Miebo (perfluorohexyloctane) — Coverage Criteria for Dry Eye Disease
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Guidance for prior authorization, clinical criteria, and coverage determination for Miebo ophthalmic solution for treatment of signs and symptoms of dry eye disease in adults; affects prescribers and pharmacy benefit adjudication.
No material clinical or coverage changes in this revision.
Coverage Criteria for Miebo (perfluorohexyloctane)
Dry Eye Disease, Initial Use
Covered when ALL of the following are met:
From Recommended Authorization Criteria
Dry Eye Disease, Continuation of Therapy
Covered when ALL of the following are met:
From Continuation of Therapy section
Concomitant use of Miebo with ophthalmic cyclosporine products (Cequa, Restasis, Vevye), Tyrvaya (varenicline nasal solution), Tryptyr (acoltremon ophthalmic solution), or Xiidra (lifitegrast ophthalmic solution) is not recommended due to lack of data supporting combined use. Providers should avoid prescribing Miebo together with these agents unless new evidence becomes available that supports concomitant administration.
Coverage is not recommended for indications or circumstances that are not specifically listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available; until then, requests outside the listed criteria should be denied or referred for further review.
Use of Miebo for conditions with limited or preliminary evidence, or where potential safety concerns exist, is not recommended. The company may deny reimbursement when the drug is considered investigational, experimental, or not medically necessary for the requested indication. Providers must supply supporting documentation when requested to justify off-label or investigational uses.
Diagnostic Criteria and Test Thresholds
Prior Authorization, Prescriber & Documentation Requirements
Prior authorization and prescriber requirement
Prior authorization is recommended for pharmacy benefit coverage of Miebo. Initial approval must be prescribed by or in consultation with a physician who specializes in the treated condition.
Age and prescriber requirements for initial and continuation therapy
Initial and continuation therapy require the patient to be 18 years or older and the medication to be prescribed by or in consultation with an ophthalmologist, optometrist, or rheumatologist; continuation also requires a beneficial response to therapy.
- Initial: patient ≥ 18 years; prescribed by or in consultation with ophthalmologist, optometrist, or rheumatologist; required diagnostic testing per policy.
- Continuation: patient ≥ 18 years; prescribed by or in consultation with ophthalmologist, optometrist, or rheumatologist; documented beneficial response (reduced irritation, dryness, redness, or burning).
Step therapy for mild DED: trial of preservative‑free artificial tears
For patients with mild dry eye disease, the patient must have tried and failed preservative‑free artificial tears before Miebo will be covered.
- Step required only when diagnosis is mild DED as specified in the initial use criteria.
Documentation must be provided on request
Make available upon request additional documentation to support coverage determinations, including patient records, test results, and provider credentials; the Company may request other documentation as needed.
- Documentation may include patient records, test results, and credentials of the provider ordering or performing the service.
- The Company reserves the right to request additional documentation during coverage review.
Denial risk triggers
The Company may deny reimbursement when the drug or services were not medically necessary, were investigational/experimental, were outside the member's benefits, or when billing/practice patterns are inappropriate or excessive.
- Denial may be issued for investigational or not medically necessary uses.
- Denial may be issued for services not within scope of benefits or for inappropriate/excessive billing or practice patterns.
Background on Miebo and Dry Eye Disease
Miebo (perfluorohexyloctane) is a semifluorinated alkane ophthalmic solution indicated for the treatment of signs and symptoms of dry eye disease (DED). The American Academy of Ophthalmology classifies DED as mild, moderate, or severe and recommends a stepwise progression of treatments; choice of therapy should reflect disease severity, clinical judgment, and patient preference.
This policy provides prior authorization and clinical criteria for Miebo in adults. The product's safety and effectiveness have not been established in patients under 18 years of age, and coverage decisions follow the Recommended Authorization Criteria that require objective testing or documented treatment failure where applicable.
Definitions
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