CurrentCignaPolicy IP0583

Miebo (perfluorohexyloctane) for Dry Eye Disease — Individual and Family Plans

Defines prior authorization and coverage criteria for Miebo ophthalmic solution for treatment of signs and symptoms of dry eye disease for Cigna-administered Individual and Family Plans.

Policy Summary

PayerCigna

PolicyMiebo (perfluorohexyloctane) for Dry Eye Disease — Individual and Family Plans

Policy CodePolicy IP0583

Change TypeMaterial updates (examples and exception added)

Effective Date

Next Review Date

Key ActionSubmit prior authorization showing patient is ≥18 and documentation of trial/intolerance to cyclosporine 0.05% or diagnosis of Meibomian gland disease.

SourceLink

POLICY UPDATE CHANGES

Keratoconjunctivitis sicca was added to the Note of examples of dry eye disease.

Preferred product criteria updated by adding an exception for patients with Meibomian gland disease.

1 yearapproval duration when criteria met

≥18minimum patient age for approval

PA requiredauthorization requirement

Meibomian gland diseasepreferred product exception

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Coverage criteria for Miebo (perfluorohexyloctane)

Dry Eye Disease (Initial)

Approve for 1 year if the patient meets BOTH of the following (A and B).

FDA-Approved Indication for Miebo: A. Patient is >= 18 years of age.

FDA-Approved Indication for Miebo: B. Preferred product criteria is met.

Examples of dry eye disease include dry eye syndrome and keratoconjunctivitis sicca.

Preferred Product Criteria / Exceptions

For Individual and Family Plans, coverage criteria are met if ONE of the following is true:

Preferred product criteria: 1) The patient has tried and, according to the prescriber, experienced inadequate efficacy OR significant intolerance with cyclosporine ophthalmic 0.05% emulsion.

Receipt of sample product does not satisfy criteria requirements.

Meibomian gland disease exception: 2) The patient has diagnosed Meibomian gland disease.

Per policy revision, Meibomian gland disease is an exception to the trial requirement.

Use of Miebo for any indication other than treatment of signs and symptoms of dry eye disease, as described in this policy, is considered not medically necessary.

Specifically, Miebo is not medically necessary for indications other than dry eye disease (keratoconjunctivitis sicca and related dry eye presentations) and will not be covered for off‑label uses unless and until policy criteria are updated based on new published evidence.

Codes and billing guidance

Covered/Required codesmixed

No codes listed

Provider requirements, prior authorization, and billing risks

Prior Authorization

Prior Authorization Required

Prior Authorization is required for prescription benefit coverage of Miebo (perfluorohexyloctane ophthalmic solution). All approvals are provided for the duration noted below.

Approval duration: 1 year for FDA‑approved indication of Dry Eye Disease when criteria are met.
Age requirement: Patient must be ≥ 18 years of age.

Step Therapy

Step Therapy Context

Miebo is positioned as a Step 2 option for dry eye disease per AAO Dry Eye Preferred Practice Pattern; it may be used when patients have insufficient response or intolerance to other Step 2 therapies. Prior therapy with cyclosporine ophthalmic 0.05% emulsion is expected unless the patient has a documented intolerance or inadequate efficacy.

Place in therapeutic pathway: Step 2 option alongside cyclosporine ophthalmic products, Tyrvaya (varenicline nasal spray), and Xiidra (lifitegrast).
Step therapy expectation: Trial of cyclosporine ophthalmic 0.05% emulsion with documented inadequate efficacy or significant intolerance OR documented diagnosis of Meibomian gland disease to meet criteria.

Key definitions

Dry eye disease — definitions

TermDry eye disease (also known as dry eye syndrome or keratoconjunctivitis sicca)

DefinitionA disorder of the tear film and ocular surface characterized by symptoms and signs (classified as mild, moderate, or severe) with emphasis on patient symptoms over signs.

Clinical classificationGenerally classified by both symptoms and signs; management is staged (four-step approach), though therapies may be chosen from any step based on provider judgment.

Examples (for diagnosis coding/assessment)Dry eye syndrome; keratoconjunctivitis sicca.

Relevance to this policyMiebo is indicated for treatment of the signs and symptoms of dry eye disease; pediatric use (<18 years) not established.

Background and drug description

Miebo (perfluorohexyloctane) is a semifluorinated alkane ophthalmic solution indicated for the treatment of the signs and symptoms of dry eye disease (also known as keratoconjunctivitis sicca). Management of dry eye disease is staged; FDA‑approved pharmacologic therapies including Miebo, cyclosporine products, and other agents are considered Step 2 options per American Academy of Ophthalmology guidance. Under this policy, prior authorization is required and, when criteria are met, approval is granted for 1 year for patients aged ≥ 18 years.

Documentation Required

Required Documentation for Prior Authorization

Documentation must accompany prior authorization requests to demonstrate medical necessity and satisfy criteria.

Diagnosis: Documented diagnosis of Dry Eye Disease (e.g., dry eye syndrome, keratoconjunctivitis sicca) or Meibomian gland disease as applicable.
Age: Evidence the patient is ≥ 18 years of age.
Prior therapy details: Documentation of trial(s) with cyclosporine ophthalmic 0.05% emulsion including duration and outcome, or documentation of significant intolerance to that product.
Clinical rationale: Prescriber statement describing inadequate efficacy or intolerance and why Miebo is medically necessary for this patient.
Samples: Receipt of sample product does not satisfy criteria — indicate prior use only if accompanied by clinical documentation.