Prior Auth Protocol

FDA Approved Indications:

Acute otitis externa (AOE) caused by susceptible strains of pseudomonas aeruginosa and staphylococcus aureus.

Health Net Approved Indications and Usage Guidelines:

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Ciprodex^R 0.3%-0.1% otic suspension (ciprofloxacin/ dexamethasone)	4 drops instilled into the affected ear(s) BID for 7 days	8 drops per day into affected ear(s) (16 drops per day)
Cipro^R HC 0.2%-1% otic suspension (ciprofloxacin/ hydrocortisone)	3 drops instilled into the affected ear(s) BID for 7 days	6 drops per day into affected ear(s) (12 drops per day)
ofloxacin 0.3% otic solution	Adults: instill 10 drops into the affected ear(s) QD for 7 days Infants and children: instill 5 drop(s) into the affected ear(s) QD for 7 days	Adults: 10 drops per day into affected ear(s) Infants and children: 5 drops per day into affected ear(s)
neomycin/ polymyxin B/ hydrocortisone	Adults: instill 4 drops into the affected ear(s) 3-4 times daily Infants and children: instill 3 drop(s) into the affected ear(s) 3-4 times daily	No maximum dosage information available
acetic acid 2% solution	Instill 4-6 drops into the affected ear(s) every 2-3 hours	No maximum dosage information available
acetic acid/hydrocortisone solution	Instill 3-5 drops into the affected ear(s) 3-4 times daily	No maximum dosage information available

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Xtoro	4 drops into the affected ear(s) BID for 7 days	Length of Benefit

Product Availability:

Xtoro: finafloxacin 0.3% otic suspension (8 ml)

References:

Xtoro [package insert]. Fort Worth, TX: Alcon Laboratories, Inc. 2014.
Rosenfeld RM, Schwartz SR, Cannon R, et al. Clinical Practice Guideline: Acute Otitis Externa. 2014 Feb;150(1 Suppl):S1-S24
Clinical Pharmacology. Available at: http://clinicalpharmacology-ip.com/. Accessed January 13, 2015.