Topical Treatments for Dry Eye Disease

Restasis, Restasis Multidose, or Cequa Documentation

For Restasis, Restasis Multidose, or Cequa, document that the requested product will not be used in combination with Xiidra and that the patient has a qualifying dry-eye condition. Document the required prior treatment history and any clinical evidence or patient history supporting an exception to a specified trial.

• Qualifying conditions include ocular inflammation associated with keratoconjunctivitis sicca; systemic inflammatory disease such as Sjögren syndrome, rheumatoid arthritis, or systemic lupus erythematosus; or ocular surface disease such as ocular rosacea, atopic keratoconjunctivitis, acute corneal graft rejection, blepharitis, herpetic stromal keratitis, or conjunctival graft-versus-host disease.
• Document trial and failure, such as intolerance or inadequate response, of Xiidra after at least 3 months, Tyrvaya, or Miebo, unless an exception is supported.
• Document trial and failure of generic cyclosporine ophthalmic emulsion, unless clinical evidence or patient history indicates it will be ineffective or cause an adverse reaction.

Tryptyr Eligibility and Treatment History

For Tryptyr, document symptomatic dry eye disease, the patient's age, and the required prior treatment history. If a listed therapy was not tried, document clinical evidence or patient history indicating that it would be ineffective or cause an adverse reaction.

• Diagnosis of symptomatic dry eye disease.
• Patient is 18 years of age or older.
• Document trial and failure of Xiidra after at least 3 months, generic cyclosporine ophthalmic emulsion, Tyrvaya, or Miebo, as applicable.

Vevye Eligibility and Treatment History

For Vevye, document the diagnosis, confirm that the product will not be used in combination with Xiidra, and provide the required treatment history. Any exception to a listed therapy must be supported by clinical evidence or patient history.

• Diagnosis of dry eye disease.
• Requested product will not be used in combination with Xiidra.
• Document trial and failure of Xiidra after at least 3 months, Tyrvaya, or Miebo.
• Document trial and failure of generic cyclosporine ophthalmic emulsion, unless an exception applies.

Generic Cyclosporine Trial and Failure

Before requesting Restasis, Restasis Multidose, Cequa, or Vevye, document a trial and failure of generic cyclosporine ophthalmic emulsion, such as intolerance or inadequate response, unless clinical evidence or patient history indicates that generic cyclosporine will be ineffective or cause an adverse reaction.

• Applies to Restasis, Restasis Multidose, Cequa, and Vevye.
• Failure to document this additional Company requirement may result in a not medically necessary determination.

Tryvaya Try/Fail Requirement

Document a trial and failure of Tryvaya when applicable as the targeted-medication step option before requesting a covered product.

• Include the outcome of the Tryvaya trial, such as intolerance or inadequate response.
• If Tryvaya was not used, document the clinical evidence or patient history supporting an exception.

90-Day Authorization Transition

When the member changes health plans during an ongoing authorized course of treatment, provide documentation of the previous health plan's authorization and confirm that the service remains covered under the Louisiana Blue health plan.

• Louisiana Blue may honor the prior authorization for the same service under the same type of in-network benefit for a 90-day transition period.
• The transition provision does not apply to medications covered under the plan's pharmacy benefit.

Alternative Dry-Eye Therapy Trial and Failure

Document the applicable alternative dry-eye therapy history before requesting Restasis, Restasis Multidose, Cequa, Tryptyr, or Vevye. The record should show trial and failure, such as intolerance or inadequate response, or a supported clinical exception.

• Document Xiidra after at least 3 months of therapy, when applicable.
• Document generic cyclosporine ophthalmic emulsion, when applicable.
• Document Tyrvaya and other applicable alternatives, including Miebo; document Tryvaya as the targeted-medication step option when applicable.
• The policy considers the requested products not medically necessary when the required alternative therapy has not been tried and failed.

Generic Cyclosporine Prerequisite

For Restasis, Restasis Multidose, Cequa, and Vevye, document the required prerequisite trial and failure of generic cyclosporine ophthalmic emulsion unless a supported exception applies.

• Acceptable failure includes intolerance or inadequate response.
• A clinical exception requires evidence or patient history that generic cyclosporine will be ineffective or cause an adverse reaction.

Tryvaya Targeted-Medication Step

Include Tryvaya in the targeted-medication step-therapy history when applicable. Document trial and failure or the clinical rationale for not using it.

• Record intolerance or inadequate response when Tryvaya was tried.
• If not tried, provide clinical evidence or patient history supporting an exception.

Clinical Eligibility and Treatment History

The request must identify the product and document the applicable diagnosis, age requirement, combination restrictions, and prior treatment history. Submit the clinical rationale and supporting records with the authorization request.

• For Restasis, Restasis Multidose, and Cequa, document a qualifying condition and no combination use with Xiidra.
• For Tryptyr, document symptomatic dry eye disease and age 18 years or older.
• For Vevye, document dry eye disease and no combination use with Xiidra.
• Document all required trials and failures and any supported exceptions.

Prior Authorization Documentation

For a member receiving an ongoing authorized course of treatment after changing health plans, provide the prior authorization documentation to support possible transition coverage.

• Documentation must be provided by the member or provider.
• The prior authorization must apply to the same service and the same type of in-network benefit.
• The service must otherwise be covered under the Louisiana Blue health plan.
• The transition provision does not apply to pharmacy-benefit medications.

Missing Alternative Therapy Failure Documentation

Failure to document the required alternative therapy trial and failure may result in a not medically necessary determination for Restasis, Restasis Multidose, Cequa, Tryptyr, or Vevye.

• Required history may include Xiidra after at least 3 months, generic cyclosporine ophthalmic emulsion, Tyrvaya, Miebo, and Tryvaya when applicable.
• If a therapy was not tried, document clinical evidence or patient history supporting an exception.

Combination with Xiidra

Do not request Restasis, Restasis Multidose, Cequa, or Vevye for concurrent use with Xiidra when the product-specific criteria prohibit that combination.

• Restasis, Restasis Multidose, and Cequa must not be used in combination with Xiidra.
• Vevye must not be used in combination with Xiidra.

Tryptyr Diagnosis or Age Criterion

Tryptyr may be denied when the patient does not have symptomatic dry eye disease or is younger than 18 years of age.

• Document the diagnosis of symptomatic dry eye disease.
• Document that the patient is 18 years of age or older.

Patient Selection Criteria Not Met

If the applicable patient selection criteria are not met, the requested product may be considered investigational, except when the policy specifically designates the unmet requirement as not medically necessary.

• Apply the product-specific eligibility, combination, diagnosis, age, and treatment-history requirements.
• The policy's separately identified unmet alternative-therapy requirements are treated as not medically necessary rather than investigational.

Investigational or Experimental Treatment

Investigational or experimental treatments, drugs, devices, procedures, and biological products are excluded from coverage. Products that do not meet the applicable patient selection criteria may be determined investigational unless the unmet criteria are designated not medically necessary.

• Investigational services are not covered, including services provided under the investigational arm of a clinical trial or study.
• Restasis, Restasis Multidose, Cequa, Tryptyr, and Vevye may be considered investigational when applicable patient selection criteria are not met.

Transition Authorization Conditions

A prior health-plan authorization for an ongoing course of treatment may be honored for a 90-day transition period only when the required documentation and coverage conditions are satisfied.

• The member changes from one health plan to another, such as to Louisiana Blue.
• The authorization is for the same service and the same type of in-network benefit.
• The prior authorization is provided by the member or provider.
• The service is otherwise covered under the Louisiana Blue health plan.
• This provision does not apply to medications covered under the pharmacy benefit.