CurrentCignaPolicy IP0474

Zylet (tobramycin 0.3% / loteprednol etabonate 0.5% ophthalmic suspension)

Defines medical necessity criteria, authorization duration, and covered alternatives for Zylet for Individual and Family Plans administered by Cigna Companies. Specifies situations when Zylet is considered medically necessary and notes non-covered uses.

Policy Summary

PayerCigna

PolicyZylet (tobramycin 0.3% / loteprednol etabonate 0.5% ophthalmic suspension)

Policy CodePolicy IP0474

Change TypeNo material change

Effective DateJan 1, 2023

Next Review DateJan 1, 2024

Key ActionConfirm benefit plan requirements and obtain authorization when Zylet is requested as a non-preferred product based on one of the medical necessity criteria.

POLICY UPDATE CHANGES

No material clinical/coverage changes.

3Permissible Coverage Criteria Options

6Initial Approval Duration (weeks)

Coverage Summary

Coverage stance: mixed. Zylet (tobramycin 0.3% / loteprednol etabonate 0.5% ophthalmic suspension) is conditionally covered for Individual and Family Plans administered by Cigna Companies when the policy's medical necessity criteria are met. Receipt of sample product does not satisfy coverage criteria.

Medical Necessity — When Zylet Is Covered

Medical Necessity / Covered when ONE of the following are met

The product Zylet is considered medically necessary when the individual meets ONE of the following (1, 2, or 3):

Inadequate response/contraindication/intolerance to preferred alternative: The individual has had an inadequate response, contraindication, or is intolerant to the following: tobramycin/dexamethasone ophthalmic suspension
Age under 2 years: Individual is less than 2 years of age
Current Zylet therapy: Individual is currently receiving Zylet for the treatment of active eye infections

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Unproven Uses and Limitations

Intended use and covered situations: Zylet is intended for steroid-responsive inflammatory ocular conditions where superficial bacterial infection or risk exists. Non-covered uses and limitations: any use outside the specified indication is considered experimental, investigational, or unproven. Coverage varies across plans and requires use of preferred products; Zylet is only considered medically necessary when one of the policy criteria is met (e.g., prior inadequate response/contraindication/intolerance to the preferred tobramycin/dexamethasone product, age <2 years, or current receipt of Zylet for active eye infections). Receipt of samples does not satisfy coverage criteria.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required when coverage varies across plans

Coverage varies across plans and requires use of preferred products per the customer's benefit plan; confirm benefit plan requirements and obtain authorization when Zylet is requested as a non-preferred product based on one of the medical necessity criteria.

Confirm benefit plan requirements and obtain authorization when Zylet is requested as a non-preferred product.

Documentation Required

Document inadequate response or intolerance

When requesting coverage under the criterion of inadequate response/contraindication/intolerance to tobramycin/dexamethasone ophthalmic suspension, document the clinical rationale and previous therapy response.

Require documentation of prior therapy and clinical rationale when requesting coverage under the inadequate response/contraindication/intolerance criterion.

Billing Rule

Initial authorization duration

If approved, initial authorization duration is up to 6 weeks; reauthorization is not applicable.

Initial authorization duration: up to 6 weeks; reauthorization not applicable.

Applicable Codes

Drug Product (Not-covered unless criteria met) / Covered Alternative referencedNDC|mixed

Zylet	tobramycin 0.3%/loteprednol etabonate 0.5% ophthalmic suspension (brand)
tobramycin/dexamethasone ophthalmic suspension	Referenced preferred product alternative (inadequate response/contraindication/intolerance must be present)

Clinical Evidence & References

Prescribing information: Zylet ophthalmic suspension prescribing information, Bausch + Lomb; October 2021.

Clinical note: Zylet combines loteprednol etabonate (a corticosteroid) and tobramycin (an aminoglycoside antibacterial) and is indicated for steroid-responsive inflammatory ocular conditions where superficial bacterial infection or a risk of bacterial ocular infection exists.

Background

Background: Zylet is a combination of loteprednol etabonate (a corticosteroid) and tobramycin (an aminoglycoside antibacterial). It is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. The policy applies to Individual and Family Plans administered by Cigna Companies and specifies that receipt of sample product does not satisfy coverage criteria.

Policy Metadata

Effective Date2023-01-01

Next Review Date2024-01-01

Policy NumberIP0474

Scope SummaryDefines medical necessity criteria, authorization duration, and covered alternatives for Zylet for Individual and Family Plans administered by Cigna Companies. Specifies situations when Zylet is considered medically necessary and notes non-covered uses.

Permissible Coverage Criteria Options3

Initial Approval Duration6 weeks