ModifiedCignaPolicy N/A

Ophthalmic glaucoma beta-adrenergic blockers step therapy

Cigna step therapy policy governing coverage (prior authorization / step requirements) for ophthalmic beta-adrenergic blocker products used to treat elevated intraocular pressure in ocular hypertension or open-angle glaucoma. Defines Step 1 and Step 2 product lists, approval rules, exception for BAK sensitivity, and revision history.

Policy Summary

PayerCigna

PolicyOphthalmic glaucoma beta-adrenergic blockers step therapy

Policy CodePolicy N/A

Change TypeStep list revisions; BAK sensitivity exception added

Effective Date

Next Review Date

Key ActionDocument a trial of one Step 1 product to approve Step 2 products, or document known BAK sensitivity to qualify for the exception.

POLICY UPDATE CHANGES

Annual revision 10/23/2024: product removals and additions across steps (historic changes summarized).

2Approval conditions (trial vs exception)

2Defined step levels

1Approval duration (years)

Summary of Material Changes

Material change (selected revision 01/15/2025): multiple generic timolol formulations were removed from Step 1 and added to Step 2; generic timolol ophthalmic solution (generic to Timoptic) remains in Step 1; generic timolol 0.5% (generic to Betimol) was added to Step 2. This is a material revision to the step placement of timolol products. (Historic annual revision 10/23/2024: product removals and additions across steps were previously recorded.)

Approval conditions (trial vs exception)2

Defined step levelsStep 1 and Step 2

Approval duration1 year

Step Therapy Criteria (When Products Are Medically Necessary)

Step therapy criteria

Products are covered as medically necessary when the following step therapy criteria are met. Any other exception is considered not medically necessary. All approvals are provided for 1 year in duration.

ALL of the following

If the patient has tried one Step 1 Product, approve a Step 2 Product.
If BAK sensitivity
- If the patient has a known benzalkonium chloride (BAK) sensitivity, approve Timoptic in Ocudose (brand and generic).
- If the patient has a known benzalkonium chloride (BAK) sensitivity, approve Timoptic XE (brand and generic).

BAK (Benzalkonium chloride): Benzalkonium chloride is a preservative in many ophthalmic products; members with known BAK sensitivity are eligible for preservative-free or alternative products per the exception criteria. Ophthalmic beta-adrenergic blockers are indicated for elevated intraocular pressure in ocular hypertension or open-angle glaucoma; products differ by preservative presence — Timoptic in Ocudose is preservative-free and the gel formulation uses benzododecinium bromide while most others contain BAK.

Step 1 and Step 2 Product Lists

Step 1 products (preferred first-line)mixedCovered

generic betaxolol 0.5% ophthalmic solution	Step 1 product
generic carteolol 1% ophthalmic solution	Step 1 product
generic levobunolol 0.5% ophthalmic solution	Step 1 product
generic timolol maleate 0.25% ophthalmic solution (generic to Timoptic)	Step 1 product
generic timolol maleate 0.5% ophthalmic solution (generic to Timoptic)	Step 1 product

Step 2 products (require prior step or exception)mixedCovered

Betimol (timolol 0.25% and 0.5% ophthalmic solution) - brand and generic	Step 2 product
Istalol (timolol maleate 0.5% ophthalmic solution) - brand and generic	Step 2 product
Timoptic (timolol maleate 0.25% and 0.5% ophthalmic solution) - brand and generic	Step 2 product
Timoptic in Ocudose (timolol maleate 0.25% and 0.5% ophthalmic solution) - brand and generic	Step 2 product; preservative-free; exception for BAK sensitivity
Timoptic XE (timolol maleate 0.25% and 0.5% ophthalmic gel forming solution) - brand and generic	Step 2 product; alternative preservative
generic timolol 0.5% ophthalmic solution (generic to Betimol)	Step 2 product

Prior Authorization, Documentation, and Exceptions

Step Therapy

Step therapy prior authorization required for Step 2 products

Step 2 products are subject to step therapy: member must have tried one Step 1 product before approval of a Step 2 product; approvals are provided for 1 year.

Approval duration: 1 year
Trial required: one Step 1 product (documented)

Prior Authorization

Exception for BAK sensitivity

If the patient has a known benzalkonium chloride (BAK) sensitivity, Timoptic in Ocudose (brand and generic) or Timoptic XE (brand and generic) may be approved without trial of a Step 1 product.

Products: Timoptic in Ocudose (brand and generic); Timoptic XE (brand and generic)
Documentation of BAK sensitivity required

Documentation Required

Document prior therapy or sensitivity

Provider must document trial of one Step 1 product to approve Step 2 products, or document known BAK sensitivity to qualify for exception.

Clinical Context and Guideline Reference

Ophthalmic beta-adrenergic blockers are indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma and in general they lower IOP by approximately 20-25%. Products differ by preservative: Timoptic in Ocudose is preservative-free; most other listed ophthalmic beta-blockers are preserved with benzalkonium chloride (BAK); the timolol gel-forming solution is preserved with benzododecinium bromide.

AAO Preferred Practice Pattern2021 guidance cited

Document Revisions

2025-01-15revisionLatest

Selected revision 01/15/2025: multiple generic timolol formulations were removed from Step 1 and added to Step 2; generic timolol ophthalmic solution (generic to Timoptic) remains in Step 1; generic timolol 0.5% (generic to Betimol) was added to Step 2. Exception criterion added to allow Timoptic in Ocudose (brand and generic) and Timoptic XE (brand and generic) for patients with known benzalkonium chloride (BAK) sensitivity.

2024-10-23annual_revision

Annual revision 10/23/2024: product removals and additions across steps (historic changes summarized), including prior moves of generic timolol products between steps and removal of obsolete products.