CurrentCignaPolicy IP0439

Verkazia (cyclosporine 0.1% ophthalmic emulsion) coverage criteria

Defines Cigna coverage and medical necessity criteria for Verkazia for treatment of vernal keratoconjunctivitis (VKC) in insured members, including plan-specific formulary rules.

Policy Summary

PayerCigna

PolicyVerkazia (cyclosporine 0.1% ophthalmic emulsion) coverage criteria

Policy CodePolicy IP0439

Change TypeNo material change

Effective DateJun 1, 2024

Next Review Date

Key ActionObtain prior authorization and document age, diagnosis of moderate to severe VKC, prior medication trials or exception rationale, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥4minimum patient age for coverage

1 yearinitial approval duration

IP0439policy id

06/01/2024effective

Coveredcoverage stance

Coverage Criteria

FDA‑Approved Indication: Vernal Keratoconjunctivitis

Covered when ALL of the following are met:

Verkazia FDA‑indication criteria

A: Patient is ≥ 4 years of age>= 4 years
B: Prescriber documents the patient has moderate to severe vernal keratoconjunctivitis
C
- C.i: Patient has tried two single‑action ophthalmic medications (mast cell stabilizers or ophthalmic antihistamines) for maintenance treatment of VKC2 single‑action agents tried
  Examples: cromolyn, lodoxamide (Alomide), cetirizine ophthalmic solution (Zerviate)
- C.ii: Patient has tried one dual‑action ophthalmic mast‑cell stabilizer/antihistamine product for maintenance treatment of VKC1 dual‑action agent tried
  Examples: azelastine, bepotastine, epinastine, olopatadine
- C.exception: Exception: prior trial of at least one other ophthalmic cyclosporine product (e.g., Cequa, Restasis, Vevye) other than the requested medication can substitute for the above trial requirements1 ophthalmic cyclosporine product tried
  Examples: Cequa (cyclosporine 0.09%), Restasis (cyclosporine 0.05%), Vevye (cyclosporine 0.1%)
D: Medication is prescribed by or in consultation with an optometrist or ophthalmologist
E: Preferred product criteria per plan formulary is met (plan‑specific rules may require different prior‑therapy or cyclosporine failure/intolerance criteria)
See Employer, Value/Advantage/Total Savings, and Individual/Family plan tables for plan‑specific criteria

Any use of Verkazia other than for the treatment of vernal keratoconjunctivitis (VKC) is considered experimental, investigational, or unproven and is not covered under this policy.

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Approve for 1 year if the patient meets the age, diagnosis, severity, prescriber, and prior therapy / preferred product conditions described in the policy (see criteria for FDA‑approved indication).

Prior authorization duration: up to 1 year when criteria met
Prescriber requirement: prescribed by or in consultation with an optometrist or ophthalmologist

Step Therapy

Step Therapy Required

Step therapy is required. Patient must have trialed and failed, been intolerant to, or have a contraindication to required prior medications before coverage of the requested product, unless an exception is documented.

Standard requirement: trial of TWO single‑action ophthalmic medications (mast cell stabilizers or antihistamines) OR ONE dual‑action ophthalmic mast‑cell stabilizer/antihistamine product
Exception: a prior trial of at least one ophthalmic cyclosporine product (e.g., Cequa, Restasis, Vevye) can substitute for the step requirement
Employer/Plan variations: some plans (Value/Advantage/Total Savings) may require only ONE single‑action trial or exclude dual‑action agents per plan — confirm benefit document

Documentation Required

Required Clinical Documentation

Prescribing clinician must document the following in the request: patient age; diagnosis of moderate to severe vernal keratoconjunctivitis; prior medication trials (names, dates, durations, and outcomes) or documented rationale for exception (e.g., intolerance, contraindication); that the medication is prescribed by or in consultation with an optometrist or ophthalmologist; and any relevant plan‑specific preferred product criteria.

Document patient is ≥ 4 years of age and has moderate to severe VKC per prescriber
List prior trials: two single‑action agents or one dual‑action agent, or prior ophthalmic cyclosporine trial if using exception
If exception requested, provide clinical rationale (intolerance, contraindication, or prior cyclosporine use)

Denial Risk

Non‑VKC Uses

Requests for uses other than treatment of vernal keratoconjunctivitis are considered experimental, investigational, or unproven and may be denied.

Definitions

inv-08: Vernal keratoconjunctivitis (VKC) — definition and clinical features.

DefinitionVernal keratoconjunctivitis (VKC) is a recurrent, bilateral allergic inflammation of the conjunctiva and the superficial cornea.

EpidemiologyMore common in males and in hot, dry, tropical or sub‑tropical climates.

Typical symptomsItching, photophobia, burning, foreign body sensation, mucoid discharge, and tearing.

PathophysiologyExacerbations are thought to involve immunoglobulin E (IgE)‑mediated immune mechanisms.

Treatment overviewMild disease: lubricating therapies (preservative‑free artificial tears, gels, ointments). Moderate–severe disease: mast cell stabilizers, ophthalmic antihistamines, dual‑action mast‑cell stabilizer/antihistamine products, NSAIDs, or corticosteroids; steroid‑sparing topical immunomodulators (cyclosporine) are alternatives.

inv-09: Verkazia — description: cyclosporine 0.1% ophthalmic emulsion indicated for VKC in patients aged 4 years and older.

DrugVerkazia (cyclosporine 0.1% ophthalmic emulsion)

Approved indicationTreatment of vernal keratoconjunctivitis (VKC)

Minimum age for usePatients aged ≥ 4 years

Drug classCalcineurin inhibitor immunosuppressant (topical ophthalmic cyclosporine)

Role in therapySteroid‑sparing topical immunomodulator option for recurrent or moderate–severe VKC

Background

Vernal keratoconjunctivitis (VKC) is a recurrent, bilateral allergic inflammation of the conjunctiva and the superficial cornea that typically presents with itching, photophobia, mucoid discharge, and tearing. It is more common in males and in hot, dry climates and can range from mild to moderate or severe disease.

First‑line management emphasizes lubricants and topical therapies; moderate to severe VKC is commonly managed with mast cell stabilizers, topical antihistamines, dual‑action mast cell stabilizer/antihistamines, topical NSAIDs, or corticosteroids. Steroid‑sparing topical immunomodulators such as topical cyclosporine (e.g., Verkazia) are alternative options for patients who require longer‑term control or to reduce steroid exposure.

Verkazia is a topical cyclosporine ophthalmic emulsion specifically indicated for VKC in patients age ≥ 4 years, and coverage under this policy requires documentation of moderate to severe VKC and adherence to the policy’s prior‑therapy and prescriber requirements.