CurrentCignaPolicy CNF810

Ophthalmology – Dry Eye Disease – Miebo Prior Authorization Policy - (CNF810)

Defines prior authorization and medical necessity criteria for coverage of Miebo for treatment of dry eye disease for Cigna-administered health benefit plans, including age requirement, approval duration, and non-covered uses.

Policy Summary

PayerCigna

PolicyOphthalmology – Dry Eye Disease – Miebo Prior Authorization Policy - (CNF810)

Policy CodePolicy CNF810

Change TypeAdded examples; removed concomitant-use restriction; review date updated

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for Miebo; document diagnosis (e.g., dry eye syndrome or keratoconjunctivitis sicca) and patient age to support a 1-year approval when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Kerato conjunctivitis sicca was added to the note of examples of dry eye disease.

Removal of restriction prohibiting concomitant use with ophthalmic cyclosporine products, Tyrvaya, or Xiidra.

Review date updated to 04/01/2026.

1Covered Indication(s)

1 yearApproval Duration

≥18Minimum Age

Coverage Summary

Defines prior authorization and medical necessity criteria for coverage of Miebo for treatment of dry eye disease for Cigna-administered health benefit plans. Miebo is covered with criteria for the FDA-approved indication of dry eye disease when all criteria are met. Approvals are provided for 1 year and the patient must be at least ≥ 18 years of age.

FDA-Approved Indication

Covered when ALL of the following are met:

Diagnosis of Dry Eye Disease (examples include dry eye syndrome and keratoconjunctivitis sicca)
Age: Patient is ≥ 18 years of age>=18
Approve for 1 year

Policy Basis: Miebo is indicated for treatment of signs and symptoms of dry eye disease; safety and effectiveness in patients <18 years have not been established.

Not Medically Necessary

Miebo is considered not medically necessary when ANY of the following apply:

Not Medically Necessary / Exclusions: Use of Miebo for ANY indication other than the FDA-approved indication of dry eye disease

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for prescription benefit coverage of Miebo; approvals are provided for 1 year when criteria are met.

Documentation Required

Diagnosis Documentation

Provider must document diagnosis of dry eye disease (examples include dry eye syndrome and keratoconjunctivitis sicca) and patient age to support authorization.

Clinical Evidence & References

Prescribing information: Miebo ophthalmic solution prescribing information, Bausch & Lomb; May 2023.

Guideline: American Academy of Ophthalmology Dry Eye Syndrome Preferred Practice Pattern, Ophthalmology 2024.

Background & Definitions

Miebo (perfluorohexyloctane) is a semifluorinated alkane indicated for the treatment of the signs and symptoms of dry eye disease. The AAO Preferred Practice Pattern (2024) lists Miebo as a Step 2 option among FDA-approved therapies for dry eye disease. Safety and effectiveness in patients <18 years of age have not been established.

Dry Eye Disease: Also known as dry eye syndrome or keratoconjunctivitis sicca; classified by symptoms and signs and managed in a staged approach per AAO.

Revision History

Early Annual Revisionmaterial_change_added