Ciprofloxacin/Fluocinolone (Otovel) otic solution
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Policy governing medical necessity and prior authorization criteria for Otovel (ciprofloxacin/fluocinolone otic solution) for treatment of acute otitis media with tympanostomy tubes in covered members across Centene lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria for Otovel (ciprofloxacin/fluocinolone)
Initial Approval — Covered when ALL of the following are met
Covered when ALL of the following are met:
Initial Approval Criteria
- 1. Diagnosis of otitis media.
- 2. Age meets requirement: at least 6 months of age.
Documented patient age must meet product labeling.
- 3. For brand Otovel requests, member must use generic ciprofloxacin/fluocinolone otic suspension unless contraindicated or clinically significant adverse effects occur (including contraindications to excipients).
- 4. Recent use of a systemic antibiotic indicated for otitis media within the last 3 months (see therapeutic alternatives Appendix B).
- 5. Presence of tympanostomy tubes documented in the medical record.
- 6. Dosing and supply limits: dose does not exceed 0.5 mL per day per affected ear (instill 0.25 mL into the affected ear twice daily) and supply does not exceed 1 carton (14 single‑dose 0.25 mL vials) per affected ear.
Approval duration: 7 days (one carton per affected ear; two cartons total if both ears treated).
ALL of the following
- Provider must submit documentation (e.g., office chart notes, laboratory results, or other clinical information) supporting that the member meets the approval criteria.
ALL of the following
- Re‑authorization is not permitted; continuation beyond the initial approval duration is not applicable.
Non‑FDA indications not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. Follow the off‑label routing referenced by line of business: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) when submitting requests for uses outside the FDA‑approved indication.
Re‑authorization is not permitted. Members must meet the initial approval criteria for any subsequent request; continuation beyond the initial approval period does not apply and approval duration is not applicable for re‑authorization.
Product Identifiers, Dosing, and Supply Limits
| NDC or specific code not provided | Product: ciprofloxacin 0.3% with fluocinolone acetonide 0.025% in single-use 0.25 mL vials (14 per carton) |
Prior Authorization, Documentation, and Therapeutic Alternatives
Prior Authorization Required
Prior authorization is required for Otovel. Provider must submit documentation (such as office chart notes, audiology/ENT notes, tympanic membrane exam findings, imaging, lab results, or other clinical information) supporting the diagnosis and that the member meets all approval criteria (see Initial Approval Criteria). Approval duration: 7 days (maximum 2 cartons — one per affected ear).
- Diagnosis of otitis media
- Documentation of recent (within 3 months) systemic antibiotic use for otitis media (see Appendix B)
- Age requirement: >= 26 months
- Presence of tympanostomy tubes when applicable
- Dose limit: does not exceed 1 carton (14 single-dose vials) per affected ear
Formulary / Off‑label Routing
Formulary status and off-label requests must follow the line-of-business specific formulary/non‑formulary and off‑label use policies. For drugs on the formulary/PDL or when no-coverage criteria apply, follow: CP.CPA.190 (Commercial), HIM.PA.33 (Health Insurance Marketplace), CP PMN.255 (Medicaid). For non‑formulary drugs follow: CP.CPA.190 (Commercial), HIM.PA.103 (Health Insurance Marketplace), CP PMN.16 (Medicaid). For off‑label use or indications not addressed in this policy, refer to the off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), CP PMN.53 (Medicaid). Requests for non‑FDA indications may be denied if sufficient off‑label documentation of efficacy and safety is not provided per those policies.
- Commercial formulary/no-coverage: CP.CPA.190
- Health Insurance Marketplace formulary/no-coverage: HIM.PA.33 (or HIM.PA.103 for non‑formulary)
- Medicaid PDL/no-coverage: CP PMN.255 (or CP PMN.16 for non‑formulary)
- Off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace), CP PMN.53 (Medicaid)
Therapeutic Alternatives
Systemic antibiotics and other otic antibiotics are listed as therapeutic alternatives and may be preferred prior to approval of Otovel. Providers should consider guideline-recommended systemic agents (see Appendix B) and document prior therapies; alternatives may themselves require prior authorization under the applicable line‑of‑business drug policies.
- See Appendix B for common systemic alternatives (e.g., amoxicillin, amoxicillin‑clavulanate, ceftriaxone, cefdinir, cefuroxime) and dosing guidance
- Therapeutic alternatives may not be on formulary for all lines of business and could require prior authorization
Provider Documentation Requirements
Provider documentation requirements: submit office notes and clinical information demonstrating diagnosis (otitis media), age, presence of tympanostomy tubes if applicable, recent systemic antibiotic use (within 3 months), dosing requested, and any contraindications or adverse reactions to generic ciprofloxacin/fluocinolone (if requesting brand Otovel). If documentation is insufficient, the request may be denied.
- Office chart notes with otoscopic/tympanic membrane findings
- Records of prior systemic antibiotic therapy (dates and agents)
- Documentation of age and presence of tympanostomy tubes
- Clinical rationale for brand product if generic alternative contraindicated (e.g., allergy to excipients)
Non‑FDA Indication Requests
Non‑FDA indication requests may be denied without sufficient evidence per the applicable off‑label use policies (see Formulary / Off‑label Routing callout). Provide clinical literature or evidence of efficacy and safety when requesting coverage for non‑FDA uses.
- Off‑label requests require supporting literature and justification per CP.CPA.09, HIM.PA.154, or CP PMN.53
- If the requested use is not listed in section III and the formulary routing policies do not permit coverage, request will follow off‑label review processes
Background on Otovel
Otovel is an otic suspension combining the fluoroquinolone antibiotic ciprofloxacin 0.3% with the corticosteroid fluocinolone acetonide 0.025%, formulated as single‑use 0.25 mL vials sold in cartons of 14 vials. The FDA‑approved indication covered by this policy is for treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients; the product is active against common AOMT pathogens including Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. Dosage guidance in the product labeling directs instillation of the contents of one single‑use vial (0.25 mL) into the affected ear twice daily for up to 7 days, not to exceed 0.5 mL/day/ear and a maximum supply of one carton (14 vials) per affected ear.
Key Definitions
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