CurrentCignaPolicy IP0630

Eohilia (budesonide oral suspension) - Coverage Criteria for Eosinophilic Esophagitis

Prior authorization policy for coverage of Eohilia for treatment of eosinophilic esophagitis in Cigna-administered health benefit plans; applies to prescribers and patients seeking pharmacy benefit coverage.

Policy Summary

PayerCigna

PolicyEohilia (budesonide oral suspension) - Coverage Criteria for Eosinophilic Esophagitis

Policy CodePolicy IP0630

Change TypeNo material change

Effective DateSep 1, 2024

Next Review Date

Key ActionObtain prior authorization and document age, biopsy with ≥15 eos/hpf, prior PPI therapy or severe disease, prescriber specialty, and preferred product step evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksapproved duration of therapy

≥ 11 yrsminimum approved patient age

≥15 eos/hpfhistologic diagnostic threshold

Prior authauthorization requirement

Respules trialpreferred product step

Policy Summary

PayerCigna

PolicyEohilia (budesonide oral suspension) - Coverage Criteria for Eosinophilic Esophagitis

Policy CodePolicy IP0630

Change TypeNo material change

Effective DateSep 1, 2024

Next Review Date

Key ActionObtain prior authorization and document age, biopsy with ≥15 eos/hpf, prior PPI therapy or severe disease, prescriber specialty, and preferred product step evidence.

SourceLink

On This Page

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FDA-Approved Indication (Eosinophilic Esophagitis)

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

Eohilia approval criteria: A) Patient is ≥ 11 years of age;

Eohilia approval criteria: B) Diagnosis of eosinophilic esophagitis confirmed by endoscopic biopsy demonstrating ≥ 15 intraepithelial eosinophils per high-power field;

Eohilia approval criteria

C(i or ii): i. Patient has received at least 8 weeks of therapy with a proton pump inhibitor (current or past);
C(i or ii): ii. Prescriber documents severe disease with esophageal stricture.

Eohilia approval criteria

D(i or ii): i. Patient has tried dietary modifications to manage eosinophilic esophagitis (examples include an elemental diet or an elimination diet);
D(i or ii): ii. Prescriber determines the patient is not an appropriate candidate for dietary modifications.

Eohilia approval criteria

E(i): i. Patient is currently receiving a course of Eohilia and additional medication is needed to complete a 12-week course of treatment;
E(ii)
- E(ii)(a): a. Patient has not been treated with Eohilia within the previous 6 months;
- E(ii)(b): b. Prescriber states the patient is experiencing recurrent worsening dysphagia after discontinuing Eohilia therapy;

Eohilia approval criteria: F) Medication is prescribed by or in consultation with an allergist or gastroenterologist;

Eohilia approval criteria: G) Preferred product criteria is met for the product as listed in the plan-specific tables.

Preferred product criteria / Step therapy

Preferred product criteria (one of the following):

Preferred product criteria: 1) Patient has tried budesonide inhalation suspension (Pulmicort Respules, generic) made into a slurry or suspension and swallowed (not inhaled).

Preferred product criteria: 2) Patient has already been started on a 12-week course of therapy with Eohilia (to allow completion).

Eohilia (budesonide oral suspension) for any use other than the FDA-approved indication of eosinophilic esophagitis is not medically necessary. This policy limits coverage to the indications and criteria detailed for EoE; requests for Eohilia to treat other diagnoses or symptoms that do not meet the policy’s EoE criteria should be denied as not medically necessary.

Use of Eohilia beyond 12 weeks is not supported by available evidence and has not been shown to be safe and effective; such extended-duration use is not covered under this policy. Coverage is limited to the approved treatment duration described in the policy and prescribing information.

Coding and Diagnostic Criteria

No specific CPT/HCPCS/ICD-10 codes listedmixed

No codes listed

inv-06: Histologic threshold — ≥ 15 eosinophils per high-power field.

Histologic diagnostic threshold≥ 15 eosinophils per high-power field on esophageal biopsy

Evidence requirementPivotal trials required histologic evidence of ≥ 15 eos/hpf despite 6–8 weeks of high‑dose PPI therapy

Guideline concordanceACG guidance diagnoses EoE by esophageal dysfunction symptoms plus ≥ 15 eos/hpf

inv-07: Minimum age — ≥ 11 years.

Minimum approved age≥ 11 years

Labeling noteApplies to adults and pediatric patients aged 11 years and older

Documentation requiredProvider must document patient age in prior authorization request

inv-08: Approved duration — 12 weeks.

Approved treatment duration12 weeks (maximum recommended treatment)

Partial-course approvalIf patient has started Eohilia but not completed 12 weeks, approve remaining weeks to total 12 weeks

Not supported beyond 12 weeksUse beyond 12 weeks has not been shown to be safe and effective

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Eohilia. Failure to obtain prior authorization will result in denial of coverage when required by the applicable benefit plan. Approvals are provided for the duration noted in the FDA‑approved indication (up to 12 weeks). Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Eohilia, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (allergist or gastroenterologist).

Prior authorization required for Eohilia (IP0630, effective 2024-09-01).
Approvals provided for up to 12 weeks per FDA‑approved indication.
Prescriber requirement: must be prescribed by or in consultation with an allergist or gastroenterologist.
Documentation must support patient age, esophageal biopsy showing ≥ 15 eosinophils/hpf, prior PPI therapy or severe disease (stricture) when applicable, attempted dietary modifications or clinical contraindication to them, and preferred product/step‑therapy criteria (trial of budesonide inhalation suspension Pulmicort Respules made into a slurry and swallowed, unless patient already started on a 12‑week course).
Receipt of sample product does not satisfy criteria requirements; Eohilia for any other use is not medically necessary.

Step Therapy

Preferred Product / Step Therapy

Employer and Individual/Family plans require meeting preferred product / step therapy criteria before Eohilia is approved unless the patient has already been started on a 12‑week course of Eohilia to allow completion of therapy.

Preferred product criteria: Trial of budesonide inhalation suspension (Pulmicort Respules, generic) made into a slurry or suspension and swallowed (not inhaled) is required prior to Eohilia for both Employer and Individual/Family plans unless the patient has already started a 12‑week course of Eohilia.
If patient started on Eohilia and has not completed 12 weeks, approve remaining weeks to complete a total of 12 weeks.

Documentation Required

Required Documentation

Documentation must be present in the prior authorization submission to support all required clinical criteria.

Document patient age (≥ 11 years).
Provide esophageal biopsy report showing ≥ 15 intraepithelial eosinophils per high-power field.
Document at least 8 weeks of proton pump inhibitor therapy (current or past) or documentation that the patient has severe disease with esophageal stricture per prescriber.
Document trial of dietary modifications (elemental or elimination diet) or clinical rationale that the patient is not an appropriate candidate for dietary modifications.
If applicable, document that patient has not been treated with Eohilia within the previous 6 months or has recurrent worsening dysphagia after discontinuing therapy, or that patient started Eohilia and requires completion of up to a 12‑week course.
Indicate whether prescriber is an allergist or gastroenterologist or that treatment is in consultation with one.

Denial Risk

Denial risk: failure to meet any of the prior authorization or documentation requirements will result in denial of coverage for Eohilia when prior authorization is required by the benefit plan.

Missing or incomplete documentation of biopsy results, PPI trial, dietary modification trial or prescriber specialty may lead to denial.
Receipt of sample product does not meet criteria and is not acceptable documentation of prior therapy.

OpenPayer

Eohilia (budesonide oral suspension) - Coverage Criteria for Eosinophilic Esophagitis

Coverage Criteria

Coding and Diagnostic Criteria

Provider Actions and Requirements

Background

Definitions