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Table 29: Anti-Allergy and Anti-Inflammatory Agents - Ophthalmic


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Anti-Allergy and Anti-Inflammatory Agents - Ophthalmic

Medication Class/Individual Agents: Anti-Allergy and Anti-Inflammatory Agents - Ophthalmic

I. Prior-Authorization Requirements

 Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Antihistamines

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

bepotastine Bepreve test   BP, A90
cetirizine ophthalmic solution Zerviate PA  
ketotifen test   *, A90

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • Nonpharmacologic treatments, such as allergen avoidance, cold compress, and lubrication to remove the allergen, may provide relief.
  • Products containing vasoconstrictors may cause rebound redness if used more frequently than the recommended treatment duration.
  • The dropper tip should not touch the eye in order to prevent contaminating the bottle.
  • Remove contact lenses before instilling eye drops as some preservatives in ocular products may be absorbed by soft contact lenses.
  • FDA-approved ages:
    •  18 years of age: bromfenac, cyclosporine 0.09%, dexamethasone, diclofenac, difluprednate, flurbiprofen, hydroxypropyl cellulose ophthalmic insert, loteprednol, prednisolone
    •  17 years of age: lifitegrast
    •  16 years of age: cyclosporine 0.05%
    •  ten years of age: nepafenac
    •  three years of age: azelastine, ketotifen, ketorolac tromethamine 0.4%, nedocromil
    •  two years of age: alcaftadine, bepotastine, cetirizine, epinastine, fluorometholone, ketorolac tromethamine 0.5%, lodoxamide, olopatadine

Pregnancy:

alcaftadine, cetirizine, lodoxamide, and nedocromil are pregnancy category B; the rest of the ophthalmic anti-allergy agents are pregnancy category C.

 

 Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Corticosteroids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

dexamethasone intravitreal implant Ozurdex test   MB
dexamethasone ophthalmic insert Dextenza test   MB
dexamethasone ophthalmic suspension Maxidex test  
dexamethasone sodium phosphate ophthalmic solution test   A90
difluprednate Durezol test   # , A90
fluorometholone FML test   # , A90
fluorometholone acetate Flarex test  
loteprednol 0.2% Alrex test   # , A90
loteprednol 0.25% suspension Eysuvis PA  
loteprednol 0.38% gel Lotemax SM PA  
loteprednol 0.5% Lotemax test   BP, A90
loteprednol 1% suspension Inveltys PA  
prednisolone acetate 0.12% ophthalmic suspension Pred Mild test  
prednisolone acetate 1% ophthalmic suspension Pred Forte test   # , A90
prednisolone acetate 1% ophthalmic suspension test   A90
prednisolone sodium phosphate ophthalmic solution test   A90

 Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Mast Cell Stabilizer /Antihistamine

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

azelastine ophthalmic solution test   A90
epinastine test   A90
olopatadine ophthalmic solution test   A90

 Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Mast Cell Stabilizers

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

cromolyn ophthalmic test   A90
lodoxamide Alomide test  
nedocromil Alocril test  

 Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – NSAIDs

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

bromfenac 0.07% Prolensa test   BP, A90
bromfenac 0.075% Bromsite PA  
bromfenac 0.09% PA   A90
diclofenac ophthalmic solution test   A90
flurbiprofen ophthalmic solution test   A90
ketorolac 0.4% ophthalmic solution Acular LS test   # , A90
ketorolac 0.45% ophthalmic solution Acuvail test  
ketorolac 0.5% ophthalmic solution Acular test   # , A90
nepafenac 0.1% ophthalmic suspension Nevanac test  
nepafenac 0.3% ophthalmic suspension Ilevro PA  

 Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

artificial tears test   *, A90
cyclosporine 0.05% ophthalmic emulsion Restasis test   # , A90
cyclosporine 0.09% ophthalmic solution Cequa PA  
cyclosporine 0.1% ophthalmic emulsion Verkazia PA  
cyclosporine multidose 0.05% ophthalmic emulsion Restasis Multidose PA  
hydroxypropyl cellulose ophthalmic insert Lacrisert test  
lifitegrast Xiidra PA  
naphazoline test   *
naphazoline / pheniramine Naphcon-A test   A90
naphazoline / pheniramine Opcon-A test   A90
perfluorohexyloctane Miebo PA  
varenicline nasal spray Tyrvaya PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without PA.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Perennial (chronic) or seasonal (short term) allergic conjunctivitis (Lastacaft OTC, Zerviate)
  • Postoperative pain and inflammation following ocular surgery (bromfenac 0.09%, Bromsite, Ilevro, Inveltys, Lotemax SM)
  • Keratoconjunctivitis sicca (KCS)/dry eyes (Cequa, Eysuvis, Miebo, Restasis Multidose, Tyrvaya, Xiidra)
  • Vernal keratoconjunctivitis (Verkazia)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency. 
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

 

bromfenac 0.09% and Bromsite

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to bromfenac 0.07% opthalmic solution.

 

Cequa

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to cyclosporine 0.05% ophthalmic emulsion; and
    • requested quantity is ≤ two units/day.

SmartPA: Claims for Cequa will usually process at the pharmacy without a PA request for a quantity of ≤ two units/day if the member is ≥ 18 years of age and there is a history of paid MassHealth pharmacy claims for at least 90 out of  the last 120 days for Cequa or if there is a history of paid claims for cyclosporine 0.05% ophthalmic solution in the last 90 days.

 

Eysuvis

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to one or contraindication to all topical corticosteroids for ophthalmic use available without PA; and
    • inadequate response, adverse reaction, or contraindication to cyclosporine 0.05% ophthalmic emulsion; and
    • requested duration is ≤ two weeks.

 

Ilevro

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ ten years of age; and
    • inadequate response or adverse reaction to nepafenac 0.1% ophthalmic suspension.

 

Inveltys and Lotemax SM (for postoperative pain and inflammation)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to loteprednol 0.5% ophthalmic gel, ointment, or suspension.

 

Lastacaft OTC and Zerviate for members ≥ three years of age

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • one of the following:
      • diagnosis of vernal keratoconjunctivitis or atopic keratoconjunctivitis; or
      • inadequate response or adverse reaction to two or contraindication to all of the following: Alocril, Alomide, azelastine ophthalmic solution, bepotastine, epinastine, ketotifen, olopatadine ophthalmic solution.

 

Lastacaft OTC and Zerviate for members ≥ two to < three years of age

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • one of the following:
      • diagnosis of vernal keratoconjunctivitis or atopic keratoconjunctivitis; or
      • inadequate response or adverse reaction to two or contraindication to all of the following: Alomide, bepotastine, epinastine, olopatadine ophthalmic solution.

 

Miebo and Tyrvaya

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to both of the following: cyclosporine 0.05% ophthalmic emulsion and Xiidra; and
    • one of the following:
      • for Miebo, requested quantity is ≤ three mL/30 days; or
      • for Tyrvaya, requested quantity is ≤ 8.4 mL/30 days.

 

Restasis Multidose

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 16 years of age; and
    • medical necessity for use of multidose formulation instead of cyclosporine 0.05% ophthalmic emulsion (single use vial formulation); and
    • requested quantity is ≤ one unit/28 days.

 

Verkazia

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ four years of age; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: azelastine ophthalmic solution, epinastine, ketotifen, olopatadine ophthalmic solution; and
    • inadequate response or adverse reaction to one or contraindication to all topical corticosteroids for ophthalmic use; and
    • requested quantity is ≤ four units/day.

 

Xiidra

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 17 years of age; and
    • inadequate response, adverse reaction, or contraindication to cyclosporine 0.05% ophthalmic emulsion; and
    • requested quantity is ≤ two units/day.

SmartPA: Claims for Xiidra will usually process at the pharmacy without a PA request for a quantity of ≤ two units/day if the member is ≥ 17 years of age and there is a history of paid MassHealth pharmacy claims for at least 90 out of the last 120 days for Xiidra or if there is a history of paid MassHealth pharmacy claims for cyclosporine 0.05% ophthalmic solution in the last 90 days.

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 04/2005

Last Revised Date: 03/2024


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Last updated 03/04/24

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