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Drug Category: Ophthalmic

Medication Class/Individual Agents: Antibacterial Agents

I. Prior-Authorization Requirements

 Antibiotics: Ophthalmic

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

azithromycin ophthalmic solution Azasite BP PA  
bacitracin ophthalmic ointment test  
besifloxacin ophthalmic suspension Besivance PA  
ciprofloxacin ophthalmic ointment Ciloxan PA  
ciprofloxacin ophthalmic solution Ciloxan # test  
erythromycin ophthalmic ointment test  
gatifloxacin ophthalmic solution Zymaxid PA  
gentamicin ophthalmic ointment, solution test  
levofloxacin ophthalmic solution test  
moxifloxacin ophthalmic solution-Moxeza Moxeza PA  
moxifloxacin ophthalmic solution-Vigamox Vigamox # test  
natamycin Natacyn test  
ofloxacin ophthalmic solution Ocuflox # test  
sulfacetamide ophthalmic ointment, solution Bleph-10 # test  
tobramycin ophthalmic solution Tobrex # test  
tobramycin ophthalmic ointment Tobrex PA  

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.

  • Mild bacterial conjunctivitis may be self-limiting and resolve spontaneously in immune-competent adults.
  • Most ophthalmic antibiotics contain the preservative benzalkonium chloride. Certain patients may have an allergic reaction or experience dose limiting ocular irritation when using agents containing preservatives.  Moxifloxacin ophthalmic solutions are preservative free.
  • Treatment should last five to seven days for bacterial conjunctivitis and five days for corneal ulcers.
  • Ointment may blur vision for up to 20 minutes but are preferred for corneal ulcers because it acts as a lubricant.
  • Contact lens wearers may require a flouroquinolone due to the high incidence of pseudomonas infection.
 

 Antibiotics: Ophthalmic – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

bacitracin / polymyxin B ophthalmic ointment test  
gentamicin / prednisolone ophthalmic ointment, suspension Pred-G PA  
neomycin / bacitracin / polymyxin B / hydrocortisone ophthalmic ointment test  
neomycin / bacitracin / polymyxin B ophthalmic ointment test  
neomycin / polymyxin B / dexamethasone ophthalmic ointment, suspension Maxitrol # test  
neomycin / polymyxin B / gramicidin test  
neomycin / polymyxin B / hydrocortisone ophthalmic suspension test  
sulfacetamide / prednisolone sodium acetate ophthalmic ointment, suspension Blephamide PA  
sulfacetamide / prednisolone sodium phosphate ophthalmic solution test  
tobramycin / loteprednol ophthalmic suspension Zylet PA  
tobramycin 0.3% / dexamethasone 0.05%, ophthalmic suspension Tobradex ST PA  
tobramycin 0.3% / dexamethasone 0.1%, ophthalmic ointment Tobradex PA  
tobramycin 0.3% / dexamethasone 0.1%, ophthalmic suspension Tobradex # test  
trimethoprim / polymyxin B ophthalmic solution Polytrim # 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.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Ocular infections involving the conjunctiva and/or cornea
    • bacterial conjunctivitis
    • bacterial keratitis/corneal ulcers
    • blepharitis/blepharoconjunctivitis
    • surgical prophylaxis

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.
  • 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 the member’s condition and requested medication (see below).

 

Single-entity agents: Azasite, Besivance, Ciloxan ointment, gatifloxacin, Moxeza, and Tobrex ointment 

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to one single-entity or combination ophthalmic antibiotic(s) agents not requiring prior authorization.

SmartPA: Claims for Besivance, gatifloxacin, and Moxeza will usually process and pay at the pharmacy without the requirements of a PA if the prescriber is an ophthalmologist.

 

Combination antibiotic/corticosteroid agents: Blephamide, Pred-G, Tobradex ointment, and Zylet

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to one of the following:
      • generic ophthalmic antibiotic/corticosteroid combination agent; or
      • generic single-entity or combination ophthalmic antibiotic(s) and single-entity ophthalmic corticosteroid agent.

 

Combination antibiotic/corticosteroid agent: Tobradex ST

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to at least one generic combination ophthalmic antibiotic/corticosteroid agent or a single-entity or combination ophthalmic antibiotic(s) and single-entity ophthalmic corticosteroid agent; and
    • an inadequate response, adverse reaction, or contraindication to generic combination tobramycin 0.3%/dexamethasone 0.1% ophthalmic suspension.

 

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: 12/2007

Last Revised Date: 08/2019


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Last updated 11/08/19