CurrentMass General Brigham Health PlanPolicy N/A

Miebo (perfluorohexyloctane) — Prior Authorization for Dry Eye Disease

Prior authorization policy for Miebo ophthalmic solution governing coverage under the pharmacy benefit for Commercial/Exchange members of Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMiebo (perfluorohexyloctane) — Prior Authorization for Dry Eye Disease

Policy CodePolicy N/A

Change TypeRevised coverage language (material)

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of DED diagnosis, prior trials of artificial tears and Restasis (brand), and for reauthorization document clinical improvement.

SourceLink

POLICY UPDATE CHANGES

Updated language for members new to the plan and updated reauthorization language, maintaining clinical intent.

12 monthsApproval duration

90 daysNew-to-plan window

Commercial/ExchangePlan applicability

PharmacyBenefit type

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Initial Therapy

Covered when ALL of the following are met

Initial approval criteria: 1) Member has a diagnosis of dry eye disease; 2) Member has inadequate response, intolerance, or contraindication to an artificial tears product; 3) Member has inadequate response, intolerance, or contraindication to Restasis (brand)all three required

Also covered for members new to the plan within 90 days who are currently receiving the medication (excludes use obtained only as samples or via manufacturer's patient assistance programs).

Continuation of Therapy / Reauthorization

Reauthorization covered when ALL of the following are met

Reauthorization criteria: Member has had an improvement in signs and symptoms of dry eye disease from baseline (e.g., ocular irritation, redness, mucous discharge, reduced visual function, ocular surface damage, reduced tear production).documented clinical improvement

Approvals (initial and reauthorizations) are for 12 months.

Use of Miebo obtained only as samples or provided through a manufacturer's patient assistance program is excluded from the new-to-plan continuity provision. For members new to the plan, the 90-day treatment continuity allowance applies only when the member is currently receiving commercially obtained Miebo, not sample or assistance‑program supplies.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. *New-to-plan members* who have been receiving the requested medication may be eligible for a 90-day continuation when enrollment in the plan is ≤ 90 days — excludes therapy obtained only as samples or via manufacturer patient assistance programs.

New-to-plan 90-day continuation allowed when member is currently receiving medication and enrolled ≤ 90 days
Excludes samples or medications obtained solely through manufacturer patient assistance programs

Step Therapy

Step Therapy Required

Step therapy must be documented: the member must have had inadequate response, intolerance, or a contraindication to both an artificial tears product and to Restasis (brand) prior to approval.

Step requirement 1: Trial and failure/intolerance/contraindication to an artificial tears product
Step requirement 2: Trial and failure/intolerance/contraindication to Restasis (brand)

Documentation Required

Required Documentation

Document the diagnosis and the clinical rationale for therapy. Include records of prior treatments and clear documentation of inadequate response, intolerance, or contraindication for each required prior therapy.

Documented diagnosis of dry eye disease
Records of prior treatments (including artificial tears and Restasis) with dates and doses
Clinical notes describing inadequate response, intolerance, or contraindication to each prior therapy

Denial Risk

Potential Denial Triggers

Potential reasons for denial include missing or incomplete documentation of the diagnosis, absence of documented trials of required prior therapies, or lack of explanation for why prior therapies failed or were not tolerated/are contraindicated.

Missing diagnosis of dry eye disease
No documentation of trial and inadequate response/intolerance/contraindication to artificial tears
No documentation of trial and inadequate response/intolerance/contraindication to Restasis (brand)
Requests for samples or manufacturer-assisted therapy only (not eligible for 90-day continuation)

Background

Miebo (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for the treatment of the signs and symptoms of dry eye disease. The policy expects prior trial and failure, intolerance, or contraindication to standard topical therapies before coverage and requires documentation of clinical improvement for continued therapy. For members new to the plan who are already receiving Miebo, the policy allows a limited continuity window of 90 days (excluding sample or manufacturer‑assistance supplies).