Ciprofloxacin/Dexamethasone (Ciprodex) Form

Ciprofloxacin/dexamethasone (Ciprodex®) otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid. FDA Approved Indication(s) Ciprodex is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: • Acute otitis media in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. • Acute otitis externa in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Ciprodex is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acute Otitis (must meet all):

1. Diagnosis of otitis;
   2. Age ≥ 6 months;
   3. For brand Ciprodex requests, member must use generic ciprofloxacin/dexamethasone otic suspension, unless contraindicated or clinically significant adverse effects are experienced (i.e., contraindication to excipients);
2. Member meets one of the following (a or b):
   a. Diagnosis of otitis externa; b. Diagnosis of otitis media with both of the following (i and ii): i. Recent (within the last 3 months) use of an oral antibiotic indicated for otitis media (see Appendix B) ii. Presence of tympanostomy tubes;

3. Dose does not exceed 7.5 mL (1 bottle). Approval duration: 14 days (1 bottle) Page 1 of 5

   CLINICAL POLICY Ciprofloxacin/Dexamethasone B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Acute Otitis
5. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):

6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid, or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Page 2 of 5

   CLINICAL POLICY Ciprofloxacin/Dexamethasone Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Dosing Regimen Drug Name amoxicillin (Amoxil®) amoxicillin- clavulanate (Augmentin®) cefdinir cefuroxime
   cefpodoxime ceftriaxone Acute Otitis Media 80 to 90 mg/kg/day PO in two divided doses Acute Otitis Media 90 mg/kg/day amoxicillin and 6.4 mg/kg/day clavulanate PO in two divided doses Acute Otitis Media 14 mg/kg PO per day in 1 or 2 doses Acute Otitis Media 30 mg/kg PO per day in 2 divided doses Acute Otitis Media 10 mg/kg PO per day in 2 divided doses Dose Limit/ Maximum Dose 90 mg/kg/day 90 mg/kg/day of amoxicillin component 600 mg/day 1,000 mg/day 400 mg/day Acute Otitis Media 50 mg IM or IV per day for 1 or 3 days 4 g/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Note: Choice of antibiotic therapy includes but is not limited to the agents listed here. Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o History of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in Ciprodex o Use in viral infections of the external canal including herpes simplex infections and fungal otic infections • Boxed warning(s): none reported V. Dosage and Administration
   Indication Acute otitis media, acute otitis externa Dosing Regimen Instill 4 drops into the affected ear BID for 7 days Maximum Dose 8 drops/ear (max: 7 days) VI. Product Availability
   Otic suspension (7.5 mL): ciprofloxacin 0.3% and dexamethasone 0.1% VII.