CurrentMass General Brigham Health PlanPolicy N/A

Ophthalmic Steroids (Step Therapy and Prior Authorization)

This policy governs step-therapy and prior authorization rules for ophthalmic steroid prescriptions under the Mass General Brigham Health Plan pharmacy benefit, affecting commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOphthalmic Steroids (Step Therapy and Prior Authorization)

Policy CodePolicy N/A

Change TypeMoved difluprednate to first-lineupdated new-to-plan continuity language

Effective DateJun 1, 2025

Next Review DateMar 12, 2025

Key ActionSubmit a prior authorization when initial step therapy requirements are not met; authorization requires inadequate response, intolerance, or contraindication to at least two first-line ophthalmic corticosteroids or one second-line agent.

SourceLink

POLICY UPDATE CHANGES

Moved generic Durezol (difluprednate) to first-line.

12 monthsstandard approval duration

180 dayslookback period

2first-line trials required

5 mL/25ddifluprednate limit

Coverage and Authorization Criteria

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Prior Authorization Clinical Criteria

Authorization may be granted when the following criteria are met:

Main authorization requirement: Member has had an inadequate response, intolerance, or contraindication to at least two first-line ophthalmic corticosteroids OR one second-line ophthalmic corticosteroidtwo first-line OR one second-line

This is required for prior authorization when step therapy not met

New-to-Plan Continuity

Authorization may be granted when ALL of the following are met for members new to the plan within 90 days:

New-to-plan continuity: Member is new to the plan within the past 90 days and is currently receiving the requested medication (excluding samples or manufacturer's patient assistance program supply)within 90 days

Allows continuity of care

Products obtained as samples or supplied through a manufacturer's patient assistance program are excluded from consideration when evaluating continuity-of-care or new-to-plan authorization requests. Only commercially dispensed prescriptions or documented fills should be used to establish prior use for continuity within the plan's eligibility window.

Prescriptions that do not meet the initial step-therapy requirements will be denied at point-of-sale. The adjudication message will indicate that prior authorization is required; submit a PA request with supporting documentation if the member meets the clinical criteria for authorization.

Products, Codes, and Lookback Rules

First-line ophthalmic steroid productsmixedCovered

difluprednate 0.05% ophthalmic emulsion	Listed as a first-line medication; quantity limit 5 mL per 25 days
dexamethasone ophthalmic	Listed as a first-line medication
fluorometholone ophthalmic	Listed as a first-line medication
prednisolone ophthalmic	Listed as a first-line medication

Second-line ophthalmic steroid productsmixedNot Covered

Lotemax 0.5% ophthalmic ointment	Listed as second-line
Lotemax SM 0.38% ophthalmic gel	Listed as second-line
loteprednol 0.5% ophthalmic gel	Listed as second-line
loteprednol 0.5% ophthalmic suspension	Listed as second-line

Prior fills lookback

Lookback period>= two different first-line medications OR one second-line medication within the past 180 days

Applies toPrior authorization determinations when initial step-therapy requirements are not met

Use of samples or manufacturer assistanceProducts obtained as samples or via manufacturer's patient assistance programs are excluded from consideration for continuity/new-to-plan (see continuity rules)

What Providers Must Do

Denial Risk

Point-of-sale denial for unmet step therapy

Prescriptions that meet the initial step therapy requirements will adjudicate automatically at the point of sale. If the prescription does not meet the initial step therapy requirements, the prescription will deny with a message indicating that prior authorization (PA) is required. Refer to the criteria below and submit a PA request for members who do not meet the initial step therapy requirements at the point of sale.

Point-of-sale claims will deny if initial step-therapy requirements are not met; denial message will indicate that prior authorization is required.

Step Therapy

Initial Step-Therapy Requirements

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

First-Line (no prior authorization required): difluprednate ophthalmic emulsion; dexamethasone ophthalmic; fluorometholone ophthalmic; prednisolone ophthalmic.
Second-Line (requires prior fill history of 2 different first-line agents or a second-line agent within 180 days): loteprednol 0.5% ophthalmic gel; loteprednol 0.5% ophthalmic suspension; Lotemax 0.5% ophthalmic ointment; Lotemax SM 0.38% ophthalmic gel.

Prior Authorization

New-to-plan continuity (provider actions)

Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication (does not include medications obtained as samples or through manufacturer patient assistance programs). Providers should include documentation of ongoing therapy when submitting the PA request to support continuity of care.

Prior Authorization

Prior authorization required when step therapy not met

Authorization may be granted when the member has had an inadequate response, intolerance, or contraindication to at least two first-line ophthalmic corticosteroids or one second-line ophthalmic corticosteroid. Include clinical justification and prior medication history with the PA request.

Clinical Background

Ophthalmic corticosteroids are indicated for treatment of ocular inflammation and postoperative inflammation/pain. This policy implements a step-therapy approach: first-line agents auto-adjudicate at the point of sale when initial requirements are met, while coverage for second-line agents requires evidence of prior trials or intolerance. For members new to the plan within 90 days, authorization may be granted to maintain continuity of an existing prescription when the member is currently receiving the requested medication, provided the supply was not obtained as samples or via a manufacturer's patient assistance program. If initial step-therapy requirements are not met, claims will deny at point-of-sale and a prior authorization request is required for further consideration.

Key Definitions

First‑Line vs Second‑Line

Definition - First‑LineMedications listed as first-line are covered without prior authorization

Definition - Second‑LineSecond-line medications require prior use of two different first-line agents or prior use of a second-line agent within the past 180 days to be covered

Examples - First‑Line agentsdifluprednate ophthalmic emulsion; dexamethasone ophthalmic; fluorometholone ophthalmic; prednisolone ophthalmic

Examples - Second‑Line agentsLotemax 0.5% ophthalmic ointment; Lotemax SM 0.38% ophthalmic gel; loteprednol 0.5% ophthalmic gel; loteprednol 0.5% ophthalmic suspension