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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 besilate 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
    • ≥ 6 years of age: Naphcon-A, Opcon-A, and Visine-A
    • ≥ 3 years old: Alaway, Alocril, Elestat, Emadine, ketotifen, Optivar, Pataday and Patanol.
    • ≥ 2 years old: Alomide, Bepreve, Lastacaft

Pregnancy:

Alocril, Alomide, Emadine and Lastacaft are pregnancy category B; 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 solution Maxidex PA  
difluprednate Durezol PA  
fluorometholone-Flarex Flarex PA  
fluorometholone-FML FML #  
loteprednol 0.2% eye drops Alrex PA  
loteprednol 0.5% Lotemax PA  
prednisolone acetate, ophthalmic suspension-Omnipred Omnipred #  
prednisolone acetate, ophthalmic suspension-Pred-Forte Pred-Forte #  
prednisolone sodium phospate, ophthalmic solution PA  
rimexolone Vexol PA  

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

Drug Generic Name

Drug Brand Name

PA
Status

azelastine Optivar PA  
epinastine Elestat PA  
ketotifen Alaway  
olopatadine 0.1% eye drops Patanol PA  
olopatadine 0.2% eye drops Pataday 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, ophthalmic 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 PA  
bromfenac 0.07% Prolensa PA  
bromfenac 0.09% Bromday PA  
diclofenac eye drops Voltaren #  
flurbiprofen 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  

 Ophthalmic Anti-allergy and Anti-inflammatory Agents - Vasoconstrictor/Antihistamine

Drug Generic Name

Drug Brand Name

PA
Status

naphazoline / pheniramine-naphcon-a Naphcon-A  
naphazoline / pheniramine-Opcon-A Opcon-A  
# 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, Bepreve, Emadine, Elestat, Lastacaft, Lotemax suspension, Optivar, Pataday, Patanol)
  • Postoperative pain and inflammation following ocular surgery (Acuvail, Bromday, bromfenac, Durezol, Ilevro, Lotemax, Nevanac, Prolensa, Vexol)
  • Steroid-responsive inflammatory conditions (Flarex, Lotemax, Maxidex, prednisolone sodium phosphate)
  • 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 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.

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

  

Alrex, Lotemax suspension (for allergic conjunctivitis)

  • Documentation of all 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 combination vasoconstrictor and antihistamine product (e.g. Naphcon-A, Opcon-A); or
    • member is at risk or currently has intraocular hypertension; and
    • an inadequate response, adverse reaction or contraindication to a ketotifen product.

  

Alocril, Alomide, Bepreve, epinastine, Emadine, Lastacaft, Optivar, Pataday, and Patanol for members ≥ 7 years of age

  • Documentation of all of the following is required:
    • an appropriate diagnosis;
    • an inadequate response, adverse reaction or contraindication to one combination vasoconstrictor and antihistamine product (e.g. Naphcon-A, Opcon-A); and
    • an inadequate response, adverse reaction or contraindication to a ketotifen product.

  

Alocril, Alomide, Bepreve, epinastine, Emadine, Lastacaft, Optivar, Pataday, or Patanol for members 3 to < 7 years of age

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

  

Alomide, Bepreve and Lastacaft for members 2 to < 3 years of age

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

 

Acuvail, Bromday, generic bromfenac, 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; or
      • diclofenac; or
      • flurbiprofen.

 

Durezol, Flarex, Maxidex, prednisolone sodium phosphate

  • 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; or
      • diclofenac; or
      • flurbiprofen.

Lotemax suspension, ointment, and gel (for postoperative pain and inflammation), 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.

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.

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: 07/2013


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Last updated 03/10/14