Ciprodex® Otic Drops Policy Number: 5.01.507 Last Review: 02/2013 Origination: 02/2005 Next Review: 02/2014
BCBSKC will provide coverage for Ciprodex® otic drops when it is determined to be medically necessary because the following criteria have been met. When Policy Topic is covered
Due to increased utilization of Ciprodex ® Otic Drops for otitis media without tympanostomy tubes, prior authorization is required for coverage. Authorization will not be given for use in otitis media without tympanostomy tubes. Ciprodex® will be given authorization for the treatment of AOMT and AOE. When prescribed by an ENT (otolaryngologist), Ciprodex ® does not require prior authorization. When Policy Topic is not covered
Ciprodex® otic drops are considered not medically necessary if the criteria above are not met. Considerations
This Blue Cross and Blue Shield of Kansas City policy Statement was developed using available resources such as, but not limited to: Hayes Medical Technology Directtory, Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, Local medical policies of other health plans, Medicare (CMS), Local providers. Description of Procedure or Service
Ciprodex® Otic is a medication for the treatment of bacterial infections of the ear. Specifically, it is indicated for acute otitis media with tympanostomy tubes (AOMT) and acute otitis externa (AOE). Ciprodex ® is not indicated for acute otitis media without tympanostomy tubes. Rationale
In otitis externa, topical agents are the preferred treatment option, however, oral antibiotics are used only when the symptoms are persistent, or if it transforms into otitis media, or if local or systemic spread has occurred. Oral medications are not typically used in acute otitis media for pediatric patients with tympanostomy tubes because the bacteria causing the infection may not be susceptible (eg, P. aeruginosa). Currently, there is a multitude of other brand and generic topical otic antibiotic products available (with or without a corticosteroid) for the management of otitis externa. Products most similar to Ciprodex® (ciprofloxacin 0.3%/dexamethasone 0.1%) incllude Cipro® HC (ciprofloxacin 0.2%/hydrocortisone 1%), which also contains the same fluoroquinolone antibiotic (ciprofloxacin) at a lower concentration and a different corticosteroid (hydrocortisone), and Floxin® Otic which contains a different fluoroquinolone antibiotic (ofloxacin 0.3%) and does not contain a corticosteroid. Cipro® HC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of P. aeruginosa, S. aureus, and Proteus mirabilis. Although this product is not indicated for treating acute otitis media in children with tympanostomy tubes, it is routinely used in practice for this indication. Floxin® Otic is indicated for otitis externa and acute otitis media in patients one year and older with tympanostomy tubes. The third indication is for chronic suppurative otitis
media in patients 12 years and older with perforated tympanic membranes due to S. aureus, P. mirabilis, and P. aeruginosa. Ciprodex® is dosed 7 days for all indications, while Floxin® Otic is given for 10 days for otitis externa and for acute otitis media with tympanostomy tubes. Steroids are added to some otic antibiotic suspensions to reduce the inflammation and edema of the ear canal and resolve symptoms more quickly. Ciprodex® has been directly compared to Floxin® Otic for the management of acute otitis media in children with tympanostomy tubes and found to have similar efficacy, however, published data is lacking. Therefore, Ciprodex® is considered a therapeutic alternative for the treatment of otitis externa, a condition with multiple drug-therapy options. However, it may have a more prevalent role in the management of acute otitis media in patients with tympanostomy tubes due to the limited topical options currently available that are appropriate for this use. References
1. Olin BR, editor. Drug Facts and Comparisons (updated monthly). St. Louis: J.B. Lippincott
Company, Facts and Comparisons Division, 2004.
2. McEvoy, Geral, K. et.al. AHFS Drug Information (online ) 2004. 3. Product Information. Cipro® HC Suspension. (Alcon) PDR 2001. 4. Hydrocortisone. Drug Reference Monographs. Micromedex, Martindale Revised Date:
5. Morden, Nancy E; Berke, E.M. Topical Fluoroquinolones for Eye and Ear. American Fam
6. Hebert RL, Vick ML, King GE, Bent JP. Tympanostomy tubes and otic suspensions: do they
reach the middle ear space? Otolaryngol Head Neck Surg Abstract 2000 Mar;122(3):330-3
7. Ciprodex® Dossier 2003. 8. Product Information Ciprodex® otic suspension. Alcon Labs July 2003. 9. Cipro® HC Otic [package insert]. Fort Worth, TX: Alcon Laboratories. Accessed 09/02/2003.
Available at: http://www.alconlabs.com/us/aj/products/RxTher/Cipro_PI.jhtml.
10. Ciprodex® otic suspension [package insert]. Fort Worth, TX: Alcon Laboratories; July 17, 2003. 11. Floxin® Otic [package insert]. Montvale, NJ: Daiichi Pharmaceutical Corporation; April 2003. 12. Sander R. Otitis externa: a practical guide to treatment and prevention. Am Fam Physician.
13. Lee L, Steinberg I, Gill MA. Management of ear infections: otitis media and otitis externa.
California Pharmacist. Spring 2001;54-64.
Billing Coding/Physician Documentation Information
N/A Ciprodex® otic drops are considered a pharmacy benefit. Additional Policy Key Words
Policy Number: 5.01.507 Related
N/A Policy Implementation/Update Information
02/2008 Reviewed – No changes made 02/2009 Reviewed – No changes made 02/2010
This Medical Policy is designed for informational purposes only and is not an authorization, an explanation of benefits, or a contract. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there is any exclusion or other benefit limitations applicable to this service or supply. Medical technology is constantly changing and Blue Cross and Blue Shield of Kansas City reserves the right to review and revise medical policy. This information is proprietary and confidential and cannot be shared without the written permission of Blue Cross and Blue Shield of Kansas City.
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Ciprodex® Otic Drops