CurrentCignaPolicy IP0026

Cyclosporine Ophthalmic Products

Coverage criteria and utilization requirements for ophthalmic cyclosporine products (e.g., Cequa, Restasis, Vevye) for treatment of dry eye disease and related conditions under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCyclosporine Ophthalmic Products

Policy CodePolicy IP0026

Change TypeMaterial revision (criteria and age updates)

Effective DateSep 15, 2025

Next Review DateAug 1, 2025

Key ActionSubmit prior authorization with documentation of patient age and product-specific trial or intolerance evidence; approvals are typically for 1 year.

SourceLink

POLICY UPDATE CHANGES

Added diagnosis and age requirements.

Updated Restasis and Restasis Multidose criteria for Employer plans and Vevye criteria for Employer and Individual and Family Plans; updated and added Cequa, Restasis and Restasis Multidose criteria for Individual and Family plans.

Miebo was removed from the contraindicated concomitant-use list.

4listed cyclosporine ophthalmic products

≥16 / ≥18age approvals by product

1 yearinitial approval duration

IP0026policy identifier

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Coverage Criteria

Dry Eye Disease (FDA-Approved)

Approved for Dry Eye Disease when ALL of the following are met

FDA-Approved Dry Eye Disease: A. Patient is >= 16 years of age; AND B. Preferred product criteria is met for the product(s) as listed in the below table(s)age >=16

Examples include dry eye syndrome and keratoconjunctivitis sicca

Dry Eye from Systemic Inflammatory Diseases

Covered when ALL of the following are met

Dry Eye due to systemic inflammatory disease: A. Patient is >= 16 years of age; AND B. Preferred product criteria is met for the product(s) as listed in the below table(s)age >=16

Examples: Sjögren syndrome, autoimmune thyroid disease, rheumatoid arthritis

Dry Eye from Ocular Surface Diseases

Covered when ALL of the following are met

Dry Eye due to ocular surface disease: A. Patient is >= 16 years of age; AND B. Preferred product criteria is met for the product(s) as listed in the below table(s)age >=16

Examples: blepharitis, conjunctivitis, herpes simplex keratitis, ocular graft-versus-host disease

Employer Plan: Restasis Multidose

Approve Restasis Multidose for Employer plans when ONE of the following is met

Employer: Restasis Multidose: 1) Patient has tried and per prescriber experienced inadequate efficacy OR significant intolerance with cyclosporine ophthalmic 0.05% emulsion single-use vials; OR 2) Patient is unable to use generic cyclosporine 0.05% single-use vials AND (A) has tried and failed/intolerant to BOTH Cequa and Xiidra OR (B) is currently receiving Restasis Multidose and has tried and failed/intolerant to Cequa.N/A

Employer plan specific sequencing

Employer Plan: Vevye

Approve Vevye for Employer plans when ONE of the following is met

Employer: Vevye: 1) Patient has tried and per prescriber experienced inadequate efficacy OR significant intolerance with TWO of: generic cyclosporine topical emulsion, Cequa, Xiidra; OR 2) Patient currently on Vevye and has tried and failed/intolerant to ONE of: generic cyclosporine topical emulsion or Cequa.N/A

Employer plan specific sequencing

Individual and Family Plans: Product Criteria

Individual and Family plan product-specific criteria

Cequa (Individual): Patient has tried and per prescriber experienced inadequate efficacy OR significant intolerance with cyclosporine ophthalmic 0.05% emulsion.N/A

Cequa requires prior trial of 0.05% emulsion

Restasis (Individual): Patient has tried bioequivalent generic cyclosporine topical emulsion and cannot take it due to a formulation difference in the inactive ingredient(s) which, per the prescriber, would result in a significant allergy or serious adverse reaction.N/A

Brand vs generic formulation intolerance rationale required

Restasis Multidose (Individual): 1) Patient has tried and per prescriber experienced inadequate efficacy OR significant intolerance with cyclosporine ophthalmic 0.05% emulsion; OR 2) Patient is unable to use generic cyclosporine 0.05% ophthalmic emulsion single-use vials.

Ophthalmic cyclosporine products for any use not listed in this policy are considered not medically necessary. The policy explicitly lists concomitant use with another ophthalmic cyclosporine product, Tryptyr (acolmetron ophthalmic solution), Tyrvaya (varenicline nasal solution), or Xiidra (lifitegrast ophthalmic solution) as conditions that are not covered due to lack of supporting data. (Ophthalmic cyclosporine products referenced include Cequa, Restasis, and Vevye.)

Concomitant use of two (or three) ophthalmic cyclosporine products, or concomitant use of an ophthalmic cyclosporine product with Tryptyr, Tyrvaya, or Xiidra, is considered not medically necessary. The policy states there are no data to support these combinations and therefore they are not recommended for approval. Note that the list of non‑covered combinations may be updated as new published data become available.

Coding and Age Limits

Coding guidancemixed

Not specified

Policy instructs to use most appropriate codes as of effective date; no specific CPT/HCPCS/ICD-10 codes listed in document.

Restasis — age threshold

Minimum age for Restasis approval>= 16 years

Approval duration when criteria metApprove for 1 year when patient meets criteria

Supporting noteRestasis safety and efficacy not established in pediatric patients < 16 years

Cequa and Vevye — age thresholds

Minimum age for Cequa approval>= 18 years

Minimum age for Vevye approval>= 18 years

Supporting note

Provider Actions and Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. Approvals are granted for up to 1 year when the patient meets the age requirement (≥ 16 years) and product-specific preferred product criteria as outlined in the coverage criteria tables (e.g., employer-plan and individual/family-plan product sequencing). Receipt of sample product does not satisfy prior authorization criteria.

Approval duration: up to 1 year when criteria are met
Age requirement: patient ≥ 16 years
Documentation: prescriber statement documenting inadequate efficacy or significant intolerance, or inability to use specified formulations

Step Therapy

Step therapy / product sequencing

Product-specific step therapy and sequencing requirements vary by plan type. Employer plans and Individual/Family plans have different preferred-product pathways (examples: Employer plans may require trial of generic cyclosporine 0.05% single-use vials and trials of Cequa and Xiidra before Restasis Multidose; Individual/Family plans may require trial of bioequivalent generic cyclosporine 0.05% emulsion before Cequa or Restasis). Prescriber documentation must state inadequate efficacy or significant intolerance to the required prior agents, or inability to use the specified formulation.

Background

Ophthalmic cyclosporine products are indicated to increase tear production and to treat the signs and symptoms of dry eye disease (keratoconjunctivitis sicca). Dry eye disease is a disorder of the tear film associated with reduced production or instability and ocular surface inflammation; systemic inflammatory conditions and ocular surface diseases can underlie or contribute to dry eye. The policy was revised to add diagnosis and age requirements and to update product‑specific criteria across plan types.

Definitions

Dry eye disease

DefinitionDry eye disease

DescriptionGroup of disorders of the tear film due to reduced tear production or tear instability associated with ocular discomfort and inflammatory disease of the ocular surface

SynonymsDry eye syndrome; keratoconjunctivitis sicca

Keratoconjunctivitis sicca (definition)

TermKeratoconjunctivitis sicca (dry eye)

DefinitionCondition of reduced tear production presumed due to ocular inflammation

Clinical context