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 |
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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.
Pregnancy: alcaftadine, cetirizine, lodoxamide, and nedocromil are pregnancy category B; the rest of the ophthalmic anti-allergy agents are pregnancy category C. |
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Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Corticosteroids |
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Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Mast Cell Stabilizer /Antihistamine |
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Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Mast Cell Stabilizers |
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Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – NSAIDs |
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Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – Not Otherwise Classified |
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# | 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 (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, Vevye, Xdemvy, Xiidra)
- Vernal keratoconjunctivitis (Verkazia)
Note: The above list may not include all FDA-approved indications.
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.
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.
Vevye
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- inadequate response, adverse reaction, or contraindication to all of the following: cyclosporine 0.05% ophthalmic emulsion, cyclosporine 0.09% ophthalmic emulsion, Xiidra, and Tyraya; and
- requested quantity is ≤ two mL/50 days.
Xdemvy
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- prescriber is an ophthalmologist or optometrist or consult notes from an ophthalmologist or optometrist are provided; and
- requested quantity is ≤ ten mL for one course of therapy.
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.†
Zerviate for members ≥ three years of age
- Documentation of the following is required:
- an appropriate diagnosis; and
- one of the following:
- inadequate response or adverse reaction to two or contraindication to all of the following: alcaftadine, Alomide, azelastine ophthalmic solution, bepotastine, epinastine, ketotifen, olopatadine ophthalmic solution; or
- both of the following:
- diagnosis of vernal keratoconjunctivitis or atopic keratoconjunctivitis; and
- inadequate response or adverse reaction to one or contraindication to all of the following: azelastine ophthalmic solution, epinastine, ketotifen, olopatadine ophthalmic solution.
Zerviate for members ≥ two to < three years of age
- Documentation of the following is required:
- an appropriate diagnosis; and
- one of the following:
- inadequate response or adverse reaction to two or contraindication to all of the following: alcaftadine, Alomide, bepotastine, epinastine, olopatadine ophthalmic solution; or
- both of the following:
- diagnosis of vernal keratoconjunctivitis or atopic keratoconjunctivitis; and
- inadequate response or adverse reaction to one or contraindication to all of the following: bepotastine, epinastine, olopatadine ophthalmic solution.
†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: 01/2025
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Last updated 01/06/25