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ph-1223

Verkazia Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1223

This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
10-01-2024

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Verkazia® (cyclosporine) Ophthalmic emulsion	Treatment of vernal keratoconjunctivitis (VKC) in children and adults		1

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

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)

REFERENCES

Number	Reference
1	Verkazia prescribing information. Santen Inc. June 2022.
2	Vernal keratoconjunctivitis. American Academy of Ophthalmology. Published January 17, 2018. https://www.aao.org/education/disease-review/vernal-keratoconjunctivitis-5
3	Varu DM, Rhee MK, Akpek EK, et al. Conjunctivitis Preferred Practice pattern®. Ophthalmology. 2019;126(1):P94-P169. doi:10.1016/j.ophtha.2018.10.020

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

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

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

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

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Verkazia	cyclosporine (ophth) emulsion	0.1 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Verkazia	cyclosporine (ophth) emulsion	0.1 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

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: ONE of the following: The patient has a diagnosis of vernal keratoconjunctivitis (VKC) AND BOTH of the following: ONE of the following: 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 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 The patient has an FDA labeled contraindication to ALL topical ophthalmic mast cell stabilizers AND antihistamines AND ONE of the following: The patient has tried and had an inadequate response to a topical ophthalmic corticosteroid used in the treatment of VKC OR The patient has an intolerance or hypersensitivity to topical ophthalmic corticosteroid therapy OR The patient has an FDA labeled contraindication to ALL topical ophthalmic corticosteroids OR The patient has another FDA labeled indication for the requested agent OR The patient has another indication that is supported in compendia for the requested agent and route of administration AND The patient will NOT be using the requested agent in combination with Cequa, Restasis, Vevye, or Xiidra AND 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. Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. Renewal Evaluation* Target Agent(s) will be approved when ALL of the following are met: 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 The patient has had clinical benefit with the requested agent AND The patient will NOT be using the requested agent in combination with Cequa, Restasis, Vevye, or Xiidra AND 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:

ONE of the following:
1. The patient has a diagnosis of vernal keratoconjunctivitis (VKC) AND BOTH of the following:
  1. ONE of the following:
    1. 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
    2. 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
    3. The patient has an FDA labeled contraindication to ALL topical ophthalmic mast cell stabilizers AND antihistamines AND
  2. ONE of the following:
    1. The patient has tried and had an inadequate response to a topical ophthalmic corticosteroid used in the treatment of VKC OR
    2. The patient has an intolerance or hypersensitivity to topical ophthalmic corticosteroid therapy OR
    3. The patient has an FDA labeled contraindication to ALL topical ophthalmic corticosteroids OR
2. The patient has another FDA labeled indication for the requested agent OR
3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
The patient will NOT be using the requested agent in combination with Cequa, Restasis, Vevye, or Xiidra AND
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.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Renewal Evaluation

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

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
The patient has had clinical benefit with the requested agent AND
The patient will NOT be using the requested agent in combination with Cequa, Restasis, Vevye, or Xiidra AND
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
QL	Quantity limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND 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

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

The requested quantity (dose) does NOT exceed the program quantity limit OR
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. 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
2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR
3. 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

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

ALBP _ Commercial _ CSReg _ Verkazia__PAQL _ProgSum_ 10-01-2024 _