Medical Policy:

12.01.059-001

Topic:

Verkazia® (cyclosporine)

Section:

Injections

Effective Date:

September 15, 2024

Issued Date:

September 15, 2024

Last Revision Date:

July 2024

Annual Review:

September 2025

Prepared By:

Sonja

FDA Labeled Indications and Dosage

Agent(s)	FDA Indication(s)
Verkazia® (cyclosporine) Ophthalmic emulsion	Treatment of vernal keratoconjunctivitis (VKC) in children and adults

See package insert for FDA prescribing information

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
PA	Initial Evaluation Target Agent(s) will be approved when ALL of the following are met: 1. ONE of the following: A. The patient has a diagnosis of vernal keratoconjunctivitis (VKC) AND BOTH of the following: 1. ONE of the following: A. The patient has tried and had an inadequate response to combination of a topical ophthalmic mast cell stabilizer AND an antihistamine used in the treatment of VKC OR B. The patient has an intolerance or hypersensitivity to combination of a topical ophthalmic mast cell stabilizer AND an antihistamine used in the treatment of VKC OR C. The patient has an FDA labeled contraindication to ALL topical ophthalmic mast cell stabilizers AND antihistamines AND 2. ONE of the following: A. The patient has tried and had an inadequate response to a topical ophthalmic corticosteroid used in the treatment of VKC OR B. The patient has an intolerance or hypersensitivity to topical ophthalmic corticosteroid therapy OR C. The patient has an FDA labeled contraindication to ALL topical ophthalmic corticosteroids OR B. The patient has another FDA labeled indication for the requested agent OR C. The patient has another indication that is supported in compendia for the requested agent and route of administration AND 2. The patient will NOT be using the requested agent in combination with Cequa, Restasis, Vevye, or Xiidra AND 3. The patient does NOT have any FDA labeled contraindications to the requested agent Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence Length of Approval: 4 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met: 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND 2. The patient has had clinical benefit with the requested agent AND 3. The patient will NOT be using the requested agent in combination with Cequa, Restasis, Vevye, or Xiidra AND 4. The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:

A. The patient has a diagnosis of vernal keratoconjunctivitis (VKC) AND BOTH of the following:

1. ONE of the following:

A. The patient has tried and had an inadequate response to combination of a topical ophthalmic mast cell stabilizer AND an antihistamine used in the treatment of VKC OR

B. The patient has an intolerance or hypersensitivity to combination of a topical ophthalmic mast cell stabilizer AND an antihistamine used in the treatment of VKC OR

C. The patient has an FDA labeled contraindication to ALL topical ophthalmic mast cell stabilizers AND antihistamines AND

2. ONE of the following:

A. The patient has tried and had an inadequate response to a topical ophthalmic corticosteroid used in the treatment of VKC OR

B. The patient has an intolerance or hypersensitivity to topical ophthalmic corticosteroid therapy OR

C. The patient has an FDA labeled contraindication to ALL topical ophthalmic corticosteroids OR

B. The patient has another FDA labeled indication for the requested agent OR

C. The patient has another indication that is supported in compendia for the requested agent and route of administration AND

2. The patient will NOT be using the requested agent in combination with Cequa, Restasis, Vevye, or Xiidra AND

3. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Length of Approval: 4 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND

2. The patient has had clinical benefit with the requested agent AND

3. The patient will NOT be using the requested agent in combination with Cequa, Restasis, Vevye, or Xiidra AND

4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
Universal QL	Quantity limit for the Target Agent(s) will be approved when ONE of the following is met: 1. The requested quantity (dose) does NOT exceed the program quantity limit OR 2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: A. BOTH of the following: 1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND 2. There is support for therapy with a higher dose for the requested indication OR B. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR C. BOTH of the following: 1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND 2. There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

Universal QL

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR

2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:

A. BOTH of the following:

1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND

2. There is support for therapy with a higher dose for the requested indication OR

B. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR

C. BOTH of the following:

1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND

2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

Reference to Our Policy Information Guidelines

CLINICAL RATIONALE

Vernal Keratoconjunctivitis

Vernal keratoconjunctivitis (VKC) is an atopic condition of the external ocular surface. VKC is typically seen in hot, dry climates. Symptoms typically present in early to mid-childhood and typically resolves after puberty. Symptoms may include eye itching, photophobia, tearing, ocular discharge, irritation, redness, and blepharospasm. VKC can be divided into three subcategories based on the presentation of disease, conjunctival, limbal, and mixed presentation. VKC is both an IgE and non-IgE mediated ocular allergic condition.(2,3)

Treatment follows a step wise approach based on disease severity (2,3)

Topical mast cell stabilizers and antihistamines for patients with micropapillae and no corneal changes
Topical corticosteroids for patients with macropapillae, mucus accumulation, and corneal vascularization
Immunomodulating agents for patients with macropapillae, macroerosion, shield ulcer, and persistent severe inflammation

Topical antihistamines and topical mast cell stabilizers in combination with pulse corticosteroids during an exacerbation is common practice for maintenance of VKC.(2,3)

The American Academy of Ophthalmology Preferred Practice Pattern indicate that topical mast cell stabilizers in combination with topical or oral antihistamines can be used for maintenance. The AAO also recommends topical ophthalmic corticosteroids for acute exacerbations to control severe symptoms and signs. Topical cyclosporine may allow for reduced used of topical steroids.(3)

Safety

Verkazia (cyclosporine) has no FDA labeled contraindications for use.(1)

Professional Statements and Societal Positions Guidelines

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Final Module	Target Agent GPI	Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Targeted NDCs When Exclusions Exist	Final Age Limit	Preferred Status	Effective Date

	86720020001630	Verkazia	cyclosporine (ophth) emulsion	0.1 %	M ; N ; O ; Y	65086000112

POLICY AGENT SUMMARY QUANTITY LIMIT

Wildcard	Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Days Supply	Duration	Targeted NDCs When Exclusions Exist	Age Limit	Effective Date	Term Date

86720020001630	Verkazia	cyclosporine (ophth) emulsion	0.1 %	120	Vials	30	DAYS	65086000112

Place of Service: Inpatient/Outpatient

The policy position applies to all commercial lines of business

Internal Sources

Medical Director

Links