ModifiedHealth NetPolicy CP PMN.294

Clinical Policy: Budesonide (Eohilia, Uceris)

Coverage and medical necessity criteria for budesonide products (extended-release tablet, rectal foam, and Eohilia oral suspension) for treatment of ulcerative colitis, eosinophilic esophagitis, microscopic colitis, and related indications for Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Budesonide (Eohilia, Uceris)

Policy CodePolicy CP PMN.294

Change TypeAdded dosage formsupdated approvals & IL step therapy bypass

Effective DateJun 1, 2024

Next Review DateN/A

Key ActionPrior authorization is required and providers must submit documentation confirming diagnosis, prescribing specialist, dosing and prior therapy trials as specified.

SourceLink

POLICY UPDATE CHANGES

Added budesonide extended-release tablet and budesonide rectal foam to Policy/Criteria section.

For Eohilia, updated product availability from single-dose stick packs to unit-dose packets per prescriber information.

Added step therapy bypass for IL HIM per IL HB 5395.

9 mg/dayMax oral dose (UC)

2 mg BIDEohilia dose

12 weeksEohilia duration

12 moApproval duration (initial)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Unit-doseAvailability

Coverage and Medical Necessity Criteria

Initial Therapy — Ulcerative Colitis

Covered when ALL of the following are met for Ulcerative Colitis (initial approval):

UC Initial: 1) Diagnosis of ulcerative colitis; 2) Request is for generic budesonide extended-release tablet, generic budesonide rectal foam, or Uceris; 3) Age 18 years or older; 4) Prescribed by or in consultation with a gastroenterologist; 5) Failure of a 4-week trial of aminosalicylates (e.g., sulfasalazine, mesalamine) unless contraindicated or intolerant; 6) Member must use generic budesonide tablet or rectal foam unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed one of the following: a) Oral: 9 mg (1 tablet) per day; b) Rectal: initial 2 canisters (1 kit) for 2 weeks (induction); maintenance 2 canisters (1 kit) every 4 weeks; Approval duration: 12 months.

Initial Therapy — Microscopic Colitis (off-label)

Covered when ALL of the following are met for Microscopic Colitis (off-label):

Microscopic Colitis Initial: 1) Diagnosis of microscopic colitis (collagenous or lymphocytic); 2) Prescribed by or in consultation with a gastroenterologist; 3) Age > 18 years; 4) Request is for Uceris tablet or generic budesonide extended-release tablet; 5) Medical justification supports inability to use budesonide capsules; 6) Member must use generic budesonide tablet unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed 9 mg (1 tablet) per day; Approval duration: 12 months.

Initial Therapy — Eosinophilic Esophagitis

Covered when ALL of the following are met for Eosinophilic Esophagitis (EoE):

EoE Initial: 1) Diagnosis of EoE confirmed by ≥ 15 intraepithelial eosinophils per high-power field on endoscopic biopsy; 2) Age ≥ 11 years; 3) Prescribed by or in consultation with an allergist, immunologist, or gastroenterologist; 4) Request is for Eohilia oral suspension; 5) Member must use generic budesonide inhalation suspension unless contraindicated or clinically significant adverse effects are experienced; 6) Dose does not exceed 4 mg (20 mL) per day (Eohilia dosing 2 mg PO BID); Approval duration: 3 months.

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (other indications):

Continued Therapy: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Member is responding positively to therapy; 3) Request is for generic budesonide extended-release tablet, generic budesonide rectal foam, or Uceris; 4) Member must use generic budesonide product unless contraindicated or clinically significant adverse effects are experienced; 5) Dose limits: a) Oral: 9 mg (1 tablet) per day; b) Rectal: 2 canisters (1 kit) every 4 weeks; Approval duration: 12 months.

Labeled dosing and duration

Coverage tied to product-specific dosing and duration per labeled indications

Uceris (Ulcerative Colitis) dosing: Extended-release tablet: 9 mg PO daily in the morning for up to 8 weeks; Rectal foam: 2 mg (1 metered dose) PR BID for 2 weeks, followed by 2 mg (1 metered dose) PR QD for 4 weeks.Maximum dose 9 mg/day

Product availability: ER tablet 9 mg; rectal foam kits: 1 kit of 2 canisters (14 doses per canister, 2 mg per metered dose).

Eohilia (EoE) dosing: Eohilia oral suspension: 2 mg PO BID for 12 weeks.Duration up to 12 weeks

Product availability updated to unit-dose packets per 2025 review.

Non‑FDA or off‑label indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CPCPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

This document segment does not list any additional explicit clinical exclusions beyond standard programmatic or line‑of‑business restrictions; updates to product forms and lines of business were administrative (addition of ER tablet, rectal foam, Eohilia, and Medicaid line of business).

The policy text does not specify particular diagnoses or scenarios that are explicitly designated as not medically necessary in this segment; instead, coverage determinations are tied to the specific criteria and approved indications described elsewhere in the policy.

Product Codes, Strengths, and Diagnostic Thresholds

Product strengths and availabilitymixed

9 mg	Uceris extended-release tablet strength / oral dose
2 mg per metered dose	Uceris rectal foam metered dose; kit of 2 canisters (14 doses per canister)
2 mg BID (Eohilia)	Eohilia oral suspension dosing per administration

EoE histologic threshold — diagnostic threshold for EoE

Diagnostic threshold≥ 15 intraepithelial eosinophils per high-power field (eos/hpf) on endoscopic biopsy

Required specimenEndoscopic biopsy of the esophagus showing intraepithelial eosinophils

Age criterion (policy)Diagnosis requirement applied for EoE initial approval (age ≥ 11 years)

Associated actionDocumentation of biopsy result must be submitted with prior authorization request

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for budesonide extended‑release tablet, budesonide rectal foam, Eohilia (budesonide oral suspension), and Uceris. Provider must document the diagnosis, prescriber specialty, patient age, prior therapies tried (including dates and outcomes), the specific product requested, dosing regimen, and intended duration of therapy. Requests that do not include sufficient clinical documentation may be delayed or denied.

Applicable products: generic budesonide extended‑release tablet, generic budesonide rectal foam, Eohilia oral suspension, Uceris (budesonide ER tablet)
Documentation must include: office chart notes, relevant lab or pathology results (e.g., endoscopic biopsy for EoE with peak eosinophils/hpf), prior medication trials and reasons for failure or intolerance, and any specialist consultation notes
Prescriber specialty: request should be prescribed by or in consultation with a gastroenterologist for UC/microscopic colitis, or an allergist/immunologist/gastroenterologist for EoE, as specified in criteria

Step Therapy

Step Therapy and Generic-First Requirement

Clinical Background

Budesonide is a glucocorticosteroid available in multiple formulations used for induction and treatment of inflammatory conditions of the gastrointestinal tract. Product formulations referenced in this policy include the extended‑release oral tablet (Uceris) 9 mg, a rectal foam formulation (metered at 2 mg per metered dose; kits of two canisters), and an oral suspension marketed as Eohilia for eosinophilic esophagitis. The policy update added the ER tablet and rectal foam into the Policy/Criteria section and incorporated Eohilia as a new dosage form with corresponding criteria and product availability revisions.

Key Definitions and Contraindications

EoE — diagnostic definition (>=15 intraepithelial eosinophils per HPF)

DefinitionEosinophilic esophagitis (EoE) diagnosis requires ≥ 15 intraepithelial eosinophils per high-power field on endoscopic biopsy

Evidence sourcePolicy references endoscopic biopsy eosinophil count as diagnostic criterion

Policy useUsed as a required criterion for initial approval of Eohilia for EoE

Contraindication — hypersensitivity to budesonide

ContraindicationHypersensitivity to budesonide

Boxed warningsNone reported in policy appendix

Clinical implication

Policy Summary

PayerHealth Net

PolicyClinical Policy: Budesonide (Eohilia, Uceris)

Policy CodePolicy CP PMN.294

Change TypeAdded dosage formsupdated approvals & IL step therapy bypass

Effective DateJun 1, 2024

Next Review DateN/A

Key ActionPrior authorization is required and providers must submit documentation confirming diagnosis, prescribing specialist, dosing and prior therapy trials as specified.

SourceLink

On This Page

Step therapy applies: a trial (and failure or contraindication) of an aminosalicylate (e.g., sulfasalazine, mesalamine) is required for ulcerative colitis prior to approval of budesonide products unless there is clinical justification (contraindication or clinically significant adverse effect). Members must use generic budesonide tablet or rectal foam when available unless contraindicated or intolerant.

Required trial: 4-week trial of an aminosalicylate prior to budesonide ER tablet or rectal foam for UC, unless contraindicated or clinically significant adverse effects
Generic-first: member must use generic budesonide tablet or rectal foam unless contraindicated or intolerant
Dose limits specified in clinical criteria must be adhered to (see Dosage and Administration)

Step Therapy

Step Therapy Bypass for Illinois HIM

Per Illinois HB 5395, for Illinois HIM (Health Insurance Marketplace) requests received on or after 2026-01-01, the step therapy requirements described above do not apply; a step therapy bypass is available for IL HIM members.

Effective 2026-01-01: IL HIM requests are exempt from the aminosalicylate step therapy requirement
Providers should indicate Illinois HIM enrollment on the prior authorization submission to ensure the bypass is applied

Documentation Required

Required Clinical Documentation

Provide complete clinical documentation with the prior authorization request. Missing or nonconforming documentation is a common reason for denial or delay.

Minimum required documentation: office chart notes, relevant laboratory or pathology reports (e.g., biopsy results for EoE with eosinophil count), prior medication history with dates and reason for discontinuation, and specialist consultation notes when applicable
For off‑label indications, include sufficient supporting literature or evidence per the plan's off‑label policies (CPCPA.09, HIM.PA.154, CP.PMN.53) to justify use

Documentation Required

Required Prescribing Details

Prescribing details must be documented and align with the product‑specific dosing regimens and maximum doses in the policy.

Indication: specify diagnosis (e.g., ulcerative colitis, microscopic colitis, eosinophilic esophagitis) and relevant diagnostic confirmation (e.g., biopsy results for EoE)
Dosing regimen and duration: state the exact dose, frequency, route, and intended duration (e.g., Uceris ER tablet 9 mg PO daily for up to 8 weeks for UC; rectal foam initial 2 canisters (1 kit) for 2 weeks then maintenance 2 canisters every 4 weeks; Eohilia 2 mg PO BID for up to 12 weeks for EoE)
Maximum dose: do not exceed 9 mg/day for ER tablets or product‑specific maximums listed in Dosage and Administration

Denial Risk

Nonconforming Requests and Risk of Denial

Nonconforming requests or requests for products/dosing not consistent with the policy criteria, including newly added dosage forms without required documentation, may be denied.

Requests inconsistent with the policy (missing required trials, exceeding dose limits, lack of necessary diagnostic confirmation) are subject to denial
New dosage forms (e.g., Eohilia oral suspension) require indication‑specific documentation per the policy; failure to provide this may result in denial
Off‑label or not listed indications will be denied unless sufficient off‑label evidence is provided per the applicable off‑label use policies

Allergy or prior severe reaction to budesonide excludes use

Uceris — product description for UC (ER tablet 9 mg; rectal foam 2 mg metered)

Product description (ER tablet)Uceris extended-release tablet: 9 mg oral tablet; dosing: 9 mg PO once daily in the morning for up to 8 weeks

Product description (rectal foam)Uceris rectal foam: 2 mg per metered dose; regimen: 2 mg PR BID for 2 weeks then 2 mg PR QD for 4 weeks; kits of 2 canisters (14 doses per canister)

Maximum daily doseMaximum noted: 9 mg/day for oral formulation

Eohilia — product indication, dosing for EoE, and updated availability to unit-dose packets

IndicationEohilia oral suspension indicated for eosinophilic esophagitis (EoE)

Dosing for EoE2 mg PO twice daily (2 mg BID) for 12 weeks; maximum 4 mg/day

Product availability updateProduct availability updated to unit-dose packets (per 2025 review) instead of single‑dose stick packs

Policy noteRequests for Eohilia for EoE require biopsy-confirmed EoE (≥15 eos/hpf) and prescriber specialty per policy