduce ocular surface inflammation and thereby increase tear production in conditions such as keratoconjunctivitis sicca (dry eye). Artificial tears are considered first-line therapy; when tears are insufficient, ophthalmic anti-inflammatory agents including cyclosporine may be used as the next therapeutic step. The policy reflects these clinical uses and aligns coverage with labeled indications and required prior-authorization documentation.

Definitions

Keratoconjunctivitis sicca (dry eye) — definition and FDA-approved indications

DefinitionKeratoconjunctivitis sicca (dry eye) is a disease characterized by suppressed tear production due to ocular inflammation.

FDA-approved indication (Cequa)Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

FDA-approved indication (Restasis)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.

Typical labeled dosingCequa/Restasis: 1 drop BID in each eye (approximately 12 hours apart); maximum 2 drops/day in each eye.

Vernal keratoconjunctivitis (VKC) — definition and age/indication notes

Definition

Revision History

03.31.26duration_updateLatest

Initial and continued therapy approval durations were extended from 6 months to 12 months for all indications (maintenance medication).

09.10.24product_addition

Klarity-C (a compounded cyclosporine ophthalmic product) was added to the policy and noted as a compounded product not reviewed by the FDA.

02.07.25policy_revision