CurrentCignaPolicy N/A

Ophthalmology - Dry Eye Disease - Cyclosporine Products Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for ophthalmic cyclosporine products (Cequa, Restasis, Restasis Multidose, Vevye) for treatment of dry eye disease and related conditions for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOphthalmology - Dry Eye Disease - Cyclosporine Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded Vevye; revised terminology; updated concomitant-use exclusions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation confirming diagnosis of dry eye disease (or supportive other use) and patient age ≥16; approvals are typically for 1 year.

POLICY UPDATE CHANGES

Vevye (cyclosporine 0.1% ophthalmic solution) was added to the policy.

Revised term 'Dry Eye Conditions due to Ocular Inflammation Associated with Keratoconjunctivitis Sicca' to 'Dry Eye Disease' to align with Cequa and Vevye labeling.

Conditions Not Covered list updated to add Tryptyr to medications that should not be used concomitantly.

Clarified that approvals for covered indications are for 1 year when patient is ≥16 years.

4Listed cyclosporine products covered

4Agents prohibited for concomitant use

1 year

Coverage Summary

Coverage stance: covered with criteria for ophthalmic cyclosporine products Cequa, Restasis, Restasis Multidose, and Vevye for Dry Eye Disease and supportive other uses. Scope defines prior authorization requirements for these products for Cigna-administered plans. Approvals are typically for 1 year when criteria are met and apply to patients aged >= 16 years (note: Cequa and Vevye labeling indicate approval ≥18 years per product PI). Concomitant use of other ophthalmic cyclosporine products or the listed agents Tryptyr, Tyrvaya, and Xiidra is prohibited and may lead to denial of coverage.

Policy quick facts

Minimum covered patient age>= 16 years

Typical approval duration1 year

Listed cyclosporine products covered4

Agents prohibited for concomitant use4

Initial Therapy / FDA-Approved Indication

Medically Necessary - FDA-Approved Indication

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Dry Eye Disease (includes dry eye syndrome and keratoconjunctivitis sicca)
Approve for 1 year if criterion met
Patient age is >= 16 years>=16 years

Other Medically Necessary Uses with Supportive Evidence

Medically Necessary - Other Uses with Supportive Evidence

Covered when ALL of the following are met:

Examples of covered other uses (each requires patient age >=16 and approval for 1 year)

Dry eye conditions due to systemic inflammatory diseases (e.g., Sjögren syndrome, autoimmune thyroid disease, rheumatoid arthritis)
Approve for 1 year if patient is >= 16 years of age
Dry eye conditions due to ocular surface diseases (e.g., blepharitis, conjunctivitis, herpes simplex keratitis, ocular graft-versus-host disease)
Approve for 1 year if patient is >= 16 years of age

Not Medically Necessary / Conditions Not Covered

Not covered when ANY of the following apply:

ANY of the following

Concomitant use with another ophthalmic cyclosporine product (examples: Cequa, Restasis, Vevye)
Concomitant use with Tryptyr (acolmetron ophthalmic solution)
Concomitant use with Tyrvaya (varenicline nasal spray)
Concomitant use with Xiidra (lifitegrast ophthalmic solution)
Any other use(s) not listed as covered (not medically necessary)

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of the listed ophthalmic cyclosporine products; approvals are provided for the duration noted (typically 1 year).

Cequa
Restasis
Restasis Multidose
Vevye

Documentation Required

Document diagnosis and age

Submit documentation confirming the diagnosis (dry eye disease or supportive other use) and that the patient is ≥ 16 years of age.

Approvals granted for 1 year when criteria are met

Applicable Codes

Drugs covered subject to PAmixedCovered

Cequa	cyclosporine 0.09% ophthalmic solution (Sun Pharmaceuticals)
Restasis	cyclosporine 0.05% ophthalmic emulsion (Allergan, generic)
Restasis Multidose	cyclosporine 0.05% ophthalmic emulsion (Allergan)
Vevye	cyclosporine 0.1% ophthalmic solution (Harrow)

Drugs not to be used concomitantlymixedNot Covered

Tryptyr	acolmetron ophthalmic solution
Tyrvaya	varenicline nasal spray
Xiidra	lifitegrast ophthalmic solution

Clinical Evidence & References

Evidence entries include the guideline and product labels cited in the policy: American Academy of Ophthalmology Dry Eye Syndrome Preferred Practice Pattern (2024) and product prescribing information for Restasis (PI Sep 2024), Cequa (PI Jul 2022), and Vevye (PI May 2024). The AAO positions these agents as Step 2 options in their staged management approach for dry eye.

Background

Background: Ophthalmic cyclosporine products are indicated to increase tear production and to treat the signs and symptoms of dry eye disease (also known as dry eye syndrome or keratoconjunctivitis sicca). Products covered include Restasis (and generic), Restasis Multidose, Cequa, and Vevye. The AAO Preferred Practice Pattern (2024) lists ophthalmic cyclosporine agents as Step 2 options for dry eye management.

Definitions: Dry Eye Disease — group of disorders of the tear film due to reduced tear production or tear instability; includes dry eye syndrome and keratoconjunctivitis sicca and is associated with ocular discomfort and ocular surface inflammation.

Revision History

07/12/2023addition (material)

Vevye (cyclosporine 0.1% ophthalmic solution) added to the policy as a covered ophthalmic cyclosporine product.

07/12/2023terminology revision (material)

Revised term 'Dry Eye Conditions due to Ocular Inflammation Associated with Keratoconjunctivitis Sicca' to 'Dry Eye Disease' to align with Cequa and Vevye labeling; added note that examples include dry eye syndrome and keratoconjunctivitis sicca.

04/30/2025clarificationLatest