CurrentMass General Brigham Health PlanPolicy N/A

Ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) — Step therapy and prior authorization

Defines prior authorization and step-therapy requirements for outpatient ophthalmic NSAID prescriptions under the commercial/exchange pharmacy benefit; applies to providers prescribing these topical ocular NSAIDs for plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOphthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) — Step therapy and prior authorization

Policy CodePolicy N/A

Change TypeRevised prior authorization languageremoved nonformulary product

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization for prescriptions that do not meet initial step-therapy requirements.

SourceLink

POLICY UPDATE CHANGES

Updated prior authorization language to mirror the step therapy program and removed Nevanac from the policy as it moved to nonformulary status.

Prior authorization requiredProgram type for ophthalmic NSAIDs

Commercial/ExchangePlan coverage indicated

12 monthsTypical approval duration

180 daysLookback period

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Coverage and Medical Necessity Criteria

Medical Necessity / Step Therapy Criteria

Covered when step-therapy requirements are met or when prior-authorization (PA) criteria below are satisfied:

Pathways to approval: Approval is granted if ANY of the following pathways are met:

Pathway A - Step therapy compliance: Member meets initial step-therapy requirements: request is for a first-line agent (covered without prior authorization), OR for a second-line agent the member has filled at least two different first-line medications or has filled a second-line medication within the past 180 days.180 days

Supports point-of-sale adjudication when met.

Pathway B - Prior authorization: failure/intolerance to first-line agents: Member has had an inadequate response, adverse reaction, or contraindication to TWO first-line ophthalmic NSAIDs.two first-line agents

Document clinical response, adverse reactions, or contraindications in the PA request.

Pathway C - Prior authorization: failure/intolerance to second-line agent: Member has had an inadequate response, adverse reaction, or contraindication to ONE second-line ophthalmic NSAID.one second-line agent

Document clinical response, adverse reactions, or contraindications in the PA request.

Continuity of care (new-to-plan): Members new to the plan within the past 90 days who are currently receiving the requested medication may be granted authorization (products obtained as samples or via manufacturer patient assistance programs are excluded from consideration).90 days

Provide documentation of prior therapy; exclude samples and manufacturer assistance when establishing prior use.

Products obtained as samples or through a manufacturer's patient assistance program are excluded from consideration when assessing continuity of therapy for new-to-plan members. This exclusion means such supplies should not be counted toward meeting the plan's requirements for prior medication use or for determining eligibility under the 90-day new-to-plan continuity provision.

Drug Coding, Formulary Tiers, and Quantity Limits

Drugs with specified quantity limitsNDC | mixed

diclofenac 0.1%	Voltaren® — quantity limit 5 mL
flurbiprofen 0.03%	Ocufen® — quantity limit 5 mL
ketorolac 0.4%	Acular® LS — quantity limit 5 mL
ketorolac 0.5%	Acular® — quantity limit 10 mL per 25 days
bromfenac 0.09%	Compare to Xibrom® — quantity limit 5 mL
Acuvail (ketorolac) 0.45%	60 single-use vials (2 boxes)
Ilevro (nepafenac) 0.3%	quantity limit 1.7 mL
Prolensa (bromfenac) 0.07%	quantity limit 3.2 mL

Formulary tiers (first-line, second-line)mixed

First-line agents	Medications listed on first-line are covered without prior-authorization.
Second-line agents	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.

Lookback period and quantity limits

Lookback period to satisfy second-line requirement180 days (member must have filled at least two different first-line agents or a second-line medication within the past 180 days)

Diclofenac 0.1% (Voltaren®) quantity limit5 mL per fill

Flurbiprofen 0.03% (Ocufen®) quantity limit5 mL per fill

Ketorolac 0.4% (Acular® LS) quantity limit5 mL per fill

Ketorolac 0.5% (Acular®) quantity limit10 mL per 25 days

Acuvail (ketorolac) 0.45% quantity limit60 single-use vials (2 boxes)

Prior Authorization, Step-Therapy, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required when a prescription does not meet the initial step-therapy requirements. Submit a PA request with supporting documentation demonstrating medical necessity or an approved step-therapy exception.

PA required when prescription is non-step-compliant
Submit PA for medical necessity or documented exception

Denial Risk

Point-of-Sale Denial Risk

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 claim will deny at point of sale with a message indicating that prior authorization is required. Providers should submit a PA at the time of fill to avoid POS denial.

Claims will deny at POS if initial step-therapy is not met

Key Definitions

First-line vs Second-line definitions

First-line (definition)Medications listed as first-line are covered without prior authorization (pay at point of sale when prescribed).

Second-line (definition)Second-line medications require that the member has filled at least two different first-line medications or a second-line medication within the past 180 days in order to pay without prior authorization.

Prior authorization alternativeIf step-therapy is not met, approval may be granted when the member has an inadequate response, adverse reaction, or contraindication to TWO first-line ophthalmic NSAIDs or to ONE second-line ophthalmic NSAID (documentation required).

Policy Background

This policy defines the scope and intent for outpatient topical ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) under the commercial/exchange pharmacy benefit. It governs formulary placement and the associated step-therapy and prior authorization processes, including rules for continuity of care for members who are new to the plan within 90 days and currently receiving therapy. The policy specifies that first-line agents are covered without prior authorization, second-line agents have step-therapy requirements (including a 180-day lookback to demonstrate prior fills), and that prior authorization is required when initial step-therapy requirements are not met; documentation of treatment failure, adverse reaction, or contraindication to the specified number of agents may be used to support exceptions.

Policy Changes and Review History

2011-04-04implementation

Policy implementation recorded in review history.

2022-06-22review

Reviewed for June P&T; no clinical changes.

2024-02-14revision

Bromfenac (generic for Prolensa) was released and replaced Prolensa as a second-line agent; Brand Prolensa moved to nonformulary (effective 2024-03-01).

Policy Summary

PayerMass General Brigham Health Plan

PolicyOphthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) — Step therapy and prior authorization

Policy CodePolicy N/A

Change TypeRevised prior authorization languageremoved nonformulary product

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization for prescriptions that do not meet initial step-therapy requirements.

SourceLink

On This Page

Ilevro (nepafenac) 0.3% quantity limit

Prolensa (bromfenac) 0.07% quantity limit3.2 mL per fill

Message will indicate PA is required

Step Therapy

Initial Step-Therapy Requirements

First-line agents are covered without prior authorization. Second-line medications require evidence of prior therapy: the member must have filled at least two different first-line medications or a second-line medication within the past 180 days, or meet clinical exception criteria. Examples of pathway relationships are provided below.

First-line agents: covered without PA
Second-line pay criteria: ≥2 different first-line fills OR a prior second-line fill within 180 days

Documentation Required

Continuity for Members New to Plan

Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication. Continuity approvals exclude medications obtained only as samples or through manufacturer patient assistance programs; those do not satisfy the 'new-to-plan' continuity exception.

Continuity rule applies if member joined plan ≤90 days and is currently on therapy
Samples and manufacturer patient assistance do NOT qualify for continuity approvals

Documentation Required

Clinical Exception Criteria

Approval exceptions can also be granted when the member meets clinical criteria: (1) inadequate response, adverse reaction, or contraindication to TWO first-line ophthalmic NSAIDs, OR (2) inadequate response, adverse reaction, or contraindication to ONE second-line ophthalmic NSAID. Provide clinical notes or prior fill history with the PA submission.

Clinical exception: failure/intolerance to TWO first-line agents
Clinical exception: failure/intolerance to ONE second-line agent
Include clinical notes or prior fill history with PA

2025-10-08material_revisionLatest

Removed Nevanac from policy as it moved to nonformulary status and updated prior authorization language to align with the step therapy program (effective 2026-01-01).