CurrentUnitedHealthcarePolicy N/A

Eohilia (budesonide oral suspension) prior authorization

Defines UnitedHealthcare prior authorization and medical necessity criteria for Eohilia (budesonide oral suspension) to treat eosinophilic esophagitis (EoE) in patients aged 11 years and older; applies to providers prescribing and seeking coverage under UnitedHealthcare plans.

Policy Summary

PayerUnitedHealthcare

PolicyEohilia (budesonide oral suspension) prior authorization

Policy CodePolicy N/A

Change TypeMaterial updates to prior authorization and reauthorization criteria

Effective DateAug 1, 2025

Next Review DateMay 20, 2025

Key ActionObtain and submit medical records documenting symptoms, esophageal biopsy with ≥15 eos/HPF, and documentation of an 8-week trial (or documented contraindication/intolerance) of both a PPI and an oral inhaled corticosteroid.

SourceLink

POLICY UPDATE CHANGES

Updated failure language to 'suboptimal response' and clarified required trial durations and agents for prior authorization.

Added reauthorization criterion requiring documentation of positive clinical response evidenced by reduction in intraepithelial eosinophils per HPF.

Program notes that Connecticut, Kentucky, and Mississippi require only a 30-day trial for initial therapy.

12 weeksFDA-indicated treatment duration for Eohilia

>=15Biopsy threshold for EoE diagnosis

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Coverage and Authorization Criteria

Initial therapy coverage

Covered when ALL of the following are met:

Initial Authorization

Diagnosis of eosinophilic esophagitis (EoE)
Symptoms: Patient is experiencing symptoms related to esophageal dysfunction (eg, dysphagia, food impaction, centrally located chest pain not responsive to antacids, GERD-like symptoms/refractory heartburn, or upper abdominal pain)
Pathology: Submission of medical records documenting eosinophil-predominant inflammation on esophageal biopsy with a peak value of >=15 intraepithelial eosinophils per high power field (HPF)>= 15 eos/HPF
Include pathology report showing peak eosinophil count
Exclude secondary causes: Secondary causes of esophageal eosinophilia have been ruled out
Prior therapies: History of suboptimal response, contraindication, or intolerance to an 8-week trial of BOTH: (1) a proton pump inhibitor (eg, pantoprazole, omeprazole) AND (2) an inhalational corticosteroid administered orally (eg, budesonide nebulized solution [Pulmicort respules], fluticasone HFA)8 weeks
Document agent name(s) and dates tried
Prescriber: Prescribed by or in consultation with an Allergist/Immunologist OR a Gastroenterologist

Authorization duration note: Authorization will be issued for 12 months (state mandates may apply; CT, KY, and MS have different trial-duration rules)12 months

Reauthorization Criteria

Reauthorization will be approved when the following is documented:

Reauthorization

Histologic response: Documentation of reduction in intraepithelial eosinophils per high power field (HPF) compared to baseline
Provide follow-up biopsy/pathology report showing decreased peak eosinophil count
Authorization duration: Authorization will be issued for 12 months (state mandates may apply)12 months

Program note: State-specific requirements may modify trial duration (eg, Connecticut, Kentucky, Mississippi require only a 30-day trial for initial therapy)

Use of Eohilia beyond 12 weeks has not been shown to be safe and effective.

Eohilia, Fluticasone HFA, Flovent HFA and brand Pulmicort Respules are typically excluded from coverage (may be plan-specific).

Coding and Diagnostic Thresholds

Coverage exclusions (drug brands)NDCNot Covered

NDC (not listed)

Eohilia, Fluticasone HFA, Flovent HFA and brand Pulmicort Respules typically excluded from coverage

Peak intraepithelial eosinophils per high power field

Diagnostic biopsy thresholdPeak intraepithelial eosinophils per high power field >= 15

Pathology documentationSubmission of medical records documenting eosinophil‑predominant inflammation on esophageal biopsy with reported peak value

Rule out secondary causesSecondary causes of esophageal eosinophilia must be ruled out prior to diagnosis

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Eohilia. Approval is contingent on meeting all listed clinical criteria, including documented diagnosis, biopsy results, ruling out secondary causes, required prior trials, and specialist prescribing or consultation. Authorization, when approved, will be issued for up to 12 months (state mandates and member benefit plan may modify duration).

Authorization duration: 12 months (state mandates or plan may modify).
Prescriber requirement: Prescribed by or in consultation with an Allergist/Immunologist or Gastroenterologist.
Note: Eohilia and certain comparator products (Eohilia, Fluticasone HFA, Flovent HFA and brand Pulmicort Respules) are typically excluded from coverage — prior authorization determination remains required.

Step Therapy

Step Therapy Requirement

Prior to approval, documentation must show that the member had a suboptimal response, contraindication, or intolerance to an 8-week trial of BOTH a proton pump inhibitor and an oral/inhaled corticosteroid administered orally. (Exceptions: Connecticut, Kentucky, and Mississippi business require only a 30-day trial.)

Clinical Background

Eosinophilic esophagitis (EoE) is an eosinophil‑predominant inflammatory disorder of the esophagus characterized by symptoms of esophageal dysfunction (for example, dysphagia and food impaction) and by esophageal biopsy showing a peak of >= 15 intraepithelial eosinophils per high‑power field after secondary causes have been excluded. Guideline bodies recommend topical/oral delivery of inhaled corticosteroids (such as budesonide or fluticasone) as first‑line therapy.

Key Definitions

Eosinophilic esophagitis (EoE) — clinicopathologic definition and biopsy threshold

Clinicopathologic definitionEosinophilic esophagitis (EoE) is a clinicopathologic disorder characterized by symptoms of esophageal dysfunction (eg, dysphagia, food impaction, chest pain, reflux‑like symptoms) and esophageal biopsy showing peak >=15 intraepithelial eosinophils per high power field after secondary causes are excluded

Required symptomsSymptoms related to esophageal dysfunction such as dysphagia, food impaction, centrally located chest pain, refractory heartburn, or upper abdominal pain

Age and treatment noteEohilia (budesonide oral suspension) is FDA‑indicated for 12 weeks of treatment in patients 11 years and older; safety/efficacy beyond 12 weeks not shown

Specialist involvementDiagnosis/prescription should be by or in consultation with an Allergist/Immunologist or Gastroenterologist