Currentmedical mutual - ohioPolicy N/A

Miebo (perfluorohexyloctane) ophthalmic solution coverage criteria

Policy governing prior authorization and medical necessity criteria for coverage of Miebo for treatment of signs and symptoms of dry eye disease in adults, applicable to Medical Mutual - Ohio members.

Policy Summary

Payermedical mutual - ohio

PolicyMiebo (perfluorohexyloctane) ophthalmic solution coverage criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateApr 17, 2025

Key ActionObtain prior authorization and ensure prescription is by or in consultation with an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age for coverage

1 yrinitial approval duration

1 yrextended approval duration

<5 mmSchirmer threshold

≥308Osmolarity threshold

Coverage & Medical Necessity Criteria

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inv-01: COVERAGE CRITERIA

Covered when ALL of the following are met:

Initial Use - Adult DED

Age: Patient is 18 years of age or older>=18 years
Prescriber: Medication is prescribed by or in consultation with an ophthalmologist, optometrist, or rheumatologist
Initial approval requires prescription by or in consultation with a physician who specializes in the condition being treated
Objective testing
- Homeostasis markers
  - Schirmer's test < 5 mm of wetting over 5 minutes<5 mm
  - Non-invasive TBUT: Non-invasive tear breakup time < 10 seconds<10 s
  - Osmolarity >= 308 mOsm/L in either eye or interocular difference > 8 mOsm/L>=308 mOsm/L or Δ>8
  - Ocular surface staining: >5 corneal spots, >9 conjunctival spots, or lid margin >=2 mm length and >=25% widthcorneal>5; conj>9; lid margin >=2 mm & >=25% width
Prior conservative therapy for mild DED: If diagnosis is mild dry eye disease, patient has tried and failed preservative-free artificial tears
Step therapy requirement for mild DED

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Concomitant use of Miebo with ophthalmic cyclosporine products (Cequa, Restasis, Vevye), Tyrvaya (varenicline nasal solution), or Xiidra (lifitegrast ophthalmic solution) is not recommended. The available data do not support combined use of Miebo with these agents, and there is no evidence demonstrating safety or added effectiveness of concurrent administration.

Coverage of Miebo is not recommended for clinical situations or indications that are not specifically listed in the Recommended Authorization Criteria. The policy will be updated if new published data become available to support additional uses.

Clinical Test Thresholds & Coding-Adjacent Criteria

inv-04: Schirmer's test

Schirmer's test threshold< 5 mm of wetting over 5 minutes

Test purposeAssesses tear production to support diagnosis of DED

Qualifying logicOne qualifying homeostasis marker required for coverage; Schirmer's meeting this cutoff satisfies the objective testing requirement

inv-05: Non-invasive tear breakup time

Non-invasive tear breakup time (TBUT) threshold< 10 seconds

Test purposeMeasures tear film stability to identify evaporative component of DED

Qualifying logicOne qualifying homeostasis marker required for coverage; TBUT meeting this cutoff satisfies the objective testing requirement

inv-06: Osmolarity

Osmolarity threshold≥ 308 mOsm/L in either eye or interocular difference > 8 mOsm/L

Test purposeIdentifies tear hyperosmolarity associated with DED

Qualifying logicOne qualifying homeostasis marker required for coverage; osmolarity meeting either criterion satisfies the objective testing requirement

inv-07: Ocular surface staining

Ocular surface staining thresholds> 5 corneal spots, > 9 conjunctival spots, or lid margin ≥ 2 mm length and ≥ 25% width

Test purposeDetects ocular surface epithelial damage consistent with DED

Qualifying logicOne qualifying homeostasis marker required for coverage; staining meeting any listed cutoff satisfies the objective testing requirement

Prior Authorization, Step Therapy, and Documentation

Prior Authorization

Prior authorization and specialist prescriber required

Prior authorization is recommended for pharmacy benefit coverage of Miebo. Initial approval requires the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., ophthalmologist, optometrist, or rheumatologist).

Initial approvals require specialist prescription or consultation.

Step Therapy

Step therapy — trial of preservative‑free artificial tears required

For patients with mild dry eye disease, a trial and failure of preservative‑free artificial tears is required before Miebo will be approved.

Applies when the diagnosis is mild dry eye disease as specified in the criteria.

Documentation Required

Documentation that may be requested

The Company may request additional documentation to support medical necessity and coverage determinations; requested materials may include patient medical records, diagnostic test results, and provider credentials.

Examples: patient records, test results, credentials of the provider ordering or performing the service.

Denial Risk

Denial triggers — medical necessity, investigational use, benefit limits, or missing documentation

The Company may deny reimbursement if the drug or services are determined not medically necessary, investigational/experimental, not within member benefits, or if required documentation is not provided.

Denial may also occur for inappropriate or excessive billing practices or when use is outside the scope of benefits.

Product Background

Miebo is a semifluorinated alkane ophthalmic solution indicated for the treatment of the signs and symptoms of dry eye disease (DED) in adults. The safety and effectiveness of Miebo in patients under 18 years of age have not been established.

Clinical guidance for DED classifies the condition by severity (mild, moderate, severe) and recommends a stepwise treatment approach; Miebo is intended for use within this context when patients meet the policy’s specified criteria. Prior authorization is recommended for pharmacy benefit coverage, and the policy excludes concomitant use with certain other ophthalmic agents where supporting data are lacking.

Key Definitions

inv-13: Dry Eye Disease (DED) — severity classification and management staging per AAO Preferred Practice Patterns

Severity classificationDED is classified as mild, moderate, or severe per AAO Preferred Practice Pattern

Management stagingAAO recommends a four-step progression of treatments; therapies may be chosen from any step based on provider judgment

Clinical use in policyManagement follows staged progression; for mild DED, trial and failure of preservative-free artificial tears is required prior to approval

Age considerationPolicy applies to adults; safety and effectiveness in patients <18 years have not been established