Eohilia (Budesonide oral suspension) — Coverage Criteria
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This policy governs prior authorization and coverage criteria for Eohilia (budesonide oral suspension) used to treat eosinophilic esophagitis (EoE) in patients, specifying indications, prescriber requirements, and approval durations for the payer's pharmacy benefit.
No material clinical or coverage changes in this revision.
Coverage Criteria for Eohilia (budesonide oral suspension)
Initial therapy (EoE)
Covered when ALL of the following are met for Eosinophilic Esophagitis (approve for 12 weeks):
Treatment with a proton pump inhibitor currently or at any time in the past counts. Examples of topical therapy include fluticasone propionate swallowed or budesonide inhalation swallowed.
Examples include an elemental diet or an elimination diet
For patients who started therapy but have not completed 12 weeks, approve remaining weeks so total treatment equals 12 weeks; maximum recommended treatment duration is 12 weeks.
Initial approval requires specialist involvement
Coverage is not recommended for circumstances that are not explicitly listed in the Recommended Authorization Criteria. This list is not exhaustive and will be updated as new published data become available.
Use of Eohilia has not been shown to be safe and effective for treatment of EoE for longer than 12 weeks.
Key Clinical Thresholds and Coding-Related Criteria
Prescriber Requirements, Prior Authorization, and Documentation
Prior Authorization and Prescriber Requirement
Prior authorization is recommended for pharmacy benefit coverage. Initial approval requires the medication be prescribed by, or in consultation with, a physician who specializes in the condition being treated. All approvals for initial therapy are provided for the initial approval duration noted in the policy; if reauthorization is allowed, a documented response to therapy is required for continuation unless otherwise noted.
- Initial prescription must be by or in consultation with a specialist for the treated condition.
- Prior authorization recommended for pharmacy benefit coverage.
- Initial approval durations follow those specified in the policy; reauthorization requires response to therapy when applicable.
Required Prior Therapies
Patient must have received at least 8 weeks of both a proton pump inhibitor and a topical (esophageal) corticosteroid prior to approval for eosinophilic esophagitis.
- Minimum 8 weeks of a proton pump inhibitor (current or any time in the past counts).
- Minimum 8 weeks of a topical (esophageal) corticosteroid (e.g., swallowed fluticasone or budesonide).
Documentation Upon Request
The Company reserves the right to request additional documentation to support medical necessity as part of its coverage determination process. Upon request, providers must make available patient records, test results, and/or credentials of the provider ordering or performing the service.
- Examples of documentation that may be requested: endoscopic biopsy results showing ≥ 15 intraepithelial eosinophils per high-power field, records of prior therapies and durations, dietary management attempts, provider credentials.
- Failure to provide requested documentation may result in denial or delay of coverage determination.
General Denial Conditions
The Company may deny reimbursement when the drug provided or services performed were not medically necessary, were investigational/experimental, or were not within the member's benefit scope. Denial may also occur when a pattern of inappropriate or excessive billing or practice is identified.
- Not medically necessary
- Investigational or experimental use
- Services or drugs outside the member benefit
- Patterns of inappropriate or excessive billing or practice
Clinical Background
Eosinophilic esophagitis (EoE) is an inflammatory condition of the esophagus. Standard approaches to management include topical (esophageal) corticosteroids and proton pump inhibitors (PPIs). Eohilia (budesonide oral suspension) is indicated for treatment of EoE for up to 12 weeks in patients aged ≥ 11 years.
Definitions and Diagnostic Thresholds
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