Ciprofloxacin/Fluocinolone (Otovel) Form

Ciprofloxacin/fluocinolone (Otovel®) otic solution is a combination of fluoroquinolone antibacterial and a corticosteroid. FDA Approved Indication(s) Otovel is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, 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 Otovel is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Otitis Media (must meet all):

1. Diagnosis of otitis media;
2. Age ≥ 6 months;
3. For brand Otovel requests, member must use generic ciprofloxacin/fluocinolone, unless contraindicated or clinically significant adverse effects are experienced (e.g., contraindications to excipients);
   4. Recent (within the last 3 months) use of a systemic antibiotic indicated for otitis media (see Appendix B);
   5. Presence of tympanostomy tubes;

4. Dose does not exceed 1 carton (14 single-dose vials) per affected ear. Approval duration: 7 days (2 cartons total – one per affected ear) B. Other diagnoses/indications (must meet 1 or 2):

   1. 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: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 5

   CLINICAL POLICY Ciprofloxacin/Fluocinolone b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, 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: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Otitis Media
   3. 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):
   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: CP.CPA.190 for commercial, 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: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   5. 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: CP.CPA.09 for commercial, 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 – CP.CPA.09 for commercial, 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 AOMT: acute otitis media with tympanostomy tubes FDA: Food and Drug Administration Page 2 of 5

   CLINICAL POLICY Ciprofloxacin/Fluocinolone 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 80 to 90 mg/kg PO per day in 2 divided doses 90 mg/kg per day amoxicillin and 6.4 mg/kg per day clavulanate PO in 2 divided doses 14 mg/kg PO per day in 1 or 2 doses 30 mg/kg PO per day in 2 divided doses 10 mg/kg PO per day in 2 divided doses 50 mg IM or IV per day for 1 or 3 days amoxicillin (Amoxil®) amoxicillin- clavulanate (Augmentin®) cefdinir cefuroxime
   cefpodoxime ceftriaxone 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. 600 mg/day 1,000 mg/day 400 mg/day 4 g/day 1,750 mg/day of amoxicillin component Dose Limit/ Maximum Dose 1,750 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of Otovel o Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections • Boxed warning(s): none reported V. Dosage and Administration
   Indication Otitis media Dosing Regimen Instill the contents of one single-dose vial (0.25 mL) into the affected ear canal BID for 7 days Maximum Dose 0.5 mL/day/ear VI. Product Availability
   Single-use vials (14 of 0.25 mL vials in a carton): ciprofloxacin 0.3% (3 mg/mL) with fluocinolone acetonide 0.025% (0.25 mg/mL) VII.