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

alcaftadine Lastacaft PA  
bepotastine Bepreve PA  
emedastine Emadine PA  
ketotifen * test  

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: loteprednol
    •  six years of age: naphazoline/pheniramine
    •  three years of age: azelastine, emedastine, ketotifen, nedocromil, and olopatadine 0.1%.
    •  two years of age: alcaftadine, bepotastine, epinastine, lodoxamide, olopatadine 0.2%, and olopatadine 0.7%.

Pregnancy:

alcaftadine, emedastine, 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

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

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

azelastine ophthalmic solution test  
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 Details

Drug Generic Name

Drug Brand Name

PA
Status

cromolyn ophthalmic test  
lodoxamide Alomide PA  
nedocromil Alocril PA  

 Ophthalmic Anti-Allergy and Anti-Inflammatory Agents – NSAIDs

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

bromfenac 0.07% Prolensa PA  
bromfenac 0.075% Bromsite PA  
bromfenac 0.09% PA  
diclofenac eye drops test  
flurbiprofen ophthalmic solution test  
ketorolac 0.4% ophthalmic solution Acular LS # test  
ketorolac 0.45% ophthalmic solution Acuvail PA  
ketorolac 0.5% ophthalmic solution Acular # test  
nepafenac 0.1% ophthalmic suspension Nevanac PA  
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

cyclosporine ophthalmic Restasis PA  
glycerin / propylene glycol Artificial Tears * test  
hydroxypropyl cellulose ophthalmic insert Lacrisert PA  
lifitegrast Xiidra PA  
naphazoline * test  
naphazoline / pheniramine Naphcon-A test  
naphazoline / pheniramine Opcon-A test  
Table Footnotes
# 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.
 
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 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, epinastine, Lastacaft, loteprednol 0.5%, olopatadine 0.1% and 0.2% eye drops, Pazeo)
  • Postoperative pain and inflammation following ocular surgery (Acuvail, bromfenac 0.09%, Bromsite, Durezol, Ilevro, loteprednol 0.5%, Nevanac, Prolensa, Vexol)
  • Steroid-responsive inflammatory conditions (loteprednol 0.5%, Maxidex)
  • Keratoconjunctivitis sicca (KCS)/dry eyes (Lacrisert, Restasis, Xiidra)

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

Back to top


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. 
  • 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 requested medication (see below).  

  

Acuvail, bromfenac 0.09%, Bromsite 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, Bepreve, Brand-name Elestat, Emadine, Lastacaft, olopatadine 0.2% eye drops, Brand-name Patanol and Pazeo for members ≥ three 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
    • an inadequate response, adverse reaction, or contraindication to azelastine ophthalmic solution; and
    • one of the following: 
      • an inadequate response or adverse reaction to epinastine; or
      • an inadequate response or adverse reaction to olopatadine eye drops; or
      • contraindication to epinastine and olopatadine eye drops; and
    • if the request is for Brand-name Elestat, Pataday, or Patanol, member must meet the above trials and provide medical records documenting an inadequate response or adverse reaction to the generic equivalent.

Alomide, Bepreve, Brand-name Elestat, Lastacaft, olopatadine 0.2% eye drops, and Pazeo for members ≥ two to < three years of age

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to epinastine; and
    • if the request is for Brand-name Elestat or Pataday, member must meet the above trials and provide medical records documenting an inadequate response or adverse reaction to the generic equivalent.

Alrex and loteprednol 0.5% (for allergic conjunctivitis)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following: 
      • an inadequate response or adverse reaction to ketotifen or azelastine ophthalmic solution; or
      • contraindication to ketotifen and azelastine ophthalmic solution.

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.

epinastine (generic) and olopatadine 0.1% eye drops (generic)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • one of the following: 
      • the request is for epinastine and the member is ≥ two years of age; or
      • the request is for olopatadine 0.1% eye drops and the member is ≥ three years of age; and
    • for members ≥ three years of age, one of the following:
      • inadequate response or adverse reaction to azelastine ophthalmic solution; or
      • inadequate response or adverse reaction to ketotifen; or
      • contraindication to azelastine ophthalmic solution and ketotifen.

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 tear 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.

loteprednol 0.5% (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 one artificial tear preparation; and
    • member is ≥ 16 years of age; and
    • one of the following:
      • if the request is for vials, requested quantity is for ≤ 60 units/30 days; or
      • if the request is for multidose bottle, requested quantity is for ≤ 1 unit/28 days; or
      • clinically appropriate rationale for dosing over the FDA approved regimen.

SmartPA: Claims for Restasis vials will usually process at the pharmacy for a quantity of ≤60 units/30 days if the member is  ≥ 16 years of age and 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 one artificial tear formulation in the most recent 90 days.

SmartPA: Claims for Restasis multidose bottle will usually process at the pharmacy for a quantity of ≤1 unit/28 days if the member is  ≥ 16 years of age and 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 one artificial tear formulation in the most recent 90 days.

Xiidra

  • Documentation of the following is required: 
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to two different artificial tear preparations; and
    • an inadequate response, adverse reaction, or contraindication to Restasis; and
    • member is ≥ 17 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 Xiidra will usually process at the pharmacy for a quantity of ≤60 units/month if the member is  ≥ 17 years of age and there is a history of paid claims for 90 out of 120 days for Xiidra or if there is a history of paid claims for Restasis and two artificial tear 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: 08/2019


Clinical Criteria Main Page | Back to topPrevious  |  Next

Last updated 11/08/19