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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 Generic Name

Drug Brand Name

PA
Status

alcaftadine Lastacaft PA  
bepotastine Bepreve PA  
emedastine Emadine PA  

Please note: In the case where the prior authorization (PA) status column indicates PA for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  Prior authorization requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

  • 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: Alrex, Lotemax
    •  six years of age: naphazoline/pheniramine
    •  three years of age: Alocril, azelastine ophthalmic solution, Emadine, ketotifen, and olopatadine 0.1% eye drops.
    •  two years of age: Alomide, Bepreve, epinastine, Lastacaft, Pataday, and Pazeo.

Pregnancy:

Alocril, Alomide, Emadine and Lastacaft 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 Generic Name

Drug Brand Name

PA
Status

dexamethasone intravitreal implant Ozurdex ^  
dexamethasone ophthalmic suspension Maxidex PA  
dexamethasone sodium phosphate ophthalmic solution  
difluprednate Durezol PA  
fluorometholone FML #  
fluorometholone acetate Flarex  
loteprednol 0.2% eye drops Alrex PA  
loteprednol 0.5% Lotemax PA  
prednisolone acetate 0.12% ophthalmic suspension Pred Mild  
prednisolone acetate 1% ophthalmic suspension Pred Forte #  
prednisolone acetate 1% ophthalmic suspension-Omnipred Omnipred #  
prednisolone sodium phosphate ophthalmic solution  
rimexolone Vexol PA  

 Ophthalmic Anti-allergy and Anti-inflammatory Agents - Mast Cell Stabilizer /Antihistamine

Drug Generic Name

Drug Brand Name

PA
Status

azelastine ophthalmic solution PA  
epinastine Elestat PA  
olopatadine 0.1% eye drops Patanol PA  
olopatadine 0.2% eye drops Pataday PA  
olopatadine 0.7% eye drops Pazeo PA  

 Ophthalmic Anti-allergy and Anti-inflammatory Agents - Mast Cell Stabilizers

Drug Generic Name

Drug Brand Name

PA
Status

cromolyn ophthalmic  
lodoxamide Alomide PA  
nedocromil Alocril PA  

 Ophthalmic Anti-allergy and Anti-inflammatory Agents - Miscellaneous

Drug Generic Name

Drug Brand Name

PA
Status

cyclosporine, ophthalmic Restasis PA  
glycerin / propylene glycol Artificial Tears *  
hydroxypropyl cellulose ophthalmic insert Lacrisert PA  

 Ophthalmic Anti-allergy and Anti-inflammatory Agents - NSAIDs

Drug Generic Name

Drug Brand Name

PA
Status

bromfenac 0.07% Prolensa PA  
bromfenac 0.09% PA  
diclofenac eye drops  
flurbiprofen ophthalmic solution Ocufen #  
ketorolac 0.4% ophthalmic solution Acular LS #  
ketorolac 0.45% ophthalmic solution Acuvail PA  
ketorolac 0.5% ophthalmic solution Acular #  
nepafenac 0.1% ophthalmic suspension Nevanac PA  
nepafenac 0.3% ophthalmic suspension Ilevro PA  
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Anterior uveitis (Vexol)
  • Endogenous anterior uveitis (Durezol)
  • Perennial (chronic) or seasonal (short term) allergic conjunctivitis (Alrex, Alocril, Alomide, azelastine ophthalmic solution, Bepreve, Emadine, epinastine, Lastacaft, Lotemax, olopatadine 0.1% eye drops, Pataday, Pazeo)
  • Postoperative pain and inflammation following ocular surgery (Acuvail, bromfenac 0.09%, Durezol, Ilevro, Lotemax, Nevanac, Prolensa, Vexol)
  • Steroid-responsive inflammatory conditions (Lotemax, Maxidex)
  • Keratoconjunctivitis sicca (KCS)/dry eyes (Lacrisert, Restasis)

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 PA status column indicates PA for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  Prior authorization requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

  • All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency. 
  • Additional criteria may apply depending upon requested medication (see below).  

  

Acuvail, bromfenac 0.09% and Prolensa

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • an inadequate response, adverse reaction, or contraindication to one of the following:
      • ketorolac 0.4% or 0.5%; or
      • diclofenac; or
      • flurbiprofen.

Alocril, Alomide, azelastine ophthalmic solution, Bepreve, Emadine, epinastine, Lastacaft, olopatadine 0.1% eye drops, Pataday, and Pazeo for members ≥ six years of age

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction or contraindication to a ketotifen product; and
    • one of the following: 
      • an inadequate response, adverse reaction or contraindication to one combination vasoconstrictor and antihistamine product (e.g. naphazoline/pheniramine); or
      • member is at risk or currently has intraocular hypertension.

Alocril, Alomide, azelastine ophthalmic solution, Bepreve, Emadine, epinastine, Lastacaft, olopatadine 0.1% eye drops, Pataday, and Pazeo for members ≥ three to < six years of age

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction or contraindication to a ketotifen product.

Alomide, Bepreve, epinastine, Lastacaft, Pataday, and Pazeo for members ≥ two to < three years of age

  • Documentation of the following is required:
    • an appropriate diagnosis.

Alrex and Lotemax (for allergic conjunctivitis)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • an inadequate response, adverse reaction or contraindication to a ketotifen product; and
    • one of the following: 
      • an inadequate response, adverse reaction or contraindication to one combination vasoconstrictor and antihistamine product (e.g. naphazoline/pheniramine); or
      • member is at risk or currently has intraocular hypertension.

Durezol and Maxidex

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • an inadequate response, adverse reaction, or contraindication to a generic topical corticosteroid for ophthalmic use.

Ilevro and Nevanac

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 10 years of age; and
    • an inadequate response, adverse reaction, or contraindication to one of the following:
      • ketorolac 0.4% or 0.5%; or
      • diclofenac; or
      • flurbiprofen.

Lacrisert

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to two different artificial tears preparations. 

SmartPA: Claims for Lacrisert will usually process at the pharmacy if there is a history of paid claims for 2 different artificial tears formulations in the most recent 90 days or if there is a history of paid claims for the requested agent for 90 out of 120 days.

Lotemax (for postoperative pain and inflammation) and Vexol

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following: 
      • an inadequate response, adverse reaction, or contraindication to a generic topical corticosteroid for ophthalmic use; or
      • member is at risk or currently has intraocular hypertension.

Restasis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to two different artificial tears preparations; and
    • member is ≥ 16 years of age; and
    • one of the following:
      • requested quantity is for ≤ 60 units/30 days; or
      • clinically appropriate rationale for dosing over the FDA approved regimen.

SmartPA: Claims for Restasis will usually process at the pharmacy for a quantity of ≤60 units/month if there is a history of paid claims for 90 out of 120 days for Restasis or if there is a history of paid claims for 2 different artificial tears formulations in the most recent 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: 05/2016


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Last updated 07/01/16