CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Budesonide_Uceris_Rectal_Foam_20250402

Policy governs coverage and authorization criteria for budesonide rectal foam (Uceris) for induction of remission in adults with active mild-to-moderate distal ulcerative colitis up to 40 cm from the anal verge. It defines required clinical prerequisites, dosing limits, coverage duration, and exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Budesonide_Uceris_Rectal_Foam_20250402

Policy CodePolicy N/A

Change TypeRevised (document review through 4/2025)

Effective DateDec 1, 2017

Next Review Date

Key ActionObtain authorization documenting age ≥18, active mild-moderate distal UC ≤40 cm for induction only, prior 4-week oral aminosalicylate trial failure, and failure/intolerance/contraindication to formulary mesalamine or hydrocortisone enema; ensure dose limits are not exceeded.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and revised multiple times; latest listed review date 4/2025.

1Covered Indications (FDA-approved)

All other usesNot covered (experimental/investigational)

2 monthsCoverage Duration (authorization)

Coverage Summary

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This policy covers budesonide rectal foam (Uceris) for adults >= 18 years for the induction of remission of active, mild-to-moderate distal ulcerative colitis that extends up to 40 cm from the anal verge. Coverage is limited to induction therapy only (Uceris is not approvable for chronic or maintenance use). Authorization requires meeting all listed criteria including prior therapy checks and dose limits. Headline policy statistics include: 1 covered (FDA-approved) indication, all other uses considered not covered/experimental, and an authorization coverage duration of approximately 2 months.

Key thresholds

Age>= 18 years

Disease extentdistal ulcerative colitis that extends up to 40 cm from the anal verge

Prior oral aminosalicylate trialfailed recent 4-week trial

Initial dose limit2 canisters for 2 weeks

Maintenance dose limit2 canisters every 4 weeks

Coverage Duration2 months

Criteria for Approval

An authorization may be granted when all the following criteria are met:

ALL of the following

Member is 18 years of age or older>= 18 years
Member has a diagnosis of active, mild to moderate distal ulcerative colitisdistal ulcerative colitis up to 40 cm from the anal verge
Requested drug is being prescribed for the induction of remission onlyInduction of remission
Uceris is limited to induction only
Member has failed a recent 4-week trial of an oral aminosalicylate product (e.g., sulfasalazine, mesalamine)4-week trial failed
ONE of
- Member has failed formulary mesalamine enema
- Member is intolerant to mesalamine enema with significant side effect/toxicity
- Member has a contraindication to formulary mesalamine enema
- Member has failed hydrocortisone enema
- Member is intolerant to hydrocortisone enema with significant side effect/toxicity
- Member has a contraindication to hydrocortisone enema
Dose does not exceed specified limitsInitial: 2 canisters for 2 weeks; Maintenance: 2 canisters every 4 weeks
Uceris is not approvable for chronic use or maintenance use

Not Covered / Experimental Indications

Not Covered / Experimental

All other indications are considered experimental/investigational and are not a covered benefit.

Budesonide rectal foam use for indications other than induction of remission of active mild to moderate distal ulcerative colitis up to 40 cm from the anal verge

Not a covered benefit (experimental/investigational)

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required with criteria

Obtain authorization demonstrating patient is >=18, has active mild-moderate distal UC (<=40 cm), drug intended for induction only, prior 4-week trial failure of oral aminosalicylate, and failure/intolerance/contraindication to formulary mesalamine enema or hydrocortisone enema; ensure dose limits are not exceeded.

Age ≥ 18 years
Diagnosis: active, mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge
Drug prescribed for induction of remission only
Failure of a recent 4-week trial of an oral aminosalicylate (e.g., sulfasalazine, mesalamine)
Failure, intolerance (significant side effect/toxicity), or contraindication to formulary mesalamine enema or hydrocortisone enema

Documentation Required

Document prior therapy and intolerance/contraindication

Document the 4-week oral aminosalicylate trial and details of failure/intolerance/contraindication to mesalamine enema or hydrocortisone enema in the prior authorization request.

Document duration of the oral aminosalicylate trial (4 weeks)
Describe nature of failure (lack of efficacy) or intolerance (significant side effects/toxicity)
If applicable, document the specific contraindication to mesalamine enema or hydrocortisone enema

Billing Rule

Dose/quantity limit enforcement

Ensure dispensed quantity does not exceed initial or maintenance canister limits; chronic or maintenance use for Uceris is not approvable per policy.

Initial limit: 2 canisters for 2 weeks
Maintenance limit: 2 canisters every 4 weeks
Uceris is not approvable for chronic or maintenance use

Background, Evidence & Definitions

Budesonide rectal foam (Uceris) is FDA-approved for induction of remission of active, mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge and is restricted by this policy to use in adults only. The policy requires that Uceris be used for induction only and not for maintenance or chronic therapy.

Prior to authorization, the policy requires documentation that the member is >= 18 years, has active mild-to-moderate distal ulcerative colitis (<= 40 cm), and has failed a recent 4-week trial of an oral aminosalicylate (e.g., sulfasalazine, mesalamine). In addition, the member must have failed, be intolerant to, or have a contraindication to formulary mesalamine enema or hydrocortisone enema. Dose and quantity limits must be observed (initial: 2 canisters for 2 weeks; maintenance dosing limited to 2 canisters every 4 weeks, noting maintenance/chronic use is not approvable).

Evidence

Definitions

Induction of remissionUse intended to induce remission of active disease (policy limits Uceris to induction only).

Age threshold>= 18 years

Disease extentDistal ulcerative colitis extending up to 40 cm from the anal verge

Prior oral therapyFailed recent 4‑week trial of an oral aminosalicylate (e.g., sulfasalazine, mesalamine)

Enema therapy requirementFailed, intolerant to, or contraindicated to formulary mesalamine enema or hydrocortisone enema

Dose limitsInitial: 2 canisters for 2 weeks; Maintenance: 2 canisters every 4 weeks

Revision History

4/2025review (non-material)Latest

Policy reviewed and revised multiple times; latest listed review date 4/2025. (No specific clinical policy statement change indicated)

4/2024review (non-material)