CurrentmhnPolicy CP.PMN.294

Budesonide (Eohilia, Uceris) prior authorization and medical necessity criteria

Clinical coverage policy that defines medical necessity, prior authorization requirements, dosing limits, and approval durations for budesonide products (extended-release tablet, rectal foam, Eohilia oral suspension, Uceris) for Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyBudesonide (Eohilia, Uceris) prior authorization and medical necessity criteria

Policy CodePolicy CP.PMN.294

Change TypeAdded products and updated criteriareferences revised

Effective DateJun 1, 2024

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, endoscopic biopsy with eosinophil count when applicable) demonstrating the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added budesonide extended-release tablet and budesonide rectal foam to Policy/Criteria section and added Medicaid line of business.

Updated Eohilia product availability from 'single-dose stick packs' to 'unit-dose packets' and updated Appendix D to include 2025 ACG guidelines for EoE.

3Indications with defined initial criteria (UC, Microscopic colitis, EoE)

9 mg/dayMaximum oral budesonide dose for UC and microscopic colitis

4 mg/dayMaximum Eohilia dose for EoE

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Medical Necessity Criteria for Budesonide Products

Initial Approval Criteria — Ulcerative Colitis

Must meet ALL of the following:

ALL of the following

Diagnosis of ulcerative colitis (UC)
Request is for generic budesonide extended-release tablet, generic budesonide rectal foam, or Uceris
Prescribed by or in consultation with a gastroenterologist
Age ≥ 18 years
Aminosalicylate step therapy
- Failure of a 4-week trial of aminosalicylates (e.g., sulfasalazine, mesalamine) unless clinically significant adverse effects are experienced or all are contraindicated
Member must use generic budesonide tablet or rectal foam unless contraindicated or clinically significant adverse effects are experienced
Dose limit (one of)
- Oral: does not exceed 9 mg (1 tablet) per day
- Rectal dosing
  - Initial: 2 canisters (1 kit) for 2 weeks
  - Maintenance: 2 canisters (1 kit) every 4 weeks

Initial Approval Criteria — Microscopic Colitis (off-label)

Must meet ALL of the following:

ALL of the following

Diagnosis of microscopic colitis, including collagenous colitis or lymphocytic colitis
Prescribed by or in consultation with a gastroenterologist
Age ≥ 18 years
Request is for Uceris tablet or generic budesonide extended-release tablet
Medical justification supports inability to use budesonide capsules
For Illinois HIM requests, step therapy bypass applies per IL HB 5395 as of 1/1/2026

Initial Approval Criteria — Eosinophilic Esophagitis (EoE)

Must meet ALL of the following:

ALL of the following

Diagnosis of EoE confirmed by ≥ 15 intraepithelial eosinophils per high-power field (eos/hpf) on endoscopic biopsy
Prescribed by or in consultation with an allergist, immunologist, or gastroenterologist
Age ≥ 11 years
Request is for Eohilia oral suspension
Member must use generic budesonide inhalation suspension unless contraindicated or clinically significant adverse effects are experienced
See Appendix D

Other Diagnoses/Indications — Initial

If requested use is not listed above or policy not updated for recent label change, follow one of the following:

ANY of the following

If drug has a label change within last 6 months not reflected in this policy, refer to appropriate no-coverage or non-formulary policy depending on formulary status (see related policies list)
If requested use is not in Section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (see related policies list)

Reauthorization Criteria — Eosinophilic Esophagitis

Re-authorization policy specific for EoE:

ALL of the following

Re-authorization is not permitted; members must meet the initial approval criteria

Reauthorization Criteria — All Other Indications in Section I

Must meet ALL of the following:

ALL of the following

Request is for generic budesonide extended-release tablet, generic budesonide rectal foam, or Uceris
One of
- Currently receiving medication via Centene benefit or previously met initial approval criteria
- Currently receiving medication and enrolled in a state/product with continuity of care regulations (see CC.PHARM.03A and CC.PHARM.03B state addendums)
Member is responding positively to therapy

Diagnoses/Indications Not Authorized

Coverage is not authorized for:

ALL of the following

Non-FDA approved indications which are not addressed in this policy, unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policies

Relevant Product Identifiers and Formulations

Relevant product identifiers / formulations (not CPT/ICD codes)mixed

Eohilia	Oral suspension budesonide (unit-dose packets), indicated for EoE for up to 12 weeks; max 4 mg/day
Uceris	Extended-release tablet (9 mg daily) and rectal foam (2 mg per metered dose kit) indicated for induction of remission in mild to moderate UC
Generic budesonide extended-release tablet	Generic formulation of Uceris extended-release tablet
Generic budesonide rectal foam	Generic formulation of Uceris rectal foam
Generic budesonide inhalation suspension	Used as topical slurry for EoE per step requirement when applicable

Prior Authorization, Documentation, Step Therapy, and Dose Limits

Prior Authorization

Prior authorization required with documentation

Submit prior authorization documentation demonstrating the member meets all approval criteria, including office chart notes, relevant laboratory results, and endoscopic biopsy reports with eosinophil counts when applicable.

Office chart notes describing diagnosis and clinical course
Relevant laboratory results supporting diagnosis or monitoring
Endoscopic biopsy report with eosinophil count for suspected EoE

Documentation Required

EoE diagnostic documentation

For eosinophilic esophagitis (EoE), include endoscopic biopsy pathology showing ≥ 15 intraepithelial eosinophils per high-power field (eos/hpf) to meet initial approval criteria.

Biopsy report must state eosinophil count ≥ 15 eos/hpf

Clinical Thresholds and Defined Terms

Key Thresholds

EoE histologic confirmation≥ 15 intraepithelial eosinophils per high-power field

Max oral budesonide dose (UC/microscopic colitis)9 mg/day

Max Eohilia dose (EoE)4 mg/day (20 mL)

Aminosalicylate trial for UC4-week trial (failure required unless contraindicated or adverse effects)

Definitions

EoEEosinophilic esophagitis

eos/hpf

Clinical and Regulatory Background

Budesonide is a glucocorticosteroid available in multiple formulations with distinct FDA-approved indications. Eohilia oral suspension is FDA-approved for the treatment of eosinophilic esophagitis (EoE) for up to 12 weeks in patients aged 11 years and older (Eohilia dosing: 2 mg twice daily; maximum 4 mg/day).

Uceris is FDA-approved for the induction of remission in adult patients with active, mild to moderate ulcerative colitis (extended-release 9 mg tablet) and for induction in patients with active mild to moderate distal UC (rectal foam). The extended-release tablet dosing limit is 9 mg/day; rectal foam dosing and canister limits are specified in the dosing section of the policy.

Microscopic colitis (including collagenous and lymphocytic colitis) is an off-label indication for budesonide tablets but is supported by guideline recommendations. The policy references the American Gastroenterological Association guidance that budesonide 9 mg daily is the preferred treatment option for microscopic colitis, and the policy includes criteria for coverage of Uceris or generic budesonide extended-release tablets for this indication.

Policy updates include the addition of the Eohilia product and corresponding EoE criteria, clarification of approval durations, and program-specific changes such as a step therapy bypass for Illinois Health Insurance Marketplace (HIM) per IL HB 5395; the clinical references and product availability language were reviewed and updated during the 2Q 2025 annual review.

Policy Changes and Review Notes

2024-04-09material change — addition

Added budesonide extended‑release tablet and budesonide rectal foam to Policy/Criteria and added Medicaid line of business; revised Commercial approval duration wording and added Eohilia dosage form and corresponding criteria (material).

2025-04-07annual review (references/product wording update)Latest

2Q 2025 annual review: updated Eohilia product availability wording from 'single-dose stick packs' to 'unit-dose packets', updated Appendix D to include 2025 ACG guidelines for EoE, reviewed and updated references, and added step therapy bypass for Illinois HIM per IL HB 5395 (non-material).

Budesonide (Eohilia, Uceris) prior authorization and medical necessity criteria

Medical Necessity Criteria for Budesonide Products

Relevant Product Identifiers and Formulations

Prior Authorization, Documentation, Step Therapy, and Dose Limits

Clinical Thresholds and Defined Terms

Clinical and Regulatory Background

Other Policies to Reference

Policy Changes and Review Notes