CurrentCignaPolicy N/A

Ophthalmic Anti-Allergics - Miscellaneous Step Therapy Policy

Defines step therapy requirements for selected ophthalmic anti-allergic medications for Cigna-administered health benefit plans, specifying Step 1 and Step 2 products and approval criteria for coverage.

Policy Summary

PayerCigna

PolicyOphthalmic Anti-Allergics - Miscellaneous Step Therapy Policy

Policy CodePolicy N/A

Change TypeRevised (product reclassification and additions)

Effective DateN/A

Next Review DateN/A

Key ActionPrescribe a Step 1 product prior to a Step 2 product unless an approved exception (concurrent use with loteprednol/Alrex, prior steroid trial, or medical director review) applies.

SourceLink

POLICY UPDATE CHANGES

Generic loteprednol etabonate 0.2% ophthalmic suspension was added to Step 2 products.

Generic bepotastine besilate 1.5% ophthalmic solution (Bepreve generic) moved from Step 1 to Step 2.

Examples of H1 antagonists and H1 antagonist/mast cell stabilizers were moved to a Note tied to the concurrent-use exception.

Step 1Initial preferred products (4 listed)

Step 2Second-line products (4 listed)

1 yearTypical approval duration

02/05/2025Review date

Coverage Criteria

Initial Step Therapy and Exceptions

Covered when ALL of the following are met unless an exception applies:

Primary requirement: Patient has tried one Step 1 Product.

If met, a Step 2 Product may be approved.

Exceptions that also permit approval of a Step 2 product without meeting the primary requirement

Concurrent corticosteroid need: Patient requires concurrent use of Alrex (brand) or generic loteprednol etabonate 0.2% ophthalmic suspension together with an H1 antagonist or an H1 antagonist/mast cell stabilizer.
Approve Alrex or generic loteprednol 0.2% for this indication.
Prior ophthalmic steroid trial: Patient has tried a different ophthalmic steroid for the current condition.

Policy Summary

PayerCigna

PolicyOphthalmic Anti-Allergics - Miscellaneous Step Therapy Policy

Policy CodePolicy N/A

Change TypeRevised (product reclassification and additions)

Effective DateN/A

Next Review DateN/A

Key ActionPrescribe a Step 1 product prior to a Step 2 product unless an approved exception (concurrent use with loteprednol/Alrex, prior steroid trial, or medical director review) applies.

SourceLink

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Provider Actions and Step Therapy Requirements

Step Therapy

Step Therapy Overview

This program encourages use of a Step 1 product before a Step 2 product. 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 below. All approvals are provided for 1 year in duration. OTC Pataday and OTC Lastacaft products are not targeted in this policy.

Step 1: generic azelastine hydrochloride 0.05% ophthalmic solution; generic epinastine hydrochloride 0.05% ophthalmic solution; prescription generic olopatadine 0.1% ophthalmic solution; prescription generic olopatadine 0.2% ophthalmic solution
Step 2: Alrex (brand and generic), Bepreve (brand and generic), Lastacaft, Zerviate
Approvals are provided for 1 year

Denial Risk

Provider Action: Coverage Determination and Exceptions

Coverage for Step 2 products will be determined by the Step Therapy criteria. Any exception not meeting these criteria is considered not medically necessary.

If the patient has tried one Step 1 product, approve a Step 2 product.
Concurrent use exception: If the patient requires concurrent use of Alrex or generic loteprednol etabonate 0.2% ophthalmic suspension with an H1 antagonist or an H1 antagonist/mast cell stabilizer, approve Alrex or generic loteprednol etabonate 0.2% ophthalmic suspension.
If the patient has tried a different ophthalmic steroid for the current condition, approve Alrex or generic loteprednol etabonate 0.2% ophthalmic suspension.

Step Therapy

Provider Action: Step 1 Before Step 2

Step 1 products must be tried prior to Step 2 products unless an exception applies. Examples of H1 antagonists include Zerviate. Examples of H1 antagonist/mast cell stabilizers include azelastine ophthalmic solution, epinastine ophthalmic solution, bepotastine ophthalmic solution (Bepreve, generic), Lastacaft, olopatadine 0.1% ophthalmic solution, and olopatadine 0.2% ophthalmic solution.

Step 1 required prior to Step 2 unless meeting listed exceptions (concurrent use, prior steroid trial, etc.)
OTC Pataday and OTC Lastacaft are not targeted by this policy

Definitions

Combination antihistamine and mast‑cell stabilizer ophthalmic agents

DefinitionCombination H1‑antagonist and mast‑cell stabilizer ophthalmic agents are dual‑mechanism topical eye medications indicated for itching associated with allergic conjunctivitis.

Examples (listed in policy Table 1)Azelastine 0.05% (generic), Epinastine 0.05% (generic), Bepotastine besilate 1.5% (Bepreve and generic), Olopatadine HCl 0.1% and 0.2% (generic), Alcaftadine 0.25% (Lastacaft).

Typical indicationTreatment or prevention of ocular itching associated with allergic conjunctivitis.

Regulatory notesSome olopatadine and Lastacaft products have OTC formulations; OTC olopatadine and OTC Lastacaft are not targeted by this policy.

Related single‑agent comparatorZerviate (cetirizine 0.24%) is a selective H1 antagonist (single mechanism) listed separately in Table 1.

Background

Ophthalmic anti-allergic agents are indicated for allergic conjunctivitis and include H1 antihistamines, mast-cell stabilizers, combination H1 antagonist/mast-cell stabilizers, and a topical corticosteroid (loteprednol) used in certain cases. Examples of H1 antagonist and combination agents include azelastine, epinastine, bepotastine, olopatadine, and alcaftadine. This policy groups products into Step 1 (preferred initial therapies such as generic azelastine 0.05%, generic epinastine 0.05%, and prescription generic olopatadine 0.1% and 0.2%) and Step 2 (second-line products including Alrex/loteprednol, Bepreve, Lastacaft, and Zerviate) to guide coverage decisions.