Eohilia (budesonide oral suspension) prior authorization — coverage criteria for eosinophilic esophagitis
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Defines UnitedHealthcare prior authorization and medical necessity criteria for Eohilia (budesonide oral suspension) for treatment of eosinophilic esophagitis (EoE) in patients age 11 and older, including initial and reauthorization requirements and authorization durations.
Updated failure language to require suboptimal response (to an 8-week trial), contraindication, or intolerance to a proton pump inhibitor or an inhalational corticosteroid administered orally.
Authorization duration updated to 12 months for initial and reauthorization approvals; reauthorization requires documentation of positive clinical response evidenced by reduction in intraepithelial eosinophils per HPF.
Updated to trial and failure language and updated references.
Coverage Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met:
State mandates: Connecticut, Kentucky, and Mississippi allow a 30-day trial instead of an 8-week trial.
inv-02: Reauthorization / Continuation Therapy
Covered when the following is met:
Authorization will be issued for 12 months.
Eohilia (budesonide oral suspension) is indicated for up to 12 weeks of treatment for eosinophilic esophagitis (EoE) in patients aged 11 years and older. The available evidence does not support use beyond 12 weeks; Eohilia has not been shown to be safe and effective for treatment of EoE for longer than 12 weeks.
Initial Therapy
inv-11: Initial
Initial authorization requirements
Authorization issued for 12 months. State mandates (CT/KY/MS) permit a 30-day trial instead of 8 weeks.
Reauthorization / Continuation Therapy
inv-12: Reauthorization
Reauthorization rules
Authorization period: 12 months.
Provider Actions and Prior Authorization Requirements
Prior authorization required — approval only when all criteria met
Prior authorization is required. Initial approval is granted only when all criteria are met, including diagnosis of eosinophilic esophagitis (EoE); presence of symptoms related to esophageal dysfunction; esophageal biopsy showing eosinophil‑predominant inflammation with peak ≥15 intraepithelial eosinophils per HPF; secondary causes ruled out; history of suboptimal response, contraindication, or intolerance to required trial therapy; and prescribed by or in consultation with an Allergist/Immunologist or Gastroenterologist.
- Diagnosis of EoE and symptoms of esophageal dysfunction required.
- Biopsy peak value ≥15 intraepithelial eosinophils per HPF required.
- Secondary causes of esophageal eosinophilia must be ruled out.
- History of suboptimal response/contraindication/intolerance to required comparator therapy must be documented.
- Prescribed by or in consultation with an Allergist/Immunologist or Gastroenterologist.
Required trial of PPI or orally administered inhaled corticosteroid
Before Eohilia will be approved, documentation must show a prior trial and suboptimal response (or documented contraindication or intolerance) to a proton pump inhibitor or an inhalational corticosteroid administered orally. The standard trial duration is 8 weeks, except Connecticut, Kentucky, and Mississippi require only a 30‑day trial.
- Example PPIs: pantoprazole, omeprazole.
- Example inhalational corticosteroids administered orally: budesonide nebulized solution (Pulmicort respules), fluticasone HFA.
- Document name of agent and date tried; note state-specific 30‑day exception for CT/KY/MS.
Submit biopsy and related diagnostic documentation
Submit medical records (for example, chart notes and laboratory values) documenting eosinophil‑predominant inflammation on esophageal biopsy with a peak value of ≥15 intraepithelial eosinophils per high power field (HPF), and evidence that secondary causes of esophageal eosinophilia have been ruled out.
- Include the peak eosinophil count (≥15 eos/HPF) from the biopsy report.
- Provide documentation ruling out secondary causes of esophageal eosinophilia.
- Document names and dates of prior therapies tried (PPI or inhaled corticosteroid) where applicable.
Denial risk for insufficient diagnostic or trial documentation
Requests that do not include required biopsy confirmation (peak ≥15 eos/HPF), documentation ruling out secondary causes, or evidence of prior trial/failure/contraindication/intolerance to a PPI or orally administered inhalational corticosteroid are at risk for denial.
- Missing biopsy peak eosinophil count (≥15 eos/HPF) may lead to denial.
- Lack of documentation ruling out secondary causes may lead to denial.
- Absence of documented prior trial, suboptimal response, contraindication, or intolerance to required comparators may lead to denial.
Step Therapy / Required Trials
| Step | Requirement | Duration / Notes |
|---|---|---|
| {"text":"1","status":""},{"text":"Trial of a proton pump inhibitor (e.g., pantoprazole, omeprazole) with suboptimal response, or contraindication/intolerance","status":""},{"text":"8-week trial required (Connecticut, Kentucky, Mississippi: 30-day trial per state mandate)","status":""} | ||
| {"text":"1","status":""},{"text":"Trial of an inhalational corticosteroid administered orally (examples: budesonide nebulized solution [Pulmicort respules], fluticasone HFA [Flovent HFA]) with suboptimal response, or contraindication/intolerance","status":""},{"text":"8-week trial required (Connecticut, Kentucky, Mississippi: 30-day trial per state mandate); note: some formulations noted as typically excluded from coverage","status":""} |
Coding and Diagnostic Thresholds
Definitions
Background
Eosinophilic esophagitis (EoE) is a clinicopathologic disorder characterized by symptoms of esophageal dysfunction and eosinophil-predominant inflammation on esophageal biopsy. Management guidelines recommend oral administration of inhalational corticosteroids (for example, fluticasone or budesonide) as first-line therapy in both adults and children. Eohilia is a budesonide oral suspension formulation intended to deliver topical corticosteroid therapy to the esophagus in this clinical context.
Revision History
Policy effective date updated to 2026-08-01 with material revisions to step-therapy and authorization duration.
Annual review updated trial and failure language and references; clarified trial/failure wording in coverage criteria.
Updated authorization duration to 12 months and added reauthorization requirement documenting positive clinical response (reduction in intraepithelial eosinophils per HPF).
Program change recorded (failure language updated to require suboptimal response).
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