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Drug Category: Otic

Medication Class/Individual Agents: Antibiotics - Otic

I. Prior-Authorization Requirements

 Otic Antibacterial Agents – Combination Products

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

acetic acid / aluminum acetate test  
acetic acid / hydrocortisone test  
ciprofloxacin / dexamethasone Ciprodex test  
ciprofloxacin / fluocinolone Otovel PA  
ciprofloxacin / hydrocortisone Cipro HC test  
colistin / neomycin / thonzonium / hydrocortisone Coly-Mycin S BP test  
neomycin / polymyxin B / hydrocortisone otic 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.

 

American Academy of Otolaryngology--Head and Neck Surgery Foundation. Clinical Practice Guideline: Acute Otitis Externa (AOE)1:

  • Topical preparations are indicated for initial therapy of diffuse, uncomplicated AOE.
  • If the infection extends outside of the ear canal or there are specific host factors (diabetes, immune deficiency, or inability to effectively deliver topical therapy despite aural toilet), systemic antimicrobial therapy should be administered.
  • No significant differences in AOE clinical outcomes were found regarding the use of an antimicrobial versus an antiseptic, a quinolone antibiotic versus a nonquinolone antibiotic(s) or a steroid-antimicrobial agent versus an antimicrobial agent alone.
  • In the presence of tympanostomy tubes or perforated ear drums, the risk of ototoxicity with the use of topical aminoglycosides is higher than when the eardrum is intact.

 

 1 Rosenfeld RM, Brown L, Cannon CR, et al, American Academy of Otolaryngology--Head and Neck Surgery Foundation. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg 2006 Apr;134(4 Suppl):S4-S23.

 

 Otic Antibacterial Agents – Single-Entity Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

acetic acid test  
ciprofloxacin 0.2% otic solution PA  
ciprofloxacin otic suspension Otiprio ^ test  
ofloxacin otic solution test  
Table Footnotes
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.
 
^ 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: 

  • Acute otitis media with tympanostomy tubes (Otovel)
  • External Otitis (ciprofloxacin 0.2% otic solution)

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). 

     

ciprofloxacin 0.2% otic solution

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to neomycin/polymyxin B/hydrocortisone otic solution or suspension; or
    • medical necessity for unit dosing.

SmartPA: Claims for ciprofloxacin 0.2% otic solution will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for neomycin/polymyxin B/hydrocortisone otic solution or suspension within the past 30 days.

 

Otovel

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to Ciprodex otic suspension.

SmartPA: Claims for Otovel will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Ciprodex otic suspension within the past 30 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: 02/2011

Last Revised Date: 08/2019


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Last updated 08/29/19