CurrentMass General Brigham Health PlanPolicy N/A

Ophthalmic Steroids — Coverage Criteria (Pharmacy)

Defines prior authorization, step therapy, quantity limits, and coverage criteria for ophthalmic corticosteroid medications under the pharmacy benefit for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOphthalmic Steroids — Coverage Criteria (Pharmacy)

Policy CodePolicy N/A

Change TypeRevised — moved generic Durezol to first-linePA criteria updated

Effective DateJun 1, 2025

Next Review DateMar 12, 2025

Key ActionSubmit prior authorization for members who do not meet initial step therapy requirements or for new-to-plan members within 90 days when current receipt is verifiable.

SourceLink

POLICY UPDATE CHANGES

Moved generic Durezol to first-line and updated prior authorization criteria to include language for members who are new to the plan.

12 monthsapproval duration

180 daysprior fill lookback

90 daysnew-to-plan window

1quantity limits

Coverage Criteria

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Standard prior authorization criteria

Authorization may be granted when the following criteria are met:

Primary authorization requirements: Member has had an inadequate response, intolerance, or contraindication to at least two first-line ophthalmic corticosteroids OR one second-line ophthalmic corticosteroid.at least 2 first-line OR at least 1 second-line

Second-line definition requires prior fills within 180 days.

Coverage exclusions

Authorization excludes the following situations:

Exclusions: Product was obtained as samples or via manufacturer's patient assistance programs.

Authorization is not granted when current treatment is only via samples or PAPs.

New-to-plan continuity criteria

Alternate authorization pathway for continuity of care:

New-to-plan continuity: Member new to the plan within the past 90 days who is currently receiving the requested medication may be authorized.<= 90 days

Current receipt must be verifiable and not via samples or manufacturer's patient assistance programs.

If not new-to-plan pathway: Standard prior authorization criteria must be met (inadequate response, intolerance, or contraindication to ≥2 first-line agents OR ≥1 second-line agent).at least 2 first-line OR at least 1 second-line

Second-line fills must be within 180 days to qualify.

Initial Therapy Placement and Requirements

Initial therapy placement and requirements

First-line and second-line placement

First-line coverage: Medications listed as first-line are covered without prior authorization (includes generic Durezol moved to first-line per policy update).

First-line agents adjudicate without prior authorization.

Second-line conditions: Second-line medications will be covered only if the member has filled at least two different first-line medications OR has filled a second-line medication within the past 180 days.>= 2 first-line fills OR >= 1 second-line fill in 180 days

List of second-line agents includes Lotemax 0.5% ointment, Lotemax SM 0.38% gel, loteprednol 0.5% formulations.

Step	Medications	Coverage requirement
{"text":"First-line","status":""},{"text":"difluprednate ophthalmic emulsion; dexamethasone ophthalmic; fluorometholone ophthalmic; prednisolone ophthalmic","status":""},{"text":"Covered without prior authorization (first-line agents are adjudicated without PA).","status":""}
{"text":"Second-line","status":""},{"text":"Lotemax 0.5% ophthalmic ointment; Lotemax SM 0.38% ophthalmic gel; loteprednol 0.5% ophthalmic gel; loteprednol 0.5% ophthalmic suspension","status":""},{"text":"Requires evidence of prior fills: member must have filled at least two different first-line medications OR one second-line medication within the past 180 days before coverage will be granted without PA; otherwise prior authorization required.","status":""}

Provider Actions and Operational Guidance

Prior Authorization

Prior Authorization Required

Prior authorization required when a prescription does not meet the initial step-therapy rules. If the claim is presented at point of sale and the prescription does not meet initial step-therapy requirements, it will deny with a message indicating prior authorization is required. Submit a PA for members who do not meet initial step therapy requirements.

Denial at point of sale when initial step therapy not met — message will indicate PA required.
Submit PA for members not meeting initial step therapy requirements.

Step Therapy

Initial Step-Therapy Requirements

First-line medications listed are covered without prior authorization. Second-line agents require that the member has filled at least two different first-line medications or a second-line medication within the past 180 days.

First-line agents: covered without PA.
Second-line agents: member must have fills for ≥2 different first-line agents OR a second-line medication within the past 180 days.

Denial Risk

Point-of-Sale Denials for Step Therapy

Prescriptions that do not meet the initial step-therapy requirements will deny at point of sale with a message indicating prior authorization is required.

Point-of-sale denial will instruct provider to submit PA.

Documentation Required

New-to-Plan Continuity and PA Submission

For members new to the plan within the past 90 days who are currently receiving the requested medication, authorization may be granted. Authorization is not granted if the member is receiving the product only as samples or through manufacturer patient assistance programs. When requesting PA for new-to-plan continuity, include documentation of current therapy (prescription history, medical record, or documentation of ongoing treatment) and the date therapy began.

New-to-plan continuity: member enrolled ≤90 days and currently receiving the medication — PA may be granted.
Exclude medications obtained only as samples or via manufacturer patient-assistance programs.
PA submission: include prescription fill history or medical record showing ongoing treatment and start date; document inadequate response/intolerance/contraindication to prior agents when applicable.

Coding and Lookback Windows

inv-04: Prior fill lookback — lookback period to consider prior fills for second-line coverage

Lookback period>= 180 days

Applies toPrior fills used to meet second-line criteria (two different first-line fills or one second-line fill)

PurposeEstablishes timeframe to verify prior medication trials for step-therapy approval

inv-05: New-to-plan continuity window — new-to-plan member treatment continuity window for potential authorization

New-to-plan continuity window<= 90 days

Eligibility conditionMember must be new to the plan within the past 90 days and currently receiving the requested medication

ExclusionDoes not apply when product was obtained as samples or via manufacturer's patient assistance programs

Definitions

inv-11: Definition — Medications listed on first-line are covered without prior authorization.

DefinitionMedications listed on first-line are covered without prior authorization.

ImplicationPrescriptions for first-line agents will adjudicate at point of sale without prior authorization when criteria met

ExamplesIncludes generic Durezol moved to first-line per policy update

inv-12: Definition — Second-line medications will pay if the member has filled at least two different first-line medications or a second-line medication within the past 180 days.

DefinitionSecond-line medications will pay if the member has filled at least two different first-line medications or a second-line medication within the past 180 days.

Required documentationEvidence of at least two different first-line fills or one second-line fill within the 180-day lookback must be verifiable

Related threshold>= 180 days lookback used to verify prior fills

Background

Ophthalmic corticosteroids are topical eye medications used to treat ocular inflammation and to manage postoperative inflammation and pain. This policy organizes these agents into first-line and second-line categories to support a step-therapy approach and to define when prior authorization is required.

Medications designated as first-line are covered without prior authorization; second-line agents are covered only when the member has either filled at least two different first-line ophthalmic corticosteroids or has filled a second-line ophthalmic corticosteroid within the prior 180 days (lookback period).

For members who are new to the plan within the past 90 days and are currently receiving the requested medication, the policy provides an alternate continuity pathway for authorization, provided the current receipt can be verified and the product was not obtained as samples or through manufacturer's patient assistance programs.

Approvals granted under this policy are issued for a duration of 12 months, and quantity limits (for example, difluprednate 0.05% ophthalmic emulsion — 1 per course) are applied as specified in the policy.