CurrentCignaPolicy IP0630

Eohilia (budesonide oral suspension) for eosinophilic esophagitis

This Cigna coverage policy governs prior authorization and medical necessity criteria for prescription benefit coverage of Eohilia for treatment of eosinophilic esophagitis in applicable members; it applies to providers prescribing or consulting on use of Eohilia.

Policy Summary

PayerCigna

PolicyEohilia (budesonide oral suspension) for eosinophilic esophagitis

Policy CodePolicy IP0630

Change TypeNew policyannual clarification

Effective Dateas written

Next Review Date

Key ActionObtain prior authorization and ensure prescriber is an allergist or gastroenterologist; approvals generally cover up to a 12-week course.

SourceLink

POLICY UPDATE CHANGES

New policy created.

Annual revision noted with no criteria changes.

12 weeksFDA-approved duration of treatment

≥ 11 yrsMinimum approved patient age

≥ 15 eos/hpfHistologic threshold

IP0630Policy Number

Coverage Criteria for Eohilia (budesonide oral suspension)

FDA-Approved Indication (Initial authorization)

Approve for 12 weeks if ALL of the following are met (A through G):

FDA-Approved Indication: A) Patient is ≥ 11 years of age; AND B) Diagnosis of eosinophilic esophagitis confirmed by endoscopic biopsy demonstrating ≥ 15 intraepithelial eosinophils per high-power field; AND C) Patient meets ONE of: (i) received at least 8 weeks of proton pump inhibitor (PPI) therapy (current or past) OR (ii) prescriber states patient has severe disease with esophageal stricture; AND D) Patient meets ONE of: (i) tried dietary modifications (e.g., elemental or elimination diet) OR (ii) prescriber determines patient is not an appropriate candidate for dietary modifications; AND E) Patient meets ONE of: (i) is currently receiving a course of Eohilia and additional medication is needed to complete a 12-week course OR (ii) patient has not been treated with Eohilia within the previous 6 months OR prescriber states patient is experiencing recurrent worsening dysphagia after discontinuing Eohilia; AND F) Medication is prescribed by or in consultation with an allergist or gastroenterologist; AND G) Preferred product criteria are met (see plan-specific criteria).

Follow plan-specific preferred product criteria (Employer or Individual/Family).

Preferred Product Criteria / Step

Preferred product criteria — ONE of the following:

Policy Summary

PayerCigna

PolicyEohilia (budesonide oral suspension) for eosinophilic esophagitis

Policy CodePolicy IP0630

Change TypeNew policyannual clarification

Effective Dateas written

Next Review Date

Key ActionObtain prior authorization and ensure prescriber is an allergist or gastroenterologist; approvals generally cover up to a 12-week course.

SourceLink

On This Page

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Key Coding and Clinical Thresholds

inv-05: Histologic eosinophil count — threshold for diagnosis

Histologic eosinophil count≥ 15 eosinophils per high-power field

Evidence requirementConfirmed by endoscopic biopsy as used in pivotal trials

ContextThreshold applied after PPI trial in clinical trials (6–8 weeks)

inv-06: Minimum age — patient age requirement

Minimum age≥ 11 years

Applicable populationsAdults and pediatric patients aged 11 years and older

Supporting statementIndication specifies patients ≥ 11 years for 12-week treatment

inv-07: Maximum recommended treatment duration — 12 weeks

Maximum recommended treatment duration12 weeks

Use beyond durationUse has not been shown to be safe and effective for treatment longer than 12 weeks

Approval windowApprovals provided to complete up to a total of 12 weeks if therapy already started

Prescriber and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Eohilia (budesonide oral suspension). Approvals are typically provided for up to 12 weeks. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients receiving Eohilia, the medication must be prescribed by or in consultation with a specialist.

Prior authorization required for prescription benefit coverage of Eohilia (Policy IP0630).
Approvals provided for up to 12 weeks (duration aligned with FDA‑approved indication).
Must be prescribed by or in consultation with an allergist or gastroenterologist.

Step Therapy

Step Therapy / Preferred Product Requirement

A step therapy (preferred product) requirement applies. For both Employer Plans and Individual & Family Plans, coverage of Eohilia is allowed only when ONE of the following is met:

Patient has tried budesonide inhalation suspension (Pulmicort Respules, generic) that has been prepared as a slurry or suspension and swallowed (not inhaled).
Patient has already been started on a 12‑week course of therapy with Eohilia and needs completion of the course (allow completion up to a total of 12 weeks).

Documentation Required

Prescriber Specialty and Documentation Expectations

Document the specialist involvement and evidence of meeting step therapy criteria in the prior authorization request (e.g., prior trial of budesonide inhalation suspension repurposed as a swallowed slurry or documentation that the patient initiated Eohilia and requires completion of a 12‑week course). Lack of required specialty consultation or missing documentation of the required step may result in denial.

Prescriber specialty requirement: allergist or gastroenterologist must prescribe or be consulted.
Required documentation: biopsy confirmation of EoE, prior PPI trial or severe disease rationale, dietary modification attempt or rationale, and evidence of the required trial of alternative budesonide formulation when applicable.
Claims or PA requests without the required specialty involvement or step therapy documentation may be denied.

OpenPayer

Eohilia (budesonide oral suspension) for eosinophilic esophagitis

Coverage Criteria for Eohilia (budesonide oral suspension)

Key Coding and Clinical Thresholds

Prescriber and Prior Authorization Requirements

Background on Eohilia and Indication

Key Definitions