CurrentCignaPolicy IP0439

Verkazia (cyclosporine 0.1% ophthalmic emulsion) — Coverage Criteria for Vernal Keratoconjunctivitis

Cigna's coverage policy for Verkazia for treatment of vernal keratoconjunctivitis (VKC) in patients aged ≥4 years, including medical necessity criteria and plan-specific formulary considerations.

Policy Summary

PayerCigna

PolicyVerkazia (cyclosporine 0.1% ophthalmic emulsion) — Coverage Criteria for VKC

Policy CodePolicy IP0439

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation that the patient is ≥4 years, has moderate to severe VKC, has tried required prior therapies (or meets exceptions), and the prescriber is or consulted with an ophthalmologist/optometrist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥4Minimum age

1 yrInitial approval

ExperimentalOther uses

06/01/2024Last review

Coverage Criteria for Verkazia (cyclosporine 0.1%)

Policy Summary

PayerCigna

PolicyVerkazia (cyclosporine 0.1% ophthalmic emulsion) — Coverage Criteria for VKC

Policy CodePolicy IP0439

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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FDA-Approved Indication: A) Patient is ≥ 4 years of age; AND B) According to the prescriber, the patient has moderate to severe vernal keratoconjunctivitis; AND C) Patient meets one of the following (i or ii): i. Patient has tried two single-action ophthalmic medications (ophthalmic mast cell stabilizers or ophthalmic antihistamines) for maintenance of VKC; OR ii. Patient has tried one dual-action ophthalmic mast-cell stabilizer/antihistamine product for maintenance of VKC; (Note: exception to prior trial requirement if the patient has already tried at least one other ophthalmic cyclosporine product); AND D) Medication is prescribed by or in consultation with an optometrist or ophthalmologist; AND E) Preferred product criteria is met as specified in plan tables.

Examples of single-action agents: cromolyn, lodoxamide (Alomide), cetirizine (Zerviate). Examples of dual-action agents: azelastine, bepotastine, epinastine, olopatadine, Lastacaft.

Plan-Specific Coverage Criteria

Plan-specific alternative criteria (employer, value/advantage, individual plans):

Employer Plans (Standard/Performance/Legacy / Value/Advantage/Total Savings): ONE of: 1) Failure or intolerance to an ophthalmic cyclosporine medication (e.g., Cequa, Restasis); OR 2) Failure, contraindication, or intolerance to EITHER: A) TWO single-action ophthalmic medications (examples: Cromolyn, Alomide, Zerviate) (Note: under Value/Advantage/Total Savings plans this may be reduced to ONE single-action agent); OR B) ONE dual-action ophthalmic mast-cell stabilizer/antihistamine (examples: azelastine, bepotastine, epinastine, olopatadine).

Dual-action agents may be excluded on some Value/Advantage/Total Savings drug lists — verify the applicable benefit document.

Individual and Family Plans: ONE of: 1) Failure or intolerance to an ophthalmic cyclosporine medication (e.g., Restasis, Cequa [may require prior authorization]); OR 2) Failure, contraindication, or intolerance to EITHER: A) TWO single-action ophthalmic medications (examples: Cromolyn, Alomide, Zerviate [may require prior authorization]); OR B) ONE dual-action ophthalmic mast-cell stabilizer/antihistamine (examples: azelastine, epinastine, olopatadine).

When coverage is available, dose, frequency, duration, and site of care should be clinically appropriate and supported by evidence; receipt of sample product does not satisfy prior trial requirements.

Provider Actions, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document the patient is ≥ 4 years of age, has moderate to severe vernal keratoconjunctivitis (per the prescriber), that the prescriber is or consulted an optometrist/ophthalmologist, and that preferred product criteria are met. Approvals are for up to 1 year when all criteria are satisfied.

Patient age ≥ 4 years
Documentation of moderate to severe vernal keratoconjunctivitis per prescriber
Prescriber is or consulted an optometrist/ophthalmologist
Preferred product criteria met
Approval duration: up to 1 year

Step Therapy

Step Therapy / Prior-Treatment Trials

Step therapy / prior-treatment trials are required unless an exception applies. The patient must have tried and failed or be intolerant/contraindicated to the required prior therapies before coverage of Verkazia is approved, per plan-specific criteria.

Standard requirement: ONE of the following must be documented: 1) Failure or intolerance to an ophthalmic cyclosporine product (e.g., Restasis, Cequa); OR 2) Failure, contraindication, or intolerance to EITHER (A) TWO single-action ophthalmic medications (e.g., cromolyn ophthalmic solution, Alomide, Zerviate) OR (B) ONE dual-action ophthalmic mast-cell stabilizer/antihistamine (e.g., azelastine, bepotastine, epinastine, olopatadine).
Value/Advantage/Total Savings Drug List Plans may require: Failure or intolerance to an ophthalmic cyclosporine OR failure/contraindication/intolerance to EITHER ONE single-action ophthalmic medication OR ONE dual-action product (note: dual-action agents may be excluded under some plans).
Individual & Family Plans: Similar requirements — failure/intolerance to an ophthalmic cyclosporine (may require prior authorization) OR failure/contraindication/intolerance to EITHER TWO single-action ophthalmic medications OR ONE dual-action product (some agents may require prior authorization).
Exception: A prior trial of two single-action agents or one dual-action agent may be waived if the patient has already tried at least one ophthalmic cyclosporine product other than the requested medication (e.g., Cequa, Restasis, Vevye).

Documentation Required

Prescriber and Documentation Requirements

Prescriber and documentation requirements must be met and retained in the medical record. Include age, VKC severity, prior therapies tried (including specific agents and outcomes), and evidence of specialist involvement when applicable.

Prescriber must be or consult an optometrist or ophthalmologist.
Document patient age (≥ 4 years) and prescriber assessment of VKC severity (moderate to severe).
Document prior treatment trials per step therapy requirements (specific agents tried, durations, and reason for failure/intolerance/contraindication).
If relying on an exception (prior cyclosporine trial), document the cyclosporine product tried and outcome.
Note: Receipt of sample product does NOT satisfy prior trial requirements.

Denial Risk

Non‑VKC Use Denial Risk

Requests for uses other than vernal keratoconjunctivitis are not covered and are considered experimental/investigational/unproven.

Coverage limited to FDA‑approved indication: Vernal Keratoconjunctivitis.
Any other use is considered experimental, investigational, or unproven and may be denied.

Background

Vernal keratoconjunctivitis (VKC) is a recurrent, bilateral allergic inflammation of the conjunctiva and superficial cornea characterized by itching, photophobia, burning, foreign body sensation, mucoid discharge, and tearing. Management ranges from lubricating agents for mild disease to mast cell stabilizers, antihistamines, dual‑action agents, NSAIDs, or topical corticosteroids for moderate to severe disease, with steroid‑sparing immunomodulators such as topical cyclosporine reserved for recurrent or steroid‑dependent cases.

Definitions

Vernal keratoconjunctivitis (VKC) — definition and characteristic symptoms

DefinitionA recurrent, bilateral allergic inflammation of the conjunctiva and the superficial cornea.

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

Epidemiology notesMore common in males and more prevalent in hot, dry, tropical and sub‑tropical climates.

PathophysiologyExacerbations are thought to be mediated in part by immunoglobulin E (IgE) immune mechanisms.

Verkazia — drug description and indication

Drug name and formulationVerkazia — cyclosporine 0.1% ophthalmic emulsion.

Drug classTopical calcineurin inhibitor immunosuppressant (topical cyclosporine).

IndicationIndicated for the treatment of vernal keratoconjunctivitis (VKC) in patients aged ≥ 4 years.

Place in therapyUsed as a steroid‑sparing immunomodulatory agent for recurrent VKC; considered for moderate to severe disease after first‑line therapies and appropriate prior topical agents per criteria.