CurrentCignaPolicy N/A

Ophthalmic Corticosteroids Step Therapy Policy

Defines Cigna's step therapy requirements for selected ophthalmic corticosteroid products for members covered under Cigna-administered health benefit plans; affects prescribers and pharmacy/medical benefit adjudication at point of service.

Policy Summary

PayerCigna

PolicyOphthalmic Corticosteroids Step Therapy Policy

Policy CodePolicy N/A

Change TypeMaterial clinical updates

Effective DateN/A

Next Review DateFeb 19, 2025

Key ActionDocument that the patient has tried two Step 1 products or document a benzalkonium chloride allergy to approve a Step 2 product.

SourceLink

POLICY UPDATE CHANGES

Durezol was added to the exception criterion for a patient with an allergy to benzalkonium chloride.

FML ophthalmic suspension 0.1% (FML SOP) removed from Step 2.

5number of Step 1 products listed

15+number of Step 2 products listed (approx.)

1 yrapproval duration

02/19/2025policy last reviewed

Coverage Criteria

Initial Step 2 Coverage Criteria

Covered when ALL of the following are met

Step therapy requirement: Patient has tried two Step 1 products prior to use of a Step 2 producttrial of two Step 1 products

Approvals are for 1 year

BAK allergy exception: If the patient has an allergy to benzalkonium chloride, approve Durezol or Lotemax ophthalmic ointment without meeting the two Step 1 trialsdocumented BAK allergy

Durezol was explicitly added to this exception

Any request for ophthalmic corticosteroid products that does not meet the Step Therapy criteria or an approved exception is considered not medically necessary. The program requires trial of two Step 1 products prior to use of a Step 2 product; if the Step Therapy rule is not met at point of service, coverage will be determined by the Step Therapy criteria below and approvals (when criteria are met) are provided for 1 year.

Policy Summary

PayerCigna

PolicyOphthalmic Corticosteroids Step Therapy Policy

Policy CodePolicy N/A

Change TypeMaterial clinical updates

Effective DateN/A

Next Review DateFeb 19, 2025

Key ActionDocument that the patient has tried two Step 1 products or document a benzalkonium chloride allergy to approve a Step 2 product.

SourceLink

On This Page

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Provider Actions and Requirements

Denial Risk

Step therapy failure may lead to denial

If the Step Therapy rule is not met for a Step 2 product at the point of service, coverage will be determined by the Step Therapy criteria. Failure to meet the required Step Therapy trials may result in denial of coverage at the time of service.

Step Therapy requires trial of two Step 1 products before approving a Step 2 product.
All approvals, when granted, are provided for 1 year in duration.

Prior Authorization

Prior authorization / step therapy documentation required

This program requires documentation that the patient has tried two Step 1 products prior to use of a Step 2 product, or qualifies for an exception (for example, a benzalkonium chloride allergy). Providers should document trials, dates, and clinical response in the medical record when submitting for coverage.

Step 1 products include: generic dexamethasone 0.1%, generic difluprednate 0.05%, generic fluorometholone 0.1%, generic prednisolone acetate 1%, generic prednisolone sodium 1%.
Step 2 products include: Clobetasol propionate 0.05% ophthalmic suspension, Durezol, Flarex, FML Forte, FML Liquifilm, Inveltys, Lotemax (ointment 0.5%, gel 0.5%, SM), generic loteprednol 0.5% (gel and suspension), Maxidex, Pred Mild.

Documentation Required

Documentation and clinical judgment

Coverage determinations require consideration of the applicable benefit plan document, any relevant laws/regulations, and collateral source materials. Medical directors and reviewers will exercise clinical judgment when making individual coverage decisions; each request is reviewed on its own merits.

Verify the member's benefit plan terms and any controlling federal or state mandates prior to approval.
Clinical judgment may override standard criteria when supported by documented medical necessity.

Step Therapy

Step therapy logic and exceptions

Step therapy logic: a trial of two Step 1 products is required prior to approval of a Step 2 product. An exception for benzalkonium chloride (BAK) allergy permits approval of Durezol or Lotemax ophthalmic ointment without completing Step 1 trials.

If two Step 1 products have been tried, approve a Step 2 product.
If patient has a BAK allergy, Durezol or Lotemax ointment may be approved as an exception.

Background

Ophthalmic corticosteroids are used to treat a range of anterior segment inflammatory conditions, including anterior uveitis, corneal injury, and inflammatory conditions of the conjunctiva, cornea, and anterior segment; they are also used for postoperative inflammation/pain and seasonal allergic conjunctivitis. Some products (for example, Durezol) have specific indications such as endogenous anterior uveitis and have demonstrated efficacy comparable to prednisolone acetate 1% in clinical trials. Many ophthalmic steroid formulations contain the preservative benzalkonium chloride (BAK); products noted as not preserved with BAK (for example, Durezol and Lotemax ophthalmic ointment) are included in the policy exception for patients with a documented BAK allergy.

OpenPayer

Ophthalmic Corticosteroids Step Therapy Policy

Coverage Criteria

Provider Actions and Requirements

Background

Definitions